Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

PubMed Central

2010-01-01

Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review. PMID:20673343

Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

PubMed

Glass, Kathleen Cranley; Kaufert, Joseph

2007-06-01

CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.

Tiny tweaks, big changes: An alternative strategy to empower ethical culture of human research in anesthesia (A Taiwan Acta Anesthesiologica Taiwanica-Ethics Review Task Force Report).

PubMed

Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen

2015-03-01

For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.

A guide to multi-centre ethics for surgical research in Australia and New Zealand.

PubMed

Boult, Maggi; Fitzpatrick, Kate; Maddern, Guy; Fitridge, Robert

2011-03-01

This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial. The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial. Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules. Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

Enabling Ethical Code Embeddedness in Construction Organizations: A Review of Process Assessment Approach.

PubMed

Oladinrin, Olugbenga Timo; Ho, Christabel Man-Fong

2016-08-01

Several researchers have identified codes of ethics (CoEs) as tools that stimulate positive ethical behavior by shaping the organisational decision-making process, but few have considered the information needed for code implementation. Beyond being a legal and moral responsibility, ethical behavior needs to become an organisational priority, which requires an alignment process that integrates employee behavior with the organisation's ethical standards. This paper discusses processes for the responsible implementation of CoEs based on an extensive review of the literature. The internationally recognized European Foundation for Quality Management Excellence Model (EFQM model) is proposed as a suitable framework for assessing an organisation's ethical performance, including CoE embeddedness. The findings presented herein have both practical and research implications. They will encourage construction practitioners to shift their attention from ethical policies to possible enablers of CoE implementation and serve as a foundation for further research on ethical performance evaluation using the EFQM model. This is the first paper to discuss the model's use in the context of ethics in construction practice.

Ethical Review as a Tool for Enhancing Postgraduate Supervision and Research Outcomes in the Creative Arts

ERIC Educational Resources Information Center

Romano, Angela

2016-01-01

This article outlines the potential for Research Higher Degree (RHD) supervisors at universities and similar institutions to use ethical review as a constructive, dynamic tool in guiding RHD students in the timely completion of effective, innovative research projects. Ethical review involves a bureaucratized process for checking that researchers…

Knowledge about the research and ethics committee at Makerere University, Kampala.

PubMed

Ibingira, B R; Ochieng, J

2013-12-01

All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to protect human participants' interests, rights and welfare. To evaluate researchers' knowledge about the functions and ethical review process of the College of Health Sciences research and ethics committee. A cross sectional study. 135 researchers consented to participate in the study, but 70 questionnaires were answered giving a 52% response. Age ranged between 30 to 61 years, majority of participants 30-39 years. Most of the respondents do agree that the REC functions include Protocol review 86%, protection of research participants 84.3%, and monitoring of ongoing research. During ethical review, the RECpays special attention to scientific design [79.7%] and ethical issues [75.3%], but less to the budget and literature review. More than 97% of the respondents believe that the REC is either average or very good, while 2.8% rank it below average. Respondents knew the major functions of the committee including protection of the rights and welfare of research participants, protocol review and monitoring of on going research, and the elements of protocol review that are given more attention include ;scientific design and ethical issues. Overall performance of the REC was ranked as average by respondents. The committee should limit delays in approval and effectively handle all functions of the committee.

The ethics of peer review in bioethics.

PubMed

Wendler, David; Miller, Franklin

2014-10-01

A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Public titles of clinical trials should have ethics review.

PubMed

Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

2015-09-01

A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

Ethics of Information Supply.

ERIC Educational Resources Information Center

Oppenheim, Charles

This discussion of the ethics of the information process provides a brief review of the process of information supply and flow, primarily in science and technology; looks at various points in the flow of information; and highlights particular ethical concerns. Facets of the process discussed in more detail include ways in which some scientists…

Getting the justification for research ethics review right.

PubMed

Dunn, Michael

2013-08-01

Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and Allen make in the paper lack force, and why the 'governance problem' in research ethics that they allude to ought to be explained differently.

Applying for ethical approval for research: the main issues.

PubMed

Gelling, Leslie

2016-01-13

The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.

[Ethic review on clinical experiments of medical devices in medical institutions].

PubMed

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

Ethics committees in New Zealand.

PubMed

Gillett, Grant; Douglass, Alison

2012-12-01

The ethical review of research in New Zealand after the Cartwright Report of 1988 produced a major change in safeguards for and empowerment of participants in health care research. Several reforms since then have streamlined some processes but also seriously weakened some of the existing safeguards. The latest reforms, against the advice of various ethics bodies and the New Zealand Law Society, further reduced and attenuated the role of ethics committees so that New Zealand has moved from being a world leader in ethical review processes to there being serious doubt whether it is in conformity to international Conventions and codes. The latest round of reforms, seemingly driven by narrow economic aspirations, anecdote and innuendo, have occurred without any clear evidence of dysfunction in the system nor any plans for the resourcing required to improve quality of ethical review or to audit the process. It is of serious concern both to ethicists and medical lawyers in New Zealand that such hasty and poorly researched changes should have been made which threaten the hard-won gains of the Cartwright reforms.

How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

PubMed Central

Coleman, Carl H; Bouësseau, Marie-Charlotte

2008-01-01

Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? PMID:18373857

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

PubMed

Nicholls, Stuart G; Hayes, Tavis P; Brehaut, Jamie C; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

2015-01-01

To date there is no established consensus of assessment criteria for evaluating research ethics review. We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

PubMed

Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

2017-01-01

Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

Opening the black box of ethics policy work: evaluating a covert practice.

PubMed

Frolic, Andrea; Drolet, Katherine; Bryanton, Kim; Caron, Carole; Cupido, Cynthia; Flaherty, Barb; Fung, Sylvia; McCall, Lori

2012-01-01

Hospital ethics committees (HECs) and ethicists generally describe themselves as engaged in four domains of practice: case consultation, research, education, and policy work. Despite the increasing attention to quality indicators, practice standards, and evaluation methods for the other domains, comparatively little is known or published about the policy work of HECs or ethicists. This article attempts to open the "black box" of this health care ethics practice by providing two detailed case examples of ethics policy reviews. We also describe the development and application of an evaluation strategy to assess the quality of ethics policy review work, and to enable continuous improvement of ethics policy review processes. Given the potential for policy work to impact entire patient populations and organizational systems, it is imperative that HECs and ethicists develop clearer roles, responsibilities, procedural standards, and evaluation methods to ensure the delivery of consistent, relevant, and high-quality ethics policy reviews.

Contesting the science/ethics distinction in the review of clinical research

PubMed Central

Dawson, Angus J; Yentis, Steve M

2007-01-01

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study's science, but that they have anobligation do so. PMID:17329389

78 FR 49335 - Agency Information Collection (Ethics Consultation Feedback Tool (ECFT)) Activity Under OMB Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-13

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0750] Agency Information Collection (Ethics...-0750''. SUPPLEMENTARY INFORMATION: Title: Ethics Consultation Feedback Tool (ECFT), VA Form 10-10065... experience during the Ethics Consultation Service. VA will be used the data to improve the process of ethics...

Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand

PubMed Central

Adams, Pornpimon; Kaewkungwal, Jaranit; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Pengsaa, Krisana; Khusmith, Srisin

2014-01-01

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research. PMID:25406085

Outcomes of Ethics Consultations in Adult ICUs: A Systematic Review and Meta-Analysis.

PubMed

Au, Selena S; Couillard, Philippe; Roze des Ordons, Amanda; Fiest, Kirsten M; Lorenzetti, Dianne L; Jette, Nathalie

2018-05-01

Clinical ethics consultation as a mechanism for supporting patients, family, and staff during ethically challenging situations has become standard of care. Despite this, there is a lack of consensus about the effectiveness of clinical ethics consultation consultation in the ICU. We performed a systematic review of outcomes associated with clinical ethics consultation within adult ICUs. We searched MEDLINE, PubMed, Cochrane CENTRAL, Embase, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature from 1984 to May 2017. Two reviewers independently screened articles, assessed eligibility, extracted data, and assessed risk of bias using the Cochrane Collaboration Risk of Bias tool and the Newcastle-Ottawa Scale. Pooled estimates of effect were calculated where possible. We screened 3,970 abstracts and reviewed 325 full-text articles of which 16 met all eligibility criteria. We examined changes in processes and outcomes as a result of clinical ethics consultation in the ICU. Categories of outcomes included user perception, clinical decision, or conflict resolution and resource utilization. The use of clinical ethics consultation in the ICU was associated with positive user experience (383/435 found clinical ethics consultation helpful), although stress and disagreement with clinical ethics consultation recommendations was greater in a subset (113/431 surrogates and providers). Consensus for a clinical decision was more frequently achieved with clinical ethics consultation (odds ratio, 4.09; 95% CI, 1.01-16.55; p = 0.05). Clinical ethics consultation was associated with lower resource utilization including significantly decreased ICU length of stay (mean difference, -4.65 d; 95% CI, -8.86 to -0.44; p = 0.03). Our review identified outcome-based assessment as the predominant measure used to report effectiveness of clinical ethics consultation consultations. In particular, clinical ethics consultation decreased ICU length of stay and increased family and healthcare provider satisfaction. However, using outcome measures as the primary endpoint may not reflect the original intent of the clinical ethics consultation service. Based on our review, we propose a list of process measures that may better capture the key domains of a quality clinical ethics consultation.

Evaluation of Research Ethics Committees: Criteria for the Ethical Quality of the Review Process.

PubMed

Scherzinger, Gregor; Bobbert, Monika

2017-01-01

Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical research trials are being discussed. Although they play a crucial role in reviewing medical research and protecting human subjects, it is far from clear to what degree they fulfill the task they have been assigned to. This eventuates in the call for an evaluation of their activity and, in some places, led to the establishment of accreditation schemes. At the same time, IRBs have become subject of detailed legislation in the process of the ongoing global juridification of medical research. Unsurprisingly, there is a tendency to understand the evaluation of RECs as a question of controlling their legal compliance. This paper discusses the need for a quality evaluation of IRBs from an ethical point of view and, by systematically reviewing the major ethical guidelines for IRBs, proposes a system of criteria that should orientate any evaluation of IRBs.

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review

PubMed Central

Nicholls, Stuart G.; Hayes, Tavis P.; Brehaut, Jamie C.; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

2015-01-01

Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Results Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Discussion Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review. PMID:26225553

Feasibility of rapid ethical assessment for the Ethiopian health research ethics review system.

PubMed

Addissie, Adamu; Davey, Gail; Newport, Melanie; Farsides, Bobbie; Feleke, Yeweyenhareg

2015-01-01

One of the challenges in the process of ethical medical research in developing countries, including Ethiopia, is translating universal principles of medical ethics into appropriate informed consent documents and their implementation. Rapid Ethical Assessment (REA) has been suggested as a feasible approach to meet this application gap. In the past few years REA has been employed in few research project in Ethiopia and have been found to be a useful and practical approach. Feasibility assessment of REA for the Ethiopian research setting was conducted between 2012-2013 in order to inform the subsequent introduction of REA into research ethics review and governance system in the country. REA was found to be an appropriate, relevant and feasible venture. We argue that REA can be integrated as part of the ethics review and governance system in Ethiopia. REA tools and techniques are considered relevant and acceptable to the Ethiopian research community, with few practical challenges anticipated in their implementation. REA are considered feasible for integration in the Ethiopian ethics review system.

Ethical dilemmas of recording and reviewing neonatal resuscitation.

PubMed

den Boer, Maria C; Houtlosser, Mirjam; van Zanten, Henriëtte Anje; Foglia, Elizabeth E; Engberts, Dirk P; Te Pas, Arjan B

2018-05-01

Neonatal resuscitation is provided to approximately 3% of neonates. Adequate ventilation is often the key to successful resuscitation, but this can be difficult to provide. There is increasing evidence that inappropriate respiratory support can have severe consequences. Several neonatal intensive care units have recorded and reviewed neonatal resuscitation procedures for quality assessment, education and research; however, ethical dilemmas sometimes make it difficult to implement this review process. We reviewed the literature on the development of recording and reviewing neonatal resuscitation and have summarised the ethical concerns involved. Recording and reviewing vital physiological parameters and video imaging of neonatal resuscitation in the delivery room is a valuable tool for quality assurance, education and research. Furthermore, it can improve the quality of neonatal resuscitation provided. We observed that ethical dilemmas arise as the review process is operating in several domains of healthcare that all have their specific moral framework with requirements and conditions on issues such as consent, privacy and data storage. These moral requirements and conditions vary due to local circumstances. Further research on the ethical aspects of recording and reviewing is desirable before wider implementation of this technique can be recommended. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Ethical review issues in collaborative research between us and low-middle income country partners: a case example.

PubMed

McIntosh, Scott; Sierra, Essie; Dozier, Ann; Diaz, Sergio; Quiñones, Zahira; Primack, Aron; Chadwick, Gary; Ossip-Klein, Deborah J

2008-09-01

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country.

Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments

PubMed Central

Scott, Anna Mae; Hofmann, Björn; Gutiérrez-Ibarluzea, Iñaki; Bakke Lysdahl, Kristin; Sandman, Lars; Bombard, Yvonne

2017-01-01

Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically underdeveloped in comparison to other areas of HTA, such as clinical or cost effectiveness. Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we systematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 experts in the field of ethics for HTA at two 2-day workshops. We subsequently refined Q-SEA through its application to an ethics analysis conducted for HTA. Results: Q-SEA instrument consists of two domains – the process domain and the output domain. The process domain consists of 5 elements: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values. Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue. PMID:28326147

Discussion of solutions to ethical issues in real-world study.

PubMed

Wang, Sicheng; Liu, Baoyan; Xiong, Ningning; Xie, Qi; Zhang, Runshun; Zhou, Xuezhong; Qiao, Jie

2014-09-01

In recent years, the paradigm of real-world study (RWS) has been at the forefront of clinical research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of real-world clinical studies are discussed, and ethical issues in different stages of RWS are raised and reviewed. Moreover, some preliminary solutions to these issues, such as protecting subjects during the process of RWS and performing ethical review, are presented based on recent practices and basic ethical rules to improve the scientific validity and ethical level of RWS.

The Role of Intent in Ethical Decision Making: The Ethical Choice Model

ERIC Educational Resources Information Center

King, Christine; Powell, Toni

2007-01-01

This paper reviews the major theories, studies and models concerning ethical decision making in organizations. The authors drew upon Jones' Model (1991) as the foundation for their Ethical Choice Model, which is designed to further clarify the ethical decision making process as it relates to the construct of intentionality. The model, illustrated…

Ethical Review Issues in Collaborative Research between US and Low – Middle Income Country Partners: A Case Example

PubMed Central

McIntosh, Scott; Sierra, Essie; Dozier, Ann; Diaz, Sergio; Quiñones, Zahira; Primack, Aron; Chadwick, Gary; Ossip-Klein, Deborah J.

2012-01-01

The current ethical structure for collaborative international health research stems largely from developed countries’ standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country. PMID:18554278

Participatory action research: considerations for ethical review.

PubMed

Khanlou, N; Peter, E

2005-05-01

This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.

Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

PubMed Central

2014-01-01

Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs. PMID:24495542

Nonrational processes in ethical decision making.

PubMed

Rogerson, Mark D; Gottlieb, Michael C; Handelsman, Mitchell M; Knapp, Samuel; Younggren, Jeffrey

2011-10-01

Most current ethical decision-making models provide a logical and reasoned process for making ethical judgments, but these models are empirically unproven and rely upon assumptions of rational, conscious, and quasilegal reasoning. Such models predominate despite the fact that many nonrational factors influence ethical thought and behavior, including context, perceptions, relationships, emotions, and heuristics. For example, a large body of behavioral research has demonstrated the importance of automatic intuitive and affective processes in decision making and judgment. These processes profoundly affect human behavior and lead to systematic biases and departures from normative theories of rationality. Their influence represents an important but largely unrecognized component of ethical decision making. We selectively review this work; provide various illustrations; and make recommendations for scientists, trainers, and practitioners to aid them in integrating the understanding of nonrational processes with ethical decision making.

Ethics approval: responsibilities of journal editors, authors and research ethics committees.

PubMed

Bain, Luchuo Engelbert

2017-01-01

Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

Report of the ASCA Ethics Committee: 1997-1999.

ERIC Educational Resources Information Center

Dansby-Giles, G.; Carpenter, J.; Howes, J.; Hubert, R. M.; Huss, S. Norris; Kraus, K.; Reed, S.; Thomas, R.; Whitledge, J.

Ethical inquiries processed by the Ethics Committee of the American School Counselor Association (ASCA) were reviewed for the years 1997-1999. During the first years, 38 inquiries were reported. In the following year, the Ethical Standards for School Counselors was published and that helped drop the number of inquiries. The topical areas of…

Institutional Ethics Committee Regulations and Current Updates in India.

PubMed

Mahuli, Amit V; Mahuli, Simpy A; Patil, Shankargouda; Bhandi, Shilpa

2017-08-01

The aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

Ethics of reviewing scientific publications.

PubMed

Napolitani, Federica; Petrini, Carlo; Garattini, Silvio

2017-05-01

The approval or rejection of scientific publications can have important consequences for scientific knowledge, so considerable responsibility lies on those who have to assess or review them. Today it seems that the peer review process, far from being considered an outdated system to be abandoned, is experiencing a new upturn. This article proposes criteria for the conduct of reviewers and of those who select them. While commenting on new emerging models, it provides practical recommendations for improving the peer-review system, like strengthening the role of guidelines and training and supporting reviewers. The process of peer review is changing, it is getting more open and collaborative, but those same ethical principles which guided it from its very origin should remain untouched and be firmly consolidated. The paper highlights how the ethics of reviewing scientific publications is needed now more than ever, in particular with regard to competence, conflict of interest, willingness to discuss decisions, complete transparency and integrity. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Australian Aboriginal and Torres Strait Islander-focused primary healthcare social and emotional wellbeing research: a systematic review protocol.

PubMed

Farnbach, Sara; Eades, Anne-Marie; Hackett, Maree Lisa

2015-12-30

Research with a focus on Aboriginal and Torres Strait Islander Australian's (hereafter referred to as Indigenous(1)) needs is crucial to ensure culturally appropriate evidence-based strategies are developed to improve health. However, concerns surrounding this research exist, arising from some previous research lacking community consultation, resulting in little community benefit or infringing on important cultural values. Values and Ethics: Guidelines for Ethical conduct in Aboriginal and Torres Strait Islander Health Research (hereafter referred to as Values and Ethics), developed by The National Health and Medical Research Council of Australia in 2003, is the ethical standard for Indigenous-focused health research. Researchers must address its Values in research design and conduct. However, its impact on research processes is unclear. Local Protocols should also be considered. This review aims to systematically examine practices related to Values and Ethics, Local Protocols and the processes of conducting Indigenous-focused primary healthcare research in collaboration with external researchers. The following electronic databases and grey literature will be searched (2003 to current): MEDLINE, EMBASE, CINAHL, Informit and HealthInfoNet--an Indigenous-specific research and program website. Indigenous-focused research will be included. Research must be conducted in one or more primary healthcare services, in collaboration with external researchers and with a focus on social and emotional well being. One reviewer will review titles and abstracts to remove obviously irrelevant research articles. Full-text research articles will be retrieved and independently examined by two reviewers. Data and quality assessment will be completed by one reviewer and verified by a second reviewer. Quality will be assessed using modified versions of established quality assessment tools. This review will provide information on research processes and the impact of Values and Ethics on Indigenous-focused primary healthcare research, informing communities and primary healthcare staff around research practices, and researchers and policy makers of strengths and weaknesses of practice. PROSPERO CRD42015024994.

The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

PubMed

Hunt, Matthew; Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa

2016-01-01

Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs), in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries. We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques. Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process. Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be taken to ensure that ethics review of disaster research remains diligent and thorough.

The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members

PubMed Central

Hunt, Matthew; Tansey, Catherine M.

2016-01-01

Background Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs), in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries. Methods We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques. Results Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process. Conclusion Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be taken to ensure that ethics review of disaster research remains diligent and thorough. PMID:27327165

[Discussion on solutions to ethical issues of clinical researches in a real world].

PubMed

Wang, Si-Cheng; Liu, Bao-Yan; Xiong, Ning-Ning; Xie, Qi; Zhang, Run-Shun; Zhou, Xue-Zhong; Qiao, Jie

2013-04-01

The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years' practices to enhance the scientificity and ethical level of real-world studies.

Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

PubMed

Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin

2013-05-01

This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

[Ethical problems experienced by nurses in primary health care: integrative literature review].

PubMed

Nora, Carlise Rigon Dalla; Zoboli, Elma Lourdes Campos Pavone; Vieira, Margarida

2015-03-01

The aim of this study is to identify ethical problems experienced by nurses in primary health care and resources for coping based on publications on the subject. An integrative literature review was performed between the months of October and November 2013, using the databases: BDTD, CINAHL, LILACS, MEDLINE, Biblioteca Cochrane, PubMed, RCAAP and SciELO. Articles, dissertations and theses published in Portuguese, English and Spanish were included, totalling 31 studies published from 1992 to 2013. This analysis resulted in four categories: ethical problems in the relationship between team members, ethical problems in the relationship with the user, ethical problems in health services management and resources for coping with ethical problems. Results showed that nurses need to be prepared to face ethical problems, emphasizing the importance of ethics education during the education process before and during professional practice to enhance the development of ethical sensitivity and competence for problem resolution.

Nature and governance of veterinary clinical research conducted in the UK.

PubMed

Fordyce, P; Mullan, S

2017-01-21

In order to quantify the amount of clinical research conducted on client-owned animals under the Veterinary Surgeons Act 1966, and the nature and extent of any ethical review of that research, a questionnaire was sent to 6 UK veterinary schools, 1 charity veterinary clinic and 12 private referral clinics. The questionnaire examined whether and how much clinical research respondents undertook, and the composition of any ethical review panels examining research proposals. The questionnaire revealed a substantial amount of clinical research was conducted in the UK, with over 200 veterinary surgeons involved in the year of the survey, with at least 170 academic papers involving clinical research published by respondents in the same year. However, it proved impossible to quantify the full extent of clinical research in the UK. All UK veterinary schools required ethical review of clinical research. The composition and working practices of their ethical review panels generally reflected skill sets in ethical review panels set-up under statute to consider the ethics of non-clinical biomedical research on animals and clinical research conducted on human patients. The process for review of clinical research in the private sector was less clear. British Veterinary Association.

Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.

PubMed

Adams, Pornpimon; Prakobtham, Sukanya; Limphattharacharoen, Chanthima; Vutikes, Pitchapa; Khusmith, Srisin; Pengsaa, Krisana; Wilairatana, Polrat; Kaewkungwal, Jaranit

2015-09-14

Malaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand. Proposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members' reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk-benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population. All 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not. Those involving vulnerable populations were more likely to attract concerns related to study rationale and design. This study stratified ethical issues raised in a broad spectrum of research proposals. The Faculty of Tropical Medicine at Mahidol University is a significant contributor to global malaria research output. The findings shed light on the ethical review process that may be useful for stakeholders, including researchers, RECs and sponsors, conducting malaria research in other endemic settings.

Making a difference: incorporating theories of autonomy into models of informed consent.

PubMed

Delany, C

2008-09-01

Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

Ethics in Higher Education Research

ERIC Educational Resources Information Center

Parsell, Mitch; Ambler, Trudy; Jacenyik-Trawoger, Christa

2014-01-01

Many educational researchers have experienced challenges in obtaining ethics approval. This article explores some of the reasons why this is the case, looking specifically at the participatory action research methodology. The authors' experience of seeking ethics approval for a project intended to introduce peer review as an enhancement process is…

Ethics interventions for healthcare professionals and students: A systematic review.

PubMed

Stolt, Minna; Leino-Kilpi, Helena; Ruokonen, Minka; Repo, Hanna; Suhonen, Riitta

2018-03-01

The ethics and value bases in healthcare are widely acknowledged. There is a need to improve and raise awareness of ethics in complex systems and in line with competing needs, different stakeholders and patients' rights. Evidence-based strategies and interventions for the development of procedures and practice have been used to improve care and services. However, it is not known whether and to what extent ethics can be developed using interventions. To examine ethics interventions conducted on healthcare professionals and healthcare students to achieve ethics-related outcomes. A systematic review. Five electronic databases were searched: CINAHL, the Cochrane Library, Philosopher's Index, PubMed and PsycINFO. We searched for published articles written in English without a time limit using the keywords: ethic* OR moral* AND intervention OR program OR pre-post OR quasi-experimental OR rct OR experimental AND nurse OR nursing OR health care. In the four-phased retrieval process, 23 full texts out of 4675 citations were included in the review. Data were analysed using conventional content analysis. Ethical consideration: This systematic review was conducted following good scientific practice in every phase. It is possible to affect the ethics of healthcare practices through professionals and students. All the interventions were educational in type. Many of the interventions were related to the ethical or moral sensitivity of the professionals, such as moral courage and empowerment. A few of the interventions focused on identifying ethical problems or research ethics. Patient-related outcomes followed by organisational outcomes can be improved by ethics interventions targeting professionals. Such outcomes are promising in developing ethical safety for healthcare patients and professionals.

Ethics guidelines, health research and Indigenous Australians.

PubMed

Anderson, Ian; Griew, Robert; McAullay, Daniel

2003-02-01

In this paper we overview the findings of a literature review that was undertaken to guide the revision of the Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NH&MRC, 1991). The literature reviewed, in general, supported the development of specific research guidelines for Aboriginal and Torres Strait Islander contexts. The findings of this review were analysed thematically, and a number of key issues were identified for consideration in the review process. We present a summary of these key issues. In the final section of the paper we consider in more detail two of the key issues raised in the review process (the assessment of relevance or benefit of proposed research; and the process of consultation and negotiation of collective consent) in order to critically consider how these issue should be engaged in revised guidelines. On the basis of this analysis, it is our contention that specific guidelines on key issues are limited to the extent to which they can anticipate all possible research contexts. In order to address this problem, and guide researchers, guidelines should also explicitly outline the values, from an Aboriginal and Torres Islander perspective that are foundational to an ethical research process.

REVIEWING HIV-RELATED RESEARCH IN EMERGING ECONOMIES: THE ROLE OF GOVERNMENT REVIEWING AGENCIES

PubMed Central

Klitzman, Robert; Sexton, Patrina; Hui, Katrina; Hanrahan, Donna; Barnes, Mark; Sugarman, Jeremy; London, Alex John

2015-01-01

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and, limited expertise, use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country’s population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. PMID:25388003

Reviewing HIV-Related Research in Emerging Economies: The Role of Government Reviewing Agencies.

PubMed

Sexton, Patrina; Hui, Katrina; Hanrahan, Donna; Barnes, Mark; Sugarman, Jeremy; London, Alex John; Klitzman, Robert

2016-04-01

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees (RECs) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN) research in emerging economies. Ministries of Health (MOH) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. © 2014 John Wiley & Sons Ltd.

Ethical review of health research: a perspective from developing country researchers.

PubMed

Hyder, A A; Wali, S A; Khan, A N; Teoh, N B; Kass, N E; Dawson, L

2004-02-01

Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs). Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations. The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.

Student Participation in Health Professions Education Research: In Pursuit of the Aristotelian Mean

ERIC Educational Resources Information Center

Chen, Ruth P.

2011-01-01

In research ethics reviews, traditional approaches of research ethics boards (REBs) balance the risks with the potential for benefit of proposed studies, and this review process has been similar for health professions education research (HPER) as it has been for clinically based studies. Health professions students are the primary population from…

Ethics and the ethnography of medical research in Africa

PubMed Central

Molyneux, Sassy; Geissler, P. Wenzel

2008-01-01

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more ‘situated ethics’ of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in ‘doing ethics’ in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels. PMID:18455856

[Responsibilities of ethics committees].

PubMed

von Bergmann, K

1999-01-15

Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

[Responsibilities of ethics committees].

PubMed

von Bergmann, K

2000-05-01

Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

Searching for solutions to alcohol and other drug abuse during pregnancy: ethics, values, and constitutional principles.

PubMed

Andrews, A B; Patterson, E G

1995-01-01

Recent efforts to develop legal mechanisms to detect prenatal substance abuse and force pregnant women into drug-free conditions have precipitated ethical struggles for social workers. This article reviews relevant social work values and ethical issues, particularly the need to balance obligations to promote client self-determination, privacy, and access to chosen services with professional values that support coercive intervention to aid vulnerable people and to protect life. The constitutional principles that most affect coercive interventions--due process and equal protection--are reviewed. Recommendations are offered to guide ethical and legal social work for case interventions and policy development.

Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

PubMed

Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

2015-05-08

UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be known about the social practices and conditions of healthcare. Our central argument is that assessment of ethical implications is important, but that the current paradigm does not facilitate an adequate understanding of the very issues it aims to invigilate.

Ethical dilemmas in journal publication.

PubMed

Babalola, Olubukola; Grant-Kels, Jane M; Parish, Lawrence Charles

2012-01-01

Physicians often face tremendous pressures and incentives to publish, sometimes leading to a compromise of ethical standards, either consciously or unconsciously. From the vantage of ethical authorship, we discuss what constitutes authorship; avoidance of ghost authorship; plagiarism, as well as self-plagiarism and duplicate publication; falsification; and fabrication. Editors also face ethical challenges, including how best to manage peer-review bias, to address reviewer tardiness, and to locate reviewers with appropriate expertise and professionalism. Editors need to deal with authors who fragment their work into multiple publications to enhance their curriculum vitae ("salami factor"), as well as to manage the financial benefits of advertising and to avoid conflicts of interest for the journal. Both authors and editors should be straightforward and principled throughout the publication process. Copyright © 2012 Elsevier Inc. All rights reserved.

Methodological and ethical challenges in studying patients' perceptions of coercion: a systematic mixed studies review.

PubMed

Soininen, Päivi; Putkonen, Hanna; Joffe, Grigori; Korkeila, Jyrki; Välimäki, Maritta

2014-06-04

Despite improvements in psychiatric inpatient care, patient restrictions in psychiatric hospitals are still in use. Studying perceptions among patients who have been secluded or physically restrained during their hospital stay is challenging. We sought to review the methodological and ethical challenges in qualitative and quantitative studies aiming to describe patients' perceptions of coercive measures, especially seclusion and physical restraints during their hospital stay. Systematic mixed studies review was the study method. Studies reporting patients' perceptions of coercive measures, especially seclusion and physical restraints during hospital stay were included. Methodological issues such as study design, data collection and recruitment process, participants, sampling, patient refusal or non-participation, and ethical issues such as informed consent process, and approval were synthesized systematically. Electronic searches of CINALH, MEDLINE, PsychINFO and The Cochrane Library (1976-2012) were carried out. Out of 846 initial citations, 32 studies were included, 14 qualitative and 18 quantitative studies. A variety of methodological approaches were used, although descriptive and explorative designs were used in most cases. Data were mainly collected in qualitative studies by interviews (n = 13) or in quantitative studies by self-report questionnaires (n = 12). The recruitment process was explained in 59% (n = 19) of the studies. In most cases convenience sampling was used, yet five studies used randomization. Patient's refusal or non-participation was reported in 37% (n = 11) of studies. Of all studies, 56% (n = 18) had reported undergone an ethical review process in an official board or committee. Respondents were informed and consent was requested in 69% studies (n = 22). The use of different study designs made comparison methodologically challenging. The timing of data collection (considering bias and confounding factors) and the reasons for non-participation of eligible participants are likewise methodological challenges, e.g. recommended flow charts could aid the information. Other challenges identified were the recruitment of large and representative samples. Ethical challenges included requesting participants' informed consent and respecting ethical procedures.

Developing an Evaluation Tool for Assessing Clinical Ethics Consultation Skills in Simulation Based Education: The ACES Project.

PubMed

Wasson, Katherine; Parsi, Kayhan; McCarthy, Michael; Siddall, Viva Jo; Kuczewski, Mark

2016-06-01

The American Society for Bioethics and Humanities has created a quality attestation (QA) process for clinical ethics consultants; the pilot phase of reviewing portfolios has begun. One aspect of the QA process which is particularly challenging is assessing the interpersonal skills of individual clinical ethics consultants. We propose that using case simulation to evaluate clinical ethics consultants is an approach that can meet this need provided clear standards for assessment are identified. To this end, we developed the Assessing Clinical Ethics Skills (ACES) tool, which identifies and specifies specific behaviors that a clinical ethics consultant should demonstrate in an ethics case simulation. The aim is for the clinical ethics consultant or student to use a videotaped case simulation, along with the ACES tool scored by a trained rater, to demonstrate their competence as part of their QA portfolio. The development and piloting of the tool is described.

The conduct of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review.

PubMed

Farnbach, Sara; Eades, Anne-Maree; Gwynn, Josephine D; Glozier, Nick; Hackett, Maree L

2018-06-14

Objectives and importance of study: Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (Values and ethics) describes key values that should underpin Aboriginal and Torres Strait Islander (Indigenous)-focused health research. It is unclear how research teams address this document in primary health care research. We systematically review the primary health care literature focusing on Indigenous social and emotional wellbeing (SEWB) to identify how Values and ethics and community preferences for standards of behaviour (local protocols) are addressed during research. Systematic review in accordance with PRISMA Guidelines and MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies. We searched four databases and one Indigenous-specific website for qualitative, quantitative and mixed-method studies published since Values and ethics was implemented (2003). Included studies were conducted in primary health care services, focused on Indigenous SEWB and were conducted by research teams. Using standard data extraction forms, we identified actions taken (reported by authors or identified by us) relating to Values and ethics and local protocols. A total of 25 studies were included. Authors of two studies explicitly mentioned the Values and ethics document, but neither reported how their actions related to the document's values. In more than half the studies, we identified at least three actions relating to the values. Some actions related to multiple values, including use of culturally sensitive research processes and involving Indigenous representatives in the research team. Local protocols were rarely reported. Addressing Values and ethics appears to improve research projects. The academic community should focus on culturally sensitive research processes, relationship building and developing the Indigenous research workforce, to facilitate acceptable research that affects health outcomes. For Values and ethics to achieve its full impact and to improve learning between research teams, authors should be encouraged to report how the principles are addressed during research, including barriers and enablers that are encountered.

Restructuring University Degree Programmes: A New Opportunity for Ethics Education?

ERIC Educational Resources Information Center

Escamez, Juan; Lopez, Rafaela Garcia; Jover, Gonzalo

2008-01-01

This article explores the possibilities of reinforcing ethics education at the university level within the context of new internationalisation processes. The situation in Spain is used as a case study. The article begins with a review of the rationale behind this issue and goes on to analyse the place of the ethical dimension in education in the…

Expanding Ethics Review Processes to Include Community-Level Protections: A Case Study from Flint, Michigan.

PubMed

Key, Kent D

2017-10-01

As the Flint community endeavors to recover and move forward in the aftermath of the Flint water crisis, distrust of scientific and governmental authorities must be overcome. Future community engagement in research will require community-level protections ensuring that no further harm is done to the community. A community ethics review explores risks and benefits and complements institutional review board (IRB) review. Using the case of Flint, I describe how community-level ethical protections can reestablish a community's trust. All IRBs reviewing protocols that include risk to communities and not merely individual participants should consider how community members are engaged in the proposed research and identify and respond to questions and domains of concern from community members. © 2017 American Medical Association. All Rights Reserved.

Description and Evaluation of the Research Ethics Review Process in Japan: Proposed Measures for Improvement.

PubMed

Suzuki, Mika; Sato, Keiko

2016-07-01

Research Ethics Committees (RECs) are designed to protect human subjects in research. It is essential to recognize whether the RECs are achieving this goal. Several studies have reported on RECs; however, detailed data regarding the quality of research protocols and the review process of RECs have not been reported in Japan. We examine research protocols reviewed by RECs and the review processes at three institutions using a novel checklist we developed. The data show that approximately half of all examined protocols lacked a clearly written "Background" section that defines the study rationale and design. These results reiterate suggestions made in previous research regarding educational programs and support departments that could enhance responsible conduct in clinical research to protect human subjects in Japan. © The Author(s) 2016.

Institutional Review Board approval and innovation in urology: current practice and safety issues.

PubMed

Sundaram, Varun; Vemana, Goutham; Bhayani, Sam B

2014-02-01

To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes. © 2013 The Authors. BJU International © 2013 BJU International.

Ethics in the laboratory examination of patients

PubMed Central

Nyrhinen, T.; Leino-Kilpi, H.

2000-01-01

Various value problems are connected with the clinical examination of patients. The purpose of this literature review is to clarify: 1) in which patient examinations ethical problems are generally found; 2) what kind of ethical problems are found in the different phases of the examination process, and 3) what kind of ethical problems are found in connection with the use of examination results. Genetic testing, autopsy, prenatal and HIV examinations were ethically the most problematic laboratory examinations. The most problematic phase in the laboratory examination process proved to be the pre-analytic phase. At present the results of laboratory examination are used more and more often for the prediction of diseases. The problems appear when the examination results are used for discrimination and stigmatisation. Because of the lack of empirical ethical research, it is important to chart empirical knowledge about present value conflict situations involved in the laboratory examination process. Key Words: Ethic • laboratory • test • examination • diagnosis • patient PMID:10701173

An Ethical (Descriptive) Framework for Judgment of Actions and Decisions in the Construction Industry and Engineering-Part I.

PubMed

Alkhatib, Omar J; Abdou, Alaa

2018-04-01

The construction industry is usually characterized as a fragmented system of multiple-organizational entities in which members from different technical backgrounds and moral values join together to develop a particular business or project. The greatest challenge in the construction process for the achievement of a successful practice is the development of an outstanding reputation, which is built on identifying and applying an ethical framework. This framework should reflect a common ethical ground for myriad people involved in this process to survive and compete ethically in today's turbulent construction market. This study establishes a framework for ethical judgment of behavior and actions conducted in the construction process. The framework was primarily developed based on the essential attributes of business management identified in the literature review and subsequently incorporates additional attributes identified to prevent breaches in the construction industry and common ethical values related to professional engineering. The proposed judgment framework is based primarily on the ethical dimension of professional responsibility. The Ethical Judgment Framework consists of descriptive approaches involving technical, professional, administrative, and miscellaneous terms. The framework provides the basis for judging actions as either ethical or unethical. Furthermore, the framework can be implemented as a form of preventive ethics, which would help avoid ethical dilemmas and moral allegations. The framework can be considered a decision-making model to guide actions and improve the ethical reasoning process that would help individuals think through possible implications and consequences of ethical dilemmas in the construction industry.

Developing and Validating a Tool to Assess Ethical Decision-Making Ability of Nursing Students, Using Rubrics

ERIC Educational Resources Information Center

Indhraratana, Apinya; Kaemkate, Wannee

2012-01-01

The aim of this paper is to develop a reliable and valid tool to assess ethical decision-making ability of nursing students using rubrics. A proposed ethical decision making process, from reviewing related literature was used as a framework for developing the rubrics. Participants included purposive sample of 86 nursing students from the Royal…

Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.

PubMed

Michelson, Kelly N; Reubenson, Gary; Weiss, Scott L; Fitzgerald, Julie C; Ackerman, Kate K; Christie, LeeAnn; Bush, Jenny L; Nadkarni, Vinay M; Thomas, Neal J; Schreiner, Mark S

2018-04-01

Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. Survey. Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. None. Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16). Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.

Auditing of clinical research ethics in a children's and women's academic hospital.

PubMed

Bortolussi, Robert; Nicholson, Diann

2002-06-01

Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits. The research audit is a valuable tool in improving research ethics performance but requires considerable resources.

Ethical Issues and Practical Challenges in Suicide Research.

PubMed

Hom, Melanie A; Podlogar, Matthew C; Stanley, Ian H; Joiner, Thomas E

2017-03-01

Research with human subjects represents a critical avenue for suicide prevention efforts; however, such research is not without its ethical and practical challenges. Specifically, given the nature of research with individuals at elevated risk for suicide (e.g., increased concerns regarding participant safety, adverse events, liability, difficulties often arise during the institutional review board (IRB) evaluation and approval process. This paper aims to discuss IRB-related issues associated with suicide prevention research, including researcher and IRB panel member responsibilities, suicide risk assessment and management ethics and procedures, informed consent considerations, preparation of study protocols, and education and training. Points to consider and components to potentially include in an IRB application for suicide-related research are additionally provided. Literature relevant to ethics in suicide research and suicide risk assessment and management was reviewed and synthesized. Suicide research can be conducted in accordance with ethical principles while also furthering the science of suicide prevention. Despite the challenging nature of suicide prevention research, empirically informed solutions exist to address difficulties that may emerge in interfacing with IRBs. There remain areas for improvement in the IRB approval process that warrant further investigation and work.

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

PubMed

De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

2016-01-01

Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

Digital storytelling as a method in health research: a systematic review protocol.

PubMed

Rieger, Kendra L; West, Christina H; Kenny, Amanda; Chooniedass, Rishma; Demczuk, Lisa; Mitchell, Kim M; Chateau, Joanne; Scott, Shannon D

2018-03-05

Digital storytelling is an arts-based research method with potential to elucidate complex narratives in a compelling manner, increase participant engagement, and enhance the meaning of research findings. This method involves the creation of a 3- to 5-min video that integrates multimedia materials including photos, participant voices, drawings, and music. Given the significant potential of digital storytelling to meaningfully capture and share participants' lived experiences, a systematic review of its use in healthcare research is crucial to develop an in-depth understanding of how researchers have used this method, with an aim to refine and further inform future iterations of its use. We aim to identify and synthesize evidence on the use, impact, and ethical considerations of using digital storytelling in health research. The review questions are as follows: (1) What is known about the purpose, definition, use (processes), and contexts of digital storytelling as part of the research process in health research? (2) What impact does digital storytelling have upon the research process, knowledge development, and healthcare practice? (3) What are the key ethical considerations when using digital storytelling within qualitative, quantitative, and mixed method research studies? Key databases and the grey literature will be searched from 1990 to the present for qualitative, quantitative, and mixed methods studies that utilized digital storytelling as part of the research process. Two independent reviewers will screen and critically appraise relevant articles with established quality appraisal tools. We will extract narrative data from all studies with a standardized data extraction form and conduct a thematic analysis of the data. To facilitate innovative dissemination through social media, we will develop a visual infographic and three digital stories to illustrate the review findings, as well as methodological and ethical implications. In collaboration with national and international experts in digital storytelling, we will synthesize key evidence about digital storytelling that is critical to the development of methodological and ethical expertise about arts-based research methods. We will also develop recommendations for incorporating digital storytelling in a meaningful and ethical manner into the research process. PROSPERO registry number CRD42017068002 .

Views of Ethical Best Practices in Sharing Individual-Level Data From Medical and Public Health Research

PubMed Central

Roberts, Nia; Parker, Michael

2015-01-01

There is increasing support for sharing individual-level data generated by medical and public health research. This scoping review of empirical research and conceptual literature examined stakeholders’ perspectives of ethical best practices in data sharing, particularly in low- and middle-income settings. Sixty-nine empirical and conceptual articles were reviewed, of which, only five were empirical studies and eight were conceptual articles focusing on low- and middle-income settings. We conclude that support for sharing individual-level data is contingent on the development and implementation of international and local policies and processes to support ethical best practices. Further conceptual and empirical research is needed to ensure data sharing policies and processes in low- and middle-income settings are appropriately informed by stakeholders’ perspectives. PMID:26297745

Teaching ethics and professionalism in plastic surgery: a systematic review.

PubMed

de Blacam, Catherine; Vercler, Christian J

2014-04-01

Maintenance of the highest ethical and professional standards in plastic surgery is in the best interests of our profession and the public whom we serve. Both the American Board of Medical Specialties and the Accreditation Council on Graduate Medical Education mandate training in ethics and professionalism for all residents. Presently there is no gold standard in ethics and professionalism education. A systematic review on teaching ethics and professionalism in plastic surgery was performed for all articles from inception to May 23, 2013 in MEDLINE, Scopus, EMBASE, CENTRAL, and ERIC. References of relevant publications were searched for additional papers. Key journals were hand searched and relevant conference proceedings were also reviewed. Duplicate and non-English articles were excluded. Inclusion and exclusion criteria were applied to find articles that described a curriculum in ethics and/or professionalism in plastic surgery. Two hundred twenty-seven relevant articles were identified. One hundred seventy-four did not meet inclusion criteria based on screening of the title, and 39 of those did not meet inclusion criteria based on screening of the abstract or introductory paragraph. Of the 14 identified for full text review, only 2 articles described a set curriculum in ethics and/or professionalism in plastic surgery training and reported outcomes. A paucity of data exists regarding the structure, content, or relevant measures that can be applied to assess outcomes of a curriculum to teach ethics and professionalism to plastic surgery trainees. Endeavors to teach ethics and professionalism to plastic surgery trainees must rigorously document the process and outcomes to facilitate the maintenance of our profession.

The Migration toward Ethical Decision Making as a Core Course into the B-School: Instructional Strategies and Approaches for Consideration

ERIC Educational Resources Information Center

Nelson, Johnathan; Smith, Lola B.; Hunt, Clifford Steven

2014-01-01

Many academicians are asking the following question: "Are we ill-preparing our business students if we fail to offer future business professionals the opportunity to engage in a greater understanding of the ethical decision making process?" The authors provide a current review of the literature on the state of ethics education in…

Rapid qualitative review of ethical issues surrounding healthcare for pregnant women or women of reproductive age in epidemic outbreaks

PubMed Central

2018-01-01

This article describes, categorizes, and discusses the results of a rapid literature review aiming to provide an overview of the ethical issues and corresponding solutions surrounding pregnancies in epidemic outbreaks. The review was commissioned by the World Health Organization to inform responses to the Zika outbreak that began in 2015. Due to the urgency of the response efforts that needed to be informed by the literature search, a rapid qualitative review of the literature published in PubMed was conducted. The search and analysis were based on the operationalization of 3 key concepts: ethics, pregnancy, and epidemic outbreak. Ethical issues and solutions were interpreted within a principlist framework. The data were analyzed using qualitative content analysis. The search identified 259 publications, of which the full text of 23 papers was read. Of those, 20 papers contained a substantive part devoted to the topic of interest and were therefore analyzed further. We clustered the ethical issues and solutions around 4 themes: uncertainty, harms, autonomy/liberty, and effectiveness. Recognition of the identified ethical issues and corresponding solutions can inform and improve response efforts, public health planning, policies, and decision-making, as well as the activities of medical staff and counselors who practice before, during, or after an epidemic outbreak that affects pregnant women or those of reproductive age. The rapid review format proved to be useful despite its limited data basis and expedited review process. PMID:29370682

Rapid qualitative review of ethical issues surrounding healthcare for pregnant women or women of reproductive age in epidemic outbreaks.

PubMed

Hummel, Patrik; Saxena, Abha; Klingler, Corinna

2018-01-01

This article describes, categorizes, and discusses the results of a rapid literature review aiming to provide an overview of the ethical issues and corresponding solutions surrounding pregnancies in epidemic outbreaks. The review was commissioned by the World Health Organization to inform responses to the Zika outbreak that began in 2015. Due to the urgency of the response efforts that needed to be informed by the literature search, a rapid qualitative review of the literature published in PubMed was conducted. The search and analysis were based on the operationalization of 3 key concepts: ethics, pregnancy, and epidemic outbreak. Ethical issues and solutions were interpreted within a principlist framework. The data were analyzed using qualitative content analysis. The search identified 259 publications, of which the full text of 23 papers was read. Of those, 20 papers contained a substantive part devoted to the topic of interest and were therefore analyzed further. We clustered the ethical issues and solutions around 4 themes: uncertainty, harms, autonomy/liberty, and effectiveness. Recognition of the identified ethical issues and corresponding solutions can inform and improve response efforts, public health planning, policies, and decision-making, as well as the activities of medical staff and counselors who practice before, during, or after an epidemic outbreak that affects pregnant women or those of reproductive age. The rapid review format proved to be useful despite its limited data basis and expedited review process.

Human research ethics committees: examining their roles and practices.

PubMed

Guillemin, Marilys; Gillam, Lynn; Rosenthal, Doreen; Bolitho, Annie

2012-07-01

Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.

Minors and euthanasia: a systematic review of argument-based ethics literature.

PubMed

Cuman, Giulia; Gastmans, Chris

2017-07-01

Euthanasia was first legalised in the Netherlands in 2002, followed by similar legislation in Belgium the same year. Since the beginning, however, only the Netherlands included the possibility for minors older than 12 years to request euthanasia. In 2014, the Belgian Act legalising euthanasia was amended to include requests by minors who possess the capacity of discernment. This amendment sparked great debate, and raised difficult ethical questions about when and how a minor can be deemed competent. We conducted a systematic review of argument-based literature on euthanasia in minors. The search process followed PRISMA guidelines. Thirteen publications were included. The four-principle approach of medical ethics was used to organise the ethical arguments underlying this debate. The justification for allowing euthanasia in minors is buttressed mostly by the principles of beneficence and respect for autonomy. Somewhat paradoxically, both principles are also used in the literature to argue against the extension of legislation to minors. Opponents of euthanasia generally rely on the principle of non-maleficence. The present analysis reveals that the debate surrounding euthanasia in minors is at an early stage. In order to allow a more in-depth ethical discussion, we suggest enriching the four-principle approach by including a care-ethics approach. What is Known: • The Netherlands and Belgium are the only two countries in the world with euthanasia legislation making it possible for minors to receive euthanasia. • This legislation provoked great debate globally, with ethical arguments for and against this legislation. What is New: • A systematic description of the ethical concepts and arguments grounding the debate on euthanasia in minors, as reported in the argument-based ethics literature. • A need has been identified to enrich the debate with a care-ethics approach to avoid oversimplifying the ethical decision-making process.

Methodological and ethical challenges in studying patients’ perceptions of coercion: a systematic mixed studies review

PubMed Central

2014-01-01

Background Despite improvements in psychiatric inpatient care, patient restrictions in psychiatric hospitals are still in use. Studying perceptions among patients who have been secluded or physically restrained during their hospital stay is challenging. We sought to review the methodological and ethical challenges in qualitative and quantitative studies aiming to describe patients’ perceptions of coercive measures, especially seclusion and physical restraints during their hospital stay. Methods Systematic mixed studies review was the study method. Studies reporting patients’ perceptions of coercive measures, especially seclusion and physical restraints during hospital stay were included. Methodological issues such as study design, data collection and recruitment process, participants, sampling, patient refusal or non-participation, and ethical issues such as informed consent process, and approval were synthesized systematically. Electronic searches of CINALH, MEDLINE, PsychINFO and The Cochrane Library (1976-2012) were carried out. Results Out of 846 initial citations, 32 studies were included, 14 qualitative and 18 quantitative studies. A variety of methodological approaches were used, although descriptive and explorative designs were used in most cases. Data were mainly collected in qualitative studies by interviews (n = 13) or in quantitative studies by self-report questionnaires (n = 12). The recruitment process was explained in 59% (n = 19) of the studies. In most cases convenience sampling was used, yet five studies used randomization. Patient’s refusal or non-participation was reported in 37% (n = 11) of studies. Of all studies, 56% (n = 18) had reported undergone an ethical review process in an official board or committee. Respondents were informed and consent was requested in 69% studies (n = 22). Conclusions The use of different study designs made comparison methodologically challenging. The timing of data collection (considering bias and confounding factors) and the reasons for non-participation of eligible participants are likewise methodological challenges, e.g. recommended flow charts could aid the information. Other challenges identified were the recruitment of large and representative samples. Ethical challenges included requesting participants’ informed consent and respecting ethical procedures. PMID:24894162

Patient decision-making: medical ethics and mediation.

PubMed Central

Craig, Y J

1996-01-01

A review of medical ethics literature relating to the importance of the participation of patients in decision-making introduces the role of rights-based mediation as a voluntary process now being developed innovatively in America. This is discussed in relation to the theory of communicative ethics and moral personhood. References are then made to the work of medical ethics committees and the role of mediation within these. Finally it is suggested that mediation is part of an eirenic ethic already being used informally in good patient care, and that there is a case for developing it further. PMID:8798939

Ethical principles in health research and review process.

PubMed

Tangwa, Godfrey B

2009-11-01

In this paper I want to reflect on the fundamental ethical principles and their application in different particular contexts, especially in health research and the ethics review process. Four fundamental ethical principles have been identified and widely discussed in bioethical literature. These principles namely are: autonomy or respect for others, beneficence, non-maleficence and justice. These principles have cross-cultural validity, relevance and applicability. Every real-life situation and every concrete particular case in which ethical decision-making is called-for is unique and different from all others; but the same fundamental ethical principles are relevant and used in addressing all such cases and situations. Very often ethical problems will present themselves in the form of dilemmas and it is then necessary to use the same fundamental principles to analyze the situations, to argue persuasively and cogently with competence for the best options or choices in such situations. The issues I will be dealing with in this paper are necessarily more abstract and theoretical, but we will be discussing them from a very practical viewpoint and impulse, with a view to application in concrete real-life situations. The paper ends with some sample practical examples of cases that the reader can use to test his/her grasp of the principles, how to apply them, how to balance them in differing situations and contexts and how to adjudicate between them when they seem to be in conflict.

Social and ethical aspects of forensic genetics: A critical review.

PubMed

Williams, R; Wienroth, M

2017-07-01

This review describes the social and ethical responses to the history of innovations in forensic genetics and their application to criminal investigations. Following an outline of the three recurrent social perspectives that have informed these responses (crime management, due process, and genetic surveillance), it goes on to introduce the repertoire of ethical considerations by describing a series of key reports that have shaped subsequent commentaries on forensic DNA profiling and databasing. Four major ethical concerns form the focus of the remainder of the paper (dignity, privacy, justice, and social solidarity), and key features of forensic genetic practice are examined in the light of these concerns. The paper concludes with a discussion of the concept of "proportionality" as a resource for balancing the social and ethical risks and benefits of the use of forensic genetics in support of criminal justice. Copyright © 2017 Central Police University.

[Disability, inability and vulnerability: on ableism or the pre-eminence of ableist and biomedical approaches of the Human Subjects Ethics Committee of UFSC].

PubMed

Mello, Anahi Guedes de

2016-10-01

Anthropology has increasingly questioned the hegemony of biomedical knowledge in ethical review processes of social research projects prevailing in Brazil, which was governed until 2012 by the Human Research Ethics Committee of each institution under the auspices of the National Research Ethics Commission (CONEP). This was mandated through Resolution No. 196/1996 prevailing in 2012 when this field research was conducted. The scope of this study is to recount and reflect upon the barriers to obtaining approval in 2012 for my master's research project from the Human Research Ethics Committee of the Federal University of Santa Catarina (CEP/UFSC) in Florianopolis. In this ethnographic experience, in the light of Crip theory, I observed how the "disability," "vulnerability" and "inability" categories are articulated to reveal the ableism and the primacy of the biomedical model in the case of an ethics review at UFSC regarding the participation and legal capacity of persons with disabilities as subjects of research.

Journal policy on ethics in scientific publication.

PubMed

Callaham, Michael L

2003-01-01

Medical journals aspire to select, through peer review, the highest quality science, and their reputations depend on the trust of readers, authors, researchers, reviewers, and patients. Almost every aspect of this process involves important ethical principles and decisions, which are seldom explicitly stated and even less often shared with the readership. A comprehensive policy on publication ethics is summarized in this article. A few of the topics addressed are study design; research subject consent; definitions and responsibilities of authorship; declaration of paid writers; types of potential conflicts of interest; management of conflicts of interest on the part of authors, journal reviewers, and members of the editorial board; blinding and confidentiality of peer review; assessment of peer review quality; public identification of degree of peer review of various portions of the journal; criteria for manuscript decisions; management of author appeals; definitions of prior publication; plagiarism; criteria for advertising and relationship between advertising and editorial matter; allegations of misconduct and journal policies for responding to them; and the relationship of the journal to the sponsoring society. Our goal in publishing these policies is to make the guiding ethical principles of this journal accessible to all of our readers and contributors.

Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity.

PubMed

Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry

2015-12-01

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed 'too great an emphasis on guidelines and research ethics review', which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. © 2014 John Wiley & Sons Ltd.

Community Partnered Research Ethics Training in Practice: A Collaborative Approach to Certification.

PubMed

Yonas, Michael A; Jaime, Maria Catrina; Barone, Jean; Valenti, Shannon; Documét, Patricia; Ryan, Christopher M; Miller, Elizabeth

2016-04-01

This report describes the development and implementation of a tailored research ethics training for academic investigators and community research partners (CRP). The Community Partnered Research Ethics Training (CPRET) and Certification is a free and publicly available model and resource created by a university and community partnership to ensure that traditional and non-traditional research partners may study, define, and apply principles of human subjects' research. To date, seven academic and 34 CRP teams have used this highly interactive, engaging, educational, and relationship building process to learn human subjects' research and be certified by the University of Pittsburgh Institutional Review Board (IRB). This accessible, flexible, and engaging research ethics training process serves as a vehicle to strengthen community and academic partnerships to conduct ethical and culturally sensitive research. © The Author(s) 2016.

Centralized drug review processes: are they fair?

PubMed

Mitton, Craig R; McMahon, Meghan; Morgan, Steve; Gibson, Jennifer

2006-07-01

Numerous countries have implemented centralized drug review processes to assist in making drug coverage decisions. In addition to examining the final recommendations of these bodies, it is also important to ensure fairness in decision making. Accountability for reasonableness is an ethics-based framework for examining the fairness of priority setting processes. The objective of this study was to assess the fairness of four internationally established centralized drug review processes using accountability for reasonableness. Semi-structured telephone interviews were conducted with stakeholders in Canada, New Zealand, Australia and the UK (n=16). Participants were asked to evaluate their country's centralized drug review process against the four conditions of accountability for reasonableness. Each centralized drug review process satisfied at least one of the four ethical conditions, but none satisfied all four conditions. All participants viewed transparency as critical to both the legitimacy and fairness of centralized drug review processes. Additional strides need to be made in each of the four countries under study to improve the fairness of their centralized drug review processes. Ideally, a fair priority setting process should foster constructive stakeholder engagement and enhance the legitimacy of decisions made in assessing pharmaceutical products for funding. As policy makers are under increasing scrutiny in allocating limited resources, fair process should be seen as a critical component of such activity. This study represents the first attempt to conduct an international comparison of the fairness of centralized drug review agencies in the eyes of participating stakeholders.

The Ontario Cancer Research Ethics Board: a central REB that works

PubMed Central

Chaddah, M.R.

2008-01-01

The Ontario Cancer Research Ethics Board (ocreb) has made its mark within Ontario as a successful, centralized, oncology-specific research ethics board. As such, ocreb has proven invaluable to principal investigators, sponsors, and study participants given its ability to reduce duplication during the submission process, to provide the highest quality of review, to shorten study start-up time, and to implement more efficient methods of reporting serious adverse events. PMID:18317585

Submission of scientifically sound and ethical manuscripts to peer-reviewed journals - a reviewer's personal perspective on bioanalytical publications.

PubMed

Weng, Naidong

2012-11-01

In the pharmaceutical industry, bioanalysis is very dynamic and is probably one of the few fields of research covering the entire drug discovery, development and post-marketing process. Important decisions on drug safety can partially rely on bioanalytical data, which therefore can be subject to regulatory scrutiny. Bioanalytical scientists have historically contributed significant numbers of scientific manuscripts in many peer-reviewed analytical journals. All of these journals provide some high-level instructions, but they also leave sufficient flexibility for reviewers to perform independent critique and offer recommendations for each submitted manuscript. Reviewers play a pivotal role in the process of bioanalytical publication to ensure the publication of high-quality manuscripts in a timely fashion. Their efforts usually lead to improved manuscripts. However, it has to be a joint effort among authors, reviewers and editors to promote scientifically sound and ethically fair bioanalytical publications. Most of the submitted manuscripts were well written with only minor or moderate revisions required for further improvement. Nevertheless, there were small numbers of submitted manuscripts that did not meet the requirements for publications because of scientific or ethical deficiencies, which are discussed in this Letter to the Editor. Copyright © 2012 John Wiley & Sons, Ltd.

Ethical standards for medical research in the Israeli military - review of the changes in the last decade.

PubMed

Hassidim, Ayal; Kayouf, Raeed; Yavnai, Nirit; Panush, Naomi; Dagan, David; Bader, Tarif; Hartal, Michael

2016-01-01

The Israel Defense Forces Medical Corps (IDF MC) institutional review board (IRB) is one of approximately 50 IRBs active in Israel. In addition to routine IRB considerations it must also address in its deliberations specific safeguards in place in the IDF to protect research volunteers in the military environment. In this report, we present the characteristics of the IDF IRB, including the unique circumstances that led to a 2008 change in the pre-IRB advisory and preparatory process (APP). We also present quantitative data on the IRB's throughput and outcomes, in order to provide a benchmark for other IRBs. We reviewed all relevant IDF regulations, both historical and current, pertaining to the structure, activity and oversight of the IRB and of medical research conducted in the IDF. Additionally, we analyzed the ethical review process for all research proposals submitted to the IDF APP between January 1, 2013 and December 31, 2015. In 2008 the IDF implemented several major changes which have had a substantial impact on the ethical regulation of military medical research. The period following these changes has seen a rise in the number of research proposals submitted to the IDF IRB annually. During the years 2013-2015, 377 research proposals entered the APP, of which 329 were deemed appropriate for IRB deliberation. Eight study protocols were granted waivers, 19 were rejected, and the remaining 302 were authorized. Overall, 345 of the 377 research proposals submitted (92 %) were ultimately cleared for execution; 310 of 329 proposals (94 %) deliberated by the IRB were authorized. The IRB required protocol revisions for 47 % of the research proposals, one-third of which were revisions directly associated with military-specific ethical precautions. Guided by the principles of protecting personal autonomy in the complex military setting, the IDF has implemented several unique measures aimed at maintaining the highest ethical standards in medical research. By sharing research approval process data similar to those presented here, medical institutions can help build and support a peer-based benchmarking process through which individual IRBs can appraise their own processes and approval rates.

Chinese ethics review system and Chinese medicine ethical review: past, present, and future.

PubMed

Li, En-Chang; Du, Ping; Ji, Ke-Zhou; Wang, Zhen

2011-11-01

The Chinese medical ethics committee and the ethical review system have made the following achievements: (1) enabled the institutionalization of medical ethics, (2) carried out the ethics review of Chinese medicine (CM) and integrative medicine extensively, (3) trained a large number of ethical professionals, (4) supported and protected the interests of patients and subjects, and (5) ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways: (1) to refine the relevant rules of ethical review, (2) to develop the relevant standards of the CM and integrative medicine ethical review, (3) to enhance the independence and authority of ethics committee, (4) to emphasize innovation and to discover and solve new problems, and (5) to increase international exchanges and improve relevant research.

Ethical Guidance for Disaster Response, Specifically Around Crisis Standards of Care: A Systematic Review.

PubMed

Leider, Jonathon P; DeBruin, Debra; Reynolds, Nicole; Koch, Angelica; Seaberg, Judy

2017-09-01

Terrorism, disease outbreaks, and other natural disasters and mass casualty events have pushed health care and public health systems to identify and refine emergency preparedness protocols for disaster response. Ethical guidance, alongside legal and medical frameworks, are increasingly common components of disaster response plans. To systematically review the prevalence and content of ethical guidance offered for disaster response, specifically around crisis standards of care (CSCs). We systematically indexed academic literature from PubMed, Google Scholar, and ISI Web of Science from 2012 to 2016. We searched for peer-reviewed articles that substantively engaged in discussion of ethical guidance for CSCs. Researchers screened potential articles for identification and discussion of ethical issues in CSC planning. We categorized and cataloged ethical concepts and principles. Of 580 peer-reviewed articles mentioning ethics and CSCs or disaster planning, 38 (6%) met selection criteria. The systematic review of the CSC ethics literature since 2012 showed that authors were primarily focused on the ethical justifications for CSC (n = 20) as well as a need for ethics guidelines for implementing CSCs; the ethical justifications for triage (n = 19), both as to which criteria to use and the appropriate processes by which to employ triage; and international issues (n = 17). In addition to these areas of focus, the scholarly literature included discussion of a number of other ethical issues, including duty to care (n = 11), concepts of a duty to plan (n = 8), utilitarianism (n = 5), moral distress (n = 4), professional norms (n = 3), reciprocity (n = 2), allocation criteria (n = 4), equity (n = 4), research ethics (n = 2), duty to steward resources (n = 2), social utility and social worth (n = 2), and a number of others (n = 20). Although public health preparedness efforts have paid increasing attention to CSCs in recent years, CSC plans have rarely been implemented within the United States to date, although some components are common (e.g., triage is used in US emergency departments regularly). Conversely, countries outside the United States more commonly implement CSCs within a natural disaster or humanitarian crisis response, and may offer significant insight into ethics and disaster response for US-based practitioners. This systematic review identifies the most oft-used and -discussed ethical concepts and principles used in disaster planning around CSCs. Although discussion of more nuanced issues (e.g., health equity) are present, the majority of items substantively engaging in ethical discussion around disaster planning do so regarding triage and why ethics is needed in disaster response generally. Public health implications. A significant evolution in disaster planning has occurred within the past decade; ethical theories and frameworks have been put to work. For ethical guidance to be useful, it must be practical and implementable. Although high-level, abstract frameworks were once prevalent in disaster planning-especially in the early days of pandemic planning-concerns about the ethically difficult concept of CSCs pervade scholarly articles. Ethical norms must be clearly stated and justified and practical guidelines ought to follow from them. Ethical frameworks should guide clinical protocols, but this requires that ethical analysis clarifies what strategies to use to honor ethical commitments and achieve ethical objectives. Such implementation issues must be considered well ahead of a disaster. As governments and health care systems plan for mass casualty events, ethical guidance that is theoretically sound and practically useful can-and should-form an important foundation from which to build practical guidance for responding to disasters with morally appropriate means.

A Scoping Study on the Ethics of Health Systems Research.

PubMed

Bachani, Abdulgafoor M; Rattani, Abbas; Hyder, Adnan A

2016-12-01

Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic. © 2016 John Wiley & Sons Ltd.

Ethical publishing in intensive care medicine: A narrative review

PubMed Central

Wiedermann, Christian J

2016-01-01

Ethical standards in the context of scientific publications are increasingly gaining attention. A narrative review of the literature concerning publication ethics was conducted as found in PubMed, Google Scholar, relevant news articles, position papers, websites and other sources. The Committee on Publication Ethics has produced guidelines and schedules for the handling of problem situations that have been adopted by professional journals and publishers worldwide as guidelines to authors. The defined requirements go beyond the disclosure of conflicts of interest or the prior registration of clinical trials. Recommendations to authors, editors and publishers of journals and research institutions were formulated with regard to issues of authorship, double publications, plagiarism, and conflicts of interest, with special attention being paid to unethical research behavior and data falsification. This narrative review focusses on ethical publishing in intensive care medicine. As scientific misconduct with data falsification damage patients and society, especially if fraudulent studies are considered important or favor certain therapies and downplay their side effects, it is important to ensure that only studies are published that have been carried out with highest integrity according to predefined criteria. For that also the peer review process has to be conducted in accordance with the highest possible scientific standards and making use of available modern information technology. The review provides the current state of recommendations that are considered to be most relevant particularly in the field of intensive care medicine. PMID:27652208

The Impact of Ethics Review on a Research-Led University Curriculum: Results of a Qualitative Study in Australia.

PubMed

Wynn, L L

2016-04-01

In the human sciences, a student research-centered pedagogy is constrained by institutional ethics review, yet there is little research on the impact of ethics review on research-led teaching. This article documents a range of ways that Australian universities are responding to ethics review of undergraduate human research. Forty teachers and administrators were interviewed at 14 universities using purposive sampling to document the range of ways teachers are avoiding ethics review or incorporating it into their curriculum. Some reported halting undergraduate research or evading ethics review, regarding it as meaningless bureaucracy divorced from actual ethical thinking. Those who incorporated ethics review into student research did so by collaborating with administrators. Institutions can facilitate research-led teaching by designing dedicated forms and decentralized review procedures for student research. © The Author(s) 2016.

Sewage epidemiology and illicit drug research: the development of ethical research guidelines.

PubMed

Prichard, Jeremy; Hall, Wayne; de Voogt, Pim; Zuccato, Ettore

2014-02-15

To discuss the need to develop ethical guidelines for researchers using sewage epidemiology to monitor drug use in the general population and specific precincts, including prisons, schools and workplaces. Describe current applications of sewage epidemiology, identify potential ethical risks associated with this science, and identify key means by which these risks may be mitigated through proportionate ethical guidance that allows this science to be fully developed. A rapidly advancing field of research is sewage epidemiology (SE) - the analysis of wastewater samples to monitor illicit drug use and other substances. Typically this research involves low ethical risks because individual participants cannot be identified and, consequently, review has been waived by human research ethics committees. In the absence of such oversight, ethical research guidelines are recommended for SE teams, peer reviewers and journal editors; guidelines will assist them to mitigate any risks in general population studies and studies of prisons, schools and workplaces. Potential harms include the stigmatisation of participants and, in the prison setting, austere policy responses to SE data that impact negatively upon inmate-participants. The risk of harm can be managed through research planning, awareness of the socio-political context in which results will be interpreted (or, in the case of media, sensationalised) and careful relations with industry partners. Ethical guidelines should be developed in consultation with SE scholars and be periodically amended. They should include publication processes that safeguard scientific rigour and be promulgated through existing research governance structures. Guidelines will assist to promote an ethical research culture among SE teams and scholars involved in the publication process and this will work to protect the reputation of the field. Copyright © 2014 Elsevier B.V. All rights reserved.

Factors influencing the effectiveness of research ethics committees.

PubMed

Schuppli, C A; Fraser, D

2007-05-01

Research ethics committees - animal ethics committees (AECs) for animal-based research and institutional research boards (IRBs) for human subjects - have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from (1) a preponderance of institutional and scientist members, (2) an intimidating atmosphere for community members and other minority members, (3) recruitment of community members who are affiliated with the institution and (4) members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees.

A Meta-analytic Comparison of Face-to-Face and Online Delivery in Ethics Instruction: The Case for a Hybrid Approach.

PubMed

Todd, E Michelle; Watts, Logan L; Mulhearn, Tyler J; Torrence, Brett S; Turner, Megan R; Connelly, Shane; Mumford, Michael D

2017-12-01

Despite the growing body of literature on training in the responsible conduct of research, few studies have examined the effectiveness of delivery formats used in ethics courses (i.e., face-to-face, online, hybrid). The present effort sought to address this gap in the literature through a meta-analytic review of 66 empirical studies, representing 106 ethics courses and 10,069 participants. The frequency and effectiveness of 67 instructional and process-based content areas were also assessed for each delivery format. Process-based contents were best delivered face-to-face, whereas contents delivered online were most effective when restricted to compliance-based instructional contents. Overall, hybrid courses were found to be most effective, suggesting that ethics courses are best delivered using a blend of formats and content areas. Implications and recommendations for future development of ethics education courses in the sciences are discussed.

Evaluating clinical ethics support in mental healthcare: a systematic literature review.

PubMed

Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

2015-06-01

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

A scoping study to identify opportunities to advance the ethical implementation and scale-up of HIV treatment as prevention: priorities for empirical research.

PubMed

Knight, Rod; Small, Will; Pakula, Basia; Thomson, Kimberly; Shoveller, Jean

2014-07-03

Despite the evidence showing the promise of HIV treatment as prevention (TasP) in reducing HIV incidence, a variety of ethical questions surrounding the implementation and "scaling up" of TasP have been articulated by a variety of stakeholders including scientists, community activists and government officials. Given the high profile and potential promise of TasP in combatting the global HIV epidemic, an explicit and transparent research priority-setting process is critical to inform ongoing ethical discussions pertaining to TasP. We drew on the Arksey and O'Malley framework for conducting scoping review studies as well as systematic approaches to identifying empirical and theoretical gaps within ethical discussions pertaining to population-level intervention implementation and scale up. We searched the health science database PubMed to identify relevant peer-reviewed articles on ethical and implementation issues pertaining to TasP. We included English language articles that were published after 2009 (i.e., after the emergence of causal evidence within this field) by using search terms related to TasP. Given the tendency for much of the criticism and support of TasP to occur outside the peer-reviewed literature, we also included grey literature in order to provide a more exhaustive representation of how the ethical discussions pertaining to TasP have and are currently taking place. To identify the grey literature, we systematically searched a set of search engines, databases, and related webpages for keywords pertaining to TasP. Three dominant themes emerged in our analysis with respect to the ethical questions pertaining to TasP implementation and scale-up: (a) balancing individual- and population-level interests; (b) power relations within clinical practice and competing resource demands within health care systems; (c) effectiveness considerations and socio-structural contexts of HIV treatment experiences within broader implementation contexts. Ongoing research and normative deliberation is required in order to successfully and ethically scale-up TasP within the continuum of HIV care models. Based on the results of this scoping review, we identify several ethical and implementation dimensions that hold promise for informing the process of scaling up TasP and that could benefit from new research.

A scoping study to identify opportunities to advance the ethical implementation and scale-up of HIV treatment as prevention: priorities for empirical research

PubMed Central

2014-01-01

Background Despite the evidence showing the promise of HIV treatment as prevention (TasP) in reducing HIV incidence, a variety of ethical questions surrounding the implementation and “scaling up” of TasP have been articulated by a variety of stakeholders including scientists, community activists and government officials. Given the high profile and potential promise of TasP in combatting the global HIV epidemic, an explicit and transparent research priority-setting process is critical to inform ongoing ethical discussions pertaining to TasP. Methods We drew on the Arksey and O’Malley framework for conducting scoping review studies as well as systematic approaches to identifying empirical and theoretical gaps within ethical discussions pertaining to population-level intervention implementation and scale up. We searched the health science database PubMed to identify relevant peer-reviewed articles on ethical and implementation issues pertaining to TasP. We included English language articles that were published after 2009 (i.e., after the emergence of causal evidence within this field) by using search terms related to TasP. Given the tendency for much of the criticism and support of TasP to occur outside the peer-reviewed literature, we also included grey literature in order to provide a more exhaustive representation of how the ethical discussions pertaining to TasP have and are currently taking place. To identify the grey literature, we systematically searched a set of search engines, databases, and related webpages for keywords pertaining to TasP. Results Three dominant themes emerged in our analysis with respect to the ethical questions pertaining to TasP implementation and scale-up: (a) balancing individual- and population-level interests; (b) power relations within clinical practice and competing resource demands within health care systems; (c) effectiveness considerations and socio-structural contexts of HIV treatment experiences within broader implementation contexts. Conclusion Ongoing research and normative deliberation is required in order to successfully and ethically scale-up TasP within the continuum of HIV care models. Based on the results of this scoping review, we identify several ethical and implementation dimensions that hold promise for informing the process of scaling up TasP and that could benefit from new research. PMID:24994501

Ethical review and informed consent in cardiovascular research reports in Argentina.

PubMed

Borracci, Raúl A; Calderón, Gustavo; Seoane, Martín R; Perez, Analía C; Doval, Hernán C

2008-05-01

Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research. To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34% responded that ethical review was not obtained, 23% reported as being exempt and 7% were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50% of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.

Perceptions about safety and risks in gender-based violence research: implications for the ethics review process.

PubMed

Sikweyiya, Yandisa; Jewkes, Rachel

2011-10-01

Does research on gender-based violence (GBV) pose greater than minimal risk to researchers and participants? This question needs to be understood particularly in light of hesitancy by Institutional Review Boards to approve research on GBV. The safety and risks of doing GBV studies and the implications for the ethical review process have not been a focus of much research. This qualitative study collected data through in-depth interviews with 12 experienced GBV researchers from various countries and a desk review. This paper explores researchers' interpretation of and meanings of the safety recommendations as provided in the WHO guidelines and whether there is empirical evidence on the presence of risks and safety concerns unique to GBV research. Informants raised a number of safety concerns about GBV research, yet in the interviews there were very few examples of problems having occurred, possibly because of the precautions applied. This paper argues that the notion that GBV studies carry greater than minimal risk when ethics precautions are followed is based on speculation, not evidence. It highlights the need for empirical evidence to support assertions of risk in research.

Ethics in clinical drug trial research in private practice.

PubMed

Beran, R G; Beran, M E

2006-09-01

Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process. Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed. The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards. Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.

AGU Launches Web Site for New Scientific Integrity and Professional Ethics Policy

NASA Astrophysics Data System (ADS)

Townsend, Randy

2013-03-01

AGU's Scientific Integrity and Professional Ethics policy, approved by the AGU Board of Directors and Council in December 2012, is now available online on a new Web site, http://ethics.agu.org. As the Web site states, the policy embodies a "set of guidelines for scientific integrity and professional ethics for the actions of the members and the governance of the Union in its internal activities; in its public persona; and most importantly, in the research and peer review processes of its scientific publications, its communications and outreach, and its scientific meetings."

Review of Instructional Approaches in Ethics Education.

PubMed

Mulhearn, Tyler J; Steele, Logan M; Watts, Logan L; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

2017-06-01

Increased investment in ethics education has prompted a variety of instructional objectives and frameworks. Yet, no systematic procedure to classify these varying instructional approaches has been attempted. In the present study, a quantitative clustering procedure was conducted to derive a typology of instruction in ethics education. In total, 330 ethics training programs were included in the cluster analysis. The training programs were appraised with respect to four instructional categories including instructional content, processes, delivery methods, and activities. Eight instructional approaches were identified through this clustering procedure, and these instructional approaches showed different levels of effectiveness. Instructional effectiveness was assessed based on one of nine commonly used ethics criteria. With respect to specific training types, Professional Decision Processes Training (d = 0.50) and Field-Specific Compliance Training (d = 0.46) appear to be viable approaches to ethics training based on Cohen's d effect size estimates. By contrast, two commonly used approaches, General Discussion Training (d = 0.31) and Norm Adherence Training (d = 0.37), were found to be considerably less effective. The implications for instruction in ethics training are discussed.

The Terri Schiavo case: legal, ethical, and medical perspectives.

PubMed

Perry, Joshua E; Churchill, Larry R; Kirshner, Howard S

2005-11-15

Although tragic, the plight of Terri Schiavo provides a valuable case study. The conflicts and misunderstandings surrounding her situation offer important lessons in medicine, law, and ethics. Despite media saturation and intense public interest, widespread confusion lingers regarding the diagnosis of persistent vegetative state, the judicial processes involved, and the appropriateness of the ethical framework used by those entrusted with Terri Schiavo's care. First, the authors review the current medical understanding of persistent vegetative state, including the requirements for patient examination, the differential diagnosis, and the practice guidelines of the American Academy of Neurology regarding artificial nutrition and hydration for patients with this diagnosis. Second, they examine the legal history, including the 2000 trial, the 2002 evidentiary hearing, and the subsequent appeals. The authors argue that the law did not fail Terri Schiavo, but produced the highest-quality evidence and provided the most judicial review of any end-of-life guardianship case in U.S. history. Third, they review alternative ethical frameworks for understanding the Terri Schiavo case and contend that the principle of respect for autonomy is paramount in this case and in similar cases. Far from being unusual, the manner in which Terri Schiavo's case was reviewed and the basis for the decision reflect a broad medical, legal, and ethical consensus. Greater clarity regarding the persistent vegetative state, less apprehension of the presumed mysteries of legal proceedings, and greater appreciation of the ethical principles at work are the chief benefits obtained from studying this provocative case.

Resisting the seduction of "ethics creep": using Foucault to surface complexity and contradiction in research ethics review.

PubMed

Guta, Adrian; Nixon, Stephanie A; Wilson, Michael G

2013-12-01

In this paper we examine "ethics creep", a concept developed by Haggerty (2004) to account for the increasing bureaucratization of research ethics boards and institutional review boards (REB/IRBs) and the expanding reach of ethics review. We start with an overview of the recent surge of academic interest in ethics creep and similar arguments about the prohibitive effect of ethics review. We then introduce elements of Michel Foucault's theoretical framework which are used to inform our analysis of empirical data drawn from a multi-phase study exploring the accessibility of community-engaged research within existing ethics review structures in Canada. First, we present how ethics creep emerged both explicitly and implicitly in our data. We then present data that demonstrate how REB/IRBs are experiencing their own form of regulation. Finally, we present data that situate ethics review alongside other trends affecting the academy. Our results show that ethics review is growing in some ways while simultaneously being constrained in others. Drawing on Foucauldian theory we reframe ethics creep as a repressive hypothesis which belies the complexity of the phenomenon it purports to explain. Our discussion complicates ethics creep by proposing an understanding of REB/IRBs that locates them at the intersection of various neoliberal discourses about the role of science, ethics, and knowledge production. Copyright © 2012 Elsevier Ltd. All rights reserved.

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine.

PubMed

Zhang, Cheng-Bin; Li, En-Chang

2018-04-01

Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

Ethical Review of Undergraduate Student Research Projects: A Proportionate, Transparent and Efficient Process?

ERIC Educational Resources Information Center

Hack, Catherine J.

2012-01-01

Undergraduate research projects in the life sciences encompass a broad range of studies, some of which may require the participation of human subjects or other activities which may raise ethical concerns. As universities are accountable for all projects undertaken under their auspices they must ensure that these projects adhere to legal…

Robot companions and ethics a pragmatic approach of ethical design.

PubMed

Cornet, Gérard

2013-12-01

From his experience as ethical expert for two Robot Companion prototype projects aiming at empowering older MCI persons to remain at home and to support their family carers, Gerard Cornet, Gerontologist, review the ethical rules, principles and pragmatic approaches in different cultures. The ethical process of these two funded projects, one European, Companionable (FP7 e-inclusion call1), the other French, Quo vadis (ANR tecsan) are described from the inclusion of the targeted end users in the process, to the assessment and ranking of their main needs and whishes to design the specifications, test the performance expected. Obstacles to turn round and limits for risks evaluation (directs or implicit), acceptability, utility, respect of intimacy and dignity, and balance with freedom and security and frontiers to artificial intelligence are discussed As quoted in the discussion with the French and Japanese experts attending the Toulouse Robotics and medicine symposium (March 26th 2011), the need of a new ethical approach, going further the present ethical rules is needed for the design and social status of ethical robots, having capacity cas factor of progress and global quality of innovation design in an ageing society.

Ethical implications of digital images for teaching and learning purposes: an integrative review.

PubMed

Kornhaber, Rachel; Betihavas, Vasiliki; Baber, Rodney J

2015-01-01

Digital photography has simplified the process of capturing and utilizing medical images. The process of taking high-quality digital photographs has been recognized as efficient, timely, and cost-effective. In particular, the evolution of smartphone and comparable technologies has become a vital component in teaching and learning of health care professionals. However, ethical standards in relation to digital photography for teaching and learning have not always been of the highest standard. The inappropriate utilization of digital images within the health care setting has the capacity to compromise patient confidentiality and increase the risk of litigation. Therefore, the aim of this review was to investigate the literature concerning the ethical implications for health professionals utilizing digital photography for teaching and learning. A literature search was conducted utilizing five electronic databases, PubMed, Embase (Excerpta Medica Database), Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, and Scopus, limited to English language. Studies that endeavored to evaluate the ethical implications of digital photography for teaching and learning purposes in the health care setting were included. The search strategy identified 514 papers of which nine were retrieved for full review. Four papers were excluded based on the inclusion criteria, leaving five papers for final analysis. Three key themes were developed: knowledge deficit, consent and beyond, and standards driving scope of practice. The assimilation of evidence in this review suggests that there is value for health professionals utilizing digital photography for teaching purposes in health education. However, there is limited understanding of the process of obtaining and storage and use of such mediums for teaching purposes. Disparity was also highlighted related to policy and guideline identification and development in clinical practice. Therefore, the implementation of policy to guide practice requires further research.

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

PubMed

Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

2018-02-27

Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.

[Posthumous sperm procurement and use--ethical and legal dilemmas].

PubMed

Crha, I; Dostál, J; Ventruba, P; Kudela, M; Záková, J

2004-07-01

To present a review of bioethical discussion and recommendations concerning posthumous sperm procurement and postmortem parenthood. Review article. Department of Obstetrics and Gynecology, Masaryk University, Brno, Department of Obstetrics and Gynecology, Palacky University, Olomouc. Literature search in Database of Abstracts of Reviews of the Evidence (DARE) and MEDLINEplus. Posthumous sperm procurement and cryopreservation must be performed within 36 hours after death. To established appropriate medical practice, it is important to consider all stakeholders in the decision-making process: the deceased, the requesting party, the child, the physician and the society. There are only few legislative measures concerning postmortem parenthood and posthumous sperm procurement. The essential elements for postmortem reproduction are: judicial order, ethics committee approval, bereavement period of at least 6 month before use. Posthumous sperm procurement is fraught with ethical and legal implications. All stakeholder should be considered. Society for reproductive medicine should prepare acceptable standard protocol.

Commodifying animals: ethical issues in genetic engineering of animals.

PubMed

Almond, B

2000-03-01

The genetic modification of living beings raises special ethical concerns which go beyond general discussion of animal rights or welfare. Although the goals may be similar, biotechnology has accelerated the process of modification of types traditionally carried out by cross-breeding. These changes are discussed in relation to two areas: biomedicine, and animal husbandry. Alternative ethical approaches are reviewed, and it is argued that the teleological thesis underlying virtue ethics has special relevance here. The case for and the case against genetic engineering and patenting of life-forms are examined, and conclusions are drawn which favour regulation, caution and respect for animals and animal species.

Pandemic influenza preparedness: an ethical framework to guide decision-making.

PubMed

Thompson, Alison K; Faith, Karen; Gibson, Jennifer L; Upshur, Ross E G

2006-12-04

Planning for the next pandemic influenza outbreak is underway in hospitals across the world. The global SARS experience has taught us that ethical frameworks to guide decision-making may help to reduce collateral damage and increase trust and solidarity within and between health care organisations. Good pandemic planning requires reflection on values because science alone cannot tell us how to prepare for a public health crisis. In this paper, we present an ethical framework for pandemic influenza planning. The ethical framework was developed with expertise from clinical, organisational and public health ethics and validated through a stakeholder engagement process. The ethical framework includes both substantive and procedural elements for ethical pandemic influenza planning. The incorporation of ethics into pandemic planning can be helped by senior hospital administrators sponsoring its use, by having stakeholders vet the framework, and by designing or identifying decision review processes. We discuss the merits and limits of an applied ethical framework for hospital decision-making, as well as the robustness of the framework. The need for reflection on the ethical issues raised by the spectre of a pandemic influenza outbreak is great. Our efforts to address the normative aspects of pandemic planning in hospitals have generated interest from other hospitals and from the governmental sector. The framework will require re-evaluation and refinement and we hope that this paper will generate feedback on how to make it even more robust.

12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

The ethics of donor human milk banking.

PubMed

Arnold, Lois D W

2006-01-01

This case study of donor human milk banking and the ethics that govern interested parties is the first time the ethics of donor milk banking has been explored. Two different models of ethics and their direct impact on donor milk banking are examined: biomedical ethics and public health ethics. How these models and principles affect different aspects of donor human milk banking and the parties involved in the delivery of this service are elucidated. Interactions of parties with each other and how the quality and type of interaction affects the ethical delivery of donor milk banking services are described. Crystallization is at the heart of the qualitative methodology used. Writing as a method of inquiry, an integrative research review, and personal experience are the three methods involved in the crystallization process. Suggestions are made for improving access and knowledge of banked donor human milk, a valuable public health resource.

Ethical issues in research.

PubMed

Artal, Raul; Rubenfeld, Sheldon

2017-08-01

Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles. Copyright © 2017. Published by Elsevier Ltd.

The history of ethical decision making in neonatal intensive care.

PubMed

Placencia, Frank X; McCullough, Laurence B

2011-01-01

Neonatal ethics has focused on 2 questions: is withholding potentially live-saving treatment from neonates ethically justified? and if so, who has the authority to decide? This article details how these questions developed and provides a description of the possible answers. In the first section, we review a selection of seminal articles by noted authors in the fields of ethics, medicine, and law. The second section provides a detailed account of the development of the Baby Doe Regulations and the impact they had on neonatal ethics, with particular attention to the emergence of the Best Interest Standard as a guideline for decision making. In the last section, we review the landmark position statements by the American Academy of Pediatric (AAP), and the focus on evidence-based decision making. We conclude that forgoing life-saving treatment is ethically justified. However, this requires a rigorous evidence-based process and is limited by the Best Interest Standard. The second question is more difficult to answer, but we feel that in light of legal limitations, physicians acting as both the infant advocate and a proxy for the state, decide what falls in the range of acceptable treatment options, with the parents free to choose within that range.

Research Ethics II: Mentoring, Collaboration, Peer Review, and Data Management and Ownership

ERIC Educational Resources Information Center

Horner, Jennifer; Minifie, Fred D.

2011-01-01

Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics II", the authors review the RCR domains of mentoring,…

A Selected Review of the Underpinnings of Ethics for Human Performance Technology Professionals--Part One: Key Ethical Theories and Research.

ERIC Educational Resources Information Center

Dean, Peter J.

1993-01-01

Provides a review of the key ethical theories and relevant empirical research relating to the practice of human performance technology. Topics addressed include ethics, morals, business ethics, ethics officers, empiricism versus normative ethical theory, consequentialism, utilitarianism, nonconsequentialism, Kohlberg model of cognitive moral…

Ethical issues in using Twitter for public health surveillance and research: developing a taxonomy of ethical concepts from the research literature.

PubMed

Conway, Mike

2014-12-22

The rise of social media and microblogging platforms in recent years, in conjunction with the development of techniques for the processing and analysis of "big data", has provided significant opportunities for public health surveillance using user-generated content. However, relatively little attention has been focused on developing ethically appropriate approaches to working with these new data sources. Based on a review of the literature, this study seeks to develop a taxonomy of public health surveillance-related ethical concepts that emerge when using Twitter data, with a view to: (1) explicitly identifying a set of potential ethical issues and concerns that may arise when researchers work with Twitter data, and (2) providing a starting point for the formation of a set of best practices for public health surveillance through the development of an empirically derived taxonomy of ethical concepts. We searched Medline, Compendex, PsycINFO, and the Philosopher's Index using a set of keywords selected to identify Twitter-related research papers that reference ethical concepts. Our initial set of queries identified 342 references across the four bibliographic databases. We screened titles and abstracts of these references using our inclusion/exclusion criteria, eliminating duplicates and unavailable papers, until 49 references remained. We then read the full text of these 49 articles and discarded 36, resulting in a final inclusion set of 13 articles. Ethical concepts were then identified in each of these 13 articles. Finally, based on a close reading of the text, a taxonomy of ethical concepts was constructed based on ethical concepts discovered in the papers. From these 13 articles, we iteratively generated a taxonomy of ethical concepts consisting of 10 top level categories: privacy, informed consent, ethical theory, institutional review board (IRB)/regulation, traditional research vs Twitter research, geographical information, researcher lurking, economic value of personal information, medical exceptionalism, and benefit of identifying socially harmful medical conditions. In summary, based on a review of the literature, we present a provisional taxonomy of public health surveillance-related ethical concepts that emerge when using Twitter data.

Ethical Issues in Using Twitter for Public Health Surveillance and Research: Developing a Taxonomy of Ethical Concepts From the Research Literature

PubMed Central

2014-01-01

Background The rise of social media and microblogging platforms in recent years, in conjunction with the development of techniques for the processing and analysis of “big data”, has provided significant opportunities for public health surveillance using user-generated content. However, relatively little attention has been focused on developing ethically appropriate approaches to working with these new data sources. Objective Based on a review of the literature, this study seeks to develop a taxonomy of public health surveillance-related ethical concepts that emerge when using Twitter data, with a view to: (1) explicitly identifying a set of potential ethical issues and concerns that may arise when researchers work with Twitter data, and (2) providing a starting point for the formation of a set of best practices for public health surveillance through the development of an empirically derived taxonomy of ethical concepts. Methods We searched Medline, Compendex, PsycINFO, and the Philosopher’s Index using a set of keywords selected to identify Twitter-related research papers that reference ethical concepts. Our initial set of queries identified 342 references across the four bibliographic databases. We screened titles and abstracts of these references using our inclusion/exclusion criteria, eliminating duplicates and unavailable papers, until 49 references remained. We then read the full text of these 49 articles and discarded 36, resulting in a final inclusion set of 13 articles. Ethical concepts were then identified in each of these 13 articles. Finally, based on a close reading of the text, a taxonomy of ethical concepts was constructed based on ethical concepts discovered in the papers. Results From these 13 articles, we iteratively generated a taxonomy of ethical concepts consisting of 10 top level categories: privacy, informed consent, ethical theory, institutional review board (IRB)/regulation, traditional research vs Twitter research, geographical information, researcher lurking, economic value of personal information, medical exceptionalism, and benefit of identifying socially harmful medical conditions. Conclusions In summary, based on a review of the literature, we present a provisional taxonomy of public health surveillance-related ethical concepts that emerge when using Twitter data. PMID:25533619

Ethical dilemmas in community-based participatory research: recommendations for institutional review boards.

PubMed

Flicker, Sarah; Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

2007-07-01

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR.

Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

PubMed Central

Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

2007-01-01

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR. PMID:17436114

Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study. Contribution of the Primary Health Care Informatics Working Group.

PubMed

Liyanage, H; Liaw, S-T; Di Iorio, C T; Kuziemsky, C; Schreiber, R; Terry, A L; de Lusignan, S

2016-11-10

Privacy, ethics, and data access issues pose significant challenges to the timely delivery of health research. Whilst the fundamental drivers to ensure that data access is ethical and satisfies privacy requirements are similar, they are often dealt with in varying ways by different approval processes. To achieve a consensus across an international panel of health care and informatics professionals on an integrated set of privacy and ethics principles that could accelerate health data access in data-driven health research projects. A three-round consensus development process was used. In round one, we developed a baseline framework for privacy, ethics, and data access based on a review of existing literature in the health, informatics, and policy domains. This was further developed using a two-round Delphi consensus building process involving 20 experts who were members of the International Medical Informatics Association (IMIA) and European Federation of Medical Informatics (EFMI) Primary Health Care Informatics Working Groups. To achieve consensus we required an extended Delphi process. The first round involved feedback on and development of the baseline framework. This consisted of four components: (1) ethical principles, (2) ethical guidance questions, (3) privacy and data access principles, and (4) privacy and data access guidance questions. Round two developed consensus in key areas of the revised framework, allowing the building of a newly, more detailed and descriptive framework. In the final round panel experts expressed their opinions, either as agreements or disagreements, on the ethics and privacy statements of the framework finding some of the previous round disagreements to be surprising in view of established ethical principles. This study develops a framework for an integrated approach to ethics and privacy. Privacy breech risk should not be considered in isolation but instead balanced by potential ethical benefit.

Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research. PMID:22347696

Ethical issues experienced by healthcare workers in nursing homes: Literature review.

PubMed

Preshaw, Deborah Hl; Brazil, Kevin; McLaughlin, Dorry; Frolic, Andrea

2016-08-01

Ethical issues are increasingly being reported by care-providers; however, little is known about the nature of these issues within the nursing home. Ethical issues are unavoidable in healthcare and can result in opportunities for improving work and care conditions; however, they are also associated with detrimental outcomes including staff burnout and moral distress. The purpose of this review was to identify prior research which focuses on ethical issues in the nursing home and to explore staffs' experiences of ethical issues. Using a systematic approach based on Aveyard (2014), a literature review was conducted which focused on ethical and moral issues, nurses and nursing assistants, and the nursing home. The most salient themes identified in the review included clashing ethical principles, issues related to communication, lack of resources and quality of care provision. The review also identified solutions for overcoming the ethical issues that were identified and revealed the definitional challenges that permeate this area of work. The review highlighted a need for improved ethics education for care-providers. © The Author(s) 2015.

Institutional ethics review of clinical study agreements

PubMed Central

DuVal, G

2004-01-01

Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review. PMID:14872068

Research ethics policies and practices in health research institutions in sub-Saharan African countries: results of a questionnaire-based survey.

PubMed

Zielinski, Chris; Kebede, Derege; Mbondji, Peter Ebongue; Sanou, Issa; Kouvividila, Wenceslas; Lusamba-Dikassa, Paul-Samson

2014-05-01

To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries. A structured questionnaire was used to solicit information on research ethics from health research institutions. Forty-two sub-Saharan African countries. Key informants from the health research institutions. Existence of institutional ethics review policies and mechanisms. About half (51%) of respondent institutions reported having policies on research ethics and 58% had written policies requiring that researchers obtain informed consent of research participants. About one-third of respondent institutions (34%) had established ethics review committees, 42% required that studies went through ethics review committees and 46% had linkages with national or regional ethics organisations. Regarding operating procedures for ethics review committees, 53% had adopted standard operating procedures. Less than one-quarter of respondent institutions reported having policies in place to monitor ongoing research. Of the institutions that monitored ongoing research, 34% did an annual ethical review and 74% required a periodic written report. Only 36% provided any type of ethics training for staff, including those conducting health research and those who were not members of the ethics review committee. There are substantial gaps in the capacity of health research institutions in the WHO African Region to undertake ethical review of studies before, during and after studies conducted. There is a need to strengthen such capacity in order to ensure the wellbeing of individuals enrolled in studies and that of communities that host these studies. © The Royal Society of Medicine.

The use of performance standards by AAALAC International to evaluate ethical review in European institutions.

PubMed

Guillen, Javier

2010-02-01

During the past several decades, society has become increasingly concerned about the welfare of animals used in research. Today, the public asks scientists to justify the use of research animals and to be accountable for their welfare. Research institutions, government bodies and other regulatory authorities have developed mechanisms to ensure that researchers follow the principles of the 3Rs and use and care for research animals in an ethical manner. Additionally, organizations such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) have developed voluntary programs that can help researchers to ensure that they are caring for research animals appropriately. The author discusses how AAALAC International uses performance standards to evaluate the ethical review processes of European institutions.

What makes public health studies ethical? Dissolving the boundary between research and practice.

PubMed

Willison, Donald J; Ondrusek, Nancy; Dawson, Angus; Emerson, Claudia; Ferris, Lorraine E; Saginur, Raphael; Sampson, Heather; Upshur, Ross

2014-08-08

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond.

A Comparison of General Medical and Clinical Ethics Consultations: What Can We Learn From Each Other?

PubMed Central

Geppert, Cynthia M.A.; Shelton, Wayne N.

2012-01-01

Despite the emergence of clinical ethics consultation as a clinical service in recent years, little is known about how clinical ethics consultation differs from, or is the same as, other medical consultations. A critical assessment of the similarities and differences between these 2 types of consultations is important to help the medical community appreciate ethics consultation as a vital service in today's health care setting. Therefore, this Special Article presents a comparison of medical and clinical ethics consultations in terms of fundamental goals of consultation, roles of consultants, and methodologic approaches to consultation, concluding with reflections on important lessons about the physician-patient relationship and medical education that may benefit practicing internists. Our aim is to examine ethics consultation as a clinical service integral to the medical care of patients. Studies for this analysis were obtained through the PubMed database using the keywords ethics consultation, medical consultation, ethics consults, medical consults, ethics consultants, and medical consultants. All English-language articles published from 1970 through August 2011 that pertained to the structure and process of medical and ethics consultation were reviewed. PMID:22469350

Curricular Approaches in Research Ethics Education: Reflecting on More and Less Effective Practices in Instructional Content.

PubMed

Torrence, Brett S; Watts, Logan L; Mulhearn, Tyler J; Turner, Megan R; Todd, E Michelle; Mumford, Michael D; Connelly, Shane

2017-01-01

Over the past decade, the effectiveness of ethics education programs has increased with regard to trainee outcomes, such as knowledge, awareness, and ethical decision making. However, despite the overall improvement in training effectiveness, considerable variability still exists across programs. One potential source of variability arises from the substantial range in instructional training content utilized across ethics training courses. The goal of the present effort was to clarify which approaches in ethics education result in positive training outcomes through the identification of instructional content themes. Through a qualitative review of ethics training courses, we identified key themes in instructional content curriculum associated with effective courses: domain-general, domain-specific, standard compliance, professionalism, and process-based. In addition, we identified key themes associated with less effective courses: mixed-specificity, narrow coverage, and idealized ethics. Descriptions and key characteristics of each theme along with example courses are provided. Implications of the content themes for ethics education are discussed.

Is mandatory research ethics reviewing ethical?

PubMed

Dyck, Murray; Allen, Gary

2013-08-01

Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen.

Supporting ethical competence of nurses during recruitment and performance reviews - the role of the nurse leader.

PubMed

Poikkeus, Tarja; Leino-Kilpi, Helena; Katajisto, Jouko

2014-09-01

The aim of this study was to analyse how nurse leaders support the ethical competence of nurses during recruitment and performance reviews. Ethical competence of nurses refers to ethical behaviour and action requiring ethical knowledge and reflection. Nurse leaders have a key role in supporting the ethical competence of nurses, but little is known about just how this should be done. The data were collected using a structured questionnaire and analysed statistically. The target sample consisted of nurse leaders (n = 198) from two university hospitals in two healthcare districts in Finland. Nurse leaders support the ethical competence of nurses more often during performance reviews than during recruitment. During recruitment, nurse leaders ensure the ethical behaviour and knowledge of nurses to varying degrees. During performance reviews, nurse leaders ensure that nurses meet the requirements for collegiality and comply with ethical guidelines and that they do so according to nursing values and principles. There seems to be a need to examine and improve support for the ethical competence of nurses, both during recruitment and performance reviews. Future priorities should include a focus on supporting the ethical knowledge, reflection and behaviour of nurses. An important aspect in terms of supporting the ethical competence of nurses has to do with the ethical knowledge and education of nurse leaders and organisational policies or recommendations for ethical support. © 2013 John Wiley & Sons Ltd.

Fitting Square Pegs into round Holes: Doing Qualitative Nursing Research in a Quantitative World.

PubMed

Newton, Lorelei; Kimpson, Sally

2014-09-01

The authors, as doctoral candidates and registered nurses, took on a qualitative research project investigating nursing practice in a research-intensive organization. Their aims were to explore and describe how nurses in the ambulatory care setting assist patients and families, including how nursing practice was carried out, constraints to practice, and the influence of the interprofessional milieu. Their first finding, in part because of the qualitative research design used, concerned the potential impact of the organizational ethics review process on the project. The authors discuss how the language, definition of risk, and notion of informed consent articulated in the organizational review process influenced both the research timeline and (potentially) the study itself. While not dismissing the value of ethics review, they explore the tension of overlaying generic criteria for quantitative research, specifically randomized controlled trials, on nursing research from other traditions. Copyright© by Ingram School of Nursing, McGill University.

Applying the institutional review board data repository approach to manage ethical considerations in evaluating and studying medical education

PubMed Central

Thayer, Erin K.; Rathkey, Daniel; Miller, Marissa Fuqua; Palmer, Ryan; Mejicano, George C.; Pusic, Martin; Kalet, Adina; Gillespie, Colleen; Carney, Patricia A.

2016-01-01

Issue Medical educators and educational researchers continue to improve their processes for managing medical student and program evaluation data using sound ethical principles. This is becoming even more important as curricular innovations are occurring across undergraduate and graduate medical education. Dissemination of findings from this work is critical, and peer-reviewed journals often require an institutional review board (IRB) determination. Approach IRB data repositories, originally designed for the longitudinal study of biological specimens, can be applied to medical education research. The benefits of such an approach include obtaining expedited review for multiple related studies within a single IRB application and allowing for more flexibility when conducting complex longitudinal studies involving large datasets from multiple data sources and/or institutions. In this paper, we inform educators and educational researchers on our analysis of the use of the IRB data repository approach to manage ethical considerations as part of best practices for amassing, pooling, and sharing data for educational research, evaluation, and improvement purposes. Implications Fostering multi-institutional studies while following sound ethical principles in the study of medical education is needed, and the IRB data repository approach has many benefits, especially for longitudinal assessment of complex multi-site data. PMID:27443407

Ethical dimensions of paediatric nursing: A rapid evidence assessment.

PubMed

Bagnasco, Annamaria; Cadorin, Lucia; Barisone, Michela; Bressan, Valentina; Iemmi, Marina; Prandi, Marzia; Timmins, Fiona; Watson, Roger; Sasso, Loredana

2018-02-01

Paediatric nurses often face complex situations requiring decisions that sometimes clash with their own values and beliefs, or with the needs of the children they care for and their families. Paediatric nurses often use new technology that changes the way they provide care, but also reduces their direct interaction with the child. This may generate ethical issues, which nurses should be able to address in the full respect of the child. Research question and objectives: The purpose of this review is to describe the main ethical dimensions of paediatric nursing. Our research question was, 'What are the most common ethical dimensions and competences related to paediatric nursing?' A rapid evidence assessment. According to the principles of the rapid evidence assessment, we searched the PubMed, SCOPUS and CINAHL databases for papers published between January 2001 and March 2015. These papers were then independently read by two researchers and analysed according to the inclusion criteria. Ethical considerations: Since this was a rapid evidence assessment, no approval from the ethics committee was required. Ten papers met our inclusion criteria. Ethical issues in paediatric nursing were grouped into three areas: (a) ethical issues in paediatric care, (b) social responsibility and (c) decision-making process. Few studies investigate the ethical dimensions and aspects of paediatric nursing, and they are mainly qualitative studies conducted in critical care settings based on nurses' perceptions and experiences. Paediatric nurses require specific educational interventions to help them resolve ethical issues, contribute to the decision-making process and fulfil their role as advocates of a vulnerable population (i.e. sick children and their families). Further research is needed to investigate how paediatric nurses can improve the involvement of children and their families in decision-making processes related to their care plan.

Navigating the IRB: The Ethics of SoTL

ERIC Educational Resources Information Center

Martin, Ryan C.

2013-01-01

This chapter discusses Institutional Review Boards (IRBs) as they apply to the SoTL. Specifically, it describes when SoTL projects must receive IRB approval, why they must get IRB approval, the review process, and some special issues of concern with regard to SoTL.

Research Ethics Education for Community-Engaged Research: A Review and Research Agenda

PubMed Central

Anderson, Emily E.; Solomon, Stephanie; Heitman, Elizabeth; DuBois, James M.; Fisher, Celia B.; Kost, Rhonda G.; Lawless, Mary Ellen; Ramsey, Cornelia; Jones, Bonnie; Ammerman, Alice; Ross, Lainie Friedman

2012-01-01

Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR. PMID:22565579

Professional Ethics for Digital Age Psychiatry: Boundaries, Privacy, and Communication.

PubMed

Sabin, James E; Harland, Jonathan Clark

2017-09-01

Internet and social media use continue to expand rapidly. Many patients and psychiatrists are bringing digital technologies into the treatment process, but relatively little attention has been paid to the ethical challenges in doing this. This review presents ethical guidelines for psychiatry in the digital age. Surveys demonstrate that patients are eager to make digital technologies part of their treatment. Substantial numbers search for professional and personal information about their therapists. Attitudes among psychiatrists about using digital technologies with patients range from dread to enthusiastic adoption. Digital technologies create four major ethical challenges for psychiatry: managing clinical boundaries; maintaining privacy and confidentiality; establishing realistic expectations regarding digital communications; and upholding professional ideals. Traditional ethical expectations are valid for the evolving digital arena, but guidance must be adapted for actual application in practice.

Dyshormonia Iatrogenica: crossroads of medicine, malpractice law, and professional ethics in clinical endocrinology.

PubMed

Goldberg, Philip A; Varriale, David J; Mercurio, Mark R

2012-01-01

To present 2 challenging cases of patients who request endocrine therapies that their physician considers to be outside of the standard of care. With these complex cases as a backdrop, we explore the constructs of medicine, malpractice law, and professional ethics that guide physicians' medical decision-making processes. These cases illustrate a common conundrum for clinical endocrinologists, who often find themselves struggling to balance patient satisfaction and well-being with generally accepted standards of medical care. From the perspective of a malpractice lawyer, we review the keys to limiting medicolegal liability, with emphasis on thorough documentation, informed consent, and effective doctor-patient communication. We then review the constructs of professional ethics that guide patient care, with emphasis on virtues of the "good physician," patients' right to self-determination, and paternalism. Finally, we explore some justifications for a compassionate physician to refuse a patient's desired treatment plan. In the end, we hope that this manuscript helps to facilitate best medical, legal, professional, and ethical practices of clinical endocrinology.

Protecting peer review: correspondence chronology and ethical analysis regarding Logothetis vs. Shmuel and Leopold.

PubMed

Fox, Peter T; Bullmore, Ed; Bandettini, Peter A; Lancaster, Jack L

2009-02-01

Editors of scientific journals are ethically bound to provide a fair and impartial peer-review process and to protect the rights of contributing authors to publish research results. If, however, a dispute arises among investigators regarding data ownership and the right to publish, the ethical responsibilities of journal editors become more complex. The editors of Human Brain Mapping recently had the unusual experience of learning of an ongoing dispute regarding data-access rights pertaining to a manuscript already accepted for publication. Herein the editors describe the nature of the dispute, the steps taken to explore and resolve the conflict, and discuss the ethical principles that govern such circumstances. Drawing on this experience and with the goal of avoiding future controversies, the editors have formulated a Data Rights Policy and a Data Rights Procedure for Human Brain Mapping. Human Brain Mapping adopts this policy effective immediately and respectfully suggests that other journals consider adopting this or similar policies.

The job of 'ethics committees'.

PubMed

Moore, Andrew; Donnelly, Andrew

2015-11-13

What should authorities establish as the job of ethics committees and review boards? Two answers are: (1) review of proposals for consistency with the duly established and applicable code and (2) review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Pandemic influenza preparedness: an ethical framework to guide decision-making

PubMed Central

Thompson, Alison K; Faith, Karen; Gibson, Jennifer L; Upshur, Ross EG

2006-01-01

Background Planning for the next pandemic influenza outbreak is underway in hospitals across the world. The global SARS experience has taught us that ethical frameworks to guide decision-making may help to reduce collateral damage and increase trust and solidarity within and between health care organisations. Good pandemic planning requires reflection on values because science alone cannot tell us how to prepare for a public health crisis. Discussion In this paper, we present an ethical framework for pandemic influenza planning. The ethical framework was developed with expertise from clinical, organisational and public health ethics and validated through a stakeholder engagement process. The ethical framework includes both substantive and procedural elements for ethical pandemic influenza planning. The incorporation of ethics into pandemic planning can be helped by senior hospital administrators sponsoring its use, by having stakeholders vet the framework, and by designing or identifying decision review processes. We discuss the merits and limits of an applied ethical framework for hospital decision-making, as well as the robustness of the framework. Summary The need for reflection on the ethical issues raised by the spectre of a pandemic influenza outbreak is great. Our efforts to address the normative aspects of pandemic planning in hospitals have generated interest from other hospitals and from the governmental sector. The framework will require re-evaluation and refinement and we hope that this paper will generate feedback on how to make it even more robust. PMID:17144926

Technology and its ethics in nursing and caring journals: An integrative literature review.

PubMed

Korhonen, Eila-Sisko; Nordman, Tina; Eriksson, Katie

2015-08-01

Over the past 20 years, the impact of technology has increased significantly in health care. The diversity of technology is growing and its knowledge scattered. The concept of technology is ambiguous in caring and nursing sciences and its ethics remains unidentified. To find evidence on how the concept of technology and its ethics are defined in caring and nursing sciences and practice. The purpose of this study is to describe and summarize the concept of technology and its ethics in the past nursing and caring literature. The integrative literature review of the past nursing and caring literature. The data were collected from caring and nursing journal articles from 2000 to 2013 focusing on technology and its ethics.The results were summarized and themed. Technology as a concept has three implications. First, technology is devices and products, including ICT and advanced, simple and assistive technology. Second, technology refers to a process consisting of methods for helping people. Third, technology as a service indicates the production of care by technology. The ethics of technology has not been established as a guiding principle. Some studies excluded ethical reflection completely. Many studies discussed the ethics of technology as benefits such as improved communication and symptoms management, and the simple use of e-health services whilst others remained critical presenting ethical problems such as unwillingness and the inability to use technology, or conflicts with human aspects or questions of inequality. In conclusion, this study indicates that technology as a concept is described diversely. The relation between technology and ethics is not a truism. Despite some evidence, more is needed to promote ethical care when using technology. © The Author(s) 2014.

Ethical, legal, and societal issues and recommendations for controlled and uncontrolled DCD.

PubMed

Haase, Bernadette; Bos, Michael; Boffa, Catherine; Lewis, Penney; Rudge, Chris; Valero, Ricard; Wind, Tineke; Wright, Linda

2016-07-01

This report deals with organ retrieval procedures in both controlled and uncontrolled DCD, looking at the ethical, legal, and psychosocial aspects during the different phases of the process. A recently published report by the UK Donation Ethics Committee (UKDEC) has served as an important reference document to outline the steps in the controlled DCD patient-donor pathway (Academy of Medical Royal Colleges. UK Donation Ethics Committee. An ethical framework for controlled donation after circulatory death. December 2011). For uncontrolled DCD, the UKDEC pathway description was adapted. At the 6th International Conference in Organ Donation held in Paris in 2013, an established expert European Working Group reviewed the UKDEC reports, which were then considered along with the available published literature. Along this pathway, the crucial ethical, legal, and psychosocial aspects have been flagged, and relevant recommendations have been formulated based on a consensus of the working group. © 2015 Steunstichting ESOT.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hourdequin, Marion, E-mail: Marion.Hourdequin@ColoradoCollege.edu; Department of Philosophy, Colorado College, 14 E. Cache La Poudre St., Colorado Springs, CO 80903; Landres, Peter

Traditional mechanisms for public participation in environmental impact assessment under U.S. federal law have been criticized as ineffective and unable to resolve conflict. As these mechanisms are modified and new approaches developed, we argue that participation should be designed and evaluated not only on practical grounds of cost-effectiveness and efficiency, but also on ethical grounds based on democratic ideals. In this paper, we review and synthesize modern democratic theory to develop and justify four ethical principles for public participation: equal opportunity to participate, equal access to information, genuine deliberation, and shared commitment. We then explore several tensions that are inherentmore » in applying these ethical principles to public participation in EIA. We next examine traditional NEPA processes and newer collaborative approaches in light of these principles. Finally, we explore the circumstances that argue for more in-depth participatory processes. While improved EIA participatory processes do not guarantee improved outcomes in environmental management, processes informed by these four ethical principles derived from democratic theory may lead to increased public engagement and satisfaction with government agency decisions. - Highlights: Black-Right-Pointing-Pointer Four ethical principles based on democratic theory for public participation in EIA. Black-Right-Pointing-Pointer NEPA and collaboration offer different strengths in meeting these principles. Black-Right-Pointing-Pointer We explore tensions inherent in applying these principles. Black-Right-Pointing-Pointer Improved participatory processes may improve public acceptance of agency decisions.« less

Quality of publication ethics in the instructions to the authors of Iranian journals of medical sciences.

PubMed

Salamat, Fatemeh; Sobhani, Abdol-Rasoul; Mallaei, Mahin

2013-03-01

Providing a perfect instruction to authors can prevent most potential publication ethics errors. This study was conducted to determine the quality of ethical considerations in the instructions to the authors of Iranian research scientific journals of medical sciences (accredited by the Commission for Accreditation and Improvement of Iranian Medical Journals) in October 2011. Checklist items (n=15) were extracted from the national manual of ethics in medical research publications, and the validity of the manual of ethics was assessed. All the accredited Iranian journals of medical sciences (n=198) were entered into the study. The instructions to the authors of 160 accredited Iranian journals were available online and were reviewed. The ANOVA and Kendall Correlation coefficient were performed to analyze the results. A total of 76 (47.5%) of the 160 journals were in English and 84 (52.5%) were in Farsi. The most frequently mentioned items related to publication ethics comprised "commitment not to send manuscripts to other journals and re-publish manuscripts" (85%, 83.8%), "aim and scope" of the journal (81.9%), "principles of medical ethics in the use of human samples" (74.4%), and "review process" (74.4%). On the other hand, the items of "principles of advertising" (1.2%), "authorship criteria" (15%), and "integrity in publication of clinical trial results" (30.6%) were the least frequently mentioned ones. Based on the study findings, the quality of publication ethics, as instructed to the authors, can improve the quality of the journals.

Professional ethics in nursing: an integrative review.

PubMed

Kangasniemi, Mari; Pakkanen, Piiku; Korhonen, Anne

2015-08-01

To conduct an integrative review and synthesize current primary studies of professional ethics in nursing. Professional ethics is a familiar concept in nursing and provides an ethical code for nursing practice. However, little is known about how professional ethics has been defined and studied in nursing science. Systematic literature searches from 1948-February 2013, using the CINAHL, PubMed and Scopus electronic databases to look at previously published peer-reviewed studies. A modified version of Cooper's five-stage integrative review was used to review and synthesize current knowledge. Fourteen papers were included in this research. According to our synthesis, professional ethics is described as an intra-professional approach to care ethics and professionals commit to it voluntarily. Professional ethics consist of values, duties, rights and responsibilities, regulated by national legislation and international agreements and detailed in professional codes. Professional ethics is well established in nursing, but is constantly changing due to internal and external factors affecting the profession. Despite the obvious importance of professional ethics, it has not been studied much in nursing science. Greater knowledge of professional ethics is needed to understand and support nurses' moral decision-making and to respond to the challenges of current changes in health care and society. © 2015 John Wiley & Sons Ltd.

Ethical Business Cultures: A Literature Review and Implications for HRD

ERIC Educational Resources Information Center

Ardichvili, Alexandre; Jondle, Douglas

2009-01-01

This literature review identifies characteristics of ethical business cultures, describes factors, considered to be important in developing such cultures, describes current practices of developing ethical culture programs, and discusses the role of HRD in developing ethical business cultures. We argue that ethical thinking and behavior can be…

Is audit research? The relationships between clinical audit and social-research.

PubMed

Hughes, Rhidian

2005-01-01

Quality has an established history in health care. Audit, as a means of quality assessment, is well understood and the existing literature has identified links between audit and research processes. This paper reviews the relationships between audit and research processes, highlighting how audit can be improved through the principles and practice of social research. The review begins by defining the audit process. It goes on to explore salient relationships between clinical audit and research, grouped into the following broad themes: ethical considerations, highlighting responsibilities towards others and the need for ethical review for audit; asking questions and using appropriate methods, emphasising transparency in audit methods; conceptual issues, including identifying problematic concepts, such as "satisfaction", and the importance of reflexivity within audit; emphasising research in context, highlighting the benefits of vignettes and action research; complementary methods, demonstrating improvements for the quality of findings; and training and multidisciplinary working, suggesting the need for closer relationships between researchers and clinical practitioners. Audit processes cannot be considered research. Both audit and research processes serve distinct purposes. Attention to the principles of research when conducting audit are necessary to improve the quality of audit and, in turn, the quality of health care.

Steps toward improving ethical evaluation in health technology assessment: a proposed framework.

PubMed

Assasi, Nazila; Tarride, Jean-Eric; O'Reilly, Daria; Schwartz, Lisa

2016-06-06

While evaluation of ethical aspects in health technology assessment (HTA) has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment (HTA) methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA. The framework was developed through the following phases: 1) a systematic review and content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework. The proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process. The proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice.

Comparing Non-Medical Sex Selection and Saviour Sibling Selection in the Case of JS and LS v Patient Review Panel: Beyond the Welfare of the Child?

PubMed

Smith, Malcolm K; Taylor-Sands, Michelle

2018-03-01

The national ethical guidelines relevant to assisted reproductive technology (ART) have recently been reviewed by the National Health and Medical Research Council (NHMRC). The review process paid particular attention to the issue of non-medical sex selection, although ultimately, the updated ethical guidelines maintain the pre-consultation position of a prohibition on non-medical sex selection. Whilst this recent review process provided a public forum for debate and discussion of this ethically contentious issue, the Victorian case of JS and LS v Patient Review Panel (Health and Privacy) [2011] VCAT 856 provides a rare instance where the prohibition on non-medical sex selection has been explored by a court or tribunal in Australia. This paper analyses the reasoning in that decision, focusing specifically on how the Victorian Civil and Administrative Tribunal applied the statutory framework relevant to ART and its comparison to other uses of embryo selection technologies. The Tribunal relied heavily upon the welfare-of-the-child principle under the Assisted Reproductive Treatment Act 2008 (Vic). The Tribunal also compared non-medical sex selection with saviour sibling selection (that is, where a child is purposely conceived as a matched tissue donor for an existing child of the family). Our analysis leads us to conclude that the Tribunal's reasoning fails to adequately justify the denial of the applicants' request to utilize ART services to select the sex of their prospective child.

Ethical international research on human subjects research in the absence of local institutional review boards.

PubMed

Bhat, S B; Hegde, T T

2006-09-01

International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified--external oversight, local oversight and subject involvement--and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans.

24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

Code of Federal Regulations, 2011 CFR

2011-04-01

... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

One Chairperson's Experience of Ethical Review: Balancing Principle, Convention, Relationship and Risk in Educational Research

ERIC Educational Resources Information Center

O'Neill, John

2010-01-01

The author's experience of ethical review over six years as an academic member and chairperson of a university human ethics committee has been largely positive and educative. The account brings together archival records and personal experience to create a "transactive" account of the practical experience of doing ethical review in one…

24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

Code of Federal Regulations, 2010 CFR

2010-04-01

... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

Code of Federal Regulations, 2014 CFR

2014-04-01

... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

Code of Federal Regulations, 2013 CFR

2013-04-01

... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

Code of Federal Regulations, 2012 CFR

2012-04-01

... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

Ethical issues in studying submissions to a medical journal.

PubMed

Olson, C M; Glass, R M; Thacker, S B; Stroup, D F

1998-07-15

A protocol to prospectively study characteristics of meta-analyses submitted to a weekly medical journal raised several ethical issues. In submitting a manuscript for publication, authors do not implicitly consent to have their work used for research. Authors must be free to refuse to consent, without it affecting their chances for publication. Systematically analyzing data on manuscript characteristics might influence the decision to publish. Having investigators who are not on the editorial staff or peer reviewers extract the manuscripts' characteristics breaks the confidentiality of the author-editor-reviewer relationship. In response to these issues, we added a statement to our journal's instructions for authors that submitted manuscripts may be systematically analyzed to improve the quality of the editorial or peer review process. Authors had to actively consent to participate, but editors and external reviewers were unaware of which authors were participating. The manuscript characteristics were not shared with authors, editors, or external reviewers. The investigators were blinded to each manuscript's author and institution. After we addressed ethical issues encountered in studying manuscripts submitted to a medical journal, 99 of 105 authors submitting a meta-analysis during the study's first 24 months agreed to participate.

[Status of ethical awareness based on 88 medical journals in China and combined evaluation].

PubMed

Chen, Liwen; Wang, Yiren; Li, Lingjiang

2015-09-01

To evaluate the status of ethical awareness of medical journals in China.
 We surveyed editorial awareness based on 88 medical journals by using self-made questionnaire. Five aspects were selected by literature and systematic analysis: Instruction for authors, the first review stage, the peer-review stage, the editing stage, as well as education and training, which covered 11 indexes in the system. Weight values of indexes were gained by scoring of senior editors, and analytic hierarchy process, TOPSIS method, and weight rank-sun ratio were used to evaluate the status of editorial awareness.
 Of the 88 biomedical journals, 56 (63.6%) had no ethical requirement in the instruction for authors in 2010, 14 (15.9%) were at high level of ethical awareness, 45 (51.1%) were at medium level, and 29(33.0%) were at low level. There were significant differences in the scores of instruction for authors and peer-review stage among the journals administrated by different authorities (H(C)=10.175, H=7.305, P<0.05). There were significant differences in the scores of instruction for authors, the first review stage, the peer-review stage, and the editing stage among the journals covered by different databases (H(C)=11.951, 7.661, 6.146, or 8.085, P<0.05), meanwhile, there was significant difference in the multi-level results of comprehensive evaluation for different databases covered journals (H(C)=6.109, P<0.05). The results from 3 comprehensive approaches were positively correlated.
 Ethical awareness of medical journals in China should be improved. Comprehensive approach is more reliable and practical than that of single approach.

Ethical, social, and cultural issues related to clinical genetic testing and counseling in low- and middle-income countries: protocol for a systematic review.

PubMed

Zhong, Adrina; Darren, Benedict; Dimaras, Helen

2017-07-11

There has been little focus in the literature on how to build genetic testing and counseling services in low- and middle-income countries in a responsible, ethical, and culturally appropriate manner. It is unclear to what extent this area is being explored and what form further research should take. The proposed knowledge synthesis aims to fill this gap in knowledge and mine the existing data to determine the breadth of work in this area and identify ethical, social, and cultural issues that have emerged. An integrated knowledge translation approach will be undertaken by engaging knowledge users throughout the review to ensure relevance to their practice. Electronic databases encompassing various disciplines, such as healthcare, social sciences, and public health, will be searched. Studies that address clinical genetic testing and/or counseling and ethical, social, and/or cultural issues of these genetic services, and are performed in low- and middle-income countries as defined by World Bank will be considered for inclusion. Two independent reviewers will be involved in a two-stage literature screening process, data extraction, and quality appraisal. Studies included in the review will be analyzed by thematic analysis. A narrative synthesis guided by the social ecological model will be used to summarize findings. This systematic review will provide a foundation of evidence regarding ethical, social, and cultural issues related to clinical genetic testing and counseling in low- and middle-income countries. Using the social ecological model as a conceptual framework will facilitate the understanding of broader influences of the sociocultural context on an individual's experience with clinical genetic testing and counseling, thereby informing interdisciplinary sectors in future recommendations for practice and policy. PROSPERO CRD42016042894.

Health policy and systems research: towards a better understanding and review of ethical issues.

PubMed

Luyckx, Valerie Ann; Biller-Andorno, Nikola; Saxena, Abha; Tran, Nhan T

2017-01-01

Given the focus on health systems in the post-millennium development goal era and moving towards the sustainable development goals, there is a compelling need for a common framework for health policy and systems research ethics to guide researchers and facilitate review by research ethics committees. A consultation of global health policy and systems research and ethics experts was convened to identify ethical considerations relevant to health policy and systems research based on existing knowledge and to identify knowledge gaps through a scoping review and further expert deliberation. Health policy and systems research is highly complex and, in the absence of guidance documents, there is significant variability in ethics review. Although fundamental ethical principles pertain to both traditional clinical research and health policy and systems research, the application of these principles requires a comprehensive understanding of the nature of health policy and systems research with its distinct challenges. Such awareness must be raised among researchers and research ethics committees. Current research ethics committees lack familiarity with health policy and systems research and because health policy and systems research is conducted in real-world contexts, committees often have difficulties in determining whether a project is indeed research and/or requires ethical review. Given the strong current focus on health policy and systems research to rapidly improve health and health systems functioning globally, greater engagement and dialogue around the ethical concerns is required to optimise research review and research conduct in this rapidly evolving field.

Health policy and systems research: towards a better understanding and review of ethical issues

PubMed Central

Biller-Andorno, Nikola; Saxena, Abha; Tran, Nhan T

2017-01-01

Given the focus on health systems in the post-millennium development goal era and moving towards the sustainable development goals, there is a compelling need for a common framework for health policy and systems research ethics to guide researchers and facilitate review by research ethics committees. A consultation of global health policy and systems research and ethics experts was convened to identify ethical considerations relevant to health policy and systems research based on existing knowledge and to identify knowledge gaps through a scoping review and further expert deliberation. Health policy and systems research is highly complex and, in the absence of guidance documents, there is significant variability in ethics review. Although fundamental ethical principles pertain to both traditional clinical research and health policy and systems research, the application of these principles requires a comprehensive understanding of the nature of health policy and systems research with its distinct challenges. Such awareness must be raised among researchers and research ethics committees. Current research ethics committees lack familiarity with health policy and systems research and because health policy and systems research is conducted in real-world contexts, committees often have difficulties in determining whether a project is indeed research and/or requires ethical review. Given the strong current focus on health policy and systems research to rapidly improve health and health systems functioning globally, greater engagement and dialogue around the ethical concerns is required to optimise research review and research conduct in this rapidly evolving field. PMID:29225934

Developing and Testing a Checklist to Enhance Quality in Ethics Consultation

PubMed Central

Flicker, Lauren Sydney; Rose, Susannah L.; Eves, Margot M.; Flamm, Anne Lederman; Sanghani, Ruchi; Smith, Martin L.

2015-01-01

Checklists have been used to improve quality in many industries, including healthcare. The use of checklists, however, has not been extensively evaluated in clinical ethics consultation. This article seeks to fill this gap by exploring the efficacy of using a checklist in ethics consultation, as tested by an empirical investigation of the use of the checklist at a large academic medical system (Cleveland Clinic). The specific aims of this project are as follows: (1) to improve the quality of ethics consultations by providing reminders to ethics consultants about process steps that are important for most patient-centered ethics consultations, (2) to create consistency in the ethics consultation process across the medical system, and (3) to establish an effective educational tool for trainers and trainees in clinical ethics consultation. The checklist was developed after a thorough literature review and an iterative process of revising and testing by a group of experienced ethics consultants. To pilot test the checklist, it was distributed to 46 ethics professionals. After a six-month pilot period in which ethics professionals used the checklist during their clinical activities, a survey was distributed to all of those who used the checklist. The 10-item survey examined consultants' perceptions regarding the three aims listed above. Of the 25 survey respondents, 11 self-reported as experts in ethics consultation, nine perceived themselves to have mid-level expertise, and five self-reported as novices. The majority (68 percent) of all respondents, regardless of expertise, believed that the checklist could be a “helpful” or “very helpful” tool in the consultation process generally. Novices were more likely than experts to believe that the checklist would be useful in conducting consultations. The limitations of this study include: reduced generalizability given that this project was conducted at one medical system, utilized a small sample size, and used self-reported quality outcome measures. Despite these limitations, to the authors' knowledge this is the first investigatation of the use of a checklist systematically to improve quality in ethics consultation. Importantly, our findings shed light on ways this checklist can be used to improve ethics consultation, including its use as an educational tool. The authors hope to test the checklist with consultants in other healthcare systems to explore its usefulness in different healthcare environments. PMID:25517564

Ethical considerations in resource allocation in a cochlear implant program.

PubMed

Westerberg, Brian D; Pijl, Sipke; McDonald, Michael

2008-04-01

To review processes of resource allocation and the ethical considerations relevant to the fair allocation of a limited number of cochlear implants to increasing numbers of potential recipients. Review of relevant considerations. Tertiary referral hospital. Editorial discussion of the ethical issues of resource allocation. Heterogeneity of audiometric thresholds, self-reported disability of hearing loss, age of the potential cochlear implant recipient, cost-effectiveness, access to resources, compliance with follow-up, social support available to the recipient, social consequences of hearing impairment, and other recipient-related factors. In a publicly funded health care system, there will always be a need for decision-making processes for allocation of finite fiscal resources. All candidates for cochlear implantation deserve fair consideration. However, they are a heterogeneous group in terms of needs and expected outcomes consisting of traditional and marginal candidates, with a wide range of benefit from acoustic amplification. We argue that implant programs should thoughtfully prioritize treatment on the basis of need and potential benefit. We reject queuing on the basis of "first-come, first-served" or on the basis of perceived social worth.

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

PubMed

Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

2018-05-23

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Evolution of Ethics in Clinical Research and Ethics Committee

PubMed Central

Das, Nilay Kanti; Sil, Amrita

2017-01-01

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013. PMID:28794547

Evolution of Ethics in Clinical Research and Ethics Committee.

PubMed

Das, Nilay Kanti; Sil, Amrita

2017-01-01

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013.

Some ethical issues in feminist-oriented therapeutic groups for women.

PubMed

Lakin, M

1991-04-01

Review of the origins of group psychotherapy reveals concerns with social as well as with personal "psychopathology." Thus, group processes have been mobilized for curative or change purposes for ideological as well as individual therapeutic goals. Psychopolitical as well as personal change are the goals for some groups. The ethical problem stems from a persistent assumption that the group's processes are inherently benign and curative and beneficial to individual participants. A more sophisticated understanding takes into account their essential neutrality and their potential use (or abuse) for purposes of ideological persuasion that may or may not be personally therapeutic. As in other ethically implicated issues in the psychotherapies, the question becomes one of treatment versus exploitation, or therapy for the individual versus recruitment on behalf of a cause.

Revised CIOMS research ethics guidance: on the importance of process for credibility.

PubMed

Schuklenk, Udo

2017-01-01

This paper reviews the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans. I argue that these new guidelines constitute a significant improvement over the guidelines they replace. However, the procedures put in place by CIOMS resulted in an authoring group consisting of a majority of authors and advisors hailing from the global North, while the guidelines squarely aim at influencing policies in the global South. I question CIOMS' strategy to produce a consensus based document, and raise concerns about frequent appeals to authority designed to establish the credibility of these guidelines and the processes that led to them. It is unclear why it should be the role of a small organisation such as CIOMS to try to guide the research ethics policies in countries of the global South.

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

PubMed

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.

PubMed

Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

2015-08-01

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees' reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures.

Towards an ethics safe harbor for global biomedical research

PubMed Central

Dove, Edward S.; Knoppers, Bartha M.; Zawati, Ma'n H.

2014-01-01

Although increasingly global, data-driven genomics and other ‘omics’-focused research hold great promise for health discoveries, current research ethics review systems around the world challenge potential improvements in human health from such research. To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles. The Safe Harbor would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary compact among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body, and also a forum for review and follow-up of policies concerning ethics norms for international research projects. It would be built on five principle elements: (1) registration, (2) compliance review, (3) recognition, (4) monitoring and enforcement, and (5) public participation. The Safe Harbor would create many benefits for researchers, countries, and the general public, and may eventually have application beyond (gen)omics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks. PMID:27774154

Research Integrity and Peer Review-past highlights and future directions.

PubMed

Boughton, Stephanie L; Kowalczuk, Maria K; Meerpohl, Joerg J; Wager, Elizabeth; Moylan, Elizabeth C

2018-01-01

In May 2016, we launched Research Integrity and Peer Review , an international, open access journal with fully open peer review (reviewers are identified on their reports and named reports are published alongside the article) to provide a home for research on research and publication ethics, research reporting, and research on peer review. As the journal enters its third year, we reflect on recent events and highlights for the journal and explore how the journal is faring in terms of gender and diversity in peer review. We also share the particular interests of our Editors-in-Chief regarding models of peer review, reporting quality, common research integrity issues that arise during the publishing process, and how people interact with the published literature. We continue to encourage further research into peer review, research and publication ethics and research reporting, as we believe that all new initiatives should be evidence-based. We also remain open to constructive discussions of the developments in the field that offer new solutions.

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review.

PubMed

Droste, Sigrid; Herrmann-Frank, Annegret; Scheibler, Fueloep; Krones, Tanja

2011-04-15

An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review

PubMed Central

2011-01-01

Background An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. Methods We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Results Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. Conclusions The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature. PMID:21496244

A decision tool to guide the ethics review of a challenging breed of emerging genomic projects.

PubMed

Joly, Yann; So, Derek; Osien, Gladys; Crimi, Laura; Bobrow, Martin; Chalmers, Don; Wallace, Susan E; Zeps, Nikolajs; Knoppers, Bartha

2016-08-01

Recent projects conducted by the International Cancer Genome Consortium (ICGC) have raised the important issue of distinguishing quality assurance (QA) activities from research in the context of genomics. Research was historically defined as a systematic effort to expand a shared body of knowledge, whereas QA was defined as an effort to ascertain whether a specific project met desired standards. However, the two categories increasingly overlap due to advances in bioinformatics and the shift toward open science. As few ethics review policies take these changes into account, it is often difficult to determine the appropriate level of review. Mislabeling can result in unnecessary burdens for the investigators or, conversely, in underestimation of the risks to participants. Therefore, it is important to develop a consistent method of selecting the review process for genomics and bioinformatics projects. This paper begins by discussing two case studies from the ICGC, followed by a literature review on the distinction between QA and research and a comparative analysis of ethics review policies from Canada, the United States, the United Kingdom, and Australia. These results are synthesized into a novel two-step decision tool for researchers and policymakers, which uses traditional criteria to sort clearly defined activities while requiring the use of actual risk levels to decide more complex cases.

Authorship Concerns and Who Truly Owns a Research Idea?

PubMed Central

Tran, Duc Q.; Kemper, Alex R.; Geme, Joseph W. St.; Lantos, John D.

2015-01-01

Researchers often face dilemmas about authorship. When the researchers are graduate students, fellows, or junior faculty, the dilemmas might involve discussions about fair criteria for more senior faculty to be acknowledged as key contributors or authors on manuscripts. This “Ethics Rounds” presents a case in which a fellow faced such a dilemma. We review current journal guidelines for authorship and some ethical considerations that should help make this process more streamlined. PMID:26459651

Social work, technology, and ethical practices: a review and evaluation of the national association of social workers' technology standards.

PubMed

Lopez, Amy

2014-10-01

Information and communication technologies (ICTs) are becoming essential to social work practice by providing increased treatment possibilities and reducing barriers to service. While recognizing the importance of ICTs in practice, social work practitioners have had concerns about ethical use. In response, NASW compiled the Standards for Technology and Social Work Practice. While the guidelines set the groundwork, they were not embedded in a process that would allow them to adapt to the swift pace of ICT changes. This article reviews the current Standards, evaluates how these have been implemented by practitioners, and offers suggestions for updates.

Beyond informed consent.

PubMed Central

Bhutta, Zulfiqar A.

2004-01-01

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings. PMID:15643799

Research Ethics III: Publication Practices and Authorship, Conflicts of Interest, and Research Misconduct

ERIC Educational Resources Information Center

Horner, Jennifer; Minifie, Fred D.

2011-01-01

Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. Method: In "Research Ethics III", they review the RCR domains of publication…

76 FR 37353 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Business Ethics Compliance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-27

...; Submission for OMB Review; Contractor Business Ethics Compliance Program and Disclosure Requirements AGENCIES... contractor business ethics compliance program and disclosure requirements. Public comments are particularly... Information Collection 9000- 0164, Contractor Business Ethics Compliance Program and Disclosure Requirements...

What makes public health studies ethical? Dissolving the boundary between research and practice

PubMed Central

2014-01-01

Background The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle – from initial planning through to knowledge exchange. Discussion The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives. The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. Summary Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond. PMID:25104180

A Moral (Normative) Framework for the Judgment of Actions and Decisions in the Construction Industry and Engineering: Part II.

PubMed

Alkhatib, Omar J

2017-12-01

The construction industry is typically characterized as a fragmented, multi-organizational setting in which members from different technical backgrounds and moral values join together to develop a particular business or project. The most challenging obstacle in the construction process is to achieve a successful practice and to identify and apply an ethical framework to manage the behavior of involved specialists and contractors and to ensure the quality of all completed construction activities. The framework should reflect a common moral ground for myriad people involved in this process to survive and compete ethically in today's turbulent construction market. This study establishes a framework for moral judgment of behavior and actions conducted in the construction process. The moral framework provides the basis of judging actions as "moral" or "immoral" based on three levels of moral accountability: personal, professional, and social. The social aspect of the proposed framework is developed primarily from the essential attributes of normative business decision-making models identified in the literature review and subsequently incorporates additional attributes related to professional and personal moral values. The normative decision-making models reviewed are based primarily on social attributes as related to moral theories (e.g., utilitarianism, duty, rights, virtue, etc.). The professional and moral attributes are established by identifying a set of common moral values recognized by professionals in the construction industry and required to prevent common construction breaches. The moral framework presented here is the complementary part of the ethical framework developed in Part I of this article and is based primarily on the personal behavior or the moral aspect of professional responsibility. The framework can be implemented as a form of preventive personal ethics, which would help avoid ethical dilemmas and moral implications in the first place. Furthermore, the moral framework can be considered as a decision-making model to guide actions and improve the moral reasoning process, which would help individuals think through possible implications and the consequences of ethical and moral issues in the construction industry.

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

PubMed Central

Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

2016-01-01

Objective Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Design Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. Participants 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Results Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. Limitations This study was a non-randomised comparison cohort study. Some data were missing. Conclusions An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. PMID:27580832

Applying for, reviewing and funding public health research in Germany and beyond.

PubMed

Gerhardus, Ansgar; Becher, Heiko; Groenewegen, Peter; Mansmann, Ulrich; Meyer, Thorsten; Pfaff, Holger; Puhan, Milo; Razum, Oliver; Rehfuess, Eva; Sauerborn, Rainer; Strech, Daniel; Wissing, Frank; Zeeb, Hajo; Hummers-Pradier, Eva

2016-06-13

Public health research is complex, involves various disciplines, epistemological perspectives and methods, and is rarely conducted in a controlled setting. Often, the added value of a research project lies in its inter- or trans-disciplinary interaction, reflecting the complexity of the research questions at hand. This creates specific challenges when writing and reviewing public health research grant applications. Therefore, the German Research Foundation (DFG), the largest independent research funding organization in Germany, organized a round table to discuss the process of writing, reviewing and funding public health research. The aim was to analyse the challenges of writing, reviewing and granting scientific public health projects and to improve the situation by offering guidance to applicants, reviewers and funding organizations. The DFG round table discussion brought together national and international public health researchers and representatives of funding organizations. Based on their presentations and discussions, a core group of the participants (the authors) wrote a first draft on the challenges of writing and reviewing public health research proposals and on possible solutions. Comments were discussed in the group of authors until consensus was reached. Public health research demands an epistemological openness and the integration of a broad range of specific skills and expertise. Applicants need to explicitly refer to theories as well as to methodological and ethical standards and elaborate on why certain combinations of theories and methods are required. Simultaneously, they must acknowledge and meet the practical and ethical challenges of conducting research in complex real life settings. Reviewers need to make the rationale for their judgments transparent, refer to the corresponding standards and be explicit about any limitations in their expertise towards the review boards. Grant review boards, funding organizations and research ethics committees need to be aware of the specific conditions of public health research, provide adequate guidance to applicants and reviewers, and ensure that processes and the expertise involved adequately reflect the topic under review.

How young is too young: ethical concerns in genital surgery of the transgender MTF adolescent.

PubMed

Milrod, Christine

2014-02-01

During the last decade, the age of youths presenting for gender confirmation has steadily fallen. Transgender adolescents are being treated with gonadotropin-releasing hormone analogues and subsequently cross-sex hormones at early or midpuberty, with genital surgery as the presumed final step in treatment for female-affirmed (male-to-female) individuals. Despite the minimum age of 18 as eligibility to undergo irreversible procedures, anecdotal reports show that vaginoplasties of female-affirmed patients under 18 have been performed by surgeons, thereby contravening the World Professional Association for Transgender Health Standards of Care. The purpose of this article is (i) to provide a review of salient factors regarding genital surgery in transgender adolescents; (ii) to review various ethical protocols for determining maturity in gender dysphoric individuals under 18; and (iii) to present a new systematic set of ethical principles largely derived from the surgical management of youths with disorders of sex development and adapted to the needs of transitioning adolescents. A literature review of the topic was performed. Ethical guidelines derived from applied treatment protocols of children with disorders of sex development were written. Progressing from the current state of ethical standards and clinical assumptions, a new development of ethical guidelines for genital surgery in the female-affirmed transgender adolescent was created. There were no controlled studies of vaginoplasties performed on female-affirmed adolescents under 18 years of age. A new set of ethical guidelines was created in order to support treatment professionals in their decision making process. Professionals across disciplines treating female-affirmed adolescents can utilize the proposed ethical guidelines to facilitate decision making on a case-by-case basis in order to protect both patients and practitioners. These guidelines may also be used in support of more open discussions and disclosures of surgical results that could further the advancement of treatment in this emerging population. © 2013 International Society for Sexual Medicine.

Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

PubMed

Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

2018-01-11

Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to improve their performance.

Ethical genetic research in Indigenous communities: challenges and successful approaches.

PubMed

McWhirter, Rebekah E; Mununggirritj, Djapirri; Marika, Dipililnga; Dickinson, Joanne L; Condon, John R

2012-12-01

Indigenous populations, in common with all populations, stand to benefit from the potential of genetic research to lead to improvements in diagnostic and therapeutic tools for a wide range of complex diseases. However, many Indigenous communities, especially ones that are isolated, are not included in genetic research efforts. This situation is largely a consequence of the challenges of ethically conducting genetic research in Indigenous communities and compounded by Indigenous peoples' negative past experiences with genetic issues. To examine ways of addressing these challenges, we review one investigation of a cancer cluster in remote Aboriginal communities in Arnhem Land, Australia. Our experiences demonstrate that genetic research can be both ethically and successfully conducted with Indigenous communities by respecting the authority of the community, involving community members, and including regular community review throughout the research process. Copyright © 2012 Elsevier Ltd. All rights reserved.

Psychology Ethics in Introductory Psychology Textbooks

ERIC Educational Resources Information Center

Zucchero, Renee' A.

2011-01-01

Previous research revealed that introductory psychology textbooks included limited information about psychology ethics. This study reviewed 48 current introductory psychology textbooks for research and other APA ethics content. These textbooks included slightly more total ethics content and were more thorough in their review of research ethics…

Nurses' ethical conflicts in performance of utilization reviews.

PubMed

Bell, Sue Ellen

2003-09-01

This article describes the ethical conflicts that a sample of US nurse utilization reviewers faced in their work, and also each nurse's self-reported ethical orientation that was used to resolve the dilemmas. Data were collected from a sample of 97 registered nurses who were working at least 20 hours per week as utilization reviewers. Respondents were recruited from three managed care organizations that conduct utilization reviews in a large midwestern city. A cross-sectional survey design was used to collect demographic data and to ask closed-response, short-answer and open-ended questions. Ethical conflicts reported by nurses were similar across utilization review settings and many were justice orientated. Self-reported ethical orientations were similar across organizations, with beneficence dominating. Implications of these findings are discussed.

A review of improved ethical practices in environmental and public health research: case examples from native communities.

PubMed

Quigley, Dianne

2006-04-01

This article presents a review of 14 case studies and articles of research ethics issues in the conduct of environmental and public health research with Native American and other indigenous populations. The purpose of this review is to highlight new practices in the ethical conduct of research with native community populations. The findings from this review can promote more dialogue and policy development on the issue of community protections in research. Formal guidelines exist in ethical codes for individual rights as human subjects, but there is a lack of development on community rights in the ethics of research. This review illustrates how community-based participatory research practices can provide working guidelines that can overcome past research harms. More important, the compilations of guidelines offer tested field methods for improving the ethical conduct of research with native community populations.

Demographic factors associated with moral sensitivity among nursing students.

PubMed

Tuvesson, Hanna; Lützén, Kim

2017-11-01

Today's healthcare environment is often characterized by an ethically demanding work situation, and nursing students need to prepare to meet ethical challenges in their future role. Moral sensitivity is an important aspect of the ethical decision-making process, but little is known regarding nursing students' moral sensitivity and its possible development during nursing education. The aims of this study were to investigate moral sensitivity among nursing students, differences in moral sensitivity according to sample sub-group, and the relation between demographic characteristics of nursing students and moral sensitivity. A convenience sample of 299 nursing students from one university completed a questionnaire comprising questions about demographic information and the revised Moral Sensitivity Questionnaire. With the use of SPSS, non-parametric statistics, including logistic regression models, were used to investigate the relationship between demographic characteristics and moral sensitivity. Ethical considerations: The study followed the regulations according to the Swedish Ethical Review Act and was reviewed by the Ethics Committee of South-East Sweden. The findings showed that mean scores of nursing students' moral sensitivity were found in the middle to upper segment of the rating scale. Multivariate analysis showed that gender (odds ratio = 3.32), age (odds ratio = 2.09; 1.73), and parental status (odds ratio = 0.31) were of relevance to nursing students' moral sensitivity. Academic year was found to be unrelated to moral sensitivity. These demographic aspects should be considered when designing ethics education for nursing students. Future studies should continue to investigate moral sensitivity in nursing students, such as if and how various pedagogical strategies in ethics may contribute to moral sensitivity in nursing students.

Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

PubMed

Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

2017-12-01

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

A Critical Review of Theories and Measures of Ethics-Related Leadership.

PubMed

Zhu, Weichun; Zheng, Xiaoming; Riggio, Ronald E; Zhang, Xi

2015-01-01

This chapter reviews the different theoretical perspectives and measurements of ethics-related leadership models, including ethical leadership, transformational leadership, authentic leadership, servant leadership, spiritual leadership, and a virtues-based approach to leadership ethics. The similarities and differences among these theoretical models and measures to ethics-related leadership are discussed. © 2015 Wiley Periodicals, Inc., A Wiley Company.

Ethical issues in palliative care for nursing homes: Development and testing of a survey instrument.

PubMed

Preshaw, Deborah Hl; McLaughlin, Dorry; Brazil, Kevin

2018-02-01

To develop and psychometrically assess a survey instrument identifying ethical issues during palliative care provision in nursing homes. Registered nurses and healthcare assistants have reported ethical issues in everyday palliative care provision. Identifying these issues provides evidence to inform practice development to support healthcare workers. Cross-sectional survey of Registered nurses and healthcare assistants in nursing homes in one region of the UK. A survey instrument, "Ethical issues in Palliative Care for Nursing homes", was developed through the findings of qualitative interviews with Registered nurses and healthcare assistants in nursing homes and a literature review. It was reviewed by an expert panel and piloted prior to implementation in a survey in 2015 with a convenience sample of 596 Registered nurses and healthcare assistants. Descriptive and exploratory factor analyses were used to assess the underlying structure of the Frequency and Distress Scales within the instrument. Analysis of 201 responses (response rate = 33.7%) revealed four factors for the Frequency Scale and five factors for the Distress Scale that comprise the Ethical issues in Palliative Care for Nursing homes. Factors common to both scales included "Processes of care," "Resident autonomy" and "Burdensome treatment." Additionally, the Frequency Scale included "Competency," and the Distress Scale included "Quality of care" and "Communication." The Ethical issues in Palliative Care for Nursing homes instrument has added to the palliative care knowledge base by considering the ethical issues experienced specifically by Registered nurses and healthcare assistants within the nursing home. This research offers preliminary evidence of the psychometric properties of the Ethical issues in Palliative Care for Nursing homes survey instrument. The two largest factors highlight the need to address the organisational aspects of caring and provide training in negotiating conflicting ethical principles. © 2017 John Wiley & Sons Ltd.

What kinds of cases do paediatricians refer to clinical ethics? Insights from 184 case referrals at an Australian paediatric hospital.

PubMed

McDougall, Rosalind J; Notini, Lauren

2016-09-01

Clinical ethics has been developing in paediatric healthcare for several decades. However, information about how paediatricians use clinical ethics case consultation services is extremely limited. In this project, we analysed a large set of case records from the clinical ethics service of one paediatric hospital in Australia. We applied a paediatric-specific typology to the case referrals, based on the triadic doctor-patient-parent relationship. We reviewed the 184 cases referred to the service in the period 2005-2014, noting features including the type of case, the referring department(s) and the patient's age at referral. The two most common types of referral involved clinician uncertainty about the appropriate care pathway for the child (26% of total referrals) and situations where the child's parents disagreed with the doctors' recommendations for the child's care (22% of total referrals). Referrals came from 28 different departments. Cancer, cardiology/cardiac surgery and general medicine referred the highest numbers of cases. The most common patient age groups were children under 1, and 14-15 years old. For three controversial areas of paediatric healthcare, clinicians had initiated processes of routine review of cases by the clinical ethics service. These insights into the way in which one very active paediatric clinical ethics service is used further our understanding of the work of paediatric clinical ethics, particularly the kinds of ethically challenging cases that paediatricians view as appropriate to refer for clinical ethics support. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Current state of ethics literature synthesis: a systematic review of reviews.

PubMed

Mertz, Marcel; Kahrass, Hannes; Strech, Daniel

2016-10-03

Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

Student participation in health professions education research: in pursuit of the Aristotelian mean.

PubMed

Chen, Ruth P

2011-05-01

In research ethics reviews, traditional approaches of research ethics boards (REBs) balance the risks with the potential for benefit of proposed studies, and this review process has been similar for health professions education research (HPER) as it has been for clinically based studies. Health professions students are the primary population from which most education researchers draw their participants although relatively little discussion has taken place in the literature regarding student participation in HPER. The majority of HPER studies could be considered minimal risk and therefore many have suggested that such studies be exempted from REB review. However, there are not only risks to student participants which require consideration, but I argue that when this issue is viewed through the lens of Aristotle's virtue ethics, there are also potential benefits to the student, for which REB oversight can be helpful, that have not factored strongly into discussions. This paper seeks to highlight the key factors involved in student participation in HPER; to explore Aristotle's doctrine of the mean and to evaluate how this ethical framework can add value to the discussion; and to propose possible applications of the Aristotelian mean to this issue and address some of the challenges that would arise with its application.

Evaluating the ethical acceptability of animal research.

PubMed

Bout, Henriëtte J; Fentener van Vlissingen, J Martje; Karssing, Edgar D

2014-11-01

The ethical acceptability of animal research is typically evaluated on a case-by-case basis. Legislation such as Directive 2010/63/EU on the protection of animals used for scientific purposes provides guidance for ethical evaluation of animal use proposals but does not dictate the outcome, leaving this determination to the ethical review committees of individual institutions. The authors assess different ethics models and how these are reflected in the guidelines of Directive 2010/63/EU. They also describe a matrix for carrying out harm-benefit analyses of animal use proposals, which they identified by examining the practices of three ethical review committees in the Netherlands. Finally, they discuss how this matrix can be applied by ethical review committees at other institutions.

Ethical issues in neonatal intensive care units.

PubMed

Liu, Jing; Chen, Xin-Xin; Wang, Xin-Ling

2016-01-01

On one hand, advances in neonatal care and rescue technology allow for the healthy survival or prolonged survival time of critically ill newborns who, in the past, would have been non-viable. On the other hand, many of the surviving critically ill infants have serious long-term disabilities. If an infant eventually cannot survive or is likely to suffer severe disability after surviving, ethical issues in the treatment process are inevitable, and this problem arises not only in developed countries but is also becoming increasingly prominent in developing countries. In addition, ethical concerns cannot be avoided in medical research. This review article introduces basic ethical guidelines that should be followed in clinical practice, including respecting the autonomy of the parents, giving priority to the best interests of the infant, the principle of doing no harm, and consent and the right to be informed. Furthermore, the major ethical concerns in neonatal intensive care units (NICUs) in China are briefly introduced.

Reporting transparency: making the ethical mandate explicit.

PubMed

Nicholls, Stuart G; Langan, Sinéad M; Benchimol, Eric I; Moher, David

2016-03-16

Improving the transparency and quality of reporting in biomedical research is considered ethically important; yet, this is often based on practical reasons such as the facilitation of peer review. Surprisingly, there has been little explicit discussion regarding the ethical obligations that underpin reporting guidelines. In this commentary, we suggest a number of ethical drivers for the improved reporting of research. These ethical drivers relate to researcher integrity as well as to the benefits derived from improved reporting such as the fair use of resources, minimizing risk of harms, and maximizing benefits. Despite their undoubted benefit to reporting completeness, questions remain regarding the extent to which reporting guidelines can influence processes beyond publication, including researcher integrity or the uptake of scientific research findings into policy or practice. Thus, we consider investigation on the effects of reporting guidelines an important step in providing evidence of their benefits.

Using video in childbirth research.

PubMed

Harte, J Davis; Homer, Caroline Se; Sheehan, Athena; Leap, Nicky; Foureur, Maralyn

2017-03-01

Conducting video-research in birth settings raises challenges for ethics review boards to view birthing women and research-midwives as capable, autonomous decision-makers. This study aimed to gain an understanding of how the ethical approval process was experienced and to chronicle the perceived risks and benefits. The Birth Unit Design project was a 2012 Australian ethnographic study that used video recording to investigate the physical design features in the hospital birthing space that might influence both verbal and non-verbal communication and the experiences of childbearing women, midwives and supporters. Participants and research context: Six women, 11 midwives and 11 childbirth supporters were filmed during the women's labours in hospital birth units and interviewed 6 weeks later. Ethical considerations: The study was approved by an Australian Health Research Ethics Committee after a protracted process of negotiation. The ethics committee was influenced by a traditional view of research as based on scientific experiments resulting in a poor understanding of video-ethnographic research, a paradigmatic view of the politics and practicalities of modern childbirth processes, a desire to protect institutions from litigation, and what we perceived as a paternalistic approach towards protecting participants, one that was at odds with our aim to facilitate situations in which women could make flexible, autonomous decisions about how they might engage with the research process. The perceived need for protection was overly burdensome and against the wishes of the participants themselves; ultimately, this limited the capacity of the study to improve care for women and babies. Recommendations are offered for those involved in ethical approval processes for qualitative research in childbirth settings. The complexity of issues within childbirth settings, as in most modern healthcare settings, should be analysed using a variety of research approaches, beyond efficacy-style randomised controlled trials, to expand and improve practice-based results.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

PubMed

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review

PubMed Central

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

Background When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. Aim To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. Method A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. Results The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. Conclusions The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure. PMID:26938863

Psychiatry and online social media: potential, pitfalls and ethical guidelines for psychiatrists and trainees.

PubMed

Frankish, Katherine; Ryan, Christopher; Harris, Anthony

2012-06-01

This paper proposes ethical guidelines for psychiatrists and psychiatry trainees when interacting with social media. A three-stage process was followed in the development of these guidelines. A literature review provided situations and possible broad rules as to how social media could be ethically engaged. A roundtable discussion by a panel of invited psychiatrists, psychiatry trainees, psychologists, e-health practitioners, lawyers and consumers was held to discuss the situations and to better formulate the ethical principles upon which psychiatrists could act. These vignettes and principles were then broadly discussed at a seminar held at the 2011 RANZCP Congress. Finally, this paper was circulated to the original invitees for final comment. A set of recommendations for working with social media were developed. The new social media provides important avenues for communication, education and treatment. These avenues pose ethical and practical dilemmas that can be resolved by the application of established ethical principles. Practical recommendations for navigating social media are proposed.

The full spectrum of ethical issues in dementia care: systematic qualitative review.

PubMed

Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina

2013-06-01

Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

Compassion and Vigilance: Investigators' Strategies To Manage Ethical Concerns in Palliative and End-of-Life Research

PubMed Central

Cartwright, Juliana C.; Nelson, Christine A.; Knafl, Kathleen

2012-01-01

Abstract Background Ethical concerns were identified as a potential barrier to advancing palliative and end-of-life science at the 2004 National Institutes of Health State of the Science Meeting. However, data are lacking about the nature of ethical concerns and strategies for balancing the need to advance science with human subjects protections. Methods A qualitative case-study design was used to follow 43 end-of-life studies from proposal development through the review process and implementation. Investigators participated in semi-structured telephone interviews and provided document data regarding their experiences with grant and IRB reviews. Using constant comparative analysis within and across cases, the investigators identified commonly encountered and unique concerns and strategies for managing these concerns. Findings Investigator strategies fell into two broad categories: 1) Recruitment and consent strategies related to subject identification and enrollment; and 2) Protocol-related strategies related to the process of data collection. These strategies shared the overarching meta-themes of compassion, as evidenced by a heightened sensitivity to the needs of the population, coupled with vigilance, as evidenced by close attention to the possible effects of study participation on the participants' well-being, clinical care, and the needs of research staff. Conclusions Ethical concerns have led to the development of compassionate and vigilant strategies designed to balance the potential for risk of harm with the need to advance the science of palliative and end-of-life care. These strategies can be used by investigators to address ethical concerns and minimize barriers to the development of palliative and end-of-life care science. PMID:22731516

Compassion and vigilance: investigators' strategies to manage ethical concerns in palliative and end-of-life research.

PubMed

Hickman, Susan E; Cartwright, Juliana C; Nelson, Christine A; Knafl, Kathleen

2012-08-01

Ethical concerns were identified as a potential barrier to advancing palliative and end-of-life science at the 2004 National Institutes of Health State of the Science Meeting. However, data are lacking about the nature of ethical concerns and strategies for balancing the need to advance science with human subjects protections. A qualitative case-study design was used to follow 43 end-of-life studies from proposal development through the review process and implementation. Investigators participated in semi-structured telephone interviews and provided document data regarding their experiences with grant and IRB reviews. Using constant comparative analysis within and across cases, the investigators identified commonly encountered and unique concerns and strategies for managing these concerns. Investigator strategies fell into two broad categories: 1) Recruitment and consent strategies related to subject identification and enrollment; and 2) Protocol-related strategies related to the process of data collection. These strategies shared the overarching meta-themes of compassion, as evidenced by a heightened sensitivity to the needs of the population, coupled with vigilance, as evidenced by close attention to the possible effects of study participation on the participants' well-being, clinical care, and the needs of research staff. Ethical concerns have led to the development of compassionate and vigilant strategies designed to balance the potential for risk of harm with the need to advance the science of palliative and end-of-life care. These strategies can be used by investigators to address ethical concerns and minimize barriers to the development of palliative and end-of-life care science.

Applying language technology to nursing documents: pros and cons with a focus on ethics.

PubMed

Suominen, Hanna; Lehtikunnas, Tuija; Back, Barbro; Karsten, Helena; Salakoski, Tapio; Salanterä, Sanna

2007-10-01

The present study discusses ethics in building and using applications based on natural language processing in electronic nursing documentation. Specifically, we first focus on the question of how patient confidentiality can be ensured in developing language technology for the nursing documentation domain. Then, we identify and theoretically analyze the ethical outcomes which arise when using natural language processing to support clinical judgement and decision-making. In total, we put forward and justify 10 claims related to ethics in applying language technology to nursing documents. A review of recent scientific articles related to ethics in electronic patient records or in the utilization of large databases was conducted. Then, the results were compared with ethical guidelines for nurses and the Finnish legislation covering health care and processing of personal data. Finally, the practical experiences of the authors in applying the methods of natural language processing to nursing documents were appended. Patient records supplemented with natural language processing capabilities may help nurses give better, more efficient and more individualized care for their patients. In addition, language technology may facilitate patients' possibility to receive truthful information about their health and improve the nature of narratives. Because of these benefits, research about the use of language technology in narratives should be encouraged. In contrast, privacy-sensitive health care documentation brings specific ethical concerns and difficulties to the natural language processing of nursing documents. Therefore, when developing natural language processing tools, patient confidentiality must be ensured. While using the tools, health care personnel should always be responsible for the clinical judgement and decision-making. One should also consider that the use of language technology in nursing narratives may threaten patients' rights by using documentation collected for other purposes. Applying language technology to nursing documents may, on the one hand, contribute to the quality of care, but, on the other hand, threaten patient confidentiality. As an overall conclusion, natural language processing of nursing documents holds the promise of great benefits if the potential risks are taken into consideration.

Ethical Challenges in Promoting the Implementation of Preventive Interventions: Report of the SPR Task Force.

PubMed

Leadbeater, Bonnie J; Dishion, Tom; Sandler, Irwin; Bradshaw, Catherine P; Dodge, Kenneth; Gottfredson, Denise; Graham, Phillip W; Lindstrom Johnson, Sarah; Maldonado-Molina, Mildred M; Mauricio, Anne M; Smith, Emilie Phillips

2018-06-23

Prevention science researchers and practitioners are increasingly engaged in a wide range of activities and roles to promote evidence-based prevention practices in the community. Ethical concerns invariably arise in these activities and roles that may not be explicitly addressed by university or professional guidelines for ethical conduct. In 2015, the Society for Prevention Research (SPR) Board of Directors commissioned Irwin Sandler and Tom Dishion to organize a series of roundtables and establish a task force to identify salient ethical issues encountered by prevention scientists and community-based practitioners as they collaborate to implement evidence-based prevention practices. This article documents the process and findings of the SPR Ethics Task Force and aims to inform continued efforts to articulate ethical practice. Specifically, the SPR membership and task force identified prevention activities that commonly stemmed from implementation and scale-up efforts. This article presents examples that illustrate typical ethical dilemmas. We present principles and concepts that can be used to frame the discussion of ethical concerns that may be encountered in implementation and scale-up efforts. We summarize value statements that stemmed from our discussion. We also conclude that the field of prevention science in general would benefit from standards and guidelines to promote ethical behavior and social justice in the process of implementing evidence-based prevention practices in community settings. It is our hope that this article serves as an educational resource for students, investigators, and Human Subjects Review Board members regarding some of the complexity of issues of fairness, equality, diversity, and personal rights for implementation of preventive interventions.

Competitive Intelligence.

ERIC Educational Resources Information Center

Bergeron, Pierrette; Hiller, Christine A.

2002-01-01

Reviews the evolution of competitive intelligence since 1994, including terminology and definitions and analytical techniques. Addresses the issue of ethics; explores how information technology supports the competitive intelligence process; and discusses education and training opportunities for competitive intelligence, including core competencies…

Expected Ethical Competencies of Public Health Professionals and Graduate Curricula in Accredited Schools of Public Health in North America

PubMed Central

Wright, Brandy; Semaan, Salaam

2013-01-01

Objectives. We assessed expected ethics competencies of public health professionals in codes and competencies, reviewed ethics instruction at schools of public health, and recommended ways to bridge the gap between them. Methods. We reviewed the code of ethics and 3 sets of competencies, separating ethics-related competencies into 3 domains: professional, research, and public health. We reviewed ethics course requirements in 2010–2011 on the Internet sites of 46 graduate schools of public health and categorized courses as required, not required, or undetermined. Results. Half of schools (n = 23) required an ethics course for graduation (master’s or doctoral level), 21 did not, and 2 had no information. Sixteen of 23 required courses were 3-credit courses. Course content varied from 1 ethics topic to many topics addressing multiple ethics domains. Conclusions. Consistent ethics education and competency evaluation can be accomplished through a combination of a required course addressing the 3 domains, integration of ethics topics in other courses, and “booster” trainings. Enhancing ethics competence of public health professionals is important to address the ethical questions that arise in public health research, surveillance, practice, and policy. PMID:22994177

Research Ethics: Institutional Review Board Oversight of Art Therapy Research

ERIC Educational Resources Information Center

Deaver, Sarah P.

2011-01-01

By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…

Communicating Qualitative Research Study Designs to Research Ethics Review Boards

ERIC Educational Resources Information Center

Ells, Carolyn

2011-01-01

Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers…

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2012 CFR

2012-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Operation of the Human Studies Review...

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2010 CFR

2010-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Operation of the Human Studies Review...

40 CFR 26.1605 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2014 CFR

2014-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Operation of the Human Studies Review...

40 CFR 26.1605 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2013 CFR

2013-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Operation of the Human Studies Review...

40 CFR 26.1603 - Operation of the Human Studies Review Board.

Code of Federal Regulations, 2011 CFR

2011-07-01

... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Operation of the Human Studies Review...

Ethical review of human experimentation in the consumer products industry.

PubMed

Steadman, J H

1998-04-01

Ethical review of human experimentation in the consumer products industry is important and provides instructive parallels and contrasts with clinical medical research. The procedures used in Unilever NV/plc are described. A central body sets standards for and monitors compliance with ethical review of human studies throughout Unilever. Guidance has been produced on many topics including issues applying generally to human experimentation and more specifically to the consumer products sector. Deficiencies and inconsistencies in the procedures for ethical review and the care of subjects during the conduct of studies have been identified and corrected. Appropriate uniform standards have been achieved across all Unilever operations. All human experimentation in the industry needs adequate ethical review. Although the methods used by individual companies may differ, procedures must ensure uniform high standards across a global industry.

Ethical challenges for accountable care organizations: a structured review.

PubMed

DeCamp, Matthew; Farber, Neil J; Torke, Alexia M; George, Maura; Berger, Zackary; Keirns, Carla C; Kaldjian, Lauris C

2014-10-01

Accountable care organizations (ACOs) are proliferating as a solution to the cost crisis in American health care, and already involve as many as 31 million patients. ACOs hold clinicians, group practices, and in many circumstances hospitals financially accountable for reducing expenditures and improving their patients' health outcomes. The structure of health care affects the ethical issues arising in the practice of medicine; therefore, like all health care organizational structures, ACOs will experience ethical challenges. No framework exists to assist key ACO stakeholders in identifying or managing these challenges. We conducted a structured review of the medical ACO literature using qualitative content analysis to inform identification of ethical challenges for ACOs. Our analysis found infrequent discussion of ethics as an explicit concern for ACOs. Nonetheless, we identified nine critical ethical challenges, often described in other terms, for ACO stakeholders. Leaders could face challenges regarding fair resource allocation (e.g., about fairly using ACOs' shared savings), protection of professionals' ethical obligations (especially related to the design of financial incentives), and development of fair decision processes (e.g., ensuring that beneficiary representatives on the ACO board truly represent the ACO's patients). Clinicians could perceive threats to their professional autonomy (e.g., through cost control measures), a sense of dual or conflicted responsibility to their patients and the ACO, or competition with other clinicians. For patients, critical ethical challenges will include protecting their autonomy, ensuring privacy and confidentiality, and effectively engaging them with the ACO. ACOs are not inherently more or less "ethical" than other health care payment models, such as fee-for-service or pure capitation. ACOs' nascent development and flexibility in design, however, present a time-sensitive opportunity to ensure their ethical operation, promote their success, and refine their design and implementation by identifying, managing, and conducting research into the ethical issues they might face.

Subject, function, and trend in medical ethics research: a comparative study of Chinese and non-Chinese literature using bibliometrics.

PubMed

Jiang, Lanhui; Shen, Jiantong; Li, Youping; Deng, Shaolin; Wu, Taixiang; Chen, Baoqing; Xie, Zhiyi; Qin, Chaoyi; Yu, Zhiyuan; Qin, Chuan; Huang, Jin; Liu, Xuemei; Li, Yan; Jiang, Jie

2012-05-01

To perform a comparative quantitative and qualitative analysis of Chinese and non-Chinese medical ethics literature using systematic research and literature analysis in order to discern research trends in the area and provide baseline data as a reference for relevant decision making and further study. We retrieved articles using MeSH terms and keywords related to medical ethics in PubMed and CNKI, and then constructed a set of charts by applying word co-occurrence, The Pathfinder Networks algorithms, an included subject chart, a research field relationship chart, and strategy coordination charts. The total of number of papers retrieved from PubMed was six times that retrieved from CNKI. Outside China, medical ethics has been studied in eight fully shaped subject fields, including morals, ethical review, physician-patient relationships, clinical trials, euthanasia, ethics education, clinical ethics, and health policy. In contrast, medical ethics research in China is still confined to five subject fields: morals, physician-patient relations, medical ethics education, ethical review, and medical research. Medical ethics research outside China emphasizes the application of medical ethics to solve emerging problems in clinical and medical research. It is mainly centered on morals, ethical review, and physician-patient relations. By comparison, medical ethics research in China places greater emphasis on morals and medical education. In order to narrow this gap between China and other countries, we should broaden the research scope of medical ethics and add more applied research, such as ethical review and medical education. © 2012 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

ENHANCING RESEARCH ETHICS REVIEW SYSTEMS IN EGYPT: THE FOCUS OF AN INTERNATIONAL TRAINING PROGRAM INFORMED BY AN ECOLOGICAL DEVELOPMENTAL APPROACH TO ENHANCING RESEARCH ETHICS CAPACITY

PubMed Central

Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry

2014-01-01

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed “too great an emphasis on guidelines and research ethics review”, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. PMID:24894063

Ethical Issues Surrounding Personalized Medicine: A Literature Review.

PubMed

Salari, Pooneh; Larijani, Bagher

2017-03-01

More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

An ethics safe harbor for international genomics research?

PubMed Central

2013-01-01

Background Genomics research is becoming increasingly globally connected and collaborative, contesting traditional ethical and legal boundaries between global and local research practice. As well, global data-driven genomics research holds great promise for health discoveries. Yet, paradoxically, current research ethics review systems around the world challenge potential improvements in human health from such research and thus undermine respect for research participants. Case reports illustrate that the current system is costly, fragmented, inefficient, inadequate, and inconsistent. There is an urgent need to improve the governance system of ethics review to enable secure and seamless genomic and clinical data sharing across jurisdictions. Discussion Building on the international privacy 'safe harbor’ model that was developed following the adoption of the European Privacy Directive, we propose an international infrastructure. The goal is to create a streamlined and harmonized ethics governance system for international, data-driven genomics research projects. The proposed 'Safe Harbor Framework for International Ethics Equivalency’ would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary agreement among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body and also a forum for review and follow-up of policies concerning ethics norms for international genomics research projects. It would be built on five principle elements: (1) registration; (2) compliance review; (3) recognition; (4) monitoring and enforcement; and (5) public participation. Summary A Safe Harbor Framework for International Ethics Equivalency would create many benefits for researchers, countries, and the general public, and may eventually have application beyond genomics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks. Among the benefits, research participants and patients would have uniform adequate protection, while researchers would be ensured expert ethics review with a reduction in cost, time, administrative hassle, and redundant regulatory hurdles. Most importantly, society would enjoy the maximization of the potential benefits of genomics research. PMID:24267880

The Need for Systematic Reviews of Reasons

PubMed Central

Sofaer, Neema; Strech, Daniel

2012-01-01

There are many ethical decisions in the practice of health research and care, and in the creation of policy and guidelines. We argue that those charged with making such decisions need a new genre of review. The new genre is an application of the systematic review, which was developed over decades to inform medical decision-makers about what the totality of studies that investigate links between smoking and cancer, for example, implies about whether smoking causes cancer. We argue that there is a need for similarly inclusive and rigorous reviews of reason-based bioethics, which uses reasoning to address ethical questions. After presenting a brief history of the systematic review, we reject the only existing model for writing a systematic review of reason-based bioethics, which holds that such a review should address an ethical question. We argue that such a systematic review may mislead decision-makers when a literature is incomplete, or when there are mutually incompatible but individually reasonable answers to the ethical question. Furthermore, such a review can be written without identifying all the reasons given when the ethical questions are discussed, their alleged implications for the ethical question, and the attitudes taken to the reasons. The reviews we propose address instead the empirical question of which reasons have been given when addressing a specified ethical question, and present such detailed information on the reasons. We argue that this information is likely to improve decision-making, both directly and indirectly, and also the academic literature. We explain the limitations of our alternative model for systematic reviews. PMID:21521251

Safe and inclusive research practices for qualitative research involving people with dementia: A review of key issues and strategies.

PubMed

Novek, Sheila; Wilkinson, Heather

2017-01-01

Aim Developing strategies to ensure the safe participation of people with dementia in research is critical to support their wider inclusion in research and to advance knowledge in the areas of dementia policy and practice. Objectives This literature review synthesizes and critically appraises different approaches to promote the safe participation of people with dementia in qualitative research. Methods Two databases were searched for articles that discuss the methodological or ethical aspects of qualitative research involving people with dementia. We did not focus on informed consent or ethical review processes as these have been reviewed elsewhere. Findings Key issues that impact participant safety include: language, gatekeepers, the research relationship, communication, dealing with distress, knowledge dissemination, and researcher skills. Conclusion By synthesizing different approaches to safety and highlighting areas of debate, we hope to advance discussion and to contribute to the development of inclusive research methods.

Exploring the Gaps in Practical Ethical Guidance for Animal Welfare Considerations of Field Interventions and Innovations Targeting Dogs and Cats.

PubMed

Tasker, Louisa; Getty, Susan F; Briggs, Joyce R; Benka, Valerie A W

2018-01-27

Domestic dogs ( Canis lupus familiaris ) and cats ( Felis silvestris catus ) are common species targeted by nongovernmental or intergovernmental organizations, veterinarians and government agencies worldwide, for field interventions (e.g., population management, rabies vaccination programs) or innovations (e.g., development of technologies or pharmaceuticals to improve animal welfare). We have a moral responsibility to ensure that the conduct of this work is humane for dogs or cats, and to consider the human communities in which the animals live. Ethical review is widely accepted as being integral to responsible practice, and it is fundamental to good science that underpins innovation. Despite the necessity of field interventions or innovations to advance the welfare of individuals or populations of animals, we found a lack of specific guidance and review processes to help navigate ethical dilemmas surrounding the conduct of such work. This can be detrimental to the wellbeing of animals and their human communities. Here we identify the gaps in existing ethical frameworks (specifically application of Reduction and Refinement principles, challenges of obtaining meaningful informed consent with variations in the quality of human-animal relationships, and limited resources regarding considerations of local stakeholders), and outline the need for additional tools to promote ethical conduct in the field.

Ethical and methodological issues in qualitative health research involving children: A systematic review.

PubMed

Huang, Xiaoyan; O'Connor, Margaret; Ke, Li-Shan; Lee, Susan

2016-05-01

The right of children to have their voice heard has been accepted by researchers, and there are increasing numbers of qualitative health studies involving children. The ethical and methodological issues of including children in research have caused worldwide concerns, and many researchers have published articles sharing their own experiences. To systematically review and synthesise experts' opinions and experiences about ethical and methodological issues of including children in research, as well as related solution strategies. The research design was a systematic review of opinion-based evidence, based on the guidelines by Joanna Briggs Institute. A search of five computerised databases has been conducted in April 2014 and 2271 articles were found. After screening the titles, abstracts, full texts and appraising the quality, 30 articles were finally included in the review. A meta-aggregative approach was applied in the data analysis and synthesis process. Ethical approval is not needed as it is a systematic review of published literature. Six themes were identified, including evaluating potential risks and benefits, gaining access, obtaining informed consent/assent, protecting confidentiality and privacy, building rapport and collecting rich data. The similarities and differences between research involving children and that involving adults were indicated. All potential incentives should be justified when designing the study. Further studies need to research how to evaluate individual capacity of children and how to balance protecting children's right to participate and their interests in the research. Cultural differences related to researching children in different regions should also be studied. © The Author(s) 2014.

Ethics and health promotion practice: exploring attitudes and practices in Western Australian health organisations.

PubMed

Reilly, T; Crawford, G; Lobo, R; Leavy, J; Jancey, J

2016-04-01

Issue addressed Evidence-informed practice underpinned by ethics is fundamental to developing the science of health promotion. Knowledge and application of ethical principles are competencies required for health promotion practice. However, these competencies are often inconsistently understood and applied. This research explored attitudes, practices, enablers and barriers related to ethics in practice in Western Australian health organisations. Methods Semistructured, in-depth interviews were conducted with 10 health promotion practitioners, purposefully selected to provide a cross-section of government and non-government organisations. Interviews were recorded, transcribed and then themed. Results The majority of participants reported consideration of ethics in their practice; however, only half reported seeking Human Research Ethics Committee (HREC) approval for projects in the past 12 months. Enablers identified as supporting ethics in practice and disseminating findings included: support preparing ethics applications; resources and training about ethical practice; ability to access HRECs for ethics approval; and a supportive organisational culture. Barriers included: limited time; insufficient resourcing and capacity; ethics approval not seen as part of core business; and concerns about academic writing. Conclusion The majority of participants were aware of the importance of ethics in practice and the dissemination of findings. However, participants reported barriers to engaging in formal ethics processes and to publishing findings. So what? Alignment of evidence-informed and ethics-based practice is critical. Resources and information about ethics may be required to support practice and encourage dissemination of findings, including in the peer-reviewed literature. Investigating the role of community-based ethics boards may be valuable to bridging the ethics-evidence gap.

Ethical considerations of research policy for personal genome analysis: the approach of the Genome Science Project in Japan.

PubMed

Minari, Jusaku; Shirai, Tetsuya; Kato, Kazuto

2014-12-01

As evidenced by high-throughput sequencers, genomic technologies have recently undergone radical advances. These technologies enable comprehensive sequencing of personal genomes considerably more efficiently and less expensively than heretofore. These developments present a challenge to the conventional framework of biomedical ethics; under these changing circumstances, each research project has to develop a pragmatic research policy. Based on the experience with a new large-scale project-the Genome Science Project-this article presents a novel approach to conducting a specific policy for personal genome research in the Japanese context. In creating an original informed-consent form template for the project, we present a two-tiered process: making the draft of the template following an analysis of national and international policies; refining the draft template in conjunction with genome project researchers for practical application. Through practical use of the template, we have gained valuable experience in addressing challenges in the ethical review process, such as the importance of sharing details of the latest developments in genomics with members of research ethics committees. We discuss certain limitations of the conventional concept of informed consent and its governance system and suggest the potential of an alternative process using information technology.

What Is Everyday Ethics? A Review and a Proposal for an Integrative Concept.

PubMed

Zizzo, Natalie; Bell, Emily; Racine, Eric

2016-01-01

"Everyday ethics" is a term that has been used in the clinical and ethics literature for decades to designate normatively important and pervasive issues in healthcare. In spite of its importance, the term has not been reviewed and analyzed carefully. We undertook a literature review to understand how the term has been employed and defined, finding that it is often contrasted to "dramatic ethics." We identified the core attributes most commonly associated with everyday ethics. We then propose an integrative model of everyday ethics that builds on the contribution of different ethical theories. This model proposes that the function of everyday ethics is to serve as an integrative concept that (1) helps to detect current blind spots in bioethics (that is, shifts the focus from dramatic ethics) and (2) mobilizes moral agents to address these shortcomings of ethical insight. This novel integrative model has theoretical, methodological, practical, and pedagogical implications, which we explore. Because of the pivotal role that moral experience plays in this integrative model, the model could help to bridge empirical ethics research with more conceptual and normative work. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

Ethics Review for Qualitative Inquiry: Adopting a Values-Based, Facilitative Approach

ERIC Educational Resources Information Center

Connolly, Kate; Reid, Adela

2007-01-01

In many institutions, the institutional review board/research ethics board (IRB/REB) uses the traditional audit approach that emerged from the biomedical community (e.g., Nuremburg Code, Belmont Report) to review the ethical acceptability of research using humans as participants. This approach is guided by participant protection and risk…

Authorship Concerns and Who Truly Owns a Research Idea?

PubMed

Syed, Sana; Tran, Duc Q; Kemper, Alex R; Geme, Joseph W St; Lantos, John D

2015-11-01

Researchers often face dilemmas about authorship. When the researchers are graduate students, fellows, or junior faculty, the dilemmas might involve discussions about fair criteria for more senior faculty to be acknowledged as key contributors or authors on manuscripts. This "Ethics Rounds" presents a case in which a fellow faced such a dilemma. We review current journal guidelines for authorship and some ethical considerations that should help make this process more streamlined. Copyright © 2015 by the American Academy of Pediatrics.

Global health ethics: an introduction to prominent theories and relevant topics

PubMed Central

Stapleton, Greg; Schröder-Bäck, Peter; Laaser, Ulrich; Meershoek, Agnes; Popa, Daniela

2014-01-01

Global health ethics is a relatively new term that is used to conceptualize the process of applying moral value to health issues that are typically characterized by a global level effect or require action coordinated at a global level. It is important to acknowledge that this account of global health ethics takes a predominantly geographic approach and may infer that the subject relates primarily to macro-level health phenomena. However, global health ethics could alternatively be thought of as another branch of health ethics. It may then relate to specific topics in themselves, which might also include micro-level health phenomena. In its broadest sense, global health ethics is a normative project that is best characterized by the challenge of developing common values and universal norms for responding to global health threats. Consequently, many subjects fall within its scope. Whilst several accounts of global health ethics have been conceptualized in the literature, a concise demarcation of the paradigm is still needed. Through means of a literature review, this paper presents a two-part introduction to global health ethics. First, the framework of ‘borrowed’ ethics that currently form the core of global health ethics is discussed in relation to two essential ethical considerations: 1) what is the moral significance of health and 2) what is the moral significance of boundaries? Second, a selection of exemplar ethical topics is presented to illustrate the range of topics within global health ethics. PMID:24560262

Global health ethics: an introduction to prominent theories and relevant topics.

PubMed

Stapleton, Greg; Schröder-Bäck, Peter; Laaser, Ulrich; Meershoek, Agnes; Popa, Daniela

2014-01-01

Global health ethics is a relatively new term that is used to conceptualize the process of applying moral value to health issues that are typically characterized by a global level effect or require action coordinated at a global level. It is important to acknowledge that this account of global health ethics takes a predominantly geographic approach and may infer that the subject relates primarily to macro-level health phenomena. However, global health ethics could alternatively be thought of as another branch of health ethics. It may then relate to specific topics in themselves, which might also include micro-level health phenomena. In its broadest sense, global health ethics is a normative project that is best characterized by the challenge of developing common values and universal norms for responding to global health threats. Consequently, many subjects fall within its scope. Whilst several accounts of global health ethics have been conceptualized in the literature, a concise demarcation of the paradigm is still needed. Through means of a literature review, this paper presents a two-part introduction to global health ethics. First, the framework of 'borrowed' ethics that currently form the core of global health ethics is discussed in relation to two essential ethical considerations: 1) what is the moral significance of health and 2) what is the moral significance of boundaries? Second, a selection of exemplar ethical topics is presented to illustrate the range of topics within global health ethics.

Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective.

PubMed

Jafarey, Aamir M

2002-07-01

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions.

Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers.

PubMed

Simpson, Bob; Khatri, Rekha; Ravindran, Deapica; Udalagama, Tharindi

2015-04-01

Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the 'human subject' and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

An Evaluation of Research Ethics in Undergraduate Health Science Research Methodology Programs at a South African University.

PubMed

Coetzee, Tanya; Hoffmann, Willem A; de Roubaix, Malcolm

2015-10-01

The amended research ethics policy at a South African University required the ethics review of undergraduate research projects, prompting the need to explore the content and teaching approach of research ethics education in health science undergraduate programs. Two qualitative data collection strategies were used: document analysis (syllabi and study guides) and semi-structured interviews with research methodology coordinators. Five main themes emerged: (a) timing of research ethics courses, (b) research ethics course content, (c) sub-optimal use of creative classroom activities to facilitate research ethics lectures, (d) understanding the need for undergraduate project research ethics review, and (e) research ethics capacity training for research methodology lecturers and undergraduate project supervisors. © The Author(s) 2015.

Progress towards a world-wide code of conduct

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, J.A.N.; Berleur, J.

1994-12-31

In this paper the work of the International Federation for Information Processing (IFIP) Task Group on Ethics is described and the recommendations presented to the General Assembly are reviewed. While a common code of ethics or conduct has been not recommended for consideration by the member societies of IMP, a set of guidelines for the establishment and evaluation of codes has been produced and procedures for the assistance of code development have been established within IMP. This paper proposes that the data collected by the Task Group and the proposed guidelines can be used as a tool for the studymore » of codes of practice providing a teachable, learnable educational module in courses related to the ethics of computing and computation, and looks at the next steps in bringing ethical awareness to the IT community.« less

Public health ethics theory: review and path to convergence.

PubMed

Lee, Lisa M

2012-01-01

Public health ethics is a nascent field, emerging over the past decade as an applied field merging concepts of clinical and research ethics. Because the "patient" in public health is the population rather than the individual, existing principles might be weighted differently, or there might be different ethical principles to consider. This paper reviewed the evolution of public health ethics, the use of bioethics as its model, and the proposed frameworks for public health ethics through 2010. Review of 13 major public health ethics frameworks published over the past 15 years yields a wide variety of theoretical approaches, some similar foundational values, and a few similar operating principles. Coming to a consensus on the reach, purpose, and ends of public health is necessary if we are to agree on what ethical underpinnings drive us, what foundational values bring us to these underpinnings, and what operating principles practitioners must implement to make ethical decisions. If public health is distinct enough from clinical medicine to warrant its own set of ethical and philosophical underpinnings, then a decision must be made as to whether a single approach is warranted or we can tolerate a variety of equal but different perspectives. © 2012 American Society of Law, Medicine & Ethics, Inc.

Research protocol for the Picture Talk Project: a qualitative study on research and consent with remote Australian Aboriginal communities

PubMed Central

Fitzpatrick, Emily F M; Carter, Maureen; Oscar, June; Lawford, Tom; Martiniuk, Alexandra L C; D’Antoine, Heather A; Elliott, Elizabeth J

2017-01-01

Introduction Research with Indigenous populations is not always designed with cultural sensitivity. Few publications evaluate or describe in detail seeking consent for research with Indigenous participants. When potential participants are not engaged in a culturally respectful manner, participation rates and research quality can be adversely affected. It is unethical to proceed with research without truly informed consent. Methods and analysis We describe a culturally appropriate research protocol that is invited by Aboriginal communities of the Fitzroy Valley in Western Australia. The Picture Talk Project is a research partnership with local Aboriginal leaders who are also chief investigators. We will interview Aboriginal leaders about research, community engagement and the consent process and hold focus groups with Aboriginal community members about individual consent. Cultural protocols will be applied to recruit and conduct research with participants. Transcripts will be analysed using NVivo10 qualitative software and themes synthesised to highlight the key issues raised by the community about the research process. This protocol will guide future research with the Aboriginal communities of the Fitzroy Valley and may inform the approach to research with other Indigenous communities of Australia or the world. It must be noted that no community is the same and all research requires local consultation and input. To conduct culturally sensitive research, respected local people from the community who have knowledge of cultural protocol and language are engaged to guide each step of the research process from the project design to the delivery of results. Ethics and dissemination Ethics approval was granted by the University of Sydney Human Research Ethics Committee (No. 2012/348, reference:14760), the Western Australia Country Health Service Ethics Committee (No. 2012:15), the Western Australian Aboriginal Health Ethics Committee and reviewed by the Kimberley Aboriginal Health Planning Forum Research Sub-Committee (No. 2012–008). Results will be disseminated through peer review articles, a local Fitzroy Valley report and conference presentations. PMID:29288181

Health research ethics review and needs of institutional ethics committees in Tanzania.

PubMed

Ikingura, J K B; Kruger, M; Zeleke, W

2007-09-01

This study was undertaken to describe the performance of health research ethics review procedures of six research centres in Tanzania. Data collection was done through a self-administered questionnaire and personal interviews. The results showed that there were on average 11 members (range = 8-14) in each Research Ethic Committee. However, female representation in the committees was low (15.2%). The largest proportion of the committee members was biomedical scientists (51.5%). Others included medical doctors (19.7%), social scientists (7.6%), laboratory technologists (10.6%), religious leaders (4.5%), statisticians (3.0%), teachers (1.5%) and lawyers (1.5). Committee members had different capacities to carry out review of research proposals (no capacity = 2%; limited capacity = 15%; moderate capacity = 20%; good capacity = 48%, excellent capacity = 13%). Only half of the respondents had prior ethics review training. Although the majority deemed that ethical guidelines were very important (66%), there were challenges in the use of ethical guidelines which included lack of awareness on the national accreditation mechanisms for ethics committee (59%). Adherence to ethical principles and regulations was influenced by being a scientist (OR = 42.47), being an employee of a professional organization (OR = 15.25), and having an interests in the use of ethical guidelines (OR = 10.85) These findings indicate the need for capacity strengthening (through training and resource support), inclusion of more female representation and other mandatory professions to the research ethics committees.

Ethical considerations in the study of online illness narratives: a qualitative review.

PubMed

Heilferty, Catherine McGeehin

2011-05-01

This aim of the review was to describe differences in ethical approaches to research on Internet communication during illness and to report conclusions drawn relevant to a proposed narrative analysis of parent blogs of childhood illness. As the study of the online expression of illness experiences becomes more expansive, discussion of related ethical issues is central to promoting research trustworthiness and rigour. Ethical considerations are central to the patient-provider relationship. The EBSCO Host, CINAHL, Medline, Communication & Mass Media Complete, and Google Scholar databases were searched from January 1990 to September 2009 using the terms 'Internet research and ethics', 'Internet research, illness and ethics' and 'blog, Internet research and ethics'. Of the 4114 references found, 21 met the inclusion criteria for the review. The review was designed to be a comprehensive assessment of the concepts analysed and the qualitative research measures taken concerning ethics in Internet research across formats. Three main approaches to ethical conduct in Internet research on illness experiences were found: human subjects, representation and open source approaches. The personal and sensitive nature of online illness narratives demand their consideration in health care as 'human subjects' research. The best hope for ethical treatment of author-participants is the creation of a comprehensive plan for addressing any and all potential ethical conflicts that may arise in the collection, analysis and reporting of data, taking into consideration rapid changes in technology. © 2011 Blackwell Publishing Ltd.

A systematic review of ethics knowledge in audiology (1980-2010).

PubMed

Naudé, Alida Maryna; Bornman, Juan

2014-06-01

The purpose of this research was to apply multiple perspectives as part of a systematic review to analyze literature regarding ethics in audiology. Audiologists are particularly vulnerable to the changing requirements of the discipline that compel them to straddle both professional obligations and business principles, creating a hybrid professional. The authors used a 2-phase mixed-method approach to analyze publications. Publications were sorted into categories, namely, ethics approach, author, decade, role of the audiologist, component of morality, and common themes. The sample consisted of peer-reviewed articles cited in MEDLINE, CINAHL, ERIC, MasterFILE Premier, E-Journals, Africa-Wide Information, and Academic Search Premier electronic databases and non-peer-reviewed articles in Seminars in Hearing. The publications were predominantly philosophical, focused on the rehabilitative role of the audiologist, and addressed the moral judgment component of moral behavior. Despite the fact that knowledge of ethics grew between 1980 and 2010, this retrospective analysis identified gaps in current knowledge. Research is needed to address the unique ethical problems commonly encountered in all 8 roles of the audiologist; patient perspectives on ethics; ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in audiology.

Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

PubMed

Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

2016-08-31

Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. This study was a non-randomised comparison cohort study. Some data were missing. An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates.

PubMed

Chiumento, Anna; Rahman, Atif; Frith, Lucy; Snider, Leslie; Tol, Wietse A

2017-02-08

Research in emergencies is needed to understand the prevalence of mental health and psychosocial problems and strengthen the evidence base for interventions. All research - including operational needs assessments, programme monitoring and evaluation, and formal academic research - must be conducted ethically. While there is broad consensus on fundamental principles codified in research ethics guidelines, these do not address the ethical specificities of conducting mental health and psychosocial support (MHPSS) research with adults in emergencies. To address this gap, this paper presents a review of multidisciplinary literature to identify specific ethical principles applicable to MHPSS research in emergencies. Fifty-nine sources meeting the literature review inclusion criteria were analysed following a thematic synthesis approach. There was consensus on the relevance of universal ethical research principles to MHPSS research in emergencies, including norms of participant informed consent and protection; ensuring benefit arises from research participation; researcher neutrality, accountability, and safety; and the duty to ensure research is well designed and accounts for contextual factors in emergency settings. We go onto discuss unresolved issues by highlighting six current debates relating to the application of ethics in emergency settings: (1) what constitutes fair benefits?; (2) how should informed consent be operationalised?; (3) is there a role for decision making capacity assessments?; (4) how do risk management approaches impact upon the construction of ethical research?; (5) how can ethical reflection best be achieved?, and (6) are ethical review boards sufficiently representative and equipped to judge the ethical and scientific merit of emergency MHPSS research? Underlying these debates is a systemic tension between procedural ethics and ethics in practice. In summary, underpinning the literature is a desire to ensure the protection of participants exposed to emergencies and in need of evidence-based MHPSS. However, there is a lack of agreement on how to contextualise guidelines and procedures to effectively maximise the perspectives of researchers, participants and ethical review boards. This is a tension that the field must address to strengthen ethical MHPSS research in emergencies.

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

PubMed

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Ethical issues in obesity prevention for school children: a systematic qualitative review.

PubMed

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2017-12-01

Planning and conducting preventive measures against obesity for school children is beset with ethical issues which should be known to make well-informed decisions. The goal of this study was to provide a comprehensive spectrum of these ethical issues by means of a systematic review. In this context, the study also assesses the value of different search strategies for ethical literature in public health. Literature was searched in Medline, EBSCO and others. Three different search strategies with varied scopes were applied and their output was compared. Qualitative content analysis was used for extracting and categorizing ethical issues. 109 publications (published from 1995 to 2015) were finally included. The qualitative analysis resulted in 60 potentially relevant ethical issues. The three search strategies showed substantial differences regarding their search results. The presented spectrum provides an initial evidence base for dealing with ethical issues adequately. The findings of the study further suggest that a broader scope is more fruitful for systematic reviews on ethical issues in the field of public health.

Ethical issues in trauma-related research: a review.

PubMed

Newman, Elana; Risch, Elizabeth; Kassam-Adams, Nancy

2006-09-01

ETHICAL DECISION-MAKING ABOUT TRAUMA-RELATED STUDIES requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so what those might be, informed consent and mandatory reporting, and supervision of trauma-related research. For each topic, we review potential ethical issues, summarize the research conducted thus far to inform ethical practice, and recommend future practice, research questions and policies to advance the field so that research on trauma can continue to be a win-win situation for all stakeholders in the research enterprise.

End-of-life care policy: An integrated care plan for the dying

PubMed Central

Myatra, Sheila Nainan; Salins, Naveen; Iyer, Shivakumar; Macaden, Stanley C.; Divatia, Jigeeshu V.; Muckaden, Maryann; Kulkarni, Priyadarshini; Simha, Srinagesh; Mani, Raj Kumar

2014-01-01

Purpose: The purpose was to develop an end-of-life care (EOLC) policy for patients who are dying with an advanced life limiting illness and to develop practical procedural guidelines for limiting inappropriate therapeutic medical interventions and improve the quality of care of the dying within an ethical framework and through a professional and family/patient consensus process. Evidence: The Indian Society of Critical Care Medicine (ISCCM) published its first guidelines on EOLC in 2005 [1] which was later revised in 2012.[2] Since these publications, there has been an exponential increase in empirical information and discussion on the subject. The literature reviewed observational studies, surveys, randomized controlled studies, as well as guidelines and recommendations, for education and quality improvement published across the world. The search terms were: EOLC; do not resuscitate directives; withdrawal and withholding; intensive care; terminal care; medical futility; ethical issues; palliative care; EOLC in India; cultural variations. Indian Association of Palliative Care (IAPC) also recently published its consensus position statement on EOLC policy for the dying.[3] Method: An expert committee of members of the ISCCM and IAPC was formed to make a joint EOLC policy for the dying patients. Proposals from the chair were discussed, debated, and recommendations were formulated through a consensus process. The members extensively reviewed national and international established ethical principles and current procedural practices. This joint EOLC policy has incorporated the sociocultural, ethical, and legal perspectives, while taking into account the needs and situation unique to India. PMID:25249748

Informed consent process: A step further towards making it meaningful!

PubMed Central

Kadam, Rashmi Ashish

2017-01-01

Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process. PMID:28828304

Seeking consent for research with indigenous communities: a systematic review.

PubMed

Fitzpatrick, Emily F M; Martiniuk, Alexandra L C; D'Antoine, Heather; Oscar, June; Carter, Maureen; Elliott, Elizabeth J

2016-10-22

When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.

What ethics for case managers? Literature review and discussion.

PubMed

Corvol, Aline; Moutel, Grégoire; Somme, Dominique

2016-11-01

Little is known about case managers' ethical issues and professional values. This article presents an overview of ethical issues in case managers' current practice. Findings are examined in the light of nursing ethics, social work ethics and principle-based biomedical ethics. A systematic literature review was performed to identify and analyse empirical studies concerning ethical issues in case management programmes. It was completed by systematic content analysis of case managers' national codes of ethics. Only nine empirical studies were identified, eight of them from North America. The main dilemmas were how to balance system goals against the client's interest and client protection against autonomy. Professional codes of ethics shared important similarities, but offered different responses to these two dilemmas. We discuss the respective roles of professional and organizational ethics. Further lines of research are suggested. © The Author(s) 2015.

Ethical experiential learning in medical, nursing and allied health education: A narrative review.

PubMed

Grace, Sandra; Innes, Ev; Patton, Narelle; Stockhausen, Lynette

2017-04-01

Students enrolled in medical, nursing and health science programs often participate in experiential learning in their practical classes. Experiential learning includes peer physical examination and peer-assisted learning where students practise clinical skills on each other. To identify effective strategies that enable ethical experiential learning for health students during practical classes. A narrative review of the literature. Pubmed, Cinahl and Scopus databases were searched because they include most of the health education journals where relevant articles would be published. A data extraction framework was developed to extract information from the included papers. Data were entered into a fillable form in Google Docs. Findings from identified studies were extracted to a series of tables (e.g. strategies for fostering ethical conduct; facilitators and barriers to peer-assisted learning). Themes were identified from these findings through a process of line by line coding and organisation of codes into descriptive themes using a constant comparative method. Finally understandings and hypotheses of relevance to our research question were generated from the descriptive themes. A total of 35 articles were retrieved that met the inclusion criteria. A total of 13 strategies for ethical experiential learning were identified and one evaluation was reported. The most frequently reported strategies were gaining written informed consent from students, providing information about the benefits of experiential learning and what to expect in practical classes, and facilitating discussions in class about potential issues. Contexts that facilitated participation in experiential learning included allowing students to choose their own groups, making participation voluntary, and providing adequate supervision, feedback and encouragement. A total of 13 strategies for ethical experiential learning were identified in the literature. A formal process for written consent was evaluated as effective; the effectiveness of other strategies remains to be determined. A comprehensive framework that integrates all recommendations from the literature is needed to guide future research and practise of ethical experiential learning in health courses. Copyright © 2017 Elsevier Ltd. All rights reserved.

Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.

PubMed

Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah; Elliott, Amy J

2016-04-01

Increasingly, Tribal Nations are forming ethics review panels, which function separately from institutional review boards (IRBs). The emergence of strong community representation coincides with a widespread effort supported by the U.S. Department of Health & Human Services and other federal agencies to establish a single IRB for all multi-site research. This article underscores the value of a tribal ethics review board and describes the tribal oversight for the Safe Passage Study-a multi-site, community-based project in the Northern Plains. Our experience demonstrates the benefits of tribal ethics review and makes a strong argument for including tribal oversight in future regulatory guidance for multi-site, community-based research. © The Author(s) 2016.

Ethical dilemmas facing chief nurses in Japan: A Pilot study.

PubMed

Ito, Chiharu; Natsume, Mikiko

2016-06-01

Chief nurses are most likely to take the lead in discussing and working to resolve ethical dilemmas, creating an ethical culture within their organization that results in effective ethics training. As the first step in this process, there is a need to define the kinds of ethical dilemmas that chief nurses grapple with on a regular basis as a target for future study. Anonymous written questionnaires and semi-structured interviews. All research procedures were approved by the Chubu University Ethics Review Board, the research institution to which the authors belong (authorization no. 250016). Responses from four chief nurses indicated that ethical dilemmas could be categorized as either those related to patient dignity or those related to management (unique to their roles as administrators). It was also learned that chief nurses struggle with the fact that although they consult with their superiors and others, these efforts do not lead to resolution. The expectation is that going forward, chief nurses will play a central role in acting as coordinators with physicians to promote better communication as well as lead group discussions aimed at providing care that respects patient dignity. © The Author(s) 2015.

RETRACTED: Growth of boron-doped diamond nanoclusters using the HFCVD technique

NASA Astrophysics Data System (ADS)

Azadfar, P.; Ghoranneviss, M.; Elahi, S. M.; Farhadyar, N.; Salar Elahi, A.

2015-04-01

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of the Principal Editor. After a thorough investigation, the Editor has concluded that the review process for this article was compromised. The acceptance was based on information from one reviewer report that was submitted from an email account provided to the journal as a suggested reviewer during the submission of the article. Although purportedly a real reviewer account, the Editor has concluded that this was not of an appropriate, independent reviewer. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewer whose identity was assumed and to the readers of the journal that this deception was not detected during the submission process.

Ethics of health policy and systems research: a scoping review of the literature.

PubMed

Pratt, Bridget; Paul, Amy; Hyder, Adnan A; Ali, Joseph

2017-07-01

Health policy and systems research (HPSR) is increasingly funded and undertaken as part of health system strengthening efforts worldwide. HPSR ethics is also a relatively new and emerging field, with numerous normative and descriptive questions that have largely not been considered. Normative questions include what ethical principles and values should guide HPSR. Descriptive questions include what ethical concerns arise when conducting HPSR. A small but growing body of scholarly work characterizes the various ethics issues inherent in HPSR. Towards informing the future development of ethics guidance for HPSR, a scoping review was undertaken to: (1) identify the range of ethics issues relevant to the conduct of HPSR-with a deliberate (though not exclusive) focus on low- and middle-income country settings and (2) describe existing guidance on key ethics issues relevant to HPSR. Using the Cochrane methods as a basis, the review identified formal and informal literature on HPSR ethics by searching the following databases: PubMed's Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs, OpenDOAR and Bielefeld Academic Search Engine. In total, 11 062 documents were identified from the formal (10 519) and informal (543) literature. One hundred and seven of these documents (formal 99 and informal 8) met at least one inclusion criterion and underwent thematic analysis. Ethical issues in four main categories were identified: upholding autonomy, identifying and balancing risks and benefits, justice and determination of ethical review requirements. The review indicated that the ethical values behind HPSR place an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical concerns relating to justice arise in HPSR. However, the majority of existing guidance focuses on obtaining or waiving informed consent and, thus, appears to be insufficient for HPSR. A list of priority ethics issues in HPSR in need of guidance development is provided. © The Author 2017. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.

Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

PubMed

Tsoka-Gwegweni, Joyce M; Wassenaar, Douglas R

2014-12-01

The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC. © The Author(s) 2014.

Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards.

PubMed

Kotecha, Jyoti A; Manca, Donna; Lambert-Lanning, Anita; Keshavjee, Karim; Drummond, Neil; Godwin, Marshall; Greiver, Michelle; Putnam, Wayne; Lussier, Marie-Thérèse; Birtwhistle, Richard

2011-10-01

To describe the challenges the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) experienced with institutional research ethics boards (IREBs) when seeking approvals across jurisdictions and to provide recommendations for overcoming challenges of ethical review for multisite and multijurisdictional surveillance and research. The CPCSSN project collects and validates longitudinal primary care health information (relating to hypertension, diabetes, depression, chronic obstructive lung disease, and osteoarthritis) from electronic medical records across Canada. Privacy and data storage security policies and processes have been developed to protect participants' privacy and confidentiality, and IREB approval is obtained in each participating jurisdiction. Inconsistent interpretation and application of privacy and ethical issues by IREBs delays and impedes research programs that could better inform us about chronic disease. The CPCSSN project's experience with gaining approval from IREBs highlights the difficulty of conducting pan-Canadian health surveillance and multicentre research. Inconsistent IREB approvals to waive explicit individual informed consent produced particular challenges for researchers. The CPCSSN experience highlights the need to develop a better process for researchers to obtain timely and consistent IREB approvals for multicentre surveillance and research. We suggest developing a specialized, national, centralized IREB responsible for approving multisite studies related to population health research.

Review of sampling, sample and data collection procedures in nursing research--An example of research on ethical climate as perceived by nurses.

PubMed

Suhonen, Riitta; Stolt, Minna; Katajisto, Jouko; Leino-Kilpi, Helena

2015-12-01

To report a review of quality regarding sampling, sample and data collection procedures of empirical nursing research of ethical climate studies where nurses were informants. Surveys are needed to obtain generalisable information about topics sensitive to nursing. Methodological quality of the studies is of key concern, especially the description of sampling and data collection procedures. Methodological literature review. Using the electronic MEDLINE database, empirical nursing research articles focusing on ethical climate were accessed in 2013 (earliest-22 November 2013). Using the search terms 'ethical' AND ('climate*' OR 'environment*') AND ('nurse*' OR 'nursing'), 376 citations were retrieved. Based on a four-phase retrieval process, 26 studies were included in the detailed analysis. Sampling method was reported in 58% of the studies, and it was random in a minority of the studies (26%). The identification of target sample and its size (92%) was reported, whereas justification for sample size was less often given. In over two-thirds (69%) of the studies with identifiable response rate, it was below 75%. A variety of data collection procedures were used with large amount of missing data about the details of who distributed, recruited and collected the questionnaires. Methods to increase response rates were seldom described. Discussion about nonresponse, representativeness of the sample and generalisability of the results was missing in many studies. This review highlights the methodological challenges and developments that need to be considered in ensuring the use of valid information in developing health care through research findings. © 2015 Nordic College of Caring Science.

Review paper on research ethics in Ethiopia: experiences and lessons learnt from Addis Ababa University College of Health Sciences 2007-2012.

PubMed

Feleke, Yeweyenhareg; Addissie, Adamu; Wamisho, Biruk L; Davey, Gail

2015-01-01

Health research in Ethiopia is increasing both in volume and type, accompanied with expansion of higher education and research since the past few years. This calls for a proportional competence in the governance of medical research ethics in Ethiopia in the respective research and higher learning institutes. The paper highlights the evolution and progress ofthe ethics review at Addis Ababa University - College of Health Sciences (AAU-CHS) in the given context of health research review system in Ethiopia. Reflections are made on the key lessons to be drawnfrom the formative experiences of the Institutional Review Board (IRB) and their implications to the Ethiopian health research review system. This article is a review paper based on review of published and un published documents on research ethics in Ethiopia and the AAU-CHS (2007-2012). Thematic summaries of review findings are presented in thematic areas - formation of ethics review and key factors in the evolution of ethics review and implications. The IRB at AAU-CHS has been pivotal in providing review and follow-up for important clinical studies in Ethiopia. It has been one of the first IRBs to get WHO/SIDCER recognition from Africa and Ethiopia. Important factors in the successes of the IRB among others included leadership commitment, its placement in institutional structure, and continued capacity building. Financial challenges and sustainability issues need to be addressed for the sustained gains registered so far. Similar factors are considered important for the new and younger IRBs within the emergent Universities and research centers in the country.

Ethical Dilemmas in Disaster Medicine

PubMed Central

Ozge Karadag, C; Kerim Hakan, A

2012-01-01

Background Disasters may lead to ethical challenges that are different from usual medical practices. In addition, disaster situations are related with public health ethics more than medical ethics, and accordingly may require stronger effort to achieve a balance between individual and collective rights. This paper aims to review some ethical dilemmas that arise in disasters and mainly focuses on health services. Disasters vary considerably with respect to their time, place and extent; therefore, ethical questions may not always have `one-size-fits-all` answers. On the other hand, embedding ethical values and principles in every aspect of health-care is of vital importance. Reviewing legal and organizational regulations, developing health-care related guidelines, and disaster recovery plans, establishing on-call ethics committees as well as adequate in-service training of health-care workers for ethical competence are among the most critical steps. It is only by making efforts before disasters, that ethical challenges can be minimized in disaster responses. PMID:23285411

The Development of a Taxonomy of Wrongdoing in Medical Practice and Research

PubMed Central

DuBois, James M.; Yates, Elena; Vasher, Meghan

2011-01-01

“Ethical disasters” or egregious violations of professional ethics in medicine often receive substantial amounts of publicity, leading to mistrust of the medical system. Efforts to understand wrongdoing in medical practice and research are hampered by the absence of a clear taxonomy. This article describes the authors’ process of developing a taxonomy based on: (1) reviews of academic literature, ethics codes, government regulations, and cases of wrongdoing; (2) consultation with experts in health law and healthcare ethics; and (3) application of the taxonomy to published cases of wrongdoing in medical research and practice. The resulting taxonomy includes 14 categories of wrongdoing in medical practice, and 15 categories of wrongdoing in medical research. This taxonomy may be useful to oversight bodies, researchers who seek to understand and reduce the prevalence of wrongdoing in medicine, and librarians who index literature on wrongdoing. PMID:22176853

Innovations in research ethics governance in humanitarian settings.

PubMed

Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome

2015-02-26

Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out research in fragile contexts and for ethics committees reviewing such research.

The Satisfaction and Use of Research Ethics Board Information Systems in Canada.

PubMed

Detlor, Brian; Wilson, Michael J

2015-10-01

This article reports findings from a national survey of Research Ethics Board (REB) personnel across Canada on the satisfaction and use of information systems that support the review and administration of research ethics protocols. Findings indicate that though a wide variety of REB systems are utilized, the majority fall short of desired characteristics. Despite these shortcomings, most respondents are satisfied with their current REB systems. Satisfaction is dependent on the volume of protocols processed in relation to the robustness of the system. Boards with higher volumes are more satisfied with full-fledged systems; however, the satisfaction of REBs with lower volumes is not affected by the robustness of the REB system used. Recommendations are provided. © The Author(s) 2015.

Qualitative assessment of a blended learning intervention in an undergraduate nursing course.

PubMed

Hsu, Li-Ling

2012-12-01

Nurses are experiencing new ethical issues because of global developments and changes in the healthcare environment. Blended learning is one of the various methods used to deliver meaningful learning experiences. Well-designed, properly administered nursing ethics education is essential for nursing students to visualize the role of professional nurses. However, a literature review shows that only a few existing studies have touched on the subject of nursing student experiences with blended learning in a nursing ethics course. This study examines how undergraduate nursing students respond to a blended learning approach in a nursing ethics course and how blended learning affects the learning process. We used a qualitative research design with in-depth interviews. Participants included 28 female undergraduate nursing students who had completed the nursing ethics course. Each interview lasted 50-100 minutes. The researcher conducted all interviews in 2009. The researcher identified six major themes and 13 subthemes from the data. The six themes included (a) enhancing thinking ability, (b) improving problem-solving skills, (c) reflecting in and on practice, (d) perceiving added workload, (e) encouraging active learning, and (f) identifying the value of nursing. Participants felt that the blended learning experience was a generally positive experience. Most participants appreciated the opportunity to take a more active role in the learning process, think about issues profoundly and critically, and exercise metacognitive powers in the thinking and decision-making process. Study findings may suggest productive ideas for fine-tuning blended learning models.

Teaching Ethics in Medical School.

ERIC Educational Resources Information Center

Ewan, Christine

1986-01-01

Reviews the literature regarding the teaching of ethics in medical schools. Defines medical ethics and attempts to determine the scope of medical ethics teaching. Discusses ways medical ethics could be taught and how that teaching can be assessed. Calls for increased attention into the teaching of medical ethics. (TW)

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC

PubMed Central

van Doorn, Eva; Hak, Eelko; Wilffert, Bob

2015-01-01

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure. PMID:26343188

National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC.

PubMed

van Doorn, Eva; Hak, Eelko; Wilffert, Bob

2015-04-14

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure.

Population screening for genetic disorders in the 21st century: evidence, economics, and ethics.

PubMed

Grosse, S D; Rogowski, W H; Ross, L F; Cornel, M C; Dondorp, W J; Khoury, M J

2010-01-01

Proposals for population screening for genetic diseases require careful scrutiny by decision makers because of the potential for harms and the need to demonstrate benefits commensurate with the opportunity cost of resources expended. We review current evidence-based processes used in the United States, the United Kingdom, and the Netherlands to assess genetic screening programs, including newborn screening programs, carrier screening, and organized cascade testing of relatives of patients with genetic syndromes. In particular, we address critical evidentiary, economic, and ethical issues that arise in the appraisal of screening tests offered to the population. Specific case studies include newborn screening for congenital adrenal hyperplasia and cystic fibrosis and adult screening for hereditary hemochromatosis. Organizations and countries often reach different conclusions about the suitability of screening tests for implementation on a population basis. Deciding when and how to introduce pilot screening programs is challenging. In certain cases, e.g., hereditary hemochromatosis, a consensus does not support general screening although cascade screening may be cost-effective. Genetic screening policies have often been determined by technological capability, advocacy, and medical opinion rather than through a rigorous evidence-based review process. Decision making should take into account principles of ethics and opportunity costs. Copyright 2009 S. Karger AG, Basel.

Ethics review of health research on human participants in South Africa.

PubMed

van Wyk, Christa

2010-06-01

In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

Factors that impact on emergency nurses' ethical decision-making ability.

PubMed

Alba, Barbara

2016-11-10

Reliance on moral principles and professional codes has given nurses direction for ethical decision-making. However, rational models do not capture the emotion and reality of human choice. Intuitive response must be considered. Supporting intuition as an important ethical decision-making tool for nurses, the aim of this study was to determine relationships between intuition, years of worked nursing experience, and perceived ethical decision-making ability. A secondary aim explored the relationships between rational thought to years of worked nursing experience and perceived ethical decision-making ability. A non-experimental, correlational research design was used. The Rational Experiential Inventory measured intuition and rational thought. The Clinical Decision Making in Nursing Scale measured perceived ethical decision-making ability. Pearson's r was the statistical method used to analyze three primary and two secondary research questions. A sample of 182 emergency nurses was recruited electronically through the Emergency Nurses Association. Participants were self-selected. Approval to conduct this study was obtained by the Adelphi University Institutional Review Board. A relationship between intuition and perceived ethical decision-making ability (r = .252, p = .001) was a significant finding in this study. This study is one of the first of this nature to make a connection between intuition and nurses' ethical decision-making ability. This investigation contributes to a broader understanding of the different thought processes used by emergency nurses to make ethical decisions. © The Author(s) 2016.

75 FR 62540 - Updated OGE Senior Executive Service Performance Review Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of... Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917; Telephone: 202-482-9300; TTY...

77 FR 76293 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-27

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review... Documents AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: The U.S. Office of Government Ethics (OGE) is publishing this first round notice and seeking comment on the twelve executive branch OGE...

78 FR 24749 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment Request for a Modified OGE Form 201 Ethics in Government Act Access Form AGENCY: Office of Government Ethics (OGE). ACTION: Notice of request for agency and public comments...

78 FR 40144 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review... Documents AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: The U.S. Office of Government Ethics (OGE) is publishing this second round notice and requesting comment on the twelve executive branch...

76 FR 60840 - Updated OGE Senior Executive Service Performance Review Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of... Government Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917; Telephone: 202-482-9300...

78 FR 56704 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-13

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment Request for a Modified OGE Form 201 Ethics in Government Act Access Form AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: After publication of this second...

78 FR 76148 - Updated OGE Senior Executive Service Performance Review Board

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-16

... OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of... Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: 202-482-9300...

77 FR 64521 - Updated OGE Senior Executive Service Performance Review Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of... Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: 202-482-9300...

75 FR 5324 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment Request for an Unmodified OGE Form 201 Ethics Act Access Form AGENCY: Office of Government Ethics (OGE). ACTION: Notice of request for agency and public comments. SUMMARY: After...

Ethical and Legal Responsibilities of Counselors.

ERIC Educational Resources Information Center

Glennen, Robert E.

In the aftermath of the Watergate scandal, each profession is reviewing its ethical practices. This paper assists in this renewal by citing the code of ethical standards of APGA; reviewing the laws of the State of Nevada regarding privileged communications; and covering the legal aspects which relate to counseling situations. (Author)

A new prescription for empirical ethics research in pharmacy: a critical review of the literature

PubMed Central

Cooper, R J; Bissell, P; Wingfield, J

2007-01-01

Empirical ethics research is increasingly valued in bioethics and healthcare more generally, but there remain as yet under‐researched areas such as pharmacy, despite the increasingly visible attempts by the profession to embrace additional roles beyond the supply of medicines. A descriptive and critical review of the extant empirical pharmacy ethics literature is provided here. A chronological change from quantitative to qualitative approaches is highlighted in this review, as well as differing theoretical approaches such as cognitive moral development and the four principles of biomedical ethics. Research with pharmacy student cohorts is common, as is representation from American pharmacists. Many examples of ethical problems are identified, as well as commercial and legal influences on ethical understanding and decision making. In this paper, it is argued that as pharmacy seeks to develop additional roles with concomitant ethical responsibilities, a new prescription is needed for empirical ethics research in pharmacy—one that embraces an agenda of systematic research using a plurality of methodological and theoretical approaches to better explore this under‐researched discipline. PMID:17264193

The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

PubMed

Barker, Roger A; Carpenter, Melissa K; Forbes, Stuart; Goldman, Steven A; Jamieson, Catriona; Murry, Charles E; Takahashi, Jun; Weir, Gordon

2018-05-08

Stem cell-based clinical interventions are increasingly advancing through preclinical testing and approaching clinical trials. The complexity and diversity of these approaches, and the confusion created by unproven and untested stem cell-based "therapies," create a growing need for a more comprehensive review of these early-stage human trials to ensure they place the patients at minimal risk of adverse events but are also based on solid evidence of preclinical efficacy with a clear scientific rationale for that effect. To address this issue and supplement the independent review process, especially that of the ethics and institutional review boards who may not be experts in stem cell biology, the International Society for Stem Cell Research (ISSCR) has developed a set of practical questions to cover the major issues for which clear evidence-based answers need to be obtained before approving a stem cell-based trial. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Study of Ethical Values and Practices in Academic Programmes at a Higher Learning Institution

NASA Astrophysics Data System (ADS)

Narayanasamy, Kogilah; Shetty, M. V.

The study on ethical values in academic programmes has attracted the attention of many researchers throughout the world especially in view of its important role today. Many academic programmes today focus on how to make profit both for the individual and the organization and on how to increase the firm`s market share and shareholders value and in the process may compromise on their ethical values and have unethical practices. Thus, this study is undertaken to evaluate the extent of integration of ethical values in the academic programmes of the higher learning operating institution involved with post graduate and higher level programs. The impact of demographics and race of the lecturer and students have been separately ascertained. The sample has been taken from one college, rated to be high in ethical values and practices, a sample of 120 students and 31 lecturers from a leading college (reputed for ethical values) have been collated and analyzed for validation of the objectives. The explanation on ethics has been done to a large extent in the study. The study also indicates the number of higher learning institutions to indicate the extent of impact if these issues are appropriately addressed. Government policy in this regard also needs to be reviewed and improved to avoid deterioration of ethical values and practices in the dynamic market place of today. This study review that, the level at which lecturers at the institutions have high ethical values and do incorporate it in their lectures and discussions in the classroom. The impact of demographic factors on the ethical values and practice of the lecturers have useful insights for academic staff recruitment and staff training. On the other hand, students` ethical values and behavior is a cause for concern to everyone as these future pillars of the nation have been found to have their ethical values and practices at low levels. The implications for the college management as to consider further emphasis on the teaching of ethics as a single subject, while incorporating a discussion of the ethical issues (like) related to the various subjects taught in the college. The college should also ensure that they support and nurture in cultivating of ethical values and practices in all aspects of their activities and operations. Eventually, this will ensure to provide advantageous environment for not only creating knowledgeable individuals but also ethical citizens and leaders.

Ethical aspects of registry-based research in the Nordic countries.

PubMed

Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

2015-01-01

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.

Ethical aspects of registry-based research in the Nordic countries

PubMed Central

Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

2015-01-01

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies. PMID:26648756

Ethical Considerations Regarding the Use of Smart Home Technologies for Older Adults: An Integrative Review.

PubMed

Chung, Jane; Demiris, George; Thompson, Hilaire J

2016-01-01

With the wide adoption and use of smart home applications, there is a need for examining ethical issues regarding smart home use at the intersection of aging, technology, and home environment. The purpose of this review is to provide an overview of ethical considerations and the evidence on these ethical issues based on an integrative literature review with regard to the utilization of smart home technologies by older adults and their family members. REVIEW DESIGN AND METHODS: We conducted an integrative literature review of the scientific literature from indexed databases (e. g., MEDLINE, CINAHL, and PsycINFO). The framework guiding this review is derived from previous work on ethical considerations related to telehealth use for older adults and smart homes for palliative care. Key ethical issues of the framework include privacy, informed consent, autonomy, obtrusiveness, equal access, reduction in human touch, and usability. Six hundred and thirty-five candidate articles were identified between the years 1990 and 2014. Sixteen articles were included in the review. Privacy and obtrusiveness issues appear to be the most important factors that can affect smart home technology adoption. In addition, this article recommends that stigmatization and reliability and maintenance of the system are additional factors to consider. When smart home technology is used appropriately, it has the potential to improve quality of life and maintain safety among older adults, ultimately supporting the desire of older adults for aging in place. The ability to respond to potential ethical concerns will be critical to the future development and application of smart home technologies that aim to enhance safety and independence.

Ethics committees and the changed clinical research environment in India in 2016: A perspective!

PubMed

Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi

2017-01-01

Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

Too much information: visual research ethics in the age of wearable cameras.

PubMed

Mok, Tze Ming; Cornish, Flora; Tarr, Jen

2015-06-01

When everything you see is data, what ethical principles apply? This paper argues that first-person digital recording technologies challenge traditional institutional approaches to research ethics, but that this makes ethics governance more important, not less so. We review evolving ethical concerns across four fields: Visual ethics; ubiquitous computing; mobile health; and grey literature from applied or market research. Collectively, these bodies of literature identify new challenges to traditional notions of informed consent, anonymity, confidentiality, privacy, beneficence and maleficence. Challenges come from the ever-increasing power, breadth and multi-functional integration of recording technologies, and the ubiquity and normalization of their use by participants. Some authors argue that these evolving relationships mean that institutional ethics governance procedures are irrelevant or no longer apply. By contrast, we argue that the fundamental principles of research ethics frameworks have become even more important for the protection of research participants, and that institutional frameworks need to adapt to keep pace with the ever-increasing power of recording technologies and the consequent risks to privacy. We conclude with four recommendations for efforts to ensure that contemporary visual recording research is held appropriately accountable to ethical standards: (i) minimizing the detail, scope, integration and retention of captured data, and limiting its accessibility; (ii) formulating an approach to ethics that takes in both the 'common rule' approaches privileging anonymity and confidentiality together with principles of contextual judgement and consent as an ongoing process; (iii) developing stronger ethical regulation of research outside academia; (iv) engaging the public and research participants in the development of ethical guidelines.

Ethics in clinical research: the Indian perspective.

PubMed

Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

Ethical Risk Management Education in Engineering: A Systematic Review.

PubMed

Guntzburger, Yoann; Pauchant, Thierry C; Tanguy, Philippe A

2017-04-01

Risk management is certainly one of the most important professional responsibilities of an engineer. As such, this activity needs to be combined with complex ethical reflections, and this requirement should therefore be explicitly integrated in engineering education. In this article, we analyse how this nexus between ethics and risk management is expressed in the engineering education research literature. It was done by reviewing 135 articles published between 1980 and March 1, 2016. These articles have been selected from 21 major journals that specialize in engineering education, engineering ethics and ethics education. Our review suggests that risk management is mostly used as an anecdote or an example when addressing ethics issues in engineering education. Further, it is perceived as an ethical duty or requirement, achieved through rational and technical methods. However, a small number of publications do offer some critical analyses of ethics education in engineering and their implications for ethical risk and safety management. Therefore, we argue in this article that the link between risk management and ethics should be further developed in engineering education in order to promote the progressive change toward more socially and environmentally responsible engineering practices. Several research trends and issues are also identified and discussed in order to support the engineering education community in this project.

5 CFR 2634.605 - Review of reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

....605 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS EXECUTIVE BRANCH FINANCIAL... reviewing official may request an intermediate review by the filer's supervisor. In the case of a filer who is detailed to another agency for more than 60 days during the reporting period, the reviewing...

Shared Decision Making in Intensive Care Units: An American College of Critical Care Medicine and American Thoracic Society Policy Statement

PubMed Central

Kon, Alexander A.; Davidson, Judy E.; Morrison, Wynne; Danis, Marion; White, Douglas B.

2015-01-01

Objectives Shared decision-making (SDM) is endorsed by critical care organizations, however there remains confusion about what SDM is, when it should be used, and approaches to promote partnerships in treatment decisions. The purpose of this statement is to define SDM, recommend when SDM should be used, identify the range of ethically acceptable decision-making models, and present important communication skills. Methods The American College of Critical Care Medicine (ACCM) and American Thoracic Society (ATS) Ethics Committees reviewed empirical research and normative analyses published in peer-reviewed journals to generate recommendations. Recommendations approved by consensus of the full Ethics Committees of ACCM and ATS were included in the statement. Main Results Six recommendations were endorsed: 1) Definition: Shared decision-making is a collaborative process that allows patients, or their surrogates, and clinicians to make health care decisions together, taking into account the best scientific evidence available, as well as the patient’s values, goals, and preferences. 2) Clinicians should engage in a SDM process to define overall goals of care (including decisions regarding limiting or withdrawing life-prolonging interventions) and when making major treatment decisions that may be affected by personal values, goals, and preferences. 3) Clinicians should use as their “default” approach a SDM process that includes three main elements: information exchange, deliberation, and making a treatment decision. 4) A wide range of decision-making approaches are ethically supportable including patient- or surrogate-directed and clinician-directed models. Clinicians should tailor the decision-making process based on the preferences of the patient or surrogate. 5) Clinicians should be trained in communication skills. 6) Research is needed to evaluate decision-making strategies. Conclusions Patient and surrogate preferences for decision-making roles regarding value-laden choices range from preferring to exercise significant authority to ceding such authority to providers. Clinicians should adapt the decision-making model to the needs and preferences of the patient or surrogate. PMID:26509317

Shared Decision Making in ICUs: An American College of Critical Care Medicine and American Thoracic Society Policy Statement.

PubMed

Kon, Alexander A; Davidson, Judy E; Morrison, Wynne; Danis, Marion; White, Douglas B

2016-01-01

Shared decision making is endorsed by critical care organizations; however, there remains confusion about what shared decision making is, when it should be used, and approaches to promote partnerships in treatment decisions. The purpose of this statement is to define shared decision making, recommend when shared decision making should be used, identify the range of ethically acceptable decision-making models, and present important communication skills. The American College of Critical Care Medicine and American Thoracic Society Ethics Committees reviewed empirical research and normative analyses published in peer-reviewed journals to generate recommendations. Recommendations approved by consensus of the full Ethics Committees of American College of Critical Care Medicine and American Thoracic Society were included in the statement. Six recommendations were endorsed: 1) DEFINITION: Shared decision making is a collaborative process that allows patients, or their surrogates, and clinicians to make healthcare decisions together, taking into account the best scientific evidence available, as well as the patient's values, goals, and preferences. 2) Clinicians should engage in a shared decision making process to define overall goals of care (including decisions regarding limiting or withdrawing life-prolonging interventions) and when making major treatment decisions that may be affected by personal values, goals, and preferences. 3) Clinicians should use as their "default" approach a shared decision making process that includes three main elements: information exchange, deliberation, and making a treatment decision. 4) A wide range of decision-making approaches are ethically supportable, including patient- or surrogate-directed and clinician-directed models. Clinicians should tailor the decision-making process based on the preferences of the patient or surrogate. 5) Clinicians should be trained in communication skills. 6) Research is needed to evaluate decision-making strategies. Patient and surrogate preferences for decision-making roles regarding value-laden choices range from preferring to exercise significant authority to ceding such authority to providers. Clinicians should adapt the decision-making model to the needs and preferences of the patient or surrogate.

The ethics of social media in dental practice: challenges.

PubMed

Peltier, Bruce; Curley, Arthur

2013-07-01

This is the first of two essays written to consider several important trends in dental practice that result from innovations in digital and social media. This essay reviews ethical and legal implications of the use of websites, Facebook, review sites, email and other digital innovations in dental practice. The second essay provides ethical tools for analysis, illuminates areas of ethical concern in today's practice environment and offers recommendations for future practice.

Research ethics III: Publication practices and authorship, conflicts of interest, and research misconduct.

PubMed

Horner, Jennifer; Minifie, Fred D

2011-02-01

In this series of articles--Research Ethics I, Research Ethics II, and Research Ethics III--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In Research Ethics III, they review the RCR domains of publication practices and authorship, conflicts of interest, and research misconduct. Whereas the legal definition of research misconduct under federal law pertains mainly to intentional falsification, fabrication, and plagiarism, they discuss a host of research practices that raise ethical concerns. The integrity of the scientific record--its accuracy, completeness, and value--ultimately impacts the health and well-being of society. For this reason, scientists are both entrusted and obligated to use the highest standards possible when proposing, performing, reviewing, and reporting research or when educating and mentoring new investigators.

Ethics in exercise science research.

PubMed

Shephard, Roy J

2002-01-01

Ethical evaluation is a vital but sometimes neglected component of research policy in the exercise sciences. This article reviews some issues in human research, with particular reference to studies undertaken by the exercise scientist. The typical composition and functions of the research review committee are examined in the context of individual and institutional ethical norms. In multicentre trials, there are often problems in coordinating ethical approval between institutions. On-going monitoring of research may have value in the detection of fraud. A reduction in the secrecy of committee proceedings would allow a closer auditing of the research review process. Authors need to give more thought to developing appropriate research questions. Scarce resources may be wasted because of inappropriate study design or an inadequate statistical analysis of the results. The costs of any proposed investigation must be weighed carefully against possible benefits. Confidentiality is particularly important when collecting data at the worksite or over the internet. Informed consent should be based on a full disclosure of risks; the participant should be competent to understand the nature and magnitude of these risks, and undue pressure to participate in an experiment must be avoided. The opposition to placebo trials expressed in the Declaration of Helsinki requires careful consideration of the use of control groups, since regular exercise is known to benefit health. If research is conducted in under-developed societies, the standards of treatment of the participants should match those expected in developed societies. The publication of findings must be fair and well balanced; examples of fraud and misconduct continue to be reported. Some journals apparently still publish papers, even if they have not received an initial institutional review. Editors should restore meaning to the word 'author', avoid the bias to a publication of 'positive' results, limit the impact of commercial sponsorship on reporting and curtail the current trend to redundant presentations and publications. Development of academic courses in research ethics may help to avoid some of these abuses.

Instructional Vignettes in Publication and Journalism Ethics in Radiology Research: Assessment via a Survey of Radiology Trainees.

PubMed

Rosenkrantz, Andrew B; Ginocchio, Luke A

2016-07-01

The aim of the present study was to assess the potential usefulness of written instructional vignettes relating to publication and journalism ethics in radiology via a survey of radiology trainees. A literature review was conducted to guide the development of vignettes, each describing a scenario relating to an ethical issue in research and publication, with subsequent commentary on the underlying ethical issue and potential approaches to its handling. Radiology trainees at a single institution were surveyed regarding the vignettes' perceived usefulness. A total of 21 vignettes were prepared, addressing institutional review board and human subjects protection, authorship issues, usage of previous work, manuscript review, and other miscellaneous topics. Of the solicited trainees, 24.7% (16/65) completed the survey. On average among the vignettes, 94.0% of the participants found the vignette helpful; 19.9 received prior formal instruction on the issue during medical training; 40.0% received prior informal guidance from a research mentor; and 42.0% indicated that the issue had arisen in their own or a peer's prior research experience. The most common previously experienced specific issue was authorship order (93.8%). Free-text responses were largely favorable regarding the value of the vignettes, although also indicated numerous challenges in properly handling the ethical issues: impact of hierarchy, pressure to publish, internal politics, reluctance to conduct sensitive conversations with colleagues, and variability in journal and professional society policies. Radiology trainees overall found the vignettes helpful, addressing commonly encountered topics for which formal and informal guidance were otherwise lacking. The vignettes are publicly available through the Association of University Radiologists (AUR) website and may foster greater insights by investigators into ethical aspects of the publication and journalism process, thus contributing to higher quality radiology research. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

The full spectrum of ethical issues in the care of patients with ALS: a systematic qualitative review.

PubMed

Seitzer, F; Kahrass, H; Neitzke, G; Strech, D

2016-02-01

Dealing systematically with ethical issues in amyotrophic lateral sclerosis (ALS) care requires an unbiased awareness of all the relevant ethical issues. The aim of the study was to determine systematically and transparently the full spectrum of ethical issues in ALS care. We conducted a systematic review in Medline and Google Books (restricted to English and German literature published between 1993 and 2014). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in ALS care. The literature review retrieved 56 references that together mentioned a spectrum of 103 ethical issues in ALS care. The spectrum was structured into six major categories that consist of first and second-order categories of ethical issues. The systematically derived spectrum of ethical issues in ALS care presented in this paper raises awareness and understanding of the complexity of ethical issues in ALS care. It also offers a basis for the systematic development of informational and training materials for health professionals, patients and their relatives, and society as a whole. Finally, it supports a rational and fair selection of all those ethical issues that should be addressed in health policies, position papers and clinical practice guidelines. Further research is needed to identify ways to systematically select the most relevant ethical issues not only in the clinical environment, but also for the development of clinical practice guidelines.

Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards.

PubMed

Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

2017-08-01

For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Ethics Committees and Mental Health.

PubMed

Yepes Delgado, Carlos Enrique; Ocampo Montoya, Andrea

Although research processes are covered by the objectivity of science, they are still influenced by the interests of those who conduct them. This is why high level committees have been tasked with defining the scope of the studies and performing a thorough assessment of them, since these imply great dilemmas. This premise leads to the emergence of Ethics Committees, where liaison psychiatry has an important place due to its communication abilities and knowledge of the human behavior. This paper attempts to provide some observations to take into account when discussing the link between ethics and mental health. In this work, the authors approach the question of ethics committees and the importance that psychiatrist performance has within them. This is done through a review of relevant papers on the subject. A detailed description on research ethics is provided in terms of justification, purpose and duties. Likewise, emphasis is placed on each of the areas in which psychiatrists are involved and bear great responsibilities in the medical decision-making process. Similarly, this description also includes the moment in which participants give their informed consent when taking part in medical research. Finally, we conclude that there are several questions regarding the relevance given to these committees in the methodological and ethical assessment of research projects. This in turn implies greater effort in the search for a culture of quality which highlights the emphasis on research subjects. Copyright © 2017 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

A systematic review of ethical issues in vaccine studies involving pregnant women.

PubMed

Beeler, Jennifer A; Lambach, Philipp; Fulton, T Roice; Narayanan, Divya; Ortiz, Justin R; Omer, Saad B

2016-08-02

Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries.

Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

ERIC Educational Resources Information Center

Mayne, Fiona; Howitt, Christine; Rennie, Léonie

2016-01-01

Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

An Analysis of Ethical Issues in Governmental Communication.

ERIC Educational Resources Information Center

Turner, John R.

A research review examined the ethical responsibilities of a communicator in contemporary American society, particularly in governmental communication. Various scholars have suggested standards of ethical governmental communication and have questioned the ethics of governmental officials in several cases. Ethical analysis of President Ronald…

77 FR 60116 - Human Studies Review Board; Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This... and ethics issues under discussion, it is not our intent to permit organizations to expand the time..., information, and recommendations to the EPA on issues related to scientific and ethical aspects of human...

78 FR 54466 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-04

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review... Disclosure Report AGENCY: Office of Government Ethics (OGE). ACTION: Notice of request for agency and public... Clearance Officer, at the U.S. Office of Government Ethics; telephone: 202-482- 9247; TTY: 800-877-8339; FAX...

76 FR 80938 - Human Studies Review Board; Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This public... of oral comments on the science and ethics issues under discussion, it is not our intent to permit... related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are...

75 FR 16809 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review... Disclosure Report AGENCY: Office of Government Ethics (OGE). ACTION: Notice of request for agency and public... Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Office of Government Ethics, by either of the...

76 FR 17121 - Human Studies Review Board (HSRB); Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... public meeting of the HSRB to advise the Agency on EPA's scientific and ethical reviews of research with... and ethics issues under discussion, it is not our intent to permit organizations to expand the time... provides advice, information, and recommendations to EPA on issues related to scientific and ethical...

75 FR 30831 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-02

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review... Disclosure Report AGENCY: Office of Government Ethics (OGE). ACTION: Notice of request for agency and public... Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Office of Government Ethics, by either of the...

A Review of Contemporary Ethical Decision-Making Models for Mental Health Professionals

ERIC Educational Resources Information Center

Francis, Perry C.

2015-01-01

Mental health professionals are faced with increasingly complex ethical decisions that are impacted by culture, personal and professional values, and the contexts in which they and their clients inhabit. This article presents the reasons for developing and implementing multiple ethical decision making models and reviews four models that address…

A review of ethical issues in dementia.

PubMed

Johnson, Rebecca A; Karlawish, Jason

2015-10-01

Dementia raises many ethical issues. The present review, taking note of the fact that the stages of dementia raise distinct ethical issues, focuses on three issues associated with stages of dementia's progression: (1) how the emergence of preclinical and asymptomatic but at-risk categories for dementia creates complex questions about preventive measures, risk disclosure, and protection from stigma and discrimination; (2) how despite efforts at dementia prevention, important research continues to investigate ways to alleviate clinical dementia's symptoms, and requires additional human subjects protections to ethically enroll persons with dementia; and (3) how in spite of research and prevention efforts, persons continue to need to live with dementia. This review highlights two major themes. First is how expanding the boundaries of dementias such as Alzheimer's to include asymptomatic but at-risk persons generate new ethical questions. One promising way to address these questions is to take an integrated approach to dementia ethics, which can include incorporating ethics-related data collection into the design of a dementia research study itself. Second is the interdisciplinary nature of ethical questions related to dementia, from health policy questions about insurance coverage for long-term care to political questions about voting, driving, and other civic rights and privileges to economic questions about balancing an employer's right to a safe and productive workforce with an employee's rights to avoid discrimination on the basis of their dementia risk. The review highlights these themes and emerging ethical issues in dementia.

Do editorial policies support ethical research? A thematic text analysis of author instructions in psychiatry journals.

PubMed

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author's instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Only every second psychiatry journal adheres to the ICMJE's recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE's recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research.

Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.

PubMed

Slack, Catherine; Strode, Ann; Fleischer, Theodore; Gray, Glenda; Ranchod, Chitra

2007-05-13

South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

PubMed Central

Slack, Catherine; Strode, Ann; Fleischer, Theodore; Gray, Glenda; Ranchod, Chitra

2007-01-01

Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. Summary This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance. PMID:17498316

HIV vaccine research--South Africa's ethical-legal framework and its ability to promote the welfare of trial participants.

PubMed

Strode, Ann; Slack, Catherine; Mushariwa, Muriel

2005-08-01

An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites.

The finer points of writing and refereeing scientific articles.

PubMed

Bain, Barbara J; Littlewood, Tim J; Szydlo, Richard M

2016-02-01

Writing scientific papers is a skill required by all haematologists. Many also need to be able to referee papers submitted to journals. These skills are not often formally taught and as a result may not be done well. We have reviewed published evidence of errors in these processes. Such errors may be ethical, scientific or linguistic, or may result from a lack of understanding of the processes. The objective of the review is, by highlighting errors, to help writers and referees to avoid them. © 2016 John Wiley & Sons Ltd.

Ethics of Health Research in Communities: Perspectives From the Southwestern United States

PubMed Central

Williams, Robert L.; Willging, Cathleen E.; Quintero, Gilbert; Kalishman, Summers; Sussman, Andrew L.; Freeman, William L.

2010-01-01

PURPOSE The increasing attention paid to community-based research highlights the question of whether human research protections focused on the individual are adequate to safeguard communities. We conducted a study to explore how community members perceive low-risk health research, the adequacy of human research protection processes, and the ethical conduct of community-based research. METHODS Eighteen focus groups were conducted among rural and urban Hispanic and Native American communities in New Mexico using a semistructured guide. Group transcriptions were analyzed using iterative readings and coding, with review of the analytic summary by group members. RESULTS Although participants recognized the value of health research, many also identified several adverse effects of research in their communities, including social (community and individual labeling, stigmatization, and discrimination) and economic (community job losses, increased insurance rates, and loss of community income). A lack of community beneficence was emphasized by participants who spoke of researchers who fail to communicate results adequately or assist with follow-through. Many group members did not believe current human research and data privacy processes were adequate to protect or assist communities. CONCLUSIONS Ethical review of community-based health research should apply the Belmont principles to communities. Researchers should adopt additional approaches to community-based research by engaging communities as active partners throughout the research process, focusing on community priorities, and taking extra precautions to assure individual and community privacy. Plans for meaningful dissemination of results to communities should be part of the research design. PMID:20843885

Extra Sinus Pathologies on the Routine CT Sinus Study: What the Radiologist Cannot Afford to Miss

DTIC Science & Technology

2017-04-30

assistance. 8. The 59 CRD/Publications and Presentations Section will route the request form to clinical investigations. 502 ISG/JAC ( Ethics Review) and...additional information. 11 . The Joint Ethics Regulation (JER) DoO 5500.07 -R. Standards of Conduct, provides standards of ethical conduct for all DoD...includes a legal ethics review to address any potential conmcts related to DoD personnel participating in non-OoD sponsored conferences

17 CFR 200.64 - Judicial review.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Judicial review. 200.64... AND ETHICS; AND INFORMATION AND REQUESTS Canons of Ethics § 200.64 Judicial review. The Congress has provided for review by the courts of the decisions and orders by this Commission. Members should recognize...

What methods do reviews of normative ethics literature use for search, selection, analysis, and synthesis? In-depth results from a systematic review of reviews.

PubMed

Mertz, Marcel; Strech, Daniel; Kahrass, Hannes

2017-12-19

(Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available. Therefore, the methods and reporting strategies of such reviews vary greatly. The purpose of the follow-up study we present was to obtain deeper methodological insight into the ways reviews of normative literature are actually conducted and to analyse the methods used. Our search in the PubMed, PhilPapers, and Google Scholar databases led to the identification of 183 reviews of ethics literature published between 1997 and 2015, of which 84 were identified as reviews of normative and mixed literature. Qualitative content analysis was used to extract and synthesise descriptions of search, selection, quality appraisal, analysis, and synthesis methods. We further assessed quantitatively how often certain methods (e.g. search strategies, data analysis procedures) were used by the reviews. The overall reporting quality varies among the analysed reviews and was generally poor even for major criteria regarding the search and selection of literature. For example, only 24 (29%) used a PRISMA flowchart. Also, only 55 (66%) reviews mentioned the information unit they sought to extract, and 12 (14%) stated an ethical approach as the theoretical basis for the analysis. Interpretable information on the synthesis method was given by 47 (60%); the most common methods applied were qualitative methods commonly used in social science research (83%). Reviews which fail to provide sufficient relevant information to readers have reduced methodological transparency regardless of actual methodological quality. In order to increase the internal validity (i.e. reproducibility) as well as the external validity (i.e. utility for the intended audience) of future reviews of normative literature, we suggest more accurate reporting regarding the goal of the review, the definition of the information unit, the ethical approach used, and technical aspects.

Social and ethical analysis in health technology assessment.

PubMed

Tantivess, Sripen

2014-05-01

This paper presents a review of the domestic and international literature on the assessment of the social and ethical implications of health technologies. It gives an overview of the key concepts, principles, and approaches that should be taken into account when conducting a social and ethical analysis within health technology assessment (HTA). Although there is growing consensus among healthcare experts that the social and ethical ramifications of a given technology should be examined before its adoption, the demand for this kind of analysis among policy-makers around the world, including in Thailand, has so far been lacking. Currently decision-makers mainly base technology adoption decisions using evidence on clinical effectiveness, value for money, and budget impact, while social and ethical aspects have been neglected. Despite the recognized importance of considering equity, justice, and social issues when making decisions regarding health resource allocation, the absence of internationally-accepted principles and methodologies, among other factors, hinders research in these areas. Given that developing internationally agreed standards takes time, it has been recommended that priority be given to defining processes that are justifiable, transparent, and contestable. A discussion of the current situation in Thailand concerning social and ethical analysis of health technologies is also presented.

The anthropological approach challenges the conventional approach to bioethical dilemmas: a Kenyan Maasai perspective.

PubMed

Sharif, Thikra; Bugo, John

2015-06-01

The cultural background, religion and societal norms have a huge influence on the decision making process for physicians, patients and their families, when faced with medical ethical dilemmas. While the medical professionals, through their training, can rely on the principles of autonomy, justice, beneficence and non-maleficence to guide them, the patients can only draw from their personal and cultural experiences. To explore some of the challenges that face physicians when presented with ethical dilemmas. A review of the literature on the principles of medical ethics and the cultural practices of the Maasai tribe, as well as, interview, interaction and observation of the patients and family during patient. management. In the Maasai community in Kenya, where family is the center of all attention and decision-making, the listed ethical principles and rules have a very different understanding of the self-determination, and autonomy becomes collective rather than individualistic. Medical practitioners when faced with ethical medical dilemmas are neither comfortable in adopting the conventional bioethical guidelines, nor in offering a health care purely based on cultural and historical practice. In our set up, developing culturally relevant principles of bioethics appears to be the most effective solution in addressing medical ethical dilemmas.

HIV Prevention Research Ethics: An Introduction to the Special Issue

PubMed Central

Fisher, Celia B.

2018-01-01

This special issue of the journal of Empirical Research on Human Research Ethics represents a sampling of projects fostered through the NIDA-funded Fordham University HIV Prevention Research Ethics Institute. The first three articles employ processes of co-learning to give voice to the experiences of individuals recovering from substance abuse and engaged in sex work who have participated in HIV prevention studies in the United States, India, and the Philippines. The fourth article describes a unique community-based approach to the development of research ethics training modules designed to increase participation of American Indian and Alaskan Native (AI/AN) tribal members as partners in research on health disparities. The last two articles focus a critical scholarly lens on two underexamined areas confronting IRB review of HIV research: The emerging and continuously changing ethical challenges of using social media sites for recruitment into HIV prevention research, and the handling of research-related complaints from participants involving perceived research harms or research experiences that do not accord with their initial expectations. Together, the articles in this special issue identify key ethical crossroads and provide suggestions for best practices that respect the values and merit the trust of research participants. PMID:24572078

Publication ethics in biomedical journals from countries in Central and Eastern Europe.

PubMed

Broga, Mindaugas; Mijaljica, Goran; Waligora, Marcin; Keis, Aime; Marusic, Ana

2014-03-01

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union. The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors' conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals' ethical policies calls for further research and active measures to harmonize policies across journals.

Consumer Participation in Co-creation: An Enlightening Model of Causes and Effects Based on Ethical Values and Transcendent Motives.

PubMed

Martínez-Cañas, Ricardo; Ruiz-Palomino, Pablo; Linuesa-Langreo, Jorge; Blázquez-Resino, Juan J

2016-01-01

In the current highly interconnected modern world, the role of consumers has changed substantially due to their active collaboration with companies in product and process innovation. Specifically, consumer participation has become key to the development of successful products and services, as companies have come to rely more and more on consumers' opinion as a source of innovative ideas and brand value. However, whereas existing research has focused on identifying the different elements involved in consumers' co-creation, there is still the need to comprehend better this complex mechanism by integrating distinct dimensional insights. With an integrative review of research into three important perspectives, one nurturing from the Service-Dominant logic, another one based on the information and communication technologies (ICTs) platforms, and (the ethical values-driven) Marketing 3.0 paradigm, this article proposes a conceptual framework in which consumers' ethical values and transcendent motivations play an important role in encouraging their engagement in co-creation activities. In this connection, and with consumers increasingly embracing the need to fulfill a social and ethical function in society, the co-creation process is here comprehended as a means to emphasize the social and moral aspects of co-creation. This article also identifies the important, supportive role of the Marketing 3.0 paradigm and Web 3.0 tools to initiate the co-creation process, as well as the important valuable benefits attained by both companies and consumers after consumers engage in this process. Importantly, these benefits are highlighted to increase when ethical products are the object of these co-creation activities. All these insights have notable implications for both research and managerial practice.

Consumer Participation in Co-creation: An Enlightening Model of Causes and Effects Based on Ethical Values and Transcendent Motives

PubMed Central

Martínez-Cañas, Ricardo; Ruiz-Palomino, Pablo; Linuesa-Langreo, Jorge; Blázquez-Resino, Juan J.

2016-01-01

In the current highly interconnected modern world, the role of consumers has changed substantially due to their active collaboration with companies in product and process innovation. Specifically, consumer participation has become key to the development of successful products and services, as companies have come to rely more and more on consumers' opinion as a source of innovative ideas and brand value. However, whereas existing research has focused on identifying the different elements involved in consumers' co-creation, there is still the need to comprehend better this complex mechanism by integrating distinct dimensional insights. With an integrative review of research into three important perspectives, one nurturing from the Service-Dominant logic, another one based on the information and communication technologies (ICTs) platforms, and (the ethical values-driven) Marketing 3.0 paradigm, this article proposes a conceptual framework in which consumers' ethical values and transcendent motivations play an important role in encouraging their engagement in co-creation activities. In this connection, and with consumers increasingly embracing the need to fulfill a social and ethical function in society, the co-creation process is here comprehended as a means to emphasize the social and moral aspects of co-creation. This article also identifies the important, supportive role of the Marketing 3.0 paradigm and Web 3.0 tools to initiate the co-creation process, as well as the important valuable benefits attained by both companies and consumers after consumers engage in this process. Importantly, these benefits are highlighted to increase when ethical products are the object of these co-creation activities. All these insights have notable implications for both research and managerial practice. PMID:27303349

Clinical group supervision for integrating ethical reasoning: Views from students and supervisors.

PubMed

Blomberg, Karin; Bisholt, Birgitta

2016-11-01

Clinical group supervision has existed for over 20 years in nursing. However, there is a lack of studies about the role of supervision in nursing students' education and especially the focus on ethical reasoning. The aim of this study was to explore and describe nursing students' ethical reasoning and their supervisors' experiences related to participation in clinical group supervision. The study is a qualitative interview study with interpretative description as an analysis approach. A total of 17 interviews were conducted with nursing students (n = 12) who had participated in clinical group supervision in their first year of nursing education, and with their supervisors (n = 5). The study was based on the ethical principles outlined in the Declaration of Helsinki, and permission was obtained from the Regional Ethical Review Board in Sweden. The analysis revealed that both the form and content of clinical group supervision stimulated reflection and discussion of handling of situations with ethical aspects. Unethical situations were identified, and the process uncovered underlying caring actions. Clinical group supervision is a model that can be used in nursing education to train ethical reflection and to develop an ethical competence among nursing students. Outcomes from the model could also improve nursing education itself, as well as healthcare organizations, in terms of reducing moral blindness and unethical nursing practice. © The Author(s) 2015.

Ethical issues in publishing in predatory journals.

PubMed

Ferris, Lorraine E; Winker, Margaret A

2017-06-15

Predatory journals, or journals that charge an article processing charge (APC) to authors, yet do not have the hallmarks of legitimate scholarly journals such as peer review and editing, Editorial Boards, editorial offices, and other editorial standards, pose a number of new ethical issues in journal publishing. This paper discusses ethical issues around predatory journals and publishing in them. These issues include misrepresentation; lack of editorial and publishing standards and practices; academic deception; research and funding wasted; lack of archived content; and undermining confidence in research literature. It is important that the scholarly community, including authors, institutions, editors, and publishers, support the legitimate scholarly research enterprise, and avoid supporting predatory journals by not publishing in them, serving as their editors or on the Editorial Boards, or permitting faculty to knowingly publish in them without consequences.

Finding boundaries inside prison walls: case study of a terminally ill inmate.

PubMed

O'Connor, Mary-Frances

2004-01-01

The number of terminally ill prison inmates rises each year. Mental health professionals are uniquely prepared to provide therapy during the end-of-life process with their assessment, training, empathy, and communication skills. This case study examines the six-month therapy of one terminally ill inmate, using a client-centered approach. Drawing from existential therapy, the review of meaningful life events in the client's life clarifies current goals and the value of the current final stage of life. Ethical issues that arose are discussed, including pain management and compassionate release. Creative solutions to these ethical dilemmas were implemented through consideration of the overt and underlying goals of the inmate, the necessary rules and protocols of the prison, and in conjunction with professional codes of ethics.

New Issues for New Methods: Ethical and Editorial Challenges for an Experimental Philosophy.

PubMed

Polonioli, Andrea

2017-08-01

This paper examines a constellation of ethical and editorial issues that have arisen since philosophers started to conduct, submit and publish empirical research. These issues encompass concerns over responsible authorship, fair treatment of human subjects, ethicality of experimental procedures, availability of data, unselective reporting and publishability of research findings. This study aims to assess whether the philosophical community has as yet successfully addressed such issues. To do so, the instructions for authors, submission process and published research papers of 29 main journals in philosophy have been considered and analyzed. In light of the evidence reported here, it is argued that the philosophical community has as yet failed to properly tackle such issues. The paper also delivers some recommendations for authors, reviewers and editors in the field.

An author's guide to publication ethics: a review of emerging standards in biomedical journals.

PubMed

Roberts, Jason

2009-04-01

Universal definitions of ethical issues related to medical publishing have remained somewhat elusive. Training in the art of writing for medical journals is inconsistent and most commonly informal, involving collaborative efforts between mentors and students. This approach inadvertently may perpetuate erroneous assumptions as to what constitutes acceptable behavior. In contrast to instruction on composition, ethical considerations related to the publication of a paper are likely to receive little attention. Even so, consequent to the ever-increasing scrutiny from the media and government agencies, journals are recognizing the need for greater transparency in peer review and are thus more inclined to enforce ethical standards. Understanding that some apparent ethical contraventions are the result of confusion or a lack of knowledge, some journals are assuming the responsibility of educating their community about ethical issues in publishing. This paper reviews the key ethical issues (eg, authorship criteria, conflicts of interest, redundant publication, data access and biases in data reporting, image manipulation) that authors should consider before submitting a manuscript. It also surveys some of the policies of the most highly cited clinical medical journals. In the future, authors can anticipate that their submissions will be required to meet an expanding array of ethical standards.

Financial remuneration for clinical and behavioral research participation: ethical and practical considerations.

PubMed

Permuth-Wey, Jennifer; Borenstein, Amy R

2009-04-01

Although the practice of providing payment to clinical research participants has been ongoing for more than a century, it remains an ethically controversial topic among members of the research community. The aims of this commentary are to summarize ethical and practical considerations regarding financial remuneration of research participants and to make recommendations for researchers contemplating this practice. A PubMed search was conducted to explore the ethical implications surrounding financial remuneration and review the body of empiric data on this topic. Financial remuneration is perceived to be ethically acceptable by many researchers and research participants and can be helpful in the recruitment process. It is recommended that when investigators are contemplating whether to offer payment to research participants, they should consider the nature of the study and the potential benefits and risks to the participants, institutional or organizational guidelines, and cultural and societal norms specific to the population being studied. Financial remuneration has the ability to serve as a sign of appreciation for the contributions of research participants and a way to facilitate clinical and behavioral research.

Commented review of the Colombian legislation regarding the ethics of health research.

PubMed

Lopera, Mónica María

2017-12-01

The scope of ethics in health research transcends its legal framework and the regulations established in Resolution 8430 of 1993. These norms represent a fundamental tool to determine the minimum protection standards for research subjects, and, therefore, they should be known, applied properly, and reflect upon by all researchers in the field.Here I present and discuss from an analytical point of view the regulations that guide research in health. In this framework, health is understood as a multidimensional process, and research in health as a multidisciplinary exercise involving basic, clinical and public health research, collective health, and other related sciences.The main analytical categories are related to the principles and actors involved in research (regulatory authorities, ethical committees, and special or vulnerable subjects and populations), and to professional ethics codes, in addition to informed consents and data management.Despite the contribution of this legislation to the qualification of health research, my conclusion is that the national legislation in ethics for health research requires updating regarding technological and scientific developments, as well as specifications from the multiple types of health studies.

Review Article: Ethical Issues in the Study of Second Language Acquisition--Resources for Researchers

ERIC Educational Resources Information Center

Thomas, Margaret

2009-01-01

Two recent books provide varied resources for exploring ethical issues in the social sciences. Reflection on ethical issues aims to sensitize scholars to a range of consequences of their research, and to scholars' responsibilities to their discipline, their colleagues, and the public. This review article assesses the utility of these texts (and of…

78 FR 57383 - Human Studies Review Board; Notification of a Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

... advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This... organization. While it is our intent to hear a full range of oral comments on the science and ethics issues..., information, and recommendations to the EPA on issues related to scientific and ethical aspects of human...

Professional Ethics Education for Future Teachers: A Narrative Review of the Scholarly Writings

ERIC Educational Resources Information Center

Maxwell, Bruce; Schwimmer, Marina

2016-01-01

This article provides a narrative review of the scholarly writings on professional ethics education for future teachers. Against the background of a widespread belief among scholars working in this area that longstanding and sustained research and reflection on the ethics of teaching have had little impact on the teacher education curriculum, the…

Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

PubMed

Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F

2017-06-26

Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the 'opportunity costs' for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care.

Reviews of Functional MRI: The Ethical Dimensions of Methodological Critique

PubMed Central

Anderson, James; Mizgalewicz, Ania; Illes, Judy

2012-01-01

Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issues are heightened in the context of neuroimaging research involving persons with mental health disorders. There has been growing interest in these issues among legal scholars, philosophers, social scientists, and as well as neuroimagers over the last decade. Less clear, however, is the extent to which members of the neuroimaging community are engaged with these issues when they undertake their research and report results. In this study, we analyze the peer-reviewed review literature involving fMRI as applied to the study of mental health disorders. Our hypothesis is that, due to the critical orientation of reviews, and the vulnerability of mental health population, the penetrance of neuroethics will be higher in the review literature in this area than it is in the primary fMRI research literature more generally. We find that while authors of reviews do focus a great deal of attention on the methodological limitations of the studies they discussed, contrary to our hypothesis, they do not frame concerns in ethical terms despite their ethical significance. We argue that an ethics lens on such discussion would increase the knowledge-value of this scholarly work. PMID:22952615

Ethics of animal research in human disease remediation, its institutional teaching; and alternatives to animal experimentation.

PubMed

Cheluvappa, Rajkumar; Scowen, Paul; Eri, Rajaraman

2017-08-01

Animals have been used in research and teaching for a long time. However, clear ethical guidelines and pertinent legislation were instated only in the past few decades, even in developed countries with Judeo-Christian ethical roots. We compactly cover the basics of animal research ethics, ethical reviewing and compliance guidelines for animal experimentation across the developed world, "our" fundamentals of institutional animal research ethics teaching, and emerging alternatives to animal research. This treatise was meticulously constructed for scientists interested/involved in animal research. Herein, we discuss key animal ethics principles - Replacement/Reduction/Refinement. Despite similar undergirding principles across developed countries, ethical reviewing and compliance guidelines for animal experimentation vary. The chronology and evolution of mandatory institutional ethical reviewing of animal experimentation (in its pioneering nations) are summarised. This is followed by a concise rendition of the fundamentals of teaching animal research ethics in institutions. With the advent of newer methodologies in human cell-culturing, novel/emerging methods aim to minimise, if not avoid the usage of animals in experimentation. Relevant to this, we discuss key extant/emerging alternatives to animal use in research; including organs on chips, human-derived three-dimensional tissue models, human blood derivates, microdosing, and computer modelling of various hues. © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

The Ethics of Sharing Plastic Surgery Videos on Social Media: Systematic Literature Review, Ethical Analysis, and Proposed Guidelines.

PubMed

Dorfman, Robert G; Vaca, Elbert E; Fine, Neil A; Schierle, Clark F

2017-10-01

Recent videos shared by plastic surgeons on social media applications such as Snapchat, Instagram, and YouTube, among others, have blurred the line between entertainment and patient care. This has left many in the plastic surgery community calling for the development of more structured oversight and guidance regarding video sharing on social media. To date, no official guidelines exist for plastic surgeons to follow. Little is known about the ethical implications of social media use by plastic surgeons, especially with regard to video sharing. A systematic review of the literature on social media use in plastic surgery was performed on October 31, 2016, with an emphasis on ethics and professionalism. An ethical analysis was conducted using the four principles of medical ethics. The initial search yielded 87 articles. Thirty-four articles were included for analyses that were found to be relevant to the use of social media in plastic surgery. No peer-reviewed articles were found that mentioned Snapchat or addressed the ethical implications of sharing live videos of plastic surgery on social media. Using the four principles of medical ethics, it was determined that significant ethical concerns exist with broadcasting these videos. This analysis fills an important gap in the plastic surgery literature by addressing the ethical issues concerning live surgery broadcasts on social media. Plastic surgeons may use the guidelines proposed here to avoid potential pitfalls.

Qualitative research ethics on the spot: Not only on the desktop.

PubMed

Øye, Christine; Sørensen, Nelli Øvre; Glasdam, Stinne

2016-06-01

The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. First, and especially, the article addresses the challenges for gatekeepers who influence the informant's decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop. © The Author(s) 2015.

Mock Institutional Review Board: Promoting Analytical and Reasoning Skills in Research Ethics.

PubMed

Dols, Jean Dowling; Hoke, Mary M; Rauschhuber, Maureen L

Although it is critical that nurses possess ethical reasoning skills for research, there is limited information on effective strategies to develop these skills in graduate health care students. A research study analyzing educational interventions including the effect of online human subjects training followed by a mock institutional review board simulation demonstrated that knowledge acquisition is not enough to acquire the ethical reasoning skills needed to implement health care research. Situational context is also needed to envision the application of ethical principles.

The Average Change in Facial Height Following Bilateral Sagittal Split Osteotomy Advancement in Class II Patients

DTIC Science & Technology

2017-04-21

The S9 CRD/Publications and Presentations Section will route the request form to clinical investigations. 502 ISG/JAC ( Ethics Review) and Public...information. 11 . The Joint Ethics Regulation (JER) DoD S500.07-R. Standards of Conduct. provides standards of ethical conduct for all DoD personnel and...a legal ethics review to address any potential conflicts related to DoD personnel participating in non-DoD sponsored conferences, professional

New AGU scientific integrity and professional ethics policy available for review

USGS Publications Warehouse

Gundersen, Linda C.

2012-01-01

The AGU Task Force on Scientific Ethics welcomes your review and comments on AGU's new Scientific Integrity and Professional Ethics Policy. The policy has at its heart a code of conduct adopted from the internationally accepted "Singapore Statement," originally created by the Second World Conference on Research Integrity (http://www.singaporestatement.org/), held in 2010. The new policy also encompasses professional and publishing ethics, providing a single source of guidance to AGU members, officers, authors, and editors

Ethics in research.

PubMed

Bevan, Joan C

2007-04-01

This review will examine research ethics in the context of globalization of clinical trials and recent rapid developments in bioscience. It will focus on international ethical guidelines and the functions of research ethics review boards in research governance. Consent issues in genetic research, which must comply with privacy laws by protecting confidentiality and privacy of personal health data, will be discussed. There has been a rapid expansion of genomic and proteonomic research and biotechnology in the last decade. International ethical guidelines have been updated and the bioscience industry has developed ethics policies. At the same time, problems in academic anesthesia in the US and UK have been identified, leading to recommendations to train physician-scientists in anesthesia to stimulate research activity in the future. Anesthesiologists are joining interdisciplinary research teams and the concept of evidence-based translational research is emerging. Anesthesiologists are moving towards participation in interdisciplinary research teams. They are well placed to speed the translation of research discovery into clinical practice and provide evidence-based perioperative care. This review provides the ethical framework that anesthesiologists will need to meet the challenges of this changing pattern of practice.

Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?

PubMed Central

Emanuel, Ezekiel J; Lemmens, Trudo; Elliot, Carl

2006-01-01

Background to the debate: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval. PMID:16848618

77 FR 67380 - Submission for OMB Review; Comment Request: Ethical Dilemmas in Surgery and Utilization of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-09

...; Comment Request: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A..., unless it displays a currently valid OMB control number. Proposed Collection: Title: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey. Type of Information Collection...

School Board Ethics: On Thin Ice?

ERIC Educational Resources Information Center

Natale, Jo Anna

1990-01-01

Cites cases of ethical violations, such as patronage and nepotism in hiring practices, in some school districts. Advises school board members to review their personal and professional ethics and to consider measures that will help guide decisions when ethical dilemmas arise. Formal ethics training is recommended for all educators. (MLF)

Curbside consultation re-imagined: Borrowing from the conflict management toolkit.

PubMed

Edelstein, Lauren M; Lynch, John J; Mokwunye, Nneka O; DeRenzo, Evan G

2010-03-01

Curbside ethics consultations occur when an ethics consultant provides guidance to a party who seeks assistance over ethical concerns in a case, without the consultant involving other stakeholders, conducting his or her own comprehensive review of the case, or writing a chart note. Some have argued that curbside consultation is problematic because the consultant, in focusing on a single narrative offered by the party seeking advice, necessarily fails to account for the full range of moral perspectives. Their concern is that any guidance offered by the ethics consultant will privilege and empower one party's viewpoint over-and to the exclusion of-other stakeholders. This could lead to serious harms, such as the ethicist being reduced to a means to an end for a clinician seeking to achieve his or her own preferred outcome, the ethicist denying the broader array of stakeholders input in the process, or the ethicist providing wrongheaded or biased advice, posing dangers to the ethical quality of decision-making. Although these concerns are important and must be addressed, we suggest that they are manageable. This paper proposes using conflict coaching, a practice developed within the discipline of conflict management, to mitigate the risks posed by curbside consultation, and thereby create new "spaces" for moral discourse in the care of patients. Thinking of curbside consultations as an opportunity for "clinical ethics conflict coaching" can more fully integrate ethics committee members into the daily ethics of patient care and reduce the frequency of ethically harmful outcomes.

Criticism and the Ethics of Negative Reviews

ERIC Educational Resources Information Center

Peters, Michael A.

2014-01-01

This paper is an attempt to work through my own angst at a negative review of my "Education, Philosophy and Politics," reviewed recently by Ian Stronach for the "British Educational Research Journal," and to provide a therapeutic reading of the ethics of negative reviews. What of "shots in the dark" and should there…

Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

PubMed Central

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

Introduction According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal’s instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author’s instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions Only every second psychiatry journal adheres to the ICMJE’s recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE’s recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research. PMID:24901366

Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

PubMed

Motari, Marion; Ota, Martin Okechukwu; Kirigia, Joses Muthuri

2015-12-02

The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. Despite the existing training initiatives, the Region still experiences a shortage of professionals trained in health research ethics/ethicists. Committees continue to face various capacity needs especially for evaluating clinical trials, for monitoring ongoing research, database management and for accrediting institutional ethics committees. Given the growing number of clinical trials involving human participants in the African Region, there is urgent need for supporting countries without NECs to establish them; capacity strengthening where they exist; and creation of a regional network and joint ethical review mechanisms, whose membership would be open to all NECs of the Region.

Ethical aspects of tissue engineering: a review.

PubMed

de Vries, Rob B M; Oerlemans, Anke; Trommelmans, Leen; Dierickx, Kris; Gordijn, Bert

2008-12-01

Tissue engineering (TE) is a promising new field of medical technology. However, like other new technologies, it is not free of ethical challenges. Identifying these ethical questions at an early stage is not only part of science's responsibility toward society, but also in the interest of the field itself. In this review, we map which ethical issues related to TE have already been documented in the scientific literature. The issues that turn out to dominate the debate are the use of human embryonic stem cells and therapeutic cloning. Nevertheless, a variety of other ethical aspects are mentioned, which relate to different phases in the development of the field. In addition, we discuss a number of ethical issues that have not yet been raised in the literature.

Built to last? The sustainability of health system improvements, interventions and change strategies: a study protocol for a systematic review

PubMed Central

Braithwaite, Jeffrey; Testa, Luke; Lamprell, Gina; Herkes, Jessica; Ludlow, Kristiana; McPherson, Elise; Campbell, Margie; Holt, Joanna

2017-01-01

Introduction The sustainability of healthcare interventions and change programmes is of increasing importance to researchers and healthcare stakeholders interested in creating sustainable health systems to cope with mounting stressors. The aim of this protocol is to extend earlier work and describe a systematic review to identify, synthesise and draw meaning from studies published within the last 5 years that measure the sustainability of interventions, improvement efforts and change strategies in the health system. Methods and analysis The protocol outlines a method by which to execute a rigorous systematic review. The design includes applying primary and secondary data collection techniques, consisting of a comprehensive database search complemented by contact with experts, and searching secondary databases and reference lists, using snowballing techniques. The review and analysis process will occur via an abstract review followed by a full-text screening process. The inclusion criteria include English-language, peer-reviewed, primary, empirical research articles published after 2011 in scholarly journals, for which the full text is available. No restrictions on location will be applied. The review that results from this protocol will synthesise and compare characteristics of the included studies. Ultimately, it is intended that this will help make it easier to identify and design sustainable interventions, improvement efforts and change strategies. Ethics and dissemination As no primary data were collected, ethical approval was not required. Results will be disseminated in conference presentations, peer-reviewed publications and among policymaker bodies interested in creating sustainable health systems. PMID:29133332

Clinical ethics revisited

PubMed Central

Singer, Peter A; Pellegrino, Edmund D; Siegler, Mark

2001-01-01

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems. PMID:11346456

Pedagogical Merit Review of Animal Use for Education in Canada

PubMed Central

Griffin, Gilly

2016-01-01

There are two components to the review of animal based protocols in Canada: review for the merit of the study itself, and review of the ethical acceptability of the work. Despite the perceived importance for the quality assurance these reviews provide; there are few studies of the peer-based merit review system for animal-based protocols for research and education. Institutional animal care committees (ACC)s generally rely on the external peer review of scientific merit for animal-based research. In contrast, peer review for animal based teaching/training is dependent on the review of pedagogical merit carried out by the ACC itself or another committee within the institution. The objective of this study was to evaluate the views of ACC members about current practices and policies as well as alternate policies for the review of animal based teaching/training. We conducted a national web-based survey of ACC members with both quantitative and qualitative response options. Responses from 167 ACC members indicated broad concerns about administrative burden despite strong support for both the current and alternate policies. Participants’ comments focused mostly on the merit review process (54%) relative to the efficiency (21%), impact (13%), and other (12%) aspects of evaluation. Approximately half (49%) of the comments were classified into emergent themes that focused on some type of burden: burden from additional pedagogical merit review (16%), a limited need for the review (12%), and a lack of resources (expertise 11%; people/money 10%). Participants indicated that the current system for pedagogical merit review is effective (60%); but most also indicated that there was at least some challenge (86%) with the current peer review process. There was broad support for additional guidance on the justification, criteria, types of animal use, and objectives of pedagogical merit review. Participants also supported the ethical review and application of the Three Rs in the review process. A clear priority from participants in the survey was updating guidance to better facilitate the merit review process of animal-based protocols for education. Balancing the need for improved guidance with the reality of limited resources at local institutions will be essential to do this successfully; a familiar dilemma to both scientists and policy makers alike. PMID:27352243

Pedagogical Merit Review of Animal Use for Education in Canada.

PubMed

Avey, Marc T; Griffin, Gilly

2016-01-01

There are two components to the review of animal based protocols in Canada: review for the merit of the study itself, and review of the ethical acceptability of the work. Despite the perceived importance for the quality assurance these reviews provide; there are few studies of the peer-based merit review system for animal-based protocols for research and education. Institutional animal care committees (ACC)s generally rely on the external peer review of scientific merit for animal-based research. In contrast, peer review for animal based teaching/training is dependent on the review of pedagogical merit carried out by the ACC itself or another committee within the institution. The objective of this study was to evaluate the views of ACC members about current practices and policies as well as alternate policies for the review of animal based teaching/training. We conducted a national web-based survey of ACC members with both quantitative and qualitative response options. Responses from 167 ACC members indicated broad concerns about administrative burden despite strong support for both the current and alternate policies. Participants' comments focused mostly on the merit review process (54%) relative to the efficiency (21%), impact (13%), and other (12%) aspects of evaluation. Approximately half (49%) of the comments were classified into emergent themes that focused on some type of burden: burden from additional pedagogical merit review (16%), a limited need for the review (12%), and a lack of resources (expertise 11%; people/money 10%). Participants indicated that the current system for pedagogical merit review is effective (60%); but most also indicated that there was at least some challenge (86%) with the current peer review process. There was broad support for additional guidance on the justification, criteria, types of animal use, and objectives of pedagogical merit review. Participants also supported the ethical review and application of the Three Rs in the review process. A clear priority from participants in the survey was updating guidance to better facilitate the merit review process of animal-based protocols for education. Balancing the need for improved guidance with the reality of limited resources at local institutions will be essential to do this successfully; a familiar dilemma to both scientists and policy makers alike.

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[Honesty and good faith: two cornerstones in the ethics of biomedical publications].

PubMed

Reyes, Humberto

2007-04-01

The editors of medical journals should take the steps necessary to assure its readers that the contents of their publications are based in true data, that they are original and fulfill the ethical rules of biomedical and clinical research, including its reporting. This editors role has become increasingly difficult since the pressure to publish scientific papers is progressively stimulated by the role that those papers play in curricula vitae when the authors apply for university positions, academic promotions, research grants and for their personal prestige. As a consequence, increasing instances of misconduct in scientific publications are detected. Some cases are noticed during the editorial process, mostly when peer reviewers identify redundant publications or plagiarism. Other cases are denounced after a manuscript was published. It is the editors duty to verify the misconduct, request an explanation from the authors and, if their answer is unsatisfactory, report the problem to the institutional authorities supporting the authors. The editors should denounce the situation in a forthcoming issue of the journal. Universities should enforce the teaching of ethical rules that govern the report of scientific information. Revista Médica de Chile follows recommendations given by the International Committee of Medical Journal Editors, the World Association of Medical Editors and other groups, but honesty and good faith in all the actors involved in the process of biomedical publications (authors, reviewers, editors) remain the cornerstones of scientific good behavior.

What Ethical Issues Really Arise in Practice at an Academic Medical Center? A Quantitative and Qualitative Analysis of Clinical Ethics Consultations from 2008 to 2013.

PubMed

Wasson, Katherine; Anderson, Emily; Hagstrom, Erika; McCarthy, Michael; Parsi, Kayhan; Kuczewski, Mark

2016-09-01

As the field of clinical ethics consultation sets standards and moves forward with the Quality Attestation process, questions should be raised about what ethical issues really do arise in practice. There is limited data on the type and number of ethics consultations conducted across different settings. At Loyola University Medical Center, we conducted a retrospective review of our ethics consultations from 2008 through 2013. One hundred fifty-six cases met the eligibility criteria. We analyzed demographic data on these patients and conducted a content analysis of the ethics consultation write-ups coding both the frequency of ethical issues and most significant, or key, ethical issue per case. Patients for whom ethics consultation was requested were typically male (55.8 %), white (57.1 %), between 50 and 69 years old (38.5 %), of non-Hispanic origin (85.9 %), and of Roman Catholic faith (43.6 %). Nearly half (47.4 %) were in the intensive care unit and 44.2 % died in the hospital. The most frequent broad ethical categories were decision-making (93.6 %), goals of care/treatment (80.8 %), and end-of-life (73.1 %). More specifically, capacity (57.1 %), patient's wishes/autonomy (54.5 %), and surrogate decision maker (51.3 %) were the most frequent particular ethical issues. The most common key ethical issues were withdrawing/withholding treatment (12.8 %), patient wishes/autonomy (12.2 %), and capacity (11.5 %). Our findings provide additional data to inform the training of clinical ethics consultants regarding the ethical issues that arise in practice. A wider research agenda should be formed to collect and compare data across institutions to improve education and training in our field.

Protection of health research participants in the United States: a review of two cases.

PubMed

Douglass, Alison; Crampton, Peter

2004-06-01

Two research-related deaths and controversies in the United States during recent years have raised public concern over the safety of research participants. This paper explores the reasons why, in two studies, there was a failure of ethical oversight. The issues exposed by these failures have international relevance as they could possibly occur anywhere where human health research is carried out. Five factors that contributed to these failures are highlighted: 1. failure to support and resource research ethics committees; 2. failure of the research oversight process to adequately assess the risks and benefits of research, while giving undue emphasis to informed consent; 3. conflicts of interest arising from financial relationships and research ethics committee membership; 4. lack of consistent oversight of privately funded research; and 5. incompetent or intentional failure to adhere by ethical guidelines. There is considerable headway to be made in the United States, as in other countries, in the fostering and maintenance of robust systems of human research oversight.

A Developmental Approach to the Teaching of Ethical Decision Making.

ERIC Educational Resources Information Center

Neukrug, Edward S.

1996-01-01

Examines the newly adopted code of ethics, reviews some ethical decision-making models, and hypothesizes how the maturity of a student might mediate the effective use of codes and of decision-making models. Provides a model for human service educators that integrates ethical guidelines and ethical decision-making models. (RJM)

24 CFR 4.36 - Action by the Ethics Law Division.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Action by the Ethics Law Division... the Ethics Law Division. (a) After review of the Inspector General's report, the Ethics Law Division... that a violation of Section 103 or this subpart B has occurred. (b) If the Ethics Law Division...

24 CFR 4.36 - Action by the Ethics Law Division.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Action by the Ethics Law Division... the Ethics Law Division. (a) After review of the Inspector General's report, the Ethics Law Division... that a violation of Section 103 or this subpart B has occurred. (b) If the Ethics Law Division...

24 CFR 4.36 - Action by the Ethics Law Division.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 1 2013-04-01 2013-04-01 false Action by the Ethics Law Division... the Ethics Law Division. (a) After review of the Inspector General's report, the Ethics Law Division... that a violation of Section 103 or this subpart B has occurred. (b) If the Ethics Law Division...

24 CFR 4.36 - Action by the Ethics Law Division.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 1 2014-04-01 2014-04-01 false Action by the Ethics Law Division... the Ethics Law Division. (a) After review of the Inspector General's report, the Ethics Law Division... that a violation of Section 103 or this subpart B has occurred. (b) If the Ethics Law Division...

24 CFR 4.36 - Action by the Ethics Law Division.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Action by the Ethics Law Division... the Ethics Law Division. (a) After review of the Inspector General's report, the Ethics Law Division... that a violation of Section 103 or this subpart B has occurred. (b) If the Ethics Law Division...

The Social Work Ethics Audit: A Risk-Management Strategy.

ERIC Educational Resources Information Center

Reamer, Frederic G.

2000-01-01

Article integrates current knowledge on social work ethics and introduces the concept of a social work ethics audit to aid social workers in their efforts to identify pertinent ethical issues; review and assess the adequacy of their current ethics-related practices; modify their practices as needed; and monitor the implementation of these changes.…

A narrative review of undergraduate peer-based healthcare ethics teaching.

PubMed

Hindmarch, Thomas; Allikmets, Silvia; Knights, Felicity

2015-12-12

This study explores the literature in establishing the value of undergraduate peer-based healthcare ethics teaching as an educational methodology. A narrative review of the literature concerning peer-based ethics teaching was conducted. MEDLINE, EMBASE, CINAHL, SCOPUS databases, and the Cochrane Library, were systematically searched for studies of peer-based ethics or professionalism teaching. Selected studies related peer-based teaching to ethics education outcomes. Ten publications were identified. Selected studies were varied in their chosen intervention methodology and analysis. Collectively, the identified studies suggest peer-based ethics education is an effective and valued educational methodology in training healthcare professionals. One paper suggests peer-based ethics teaching has advantages over traditional didactic methods. Peer-based ethics teaching also receives positive feedback from student participants. However, the limited literature base demonstrates a clear need for more evaluation of this pedagogy. The current literature base suggests that undergraduate peer based healthcare ethics teaching is valuable in terms of efficacy and student satisfaction. We conclude that the medical community should invest in further study in order to capitalise upon the potential of peer-based ethics teaching in undergraduate healthcare education.

In-home monitoring of persons with dementia: ethical guidelines for technology research and development.

PubMed

Mahoney, Diane F; Purtilo, Ruth B; Webbe, Frank M; Alwan, Majd; Bharucha, Ashok J; Adlam, Tim D; Jimison, Holly B; Turner, Beverly; Becker, S Ann

2007-07-01

Innovative technologies are rapidly emerging that offer caregivers the support and means to assist older adults with cognitive impairment to continue living "at home." Technology research and development efforts applied to older adults with dementia invoke special grant review and institutional review board concerns, to ensure not only safe but also ethically appropriate interventions. Evidence is emerging, however, that tensions are growing between innovators and reviewers. Reviewers with antitechnology biases are in a position to stifle needed innovation. Technology developers who fail to understand the clinical and caregiving aspects of dementia may design applications that are not in alignment with users' capabilities. To bridge this divide, we offer an analysis of the ethical issues surrounding home monitoring, a model framework, and ethical guidelines for technology research and development for persons with Alzheimer's disease and their caregivers.

A systematic review of ethical issues in vaccine studies involving pregnant women

PubMed Central

Beeler, Jennifer A.; Lambach, Philipp; Fulton, T. Roice; Narayanan, Divya; Ortiz, Justin R.; Omer, Saad B.

2016-01-01

ABSTRACT Background: Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. Aims: To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. Method: We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Results: Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. Conclusion: This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women – offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries. PMID:27246403

Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

PubMed

Hemminki, Elina; Virtanen, Jorma I; Regushevskaya, Elena

2015-10-01

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was <30 days, 16% had >89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects. © The Author(s) 2015.

Justice in human research ethics. A conceptual and practical guide.

PubMed

Pieper, Ian; Thomson, Colin J H

2013-03-01

One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

Ethical problems in pediatrics: what does the setting of care and education show us?

PubMed

Guedert, Jucélia Maria; Grosseman, Suely

2012-03-16

Pediatrics ethics education should enhance medical students' skills to deal with ethical problems that may arise in the different settings of care. This study aimed to analyze the ethical problems experienced by physicians who have medical education and pediatric care responsibilities, and if those problems are associated to their workplace, medical specialty and area of clinical practice. A self-applied semi-structured questionnaire was answered by 88 physicians with teaching and pediatric care responsibilities. Content analysis was performed to analyze the qualitative data. Poisson regression was used to explore the association of the categories of ethical problems reported with workplace and professional specialty and activity. 210 ethical problems were reported, grouped into five areas: physician-patient relationship, end-of-life care, health professional conducts, socioeconomic issues and health policies, and pediatric teaching. Doctors who worked in hospitals as well as general and subspecialist pediatricians reported fewer ethical problems related to socioeconomic issues and health policies than those who worked in Basic Health Units and who were family doctors. Some ethical problems are specific to certain settings: those related to end-of-life care are more frequent in the hospital settings and those associated with socioeconomic issues and public health policies are more frequent in Basic Health Units. Other problems are present in all the setting of pediatric care and learning and include ethical problems related to physician-patient relationship, health professional conducts and the pediatric education process. These findings should be taken into consideration when planning the teaching of ethics in pediatrics. This research article didn't reports the results of a controlled health care intervention. The study project was approved by the Institutional Ethical Review Committee (Report CEP-HIJG 032/2008).

Organizational ethics: a literature review.

PubMed

Suhonen, Riitta; Stolt, Minna; Virtanen, Heli; Leino-Kilpi, Helena

2011-05-01

The aim of the study was to report the results of a systematically conducted literature review of empirical studies about healthcare organizations' ethics and management or leadership issues. Electronic databases MEDLINE and CINAHL yielded 909 citations. After a two stage application of the inclusion and exclusion criteria 56 full-text articles were included in the review. No large research programs were identified. Most of the studies were in acute hospital settings from the 1990s onwards. The studies focused on ethical challenges, dilemmas in practice, employee moral distress and ethical climates or environments. Study samples typically consisted of healthcare practitioners, operational, executive and strategic managers. Data collection was mainly by questionnaires or interviews and most of the studies were descriptive, correlational and cross-sectional. There is need to develop conceptual clarity and a theoretical framework around the subject of organizational ethics and the breadth of the contexts and scope of the research needs to be increased. © The Author(s) 2011

[Voluntary Refusal of Food and Fluid in palliative care: a mapping literature review].

PubMed

Klein Remane, Ursula; Fringer, André

2013-12-01

Voluntary Refusal of Food and Fluid (VRFF) is one possibility for patients in palliative situations to hasten death and avoid further suffering. By means of a mapping literature review this article describes the medical, nursing, ethical and legal perspective of care for people who wish to hasten death using VRFF. The results show that the wish to die is affected by psychological, social, spiritual and physical factors. VRFF is a little-known, legal and independently viable method to hasten death. Reducing fluid intake to 40 ml daily, the dying process takes one to three weeks. VRFF can be regarded as a natural death, foregoing treatment or as suicide. In contrast to physician assisted suicide or euthanasia, patients dying by VRFF experience a "natural" dying process and the decision is reversible in the first few days. As authority to act lies with the person wishing to die professionals and family caring for the dying are practicing palliative care, as opposed to assisted suicide or euthanasia. Professionals and family involved in the decision-making process are confronted with various ethical problems. Further research concerning VRFF and its implications for practice is necessary.

A qualitative description of service providers' experiences of ethical issues in HIV care.

PubMed

Sabone, Motshedisi B; Mogobe, Keitshokile Dintle; Matshediso, Ellah; Shaibu, Sheila; Ntsayagae, Esther I; Corless, Inge B; Cuca, Yvette P; Holzemer, William L; Dawson-Rose, Carol; Baez, Solymar S Soliz; Rivero-Mendz, Marta; Webel, Allison R; Eller, Lucille Sanzero; Reid, Paula; Johnson, Mallory O; Kemppainen, Jeanne; Reyes, Darcel; Nokes, Kathleen; Wantland, Dean; Nicholas, Patrice K; Lingren, Teri; Portillo, Carmen J; Sefcik, Elizabeth; Long-Middleton, Ellen

2018-01-01

Managing HIV treatment is a complex multi-dimensional task because of a combination of factors such as stigma and discrimination of some populations who frequently get infected with HIV. In addition, patient-provider encounters have become increasingly multicultural, making effective communication and provision of ethically sound care a challenge. This article explores ethical issues that health service providers in the United States and Botswana encountered in their interaction with patients in HIV care. A descriptive qualitative design was used to collect data from health service providers and patients using focused group discussions. This article is based on responses from health service providers only. Participants and context: This article is based on 11 focused group discussions with a total sample of 71 service providers in seven US sites and one Botswana site. Ethical considerations: Ethical review boards at all the study sites reviewed the study protocol and approved it. Ethical review boards of the study's coordinating centers, Rutgers University and the University of California at San Francisco, also approved it. The study participants provided a written informed consent to participate. HIV service providers encountered ethical challenges in all the four Beauchamp and Childress' biomedical ethics of respect for patients' autonomy, beneficence, justice, and nonmaleficence. The finding that HIV service providers encounter ethical challenges in their interaction with patients is supported by prior studies. The ethical challenges are particularly prominent in multicultural care and resource-constrained care environments. Provision of HIV care is fraught with ethical challenges that tend to pose different issues depending on a given care environment. It is important that strong partnerships are developed among key stakeholders in HIV care. In addition, health service providers need to be provided with resources so they can provide quality and ethically sound care.

Unconscious emotional reasoning and the therapeutic misconception.

PubMed

Charuvastra, A; Marder, S R

2008-03-01

The "therapeutic misconception" describes a process whereby research volunteers misinterpret the intentions of researchers and the nature of clinical research. This misinterpretation leads research volunteers to falsely attribute a therapeutic potential to clinical research, and compromises informed decision making, therefore compromising the ethical integrity of a clinical experiment. We review recent evidence from the neurobiology of social cognition to provide a novel framework for thinking about the therapeutic misconception. We argue that the neurobiology of social cognition should be considered in any ethical analysis of how people make decisions about participating in clinical trials. The neurobiology of social cognition also suggests how the complicated dynamics of the doctor-patient relationship may unavoidably interfere with the process of obtaining informed consent. Following this argument we suggest new ways to prevent or at least mitigate the therapeutic misconception.

The legacy of Tom Andersen: The ethics of reflecting processes.

PubMed

Gehart, Diane R

2018-03-08

Tom Andersen and his pioneering work with reflecting conservations has had a lasting influence on the field of family therapy and mental health more broadly. Most family therapists are familiar with his contributions related to reflecting teams; however, fewer are familiar with his conceptualization of reflecting processes, which offer practical ways to approach therapeutic conversations to address challenging problems. This article provides a brief history of Andersen's career and reviews four key elements of his approach, including: (a) his way of being in relationship, (b) appropriately unusual comments, (c) inner and outer dialogs, and (d) ethics of dialogical relating. Finally, this article introduces readers to the context of the video that will be analyzed in the articles that follow in this special section. © 2018 American Association for Marriage and Family Therapy.

Teaching ethics in psychiatry: a one-day workshop for clinical students.

PubMed Central

Green, B; Miller, P D; Routh, C P

1995-01-01

In this paper we describe the objectives of teaching medical ethics to undergraduates and the teaching methods used. We describe a workshop used in the University of Liverpool Department of Psychiatry, designed to enhance ethical sensitivity in psychiatry. The workshop reviews significant historical and current errors in the ethical practice of psychiatry and doctors' defence mechanisms against accepting responsibility for deficiencies in ethical practice. The workshop explores the student doctors' own group ethos in response to ethical dilemmas, and demonstrates how the individual contributes to and is responsible for the group ethos through participation and also through nonparticipation. The student feedback about the workshop is reviewed. The Toronto Ethical Sensitivity Instrument was used to assess whether or not the workshop altered sensitivity. Compared to a control group the attenders' sensitivity was significantly increased (on Student's t-test p equals or is less than 0.002). PMID:7473644

APPLYING RESEARCH ETHICS GUIDELINES: THE VIEW FROM A SUB-SAHARAN RESEARCH ETHICS COMMITTEE

PubMed Central

Henderson, Gail E.; Corneli, Amy L.; Mahoney, David B.; Nelson, Daniel K.; Mwansambo, Charles

2009-01-01

Considerable variation has been demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of international regulations. We conducted a qualitative descriptive pilot study with members of the national REC in Malawi to determine criteria they use to review research, and their views on international collaborations. Qualitative content analysis demonstrated that international guidelines are interpreted in light of local African conditions such that emphasis is placed on examining benefit to the community and ensuring the informed consent process translates concepts in locally-meaningful ways. Members suggest that RECs often must comply with regulations that do not fit local conditions. Recommendations are provided for improving such international collaborations. PMID:19385794

Pediatric Perioperative Nurses and the Ethics of Organ Donation After Cardiac Death.

PubMed

Austin, Elizabeth A; Lovett, Pamela; Moore, Wendy C; Zuzarte, Ingrid

2018-04-01

Pediatric perioperative nurses are experiencing increased opportunities to participate in donations after cardiac death. An increased public awareness regarding transplantation has inspired more people to donate than in previous years. The demand for transplantable organs has led to opportunities that have increased donor candidates including living donors and cardiac death donors. Cardiac death in children is often sudden and unexpected, and is an emotional time not only for the family members but also for the hospital staff members, including perioperative nurses. However, when perioperative nurses adhere to standards and guidelines, they can perform their responsibilities in an ethical and compassionate manner and assist their team in doing so. This article reviews the guiding principles of pediatric organ donation after cardiac death, the phases of the process, and the ethical and moral issues surrounding donation. © AORN, Inc, 2018.

Getting from A to IRB: developing an institutional review board at a historically black university.

PubMed

Howard, Daniel L; Boyd, Carlton L; Nelson, Daniel K; Godley, Paul

2010-03-01

Shaw University, the oldest historically black college or university in the southern USA, recently partnered with the University of North Carolina at Chapel Hill, a major research institution in North Carolina, to further develop Shaw's research infrastructure. One aim of the partnership involved establishing a human research ethics committee and an accompanying administrative structure and research ethics education program. This paper describes the process of developing an entire human research protection program de novo through collaboration with and mentoring by the members of the human research protection program at a nearby major research institution. This paper provides a detailed description of the aims, procedures, accomplishments, and challenges involved in such a project, which may serve as a useful model for other primarily teaching institutions wishing to develop research infrastructure and ethical capacity.

Getting From A to IRB: Developing an Institutional Review Board at a Historically Black University

PubMed Central

Howard, Daniel L.; Boyd, Carlton L.; Nelson, Daniel K.; Godley, Paul

2011-01-01

Shaw University, the oldest historically black college or university in the southern USA, recently partnered with the University of North Carolina at Chapel Hill, a major research institution in North Carolina, to further develop Shaw’s research infrastructure. One aim of the partnership involved establishing a human research ethics committee and an accompanying administrative structure and research ethics education program. This paper describes the process of developing an entire human research protection program de novo through collaboration with and mentoring by the members of the human research protection program at a nearby major research institution. This paper provides a detailed description of the aims, procedures, accomplishments, and challenges involved in such a project, which may serve as a useful model for other primarily teaching institutions wishing to develop research infrastructure and ethical capacity. PMID:20235865

Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.

PubMed

Martellet, Lionel; Sow, Samba O; Diallo, Aldiouma; Hodgson, Abraham; Kampmann, Beate; Hirve, Siddhivinayak; Tapia, Milagritos; Haidara, Fadima Cheick; Ndiaye, Assane; Diarra, Bou; Ansah, Patrick Odum; Akinsola, Adebayo; Idoko, Olubukola T; Adegbola, Richard A; Bavdekar, Ashish; Juvekar, Sanjay; Viviani, Simonetta; Enwere, Godwin C; Marchetti, Elisa; Chaumont, Julie; Makadi, Marie-Francoise; Pallardy, Flore; Kulkarni, Prasad S; Preziosi, Marie-Pierre; LaForce, F Marc

2015-11-15

The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards. Because of the public-private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access. Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts. Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved. ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007). © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

Teaching for Ethical Reasoning

ERIC Educational Resources Information Center

Sternberg, Robert J.

2012-01-01

This article argues for the importance of teaching for ethical reasoning. Much of our teaching is in vain if it is not applied to life in an ethical manner. The article reviews lapses in ethical reasoning and the great costs they have had for society. It proposes that ethical reasoning can be taught across the curriculum. It presents an eight-step…

Ethics Education for Professionals in Japan: A Critical Review

ERIC Educational Resources Information Center

Maruyama, Yasushi; Ueno, Tetsu

2010-01-01

Ethics education for professionals has become popular in Japan over the last two decades. Many professional schools now require students to take an applied ethics or professional ethics course. In contrast, very few courses of professional ethics for teaching exist or have been taught in Japan. In order to obtain suggestions for teacher education,…

The ethics of neonatal research: An ethicist's and a parents' perspective.

PubMed

Janvier, Annie; Farlow, Barbara

2015-12-01

The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Everyday Ethics: Reflections on Practice

ERIC Educational Resources Information Center

Rossman, Gretchen B.; Rallis, Sharon F.

2010-01-01

This introductory article frames the contributions for this issue on everyday ethics--moments that demand moral considerations and ethical choices that researchers encounter. We discuss concerns raised within the research community about the tendency to observe merely obligatory ethical procedures as outlined in Human Subjects Review regulations.…

RETRACTED: Novel drug delivery carrier from alginate-carrageenan and glycerol as plasticizer

NASA Astrophysics Data System (ADS)

Darmokoesoemo, Handoko; Pudjiastuti, Pratiwi; Rahmatullah, Bagus; Kusuma, Heri Septya

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy) This article has been retracted at the request of the Editors-in-Chief. After a thorough investigation, the Editors have concluded that the acceptance of this article was based upon the positive advice of at least three illegitimate reviewer reports. The reports were submitted from email accounts which were provided to the journal as suggested reviewers during the submission of the article. Although purportedly real reviewer accounts, the Editors have concluded that these were not of appropriate, independent reviewers. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewers whose identities were assumed and to the readers of the journal that this deception was not detected during the submission process.

RETRACTED: Development of electrode carbon paste/molecularly imprinted polymer (MIP) with methacrylic acid as monomer to analyze glucose by potentiometry

NASA Astrophysics Data System (ADS)

Khasanah, Miratul; Darmokoesoemo, Handoko; Kustyarini, Lendhy; Kadmi, Yassine; Elmsellem, Hicham; Kusuma, Heri Septya

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy) This article has been retracted at the request of the Editors-in-Chief. After a thorough investigation, the Editors have concluded that the acceptance of this article was based upon the positive advice of two illegitimate reviewer reports. The reports were submitted from email accounts which were provided to the journal as suggested reviewers during the submission of the article. Although purportedly real reviewer accounts, the Editors have concluded that these were not of appropriate, independent reviewers. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewers whose identities were assumed and to the readers of the journal that this deception was not detected during the submission process.

RETRACTED: Development of electrode carbon paste modified by molecularly imprinted polymer as sensor for analysis of creatinine by potentiometric

NASA Astrophysics Data System (ADS)

Khasanah, Miratul; Darmokoesoemo, Handoko; Sari, Nunung Mareta; Kadmi, Yassine; Elmsellem, Hicham; Kusuma, Heri Septya

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy) This article has been retracted at the request of the Editors-in-Chief. After a thorough investigation, the Editors have concluded that the acceptance of this article was based upon the positive advice of two illegitimate reviewer reports. The reports were submitted from email accounts which were provided to the journal as suggested reviewers during the submission of the article. Although purportedly real reviewer accounts, the Editors have concluded that these were not of appropriate, independent reviewers. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewers whose identities were assumed and to the readers of the journal that this deception was not detected during the submission process.

RETRACTED: Development of carbon paste electrodes modified by molecularly imprinted polymer as potentiometry sensor of uric acid

NASA Astrophysics Data System (ADS)

Khasanah, Miratul; Darmokoesoemo, Handoko; Widayanti, Nesti; Kadmi, Yassine; Elmsellem, Hicham; Kusuma, Heri Septya

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy) This article has been retracted at the request of the Editors-in-Chief. After a thorough investigation, the Editors have concluded that the acceptance of this article was based upon the positive advice of two illegitimate reviewer reports. The reports were submitted from email accounts which were provided to the journal as suggested reviewers during the submission of the article. Although purportedly real reviewer accounts, the Editors have concluded that these were not of appropriate, independent reviewers. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewers whose identities were assumed and to the readers of the journal that this deception was not detected during the submission process.

"Let Me Keep My Dead Husband's Sperm": Ethical Issues in Posthumous Reproduction.

PubMed

Panagiotopoulou, Nikoletta; Karavolos, Stamatios

2015-01-01

The feasibility of posthumous reproduction when the surviving partner is female has brought to light many ethical, moral, social, and legal issues. This review aims to summarize these issues and to assist clinicians who may be faced with such requests. A question list, used for health technologies assessment, was utilized in a question-answer approach as the review methodology. Of the 1,208 publications identified through a comprehensive literature search in biomedical, psychological, and ethical databases, 31 articles included arguments related to one or more questions from the predefined question set. Key stakeholders identified include the deceased, the requesting party, the resultant child, the physician, and society. Key ethical issues relevant to posthumous reproduction include the four traditional pillars of medical ethics--autonomy, beneficence, nonmaleficence, justice--as well as the stakeholders' rights and sociocultural attitudes. The ethical framework formulated by these issues has been incorporated in a clinical ethics decision-making tool that could prove useful to clinicians and decision makers. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Clinical governance and research ethics as barriers to UK low-risk population-based health research?

PubMed Central

van Teijlingen, Edwin R; Douglas, Flora; Torrance, Nicola

2008-01-01

Background Since the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research. Recently, a range of factors led to the development of more stringent bureaucratic procedures, governing the conduct of low-risk population-based health research in the United Kingdom. Methods Our paper highlights a case study of the application process to medical research ethics committees in the United Kingdom for a study of the promotion of physical activity by health care providers. The case study presented here is an illustration of the challenges in conducting low-risk population-based health research. Results Our mixed-methods approach involved a questionnaire survey of and semi-structured interviews with health professionals (who were all healthy volunteers). Since our study does not involve the participation of either patients or the general population, one would expect the application to the relevant research ethics committees to be a formality. This proved not to be the case! Conclusion Research ethics committees could be counter-productive, rather than protecting the vulnerable in the research process, they can stifle low-risk population-based health research. Research ethics in health services research is first and foremost the responsibility of the researcher(s), and we need to learn to trust health service researchers again. The burden of current research governance regulation to address the perceived ethical problems is neither appropriate nor adequate. Senior researchers/academics need to educate and train students and junior researchers in the area of research ethics, whilst at the same time reducing pressures on them that lead to unethical research, such as commercial funding, inappropriate government interference and the pressure to publish. We propose that non-invasive low-risk population-based health studies such as face-to-face interviews with health and social care professionals or postal questionnaire studies with patients on non-sensitive topics are given a waiver or a light touch review. We suggest that this can be achieved through a two-staged ethics application process. The first stage starts with a one or two-page outline application which ethics committees can use as the basis to grant a waiver or request a full application. PMID:19040750

[Transgressive Conducts in the Academic Environment].

PubMed

Campo-Cabal, Gerardo

2012-01-01

This article presents a historical review, from an ethic standpoint, of the national legislation that rules the practice of Medicine in Colombia; ity also refers to the deontological code and the Colombian psychiatric code as well as to the commitment of the Health Faculty of the Universidad del Valle regarding ethical conducts. Ethics is introduced as an original innate faculty, resulting from cognitive development and learning while being also a manifestation of underlying biological processes or a result of the interaction of different models. The teaching-learning process is a situation in which teachers and students get together in order to acquire competences that are to be ethically expressed. Empirical studies have shown transgressive forms of behavior in teachers, students and academic administrators throughout the world; in addition, the mass media expose transgressions committed by other social groups such as politicians, financiers, clergymen, researchers, etc. Firstly proposed as a problem-solving strategy is the acceptance of the very existence of transgressions, followed by the conformation of a committee aimed at principle-identification for, subsequently, undertaking eductional and following-up actions, while administering sanctions when necessary. The proposal for adopting problem-solving strategies for the Faculty of Health of the Universidad del Valle is also presented. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Scoping review protocol: education initiatives for medical psychiatry collaborative care

PubMed Central

Shen, Nelson; Sockalingam, Sanjeev; Abi Jaoude, Alexxa; Bailey, Sharon M; Bernier, Thérèse; Freeland, Alison; Hawa, Aceel; Hollenberg, Elisa; Woldemichael, Bethel; Wiljer, David

2017-01-01

Introduction The collaborative care model is an approach providing care to those with mental health and addictions disorders in the primary care setting. There is a robust evidence base demonstrating its clinical and cost-effectiveness in comparison with usual care; however, the transitioning to this new paradigm of care has been difficult. While there are efforts to train and prepare healthcare professionals, not much is known about the current state of collaborative care training programmes. The objective of this scoping review is to understand how widespread these collaborative care education initiatives are, how they are implemented and their impacts. Methods and analysis The scoping review methodology uses the established review methodology by Arksey and O’Malley. The search strategy was developed by a medical librarian and will be applied in eight different databases spanning multiple disciplines. A two-stage screening process consisting of a title and abstract scan and a full-text review will be used to determine the eligibility of articles. To be included, articles must report on an existing collaborative care education initiative for healthcare providers. All articles will be independently assessed for eligibility by pairs of reviewers, and all eligible articles will be abstracted and charted in duplicate using a standardised form. The extracted data will undergo a ‘narrative review’ or a descriptive analysis of the contextual or process-oriented data and simple quantitative analysis using descriptive statistics. Ethics and dissemination Research ethics approval is not required for this scoping review. The results of this scoping review will inform the development of a collaborative care training initiative emerging from the Medical Psychiatry Alliance, a four-institution philanthropic partnership in Ontario, Canada. The results will also be presented at relevant national and international conferences and published in a peer-reviewed journal. PMID:28871017

Identifying Ethical Issues in Mental Health Research with Minors Adolescents: Results of a Delphi Study

PubMed Central

Hiriscau, Elisabeta Ioana; Stingelin-Giles, Nicola; Wasserman, Danuta; Reiter-Theil, Stella

2016-01-01

Research with minors, especially for preventive purposes, e.g., suicide prevention, investigating risk or self-destructive behaviors such as deviance, drug abuse, or suicidal behavior, is ethically sensitive. We present a Delphi study exploring the ethical implications of the needs formulated by researchers in an international pre-conference who would benefit from ethics support and guidance in conducting Mental Health Research with minors. The resulting List of Ethical Issues (LEI) was submitted to a 2-rounds Delphi process via the Internet, including 34 multidisciplinary experts. In the first round, the experts reviewed the LEI and completed a questionnaire. Results from this round were analyzed and grouped in nine categories comprising 40 items. In the second round, the experts had to agree/disagree with the needs expressed in the LEI leading to a final list of 25 ethical issues considered relevant for Mental Health Research with minors such as: confidentiality of the sensitive data, competence for consenting alone and risk of harm and stigma related to the methodology used in research. It was shown that studies like SEYLE (Saving and Empowering Young Lives in Europe) trigger among researchers wishes to obtain specific recommendations helping to comply with standards for good practice in conducting research with minors. PMID:27187425

Identifying Ethical Issues in Mental Health Research with Minors Adolescents: Results of a Delphi Study.

PubMed

Hiriscau, Elisabeta Ioana; Stingelin-Giles, Nicola; Wasserman, Danuta; Reiter-Theil, Stella

2016-05-11

Research with minors, especially for preventive purposes, e.g., suicide prevention, investigating risk or self-destructive behaviors such as deviance, drug abuse, or suicidal behavior, is ethically sensitive. We present a Delphi study exploring the ethical implications of the needs formulated by researchers in an international pre-conference who would benefit from ethics support and guidance in conducting Mental Health Research with minors. The resulting List of Ethical Issues (LEI) was submitted to a 2-rounds Delphi process via the Internet, including 34 multidisciplinary experts. In the first round, the experts reviewed the LEI and completed a questionnaire. Results from this round were analyzed and grouped in nine categories comprising 40 items. In the second round, the experts had to agree/disagree with the needs expressed in the LEI leading to a final list of 25 ethical issues considered relevant for Mental Health Research with minors such as: confidentiality of the sensitive data, competence for consenting alone and risk of harm and stigma related to the methodology used in research. It was shown that studies like SEYLE (Saving and Empowering Young Lives in Europe) trigger among researchers wishes to obtain specific recommendations helping to comply with standards for good practice in conducting research with minors.

The bioethics of separating conjoined twins in plastic surgery.

PubMed

Lee, Michelle; Gosain, Arun K; Becker, Devra

2011-10-01

The incidence of craniopagus twins approximates four to six per 10 million births. Although rare, surgical separation of conjoined twins poses significant technical and ethical challenges. The present report uses the case of craniopagus twins AD and TD to examine the bioethical issues faced by a multidisciplinary medical team in planning the separation of craniopagus twins. AD and TD are craniopagus twins conjoined at the head. TD's head is conjoined to the back of AD's head. Neurologically, AD has the dominant cerebral circulation. TD has two normal kidneys, whereas AD has none. AD depends on TD's renal function and, on separation, will require either a kidney transplant or lifelong dialysis. This case report reviews one approach to analyzing and solving complex ethical dilemmas in pediatric plastic surgery. The principles reviewed are (1) autonomy and informed consent, focusing especially on the role of children in the informed consent process; (2) beneficence and nonmaleficence, two intricately intertwined principles because separation could potentially cause irreversible harm to one twin while improving the quality of life for the other (as separation is not a life-saving procedure, is it ethical to perform a procedure with unknown surgical risk to improve children's quality of life?); and (3) justice (is it fair to allocate excessive medical resources for the twins' separation?). The present report explores the ethics behind such decisions with respect to the separation of conjoined twins.

Can Neuroscience Contribute to Practical Ethics? A Critical Review and Discussion of the Methodological and Translational Challenges of the Neuroscience of Ethics.

PubMed

Racine, Eric; Dubljević, Veljko; Jox, Ralf J; Baertschi, Bernard; Christensen, Julia F; Farisco, Michele; Jotterand, Fabrice; Kahane, Guy; Müller, Sabine

2017-06-01

Neuroethics is an interdisciplinary field that arose in response to novel ethical challenges posed by advances in neuroscience. Historically, neuroethics has provided an opportunity to synergize different disciplines, notably proposing a two-way dialogue between an 'ethics of neuroscience' and a 'neuroscience of ethics'. However, questions surface as to whether a 'neuroscience of ethics' is a useful and unified branch of research and whether it can actually inform or lead to theoretical insights and transferable practical knowledge to help resolve ethical questions. In this article, we examine why the neuroscience of ethics is a promising area of research and summarize what we have learned so far regarding its most promising goals and contributions. We then review some of the key methodological challenges which may have hindered the use of results generated thus far by the neuroscience of ethics. Strategies are suggested to address these challenges and improve the quality of research and increase neuroscience's usefulness for applied ethics and society at large. Finally, we reflect on potential outcomes of a neuroscience of ethics and discuss the different strategies that could be used to support knowledge transfer to help different stakeholders integrate knowledge from the neuroscience of ethics. © 2017 John Wiley & Sons Ltd.

Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review.

PubMed

Salman Popattia, Amber; Winch, Sarah; La Caze, Adam

2018-04-01

The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists' practices or perceptions, consumers' expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists' responsibilities in selling complementary medicines were included in the review. Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict. There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines. © 2018 Royal Pharmaceutical Society.

Qualitative Evaluation Methods in Ethics Education: A Systematic Review and Analysis of Best Practices.

PubMed

Watts, Logan L; Todd, E Michelle; Mulhearn, Tyler J; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

2017-01-01

Although qualitative research offers some unique advantages over quantitative research, qualitative methods are rarely employed in the evaluation of ethics education programs and are often criticized for a lack of rigor. This systematic review investigated the use of qualitative methods in studies of ethics education. Following a review of the literature in which 24 studies were identified, each study was coded based on 16 best practices characteristics in qualitative research. General thematic analysis and grounded theory were found to be the dominant approaches used. Researchers are effectively executing a number of best practices, such as using direct data sources, structured data collection instruments, non-leading questioning, and expert raters. However, other best practices were rarely present in the courses reviewed, such as collecting data using multiple sources, methods, raters, and timepoints, evaluating reliability, and employing triangulation analyses to assess convergence. Recommendations are presented for improving future qualitative research studies in ethics education.

Ethical Issues in the Mental Health Treatment of Gender Dysphoric Adolescents.

ERIC Educational Resources Information Center

Swann, Stephanie; Herbert, Sarah E.

1999-01-01

Examines ethical dilemmas arising when treating adolescents with gender dysphoria, discussing ethical and legal issues pertinent to treating any adolescent and highlighting gender dysphoric adolescents. Reviews legal decisions, existing data on adolescent decision making, and ethical principles for resolving complex situations. Illustrates ethical…

Teaching Ethics across the Public Relations Curriculum.

ERIC Educational Resources Information Center

Hutchison, Liese L.

2002-01-01

Suggests ways of incorporating ethics across the undergraduate public relations curriculum. Reviews current coverage of ethics in public relations principles, writing, cases, and textbooks. Suggests other methods that teachers can use to incorporate ethical pedagogical tools in all public relations courses in an effort to develop students' ethical…

Marketing in Adult Education. A Critical Review of Literature.

ERIC Educational Resources Information Center

Wells, Rita L.

In the literature on marketing in adult education there is much debate on the ethics of marketing educational programs; although many individuals have written about the potential negative impacts of big business and high-pressure advertising in education, others have viewed marketing as an acceptable process that attempts to establish mutually…

Hearing How Students "Make Meaning": Listening Through Perry Ears.

ERIC Educational Resources Information Center

Stonewater, Jerry K.; And Others

Perry's theory of intellectual and ethical development of college students is briefly reviewed. This theory was based on work with Harvard University students, and addresses dualism, multiplicity, and relativism. In the first stage, a student sees the world in right-wrong, black-white terms, with no room in the thinking process for conditional or…

76 FR 47271 - Implementation of Scientific Integrity Principles: Draft Plan for Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... Communications The Office of Legislative and Public Affairs (OLPA) is the authorized news media liaison for NSF... follows: Media Policy: Purpose This document establishes NSF's media policy governing media communications... conduct our merit review process and make funding decisions to adhere to the highest standards of ethical...

Ethical aspects in placental perfusion studies: views of the researchers.

PubMed

Halkoaho, A; Pietilä, A-M; Vähäkangas, K

2011-07-01

Within the EU-project NewGeneris human placental perfusion has been used for predicting fetal exposure to food carcinogens. Within the work package of ethical aspects of the research, we studied opinions of the researchers (n = 23) who carried out perfusions of human placenta. Data were collected by focus group interviews (n = 12) and an open-ended questionnaire (n =19 of which 8 were also attending the group session) from scientists representing 9 different nationalities. Both types of data were analysed together thematically and with data triangulation. Studied researchers considered communication between all stakeholders extremely important. Good communication was considered a prerequisite for the recruitment of mothers to donate the placenta, as well as for the process of getting the informed consent. Voluntariness, confidentiality and societal meaning were mentioned as important by all studied researchers. Educating the hospital personnel was regarded as essential in order to provide the best possible information to the mothers. The researchers also pointed out that cultural aspects should be respected, and that in Western thinking placenta is mostly considered as waste. Some researchers suggested that current guidelines and processes for obtaining informed consent should be reviewed also from a cultural perspective. With the development of biobanks, the use of human tissues, including placenta will most probably increase in the future, and the awareness of ethical considerations both in legislation and in practice need support. Thus, continuous effort for better research ethics is essential and requires research on research ethics. Copyright © 2011 Elsevier Ltd. All rights reserved.

Innovations in design and technology. The story of hip arthroplasty.

PubMed

Amstutz, H C

2000-09-01

The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty and the subsequent methodological evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administration with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing the history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems inherent in the current methodology of the approval process from the Food and Drug Administration using the 5-10K, Investigative Device Exemption, and the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing. Finally, the ethical dilemmas created by managed care are addressed. Industry involvements of the surgeon-spokesmen are cited.

Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

PubMed Central

2011-01-01

Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Results Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Conclusion Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. PMID:21943406

Medical Education and the Pharmaceutical Industry: A Review of Ethical Guidelines and Their Implications for Psychiatric Training

ERIC Educational Resources Information Center

Geppert, Cynthia M. A.

2007-01-01

Objective: This article reviews and summarizes eight ethical guidelines of major professional organizations regarding the pharmaceutical industry's role in the psychiatric education of trainees. Method: The author conducted a literature review of research and guidelines pertaining to the pharmaceutical industry's relationship to trainees, with…

Biomedical Research Ethics Committees in sub-Saharan Africa: a collective review of their structure, functioning, and outcomes.

PubMed

Silaigwana, Blessing; Wassenaar, Douglas

2015-04-01

Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what is known and identifying gaps in our knowledge. We conducted a literature search of the EBSCO, PubMed, and Google Scholar electronic databases. Twenty-three empirical studies reporting on the structure, functions, and outcomes of African RECs were included in our analysis. The review yielded limited systematic data on RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs. © The Author(s) 2015.

Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.

PubMed

van Lent, Marlies; Rongen, Gerard A; Out, Henk J

2014-12-10

Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature. Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95). RECs identified important ethical and methodological shortcomings in protocols of both industry-sponsored and non-industry drug trials. Investigators, especially of non-industry trials, should better prepare their research protocols in order to facilitate the ethical review process.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

Hidden in plain view: feminists doing engineering ethics, engineers doing feminist ethics.

PubMed

Riley, Donna

2013-03-01

How has engineering ethics addressed gender concerns to date? How have the ideas of feminist philosophers and feminist ethicists made their way into engineering ethics? What might an explicitly feminist engineering ethics look like? This paper reviews some major themes in feminist ethics and then considers three areas in which these themes have been taken up in engineering ethics to date. First, Caroline Whitbeck's work in engineering ethics integrates considerations from her own earlier writings and those of other feminist philosophers, but does not use the feminist label. Second, efforts to incorporate the Ethic of Care and principles of Social Justice into engineering have drawn on feminist scholarship and principles, but these commitments can be lost in translation to the broader engineering community. Third, the film Henry's Daughters brings gender considerations into the mainstream of engineering ethics, but does not draw on feminist ethics per se; despite the best intentions in broaching a difficult subject, the film unfortunately does more harm than good when it comes to sexual harassment education. I seek not only to make the case that engineers should pay attention to feminist ethics and engineering ethicists make more use of feminist ethics traditions in the field, but also to provide some avenues for how to approach integrating feminist ethics in engineering. The literature review and analysis of the three examples point to future work for further developing what might be called feminist engineering ethics.

Evaluating the Intervention of an Ethics' Class in Students' Ethical Decision-Making: A Summative Review

ERIC Educational Resources Information Center

Walker, Marquita

2013-01-01

This summative evaluation is the result of two years' of data reflecting the impact of an ethics class in terms of students' ethical decision-making. The research compares aggregate responses from scenario-based pre- and post-survey open-ended survey questions designed to measure changes in ethical decision-making by comparing students' cognitive…

Internet Research Ethics and the Policy Gap for Ethical Practice in Online Research Settings

ERIC Educational Resources Information Center

Warrell, Jacqueline G.; Jacobsen, Michele

2014-01-01

A growing number of education and social science researchers design and conduct online research. In this review, the Internet Research Ethics (IRE) policy gap in Canada is identified along with the range of stakeholders and groups that either have a role or have attempted to play a role in forming better ethics policy. Ethical issues that current…

A narrative review of undergraduate peer-based healthcare ethics teaching

PubMed Central

Allikmets, Silvia; Knights, Felicity

2015-01-01

Objectives This study explores the literature in establishing the value of undergraduate peer-based healthcare ethics teaching as an educational methodology. Methods A narrative review of the literature concerning peer-based ethics teaching was conducted. MEDLINE, EMBASE, CINAHL, SCOPUS databases, and the Cochrane Library, were systematically searched for studies of peer-based ethics or professionalism teaching. Selected studies related peer-based teaching to ethics education outcomes. Results Ten publications were identified. Selected studies were varied in their chosen intervention methodology and analysis. Collectively, the identified studies suggest peer-based ethics education is an effective and valued educational methodology in training healthcare professionals. One paper suggests peer-based ethics teaching has advantages over traditional didactic methods. Peer-based ethics teaching also receives positive feedback from student participants. However, the limited literature base demonstrates a clear need for more evaluation of this pedagogy. Conclusions The current literature base suggests that undergraduate peer based healthcare ethics teaching is valuable in terms of efficacy and student satisfaction. We conclude that the medical community should invest in further study in order to capitalise upon the potential of peer-based ethics teaching in undergraduate healthcare education. PMID:26668050

Steps to strengthen ethics in organizations: research findings, ethics placebos, and what works.

PubMed

Pope, Kenneth S

2015-01-01

Research shows that many organizations overlook needs and opportunities to strengthen ethics. Barriers can make it hard to see the need for stronger ethics and even harder to take effective action. These barriers include the organization's misleading use of language, misuse of an ethics code, culture of silence, strategies of justification, institutional betrayal, and ethical fallacies. Ethics placebos tend to take the place of steps to see, solve, and prevent problems. This article reviews relevant research and specific steps that create change.

Teaching Behavioral Ethics: Overcoming the Key Impediments to Ethical Behavior

ERIC Educational Resources Information Center

Schwartz, Mark S.

2017-01-01

To better understand the ethical decision-making process and why individuals fail to act ethically, the aim of this article is to explore what are seen as the key impediments to ethical behavior and their pedagogical implications. Using the ethical decision-making process proposed by Rest as an overarching framework, the article examines the…

A Conceptual Framework of Corporate and Business Ethics across Organizations: Structures, Processes and Performance

ERIC Educational Resources Information Center

Svensson, Goran; Wood, Greg

2011-01-01

Purpose: The objective of this paper is to introduce and describe a conceptual framework of corporate and business ethics across organizations in terms of ethical structures, ethical processes and ethical performance. Design/methodology/approach: A framework is outlined and positioned incorporating an ethical frame of reference in the field of…

Leveraging ongoing research to evaluate the health impacts of South Africa's salt reduction strategy: a prospective nested cohort within the WHO-SAGE multicountry, longitudinal study

PubMed Central

Charlton, Karen; Menyanu, Elias; Biritwum, Richard Berko; Naidoo, Nirmala; Pieterse, Chiné; Madurai, Savathree (Lorna); Baumgartner, Jeannine; Asare, George A; Thiele, Elizabeth; Schutte, Aletta E; Kowal, Paul

2016-01-01

Introduction Attempting to curb the rising epidemic of hypertension, South Africa implemented legislation in June 2016 mandating maximum sodium levels in a range of manufactured foods that contribute significantly to population salt intake. This natural experiment, comparing two African countries with and without salt legislation, will provide timely information on the impact of legislative approaches addressing the food supply to improve blood pressure in African populations. This article outlines the design of this ongoing prospective nested cohort study. Methods and analysis Baseline sodium intake was assessed in a nested cohort of the WHO Study on global AGEing and adult health (WHO-SAGE) wave 2 (2014–2015), a multinational longitudinal study on the health and well-being of adults and the ageing process. The South African cohort consisted of randomly selected households (n=4030) across the country. Spot and 24-hour urine samples are collected in a random subsample (n=1200) and sodium, potassium, creatinine and iodine analysed. Salt behaviour and sociodemographic data are captured using face-to-face interviews, alongside blood pressure and anthropometric measures. Ghana, the selected control country with no formal salt policy, provided a nested subsample (n=1200) contributing spot and 24-hour urine samples from the SAGE Ghana cohort (n=5000). Follow-up interviews and urine collection (wave 3) in both countries will take place in 2017 (postlegislation) to assess change in population-level sodium intake and blood pressure. Ethics and dissemination SAGE was approved by the WHO Ethics Review Committee (reference number RPC149) with local approval from the North-West University Human Research Ethics Committee and University of the Witwatersrand Human Research Ethics Committee (South Africa), and University of Ghana Medical School Ethics and Protocol Review Committee (Ghana). The results of the study will be published in peer-reviewed international journals, presented at national and international conferences, and summarised as research and policy briefs. PMID:27903563

Recommendations for the ethical use and design of artificial intelligent care providers.

PubMed

Luxton, David D

2014-09-01

This paper identifies and reviews ethical issues associated with artificial intelligent care providers (AICPs) in mental health care and other helping professions. Specific recommendations are made for the development of ethical codes, guidelines, and the design of AICPs. Current developments in the application of AICPs and associated technologies are reviewed and a foundational overview of applicable ethical principles in mental health care is provided. Emerging ethical issues regarding the use of AICPs are then reviewed in detail. Recommendations for ethical codes and guidelines as well as for the development of semi-autonomous and autonomous AICP systems are described. The benefits of AICPs and implications for the helping professions are discussed in order to weigh the pros and cons of their use. Existing ethics codes and practice guidelines do not presently consider the current or the future use of interactive artificial intelligent agents to assist and to potentially replace mental health care professionals. AICPs present new ethical issues that will have significant ramifications for the mental health care and other helping professions. Primary issues involve the therapeutic relationship, competence, liability, trust, privacy, and patient safety. Many of the same ethical and philosophical considerations are applicable to use and design of AICPs in medicine, nursing, social work, education, and ministry. The ethical and moral aspects regarding the use of AICP systems must be well thought-out today as this will help to guide the use and development of these systems in the future. Topics presented are relevant to end users, AI developers, and researchers, as well as policy makers and regulatory boards. Published by Elsevier B.V.

A Systematic Literature Review of US Engineering Ethics Interventions.

PubMed

Hess, Justin L; Fore, Grant

2018-04-01

Promoting the ethical formation of engineering students through the cultivation of their discipline-specific knowledge, sensitivity, imagination, and reasoning skills has become a goal for many engineering education programs throughout the United States. However, there is neither a consensus throughout the engineering education community regarding which strategies are most effective towards which ends, nor which ends are most important. This study provides an overview of engineering ethics interventions within the U.S. through the systematic analysis of articles that featured ethical interventions in engineering, published in select peer-reviewed journals, and published between 2000 and 2015. As a core criterion, each journal article reviewed must have provided an overview of the course as well as how the authors evaluated course-learning goals. In sum, 26 articles were analyzed with a coding scheme that included 56 binary items. The results indicate that the most common methods for integrating ethics into engineering involved exposing students to codes/standards, utilizing case studies, and discussion activities. Nearly half of the articles had students engage with ethical heuristics or philosophical ethics. Following the presentation of the results, this study describes in detail four articles to highlight less common but intriguing pedagogical methods and evaluation techniques. The findings indicate that there is limited empirical work on ethics education within engineering across the United States. Furthermore, due to the large variation in goals, approaches, and evaluation methods described across interventions, this study does not detail "best" practices for integrating ethics into engineering. The science and engineering education community should continue exploring the relative merits of different approaches to ethics education in engineering.

Evidence-based ethics – What it should be and what it shouldn't

PubMed Central

Strech, Daniel

2008-01-01

Background The concept of evidence-based medicine has strongly influenced the appraisal and application of empirical information in health care decision-making. One principal characteristic of this concept is the distinction between "evidence" in the sense of high-quality empirical information on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10 years an increasing number of articles published in international journals have made use of the term "evidence-based ethics", making a systematic analysis and explication of the term and its applicability in ethics important. Discussion In this article four descriptive and two normative characteristics of the general concept "evidence-based" are presented and explained systematically. These characteristics are to then serve as a framework for assessing the methodological and practical challenges of evidence-based ethics as a developing methodology. The superiority of evidence in contrast to other empirical information has several normative implications such as the legitimization of decisions in medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent on which sort of empirical information deserves the label "evidence" and which does not. In empirical ethics, which relies primarily on interview research and other methods from the social sciences, we still lack gold standards for assessing the quality of study designs and appraising their findings. Conclusion The use of the term "evidence-based ethics" should be discouraged, unless there is enough consensus on how to differentiate between high- and low-quality information produced by empirical ethics. In the meantime, whenever empirical information plays a role, the process of ethical decision-making should make use of systematic reviews of empirical studies that involve a critical appraisal and comparative discussion of data. PMID:18937838

Analysis of research ethics board approval times in an academic department of medicine.

PubMed

Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S

2015-04-01

As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.

Social Media, Big Data, and Mental Health: Current Advances and Ethical Implications.

PubMed

Conway, Mike; O'Connor, Daniel

2016-06-01

Mental health (including substance abuse) is the fifth greatest contributor to the global burden of disease, with an economic cost estimated to be US $2.5 trillion in 2010, and expected to double by 2030. Developing information systems to support and strengthen population-level mental health monitoring forms a core part of the World Health Organization's Comprehensive Action Plan 2013-2020. In this paper, we review recent work that utilizes social media "big data" in conjunction with associated technologies like natural language processing and machine learning to address pressing problems in population-level mental health surveillance and research, focusing both on technological advances and core ethical challenges.

An Online Course for Instruction in the Reponsible Conduct of Research

DOE Office of Scientific and Technical Information (OSTI.GOV)

Michael Kalichman

2004-10-12

Responsible Conduct of Research (RCR) is the process by which regulations, guidelines, standards and ethics are reconciled to promote integrity in research. The development of this online resource, with contributions from the Department of Health and Human Services (DHHS), will allow the DOE system to offer state-of-the-art education in RCR to its sites. The intent of the project is to establish basic RCR content websites, publicize for public use and review, revise as recommended or as ethics change, and to continue supplementing with new material. The resulting resources will be posted on the Web (http://rcrec.org/r)

Doing what's right: A grounded theory of ethical decision-making in occupational therapy.

PubMed

VanderKaay, Sandra; Letts, Lori; Jung, Bonny; Moll, Sandra E

2018-04-20

Ethical decision-making is an important aspect of reasoning in occupational therapy practice. However, the process of ethical decision-making within the broader context of reasoning is yet to be clearly explicated. The purpose of this study was to advance a theoretical understanding of the process by which occupational therapists make ethical decisions in day-to-day practice. A constructivist grounded theory approach was adopted, incorporating in-depth semi-structured interviews with 18 occupational therapists from a range of practice settings and years of experience. Initially, participants nominated as key informants who were able to reflect on their decision-making processes were recruited. Theoretical sampling informed subsequent stages of data collection. Participants were asked to describe their process of ethical decision-making using scenarios from clinical practice. Interview transcripts were analyzed using a systematic process of initial then focused coding, and theoretical categorization to construct a theory regarding the process of ethical decision-making. An ethical decision-making prism was developed to capture three main processes: Considering the Fundamental Checklist, Consulting Others, and Doing What's Right. Ethical decision-making appeared to be an inductive and dialectical process with the occupational therapist at its core. Study findings advance our understanding of ethical decision-making in day-to-day clinical practice.

Teaching Medical Ethics in Graduate and Undergraduate Medical Education: A Systematic Review of Effectiveness.

PubMed

de la Garza, Santiago; Phuoc, Vania; Throneberry, Steven; Blumenthal-Barby, Jennifer; McCullough, Laurence; Coverdale, John

2017-08-01

One objective was to identify and review studies on teaching medical ethics to psychiatry residents. In order to gain insights from other disciplines that have published research in this area, a second objective was to identify and review studies on teaching medical ethics to residents across all other specialties of training and on teaching medical students. PubMed, EMBASE, and PsycINFO were searched for controlled trials on teaching medical ethics with quantitative outcomes. Search terms included ethics, bioethics, medical ethics, medical students, residents/registrars, teaching, education, outcomes, and controlled trials. Nine studies were found that met inclusion criteria, including five randomized controlled trails and four controlled non-randomized trials. Subjects included medical students (5 studies), surgical residents (2 studies), internal medicine house officers (1 study), and family medicine preceptors and their medical students (1 study). Teaching methods, course content, and outcome measures varied considerably across studies. Common methodological issues included a lack of concealment of allocation, a lack of blinding, and generally low numbers of subjects as learners. One randomized controlled trial which taught surgical residents using a standardized patient was judged to be especially methodologically rigorous. None of the trials incorporated psychiatry residents. Ethics educators should undertake additional rigorously controlled trials in order to secure a strong evidence base for the design of medical ethics curricula. Psychiatry ethics educators can also benefit from the findings of trials in other disciplines and in undergraduate medical education.

Rethinking Ethics Review as Institutional Discourse

ERIC Educational Resources Information Center

Halse, Christine; Honey, Anne

2007-01-01

In this article, the authors trace the emergence of an institutional discourse of ethical research and interrogate its effects in constituting what ethical research is taken to be and how ethical researchers are configured. They illuminate the dissonance between this regime of truth and research practice and the implications for the injunction to…

75 FR 26345 - Agency Information Collection (Ethics Consultation Feedback Tool (ECFT)) New Enrollee Survey...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

... Collection (Ethics Consultation Feedback Tool (ECFT)) New Enrollee Survey) Activity Under OMB Review AGENCY...).'' SUPPLEMENTARY INFORMATION: Title: Ethics Consultation Feedback Tool (ECFT), VA Form 10-0502. OMB Control Number... collect data from patients and family members about their experience during the Ethics Consultation...

77 FR 66075 - Agency Information Collection Activities; Emergency Clearance Submission for Expedited OMB Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-01

... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Emergency Clearance... 201-A Ethics in Government Act Access Form AGENCY: Office of Government Ethics (OGE). ACTION... Ethics (OGE) is submitting a request to the Office of Management and Budget (OMB) for an expedited...

Research Ethics Review: Identifying Public Policy and Program Gaps

PubMed Central

Strosberg, Martin A.; Gefenas, Eugenijus; Famenka, Andrei

2014-01-01

We present an analytical frame-work for use by fellows of the Fogarty International Center–sponsored Advanced Certificate Program in Research Ethics for Central and Eastern Europe to identify gaps in the public policies establishing research ethics review systems that impede them from doing their job of protecting human research subjects. The framework, illustrated by examples from post-Communist countries, employs a logic model based on the public policy and public management literature. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum program. PMID:24782068

Evaluation of ethics education in obstetrics and gynecology residency programs.

PubMed

Byrne, John; Straub, Heather; DiGiovanni, Laura; Chor, Julie

2015-03-01

The objective of the study was to assess the current status of ethics education in obstetrics-gynecology residency programs. A cross-sectional, web-based survey was designed in conjunction with a professional survey laboratory at the University of Chicago. The survey was piloted with a convenience sample of clinical medical ethics fellows to assess question content and clarity. The survey was deployed by e-mail to all obstetrics-gynecology residency program directors. Descriptive statistics were used to analyze participant responses. The University of Chicago's Institutional Review Board deemed this study exempt from institutional review board formal review. Of 242 eligible obstetrics-gynecology residency program directors, 118 (49%) completed the survey. Most respondents were from university-based programs (n = 78, 66%) that were not religiously affiliated (n = 98, 83%) and trained 4-6 residents per postgraduate year (n = 64, 70%). Although 50% of program directors (n = 60) reported having ethics as part of their core curriculum, most programs teach ethics in an unstructured manner. Fifty-seven percent of respondents (n = 66) stated their program dedicated 5 or fewer hours per year to ethics. The majority of program directors (n = 80, 73%) responded they would like more to a lot more ethics education and believed that ethics education should be required (n = 93, 85%) for residents to complete their training. Respondents identified that crowding in the curriculum was a significant barrier to increased ethics training (n = 50, 45%) and two-thirds (n = 74, 67%) reported a lack of faculty expertise as a moderate barrier to providing ethics education in the residency curriculum. This study found that a lack of structured curricula, inadequate faculty expertise, and limited time were important barriers for ethics education in obstetrics-gynecology programs across the nation. Despite these existing challenges, program directors have a strong interest in increasing ethics education in residency training. Therefore, additional resources are needed to assist program directors in enhancing resident ethics education. Copyright © 2015 Elsevier Inc. All rights reserved.

Encouraging translation and assessing impact of the Centre for Research Excellence in Integrated Quality Improvement: rationale and protocol for a research impact assessment

PubMed Central

Ramanathan, Shanthi; Reeves, Penny; Deeming, Simon; Bailie, Ross Stewart; Bailie, Jodie; Bainbridge, Roxanne; Cunningham, Frances; Doran, Christopher; McPhail Bell, Karen; Searles, Andrew

2017-01-01

Introduction There is growing recognition among health researchers and funders that the wider benefits of research such as economic, social and health impacts ought to be assessed and valued alongside academic outputs such as peer-reviewed papers. Research translation needs to increase and the pathways to impact ought to be more transparent. These processes are particularly pertinent to the Indigenous health sector given continued concerns that Indigenous communities are over-researched with little corresponding improvement in health outcomes. This paper describes the research protocol of a mixed methods study to apply FAIT (Framework to Assess the Impact from Translational health research) to the Centre for Research Excellence in Integrated Quality Improvement (CRE-IQI). FAIT will be applied to five selected CRE-IQI Flagship projects to encourage research translation and assess the wider impact of that research. Methods and analysis Phase I will develop a modified programme logic model for each Flagship project including identifying process, output and impact metrics so progress can be monitored. A scoping review will inform potential benefits. In phase II, programme logic models will be updated to account for changes in the research pathways over time. Audit and feedback will be used to encourage research translation and collect evidence of achievement of any process, output and interim impacts. In phase III, three proven methodologies for measuring research impact—Payback, economic assessment and narratives—will be applied. Data on the application of FAIT will be collected and analysed to inform and improve FAIT’s performance. Ethics and dissemination This study is funded by a nationally competitive grant (ID 1078927) from the Australian National Health and Medical Research Council. Ethics approval was obtained from the University of Newcastle’s Human Research Ethics Committee (ID: H-2017–0026). The results from the study will be presented in several peer-reviewed publications, through conference presentations and via social media. PMID:29208619

Peas, please: a case report and neuroscientific review of dissociative amnesia and fugue.

PubMed

MacDonald, Kai; MacDonald, Tina

2009-01-01

Dissociative amnesia that encompasses one's entire life and identity is a rare disorder, as is dissociative fugue. In evaluating such cases, a dichotomy is often invoked between functional and organic etiologies. However, this dichotomy suffers from both conceptual and ethical flaws. Conceptually, putative brain-based, organic etiologies for many dissociative disorders-including dissociative amnesia-exist. Ethically, such dichotomies may result in dismissive care for patients with distress-based disorders like dissociative amnesia. In support of humane, neurobiologically informed treatment of patients with dissociative amnesia, we present excerpts from 2 post-event interviews with a patient who suffered and recovered from an episode of dissociative amnesia and fugue. Following this, we review current neurobiological models of dissociative amnesia that undermine the dichotomy of functional versus organic, and suggest that the crucial distinction in such cases is between a patient's willful, conscious deceit and processes that occur without conscious intent.

Ethical dilemmas in scientific publication: pitfalls and solutions for editors.

PubMed

Gollogly, Laragh; Momen, Hooman

2006-08-01

Editors of scientific journals need to be conversant with the mechanisms by which scientific misconduct is amplified by publication practices. This paper provides definitions, ways to document the extent of the problem, and examples of editorial attempts to counter fraud. Fabrication, falsification, duplication, ghost authorship, gift authorship, lack of ethics approval, non-disclosure, 'salami' publication, conflicts of interest, auto-citation, duplicate submission, duplicate publications, and plagiarism are common problems. Editorial misconduct includes failure to observe due process, undue delay in reaching decisions and communicating these to authors, inappropriate review procedures, and confounding a journal's content with its advertising or promotional potential. Editors also can be admonished by their peers for failure to investigate suspected misconduct, failure to retract when indicated, and failure to abide voluntarily by the six main sources of relevant international guidelines on research, its reporting and editorial practice. Editors are in a good position to promulgate reasonable standards of practice, and can start by using consensus guidelines on publication ethics to state explicitly how their journals function. Reviewers, editors, authors and readers all then have a better chance to understand, and abide by, the rules of publishing.

South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

PubMed

Essack, Zaynab; Wassenaar, Douglas R

2018-04-01

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

Ethics and Community Involvement in Syntheses Concerning American Indian, Alaska Native, or Native Hawaiian Health: A Systematic Review

PubMed Central

Around Him, Deana M.

2014-01-01

Background The objective of the research was to review reporting of ethical concerns and community involvement in peer-reviewed systematic reviews or meta-analyses concerning American Indian, Alaska Native, or Native Hawaiian (AI/AN/NH) health. Methods Text words and indexed vocabulary terms were used to query PubMed, Embase, Cochrane Library, and the Native Health Database for systematic reviews or meta-analyses concerning AI/AN/NH health published in peer-reviewed journals, followed by a search through reference lists. Each article was abstracted by two independent reviewers; results were discussed until consensus was reached. Results We identified 107 papers published from 1986–2012 that were primarily about AI/AN/NH health or presented findings separately for AI/AN/NH communities. Two reported seeking indigenous reviewer feedback; none reported seeking input from tribes and communities. Approximately 7% reported on institutional review board (IRB) approval of included studies, 5% reported on tribal approval, and 4% referenced the sovereignty of AI/AN tribes. Approximately 63% used evidence from more than one AI/AN/NH population study, and 28% discussed potential benefits to communities from the synthesis research. Conclusions Reporting of ethics and community involvement are not prominent. Systematic reviews and meta-analyses making community-level inferences may pose risks to communities. Future systematic reviews and meta-analyses should consider ethical and participatory dimensions of research. PMID:25089283

Allergic Bronchopulmonary Mycosis Caused by Cladosporidium

DTIC Science & Technology

2017-05-23

request form to clinical investigations, S02 ISG/JAC ( Ethics Review) and Public Affairs (S9 MOW/PA) for review and then forward you a final letter of...Presentation and Publication of Medical and Technical Papers. for additional information. 11 . The Joint Ethics Regulation (JER) DoD SS00.07-R...Standards of Conduct, provides standards of ethical conduct for all OoO personnel and their interactions with other non-DoD entities, organizations

Teaching ethics to engineers: ethical decision making parallels the engineering design process.

PubMed

Bero, Bridget; Kuhlman, Alana

2011-09-01

In order to fulfill ABET requirements, Northern Arizona University's Civil and Environmental engineering programs incorporate professional ethics in several of its engineering courses. This paper discusses an ethics module in a 3rd year engineering design course that focuses on the design process and technical writing. Engineering students early in their student careers generally possess good black/white critical thinking skills on technical issues. Engineering design is the first time students are exposed to "grey" or multiple possible solution technical problems. To identify and solve these problems, the engineering design process is used. Ethical problems are also "grey" problems and present similar challenges to students. Students need a practical tool for solving these ethical problems. The step-wise engineering design process was used as a model to demonstrate a similar process for ethical situations. The ethical decision making process of Martin and Schinzinger was adapted for parallelism to the design process and presented to students as a step-wise technique for identification of the pertinent ethical issues, relevant moral theories, possible outcomes and a final decision. Students had greatest difficulty identifying the broader, global issues presented in an ethical situation, but by the end of the module, were better able to not only identify the broader issues, but also to more comprehensively assess specific issues, generate solutions and a desired response to the issue.

A Code of Ethics and Integrity for HRD Research and Practice.

ERIC Educational Resources Information Center

Hatcher, Tim; Aragon, Steven R.

2000-01-01

Describes the rationale for a code of ethics and integrity in human resource development (HRD). Outlines the Academy of Human Resource Development's standards. Reviews ethical issues faced by the HRD profession. (SK)

Ethical concerns of nursing reviewers: an international survey.

PubMed

Broome, Marion; Dougherty, Molly C; Freda, Margaret C; Kearney, Margaret H; Baggs, Judith G

2010-11-01

Editors of scientific literature rely heavily on peer reviewers to evaluate the integrity of research conduct and validity of findings in manuscript submissions. The purpose of this study was to describe the ethical concerns of reviewers of nursing journals. This descriptive cross-sectional study was an anonymous online survey. The findings reported here were part of a larger investigation of experiences of reviewers. Fifty-two editors of nursing journals (six outside the USA) agreed to invite their review panels to participate. A 69-item forced-choice and open-ended survey developed by the authors based on the literature was pilot tested with 18 reviewers before being entered into SurveyMonkey(TM). A total of 1675 reviewers responded with useable surveys. Six questions elicited responses about ethical issues, such as conflict of interest, protection of human research participants, plagiarism, duplicate publication, misrepresentation of data and 'other'. The reviewers indicated whether they had experienced such a concern and notified the editor, and how satisfied they were with the outcome. They provided specific examples. Approximately 20% of the reviewers had experienced various ethical dilemmas. Although the majority reported their concerns to the editor, not all did so, and not all were satisfied with the outcomes. The most commonly reported concern perceived was inadequate protection of human participants. The least common was plagiarism, but this was most often reported to the editor and least often led to a satisfactory outcome. Qualitative responses at the end of the survey indicate this lack of satisfaction was most commonly related to feedback provided on resolution by the editor. The findings from this study suggest several areas that editors should note, including follow up with reviewers when they identify ethical concerns about a manuscript.

Ethics and Scientific Publication

ERIC Educational Resources Information Center

Benos, Dale J.; Fabres, Jorge; Farmer, John; Gutierrez, Jessica P.; Hennessy, Kristin; Kosek, David; Lee, Joo Hyoung; Olteanu, Dragos; Russell, Tara; Wang, Kai

2005-01-01

This article summarizes the major categories of ethical violations encountered during submission, review, and publication of scientific articles. We discuss data fabrication and falsification, plagiarism, redundant and duplicate publication, conflict of interest, authorship, animal and human welfare, and reviewer responsibility. In each section,…

RETRACTED: Application of RF magnetron sputtering for growth of AZO on glass substrate

NASA Astrophysics Data System (ADS)

Ghorannevis, Z.; Akbarnejad, E.; Salar Elahi, A.; Ghoranneviss, M.

2016-08-01

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of the Principal Editor. After a thorough investigation, the Editor has concluded that the review process for this article was compromised. The acceptance was based on information from at least one reviewer report that was submitted from an email account provided to the journal as a suggested reviewer during the submission of the article. Although purportedly a real reviewer account, the Editor has concluded that this was not of an appropriate, independent reviewer. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewers whose identities were assumed and to the readers of the journal that this deception was not detected during the submission process. In addition, the author names Z. Ghorannevis and E. Akbarnejad were added to the article at revision - the corresponding author was not able to explain the reason.

RETRACTED: A new perspective on structural, materials, and simulation of flow and cavitation around the propeller with energy saving system

NASA Astrophysics Data System (ADS)

Fathololumi, S.; Hassanabad, M. Ghodsi

2016-12-01

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of the Principal Editor. After a thorough investigation, the Editor has concluded that the review process for this article was compromised. The acceptance was based on information from two reviewer reports that were submitted from email accounts provided to the journal as suggested reviewers during the submission of the article. Although purportedly real reviewer accounts, the Editor has concluded that these were not of appropriate, independent reviewers. This manipulation of the peer-review process represents a clear violation of the fundamentals of peer review, our publishing policies, and publishing ethics standards. Apologies are offered to the reviewers whose identities were assumed and to the readers of the journal that this deception was not detected during the submission process. Further, no reason has been provided for the removal of three authors and addition of the authors S. Fathololumi and M. Ghodsi Hassanabad upon revision of the article.

Research Ethics I: Responsible Conduct of Research (RCR)--Historical and Contemporary Issues Pertaining to Human and Animal Experimentation

ERIC Educational Resources Information Center

Horner, Jennifer; Minifie, Fred D.

2011-01-01

Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics I", they present a historical overview of the evolution of…

Teaching Business Ethics: A Practical Guide and Case Studies. SBDC Professional Enrichment.

ERIC Educational Resources Information Center

Collins, Denis; Page, Laura V.

This teaching guide is for instructors who wish to include a discussion of ethical dilemmas in their regular business seminars and workshops. It discusses why it is essential to teach ethics and how to do so. It reviews the format of specially annotated ethics cases that are designed to help teach business ethics and shows how to use them. These…

An Empirical Ethics Agenda for Psychiatric Research Involving Prisoners

PubMed Central

Christopher, Paul P.; Candilis, Philip J.; Rich, Josiah D.; Lidz, Charles W.

2012-01-01

In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nation’s most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic. PMID:25309805

Human rights, politics, and reviews of research ethics.

PubMed

Beyrer, Chris; Kass, Nancy E

2002-07-20

Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review--the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations--can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.

The ethical desirability of moral bioenhancement: a review of reasons

PubMed Central

2014-01-01

Background The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and against moral bioenhancement. Discussion A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don’t) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. Summary Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing ‘the whole of humanity’, we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise. PMID:25227512

The ethical desirability of moral bioenhancement: a review of reasons.

PubMed

Specker, Jona; Focquaert, Farah; Raus, Kasper; Sterckx, Sigrid; Schermer, Maartje

2014-09-16

The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and against moral bioenhancement. A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don't) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing 'the whole of humanity', we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise.

Ethical issues in public health surveillance: a systematic qualitative review.

PubMed

Klingler, Corinna; Silva, Diego Steven; Schuermann, Christopher; Reis, Andreas Alois; Saxena, Abha; Strech, Daniel

2017-04-04

Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent. Ethical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis. Our search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures. This is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

Ethical and legal issues in the clinical practice of primary health care.

PubMed

Maestro, Francisco Javier; Martinez-Romero, Marcos; Vazquez-Naya, Jose Manuel; Pereira, Javier; Pazos, Alejandro

2013-01-01

Since it was conceived, the notion of primary care has been a crucial concept in health services. Most health care is provided at this level and primary care clinicians have an essential role, both in terms of disease prevention and disease management. During the last decades, primary health care has evolved from a traditional paternalistic model, in which patients played the role of passive recipient of care, towards a situation in which patients are partners involved in the decision making-process. This new context opened a considerable number of new ethical and legal aspects, which need to be comprehensively analyzed and discussed in order to preserve the quality of primary health care all around the world. This work reviews the most important ethical and legal issues in primary health care. Legislation issues are explained in the context of the Spanish Health Services.

Evaluation of EU legislation on blood: a bioethical point of view.

PubMed

Petrini, Carlo

2017-01-01

A review of the European Union (EU) regulations concerning blood, tissues, and cells of human origin is under way in the EU. From the ethical point of view, the non-remuneration of donations and the ban on deriving gain from human biological materials are of particular significance. While the basic ethical principles involved in the procurement, preservation, and use of these materials are the same, their practical application should be adapted to the specific context of each material. In the case of donation and use of blood, in particular, the issue of legitimate reimbursements to donors and for transfusion centers has to be managed in accordance with the principle of non-commercialization. There is also a need for strict rules to avoid possible commercial spillover effects from blood-derived products. The author proposes ethical criteria regarding reimbursements to donors, costs associated with processing, and the development (and possible marketing) of products.

Piercing the veil: ethical issues in ethnographic research.

PubMed

Schrag, Brian

2009-06-01

It is not unusual for researchers in ethnography (and sometimes Institutional Review Boards) to assume that research of "public" behavior is morally unproblematic. I examine an historical case of ethnographic research and the sustained moral outrage to the research expressed by the subjects of that research. I suggest that the moral outrage was legitimate and articulate some of the ethical issues underlying that outrage. I argue that morally problematic Ethnographic research of public behavior can derive from research practice that includes a tendency to collapse the distinction between harm and moral wrong, a failure to take account of recent work on ethical issues in privacy; failure to appreciate the deception involved in ethnographers' failure to reveal their role as researchers to subjects and finally a failure to appropriately weigh the moral significance of issues of invasion of privacy and inflicted insight in both the research process and subsequent publication of research.

Ethics education in research involving human beings in undergraduate medicine curriculum in Brazil.

PubMed

Novaes, Maria Rita Garbi; Guilhem, Dirce; Barragan, Elena; Mennin, Stewart

2013-12-01

The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1--ethics in research (26); 2--ethical procedures and advanced technology (46); 3--ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. © 2012 John Wiley & Sons Ltd.

The Technologies of Normalization and Self: Thinking about IRBs and Extrinsic Research Ethics with Foucault

ERIC Educational Resources Information Center

Koro-Ljungberg, Mirka; Gemignani, Marco; Brodeur, Cheri Winton; Kmiec, Cheryl

2007-01-01

In this article, the authors discuss the technologies of normalization and self in relation to ethics and the problematization of extrinsic research ethics. They argue that institutional review boards (IRBs) and other similar institutional mechanisms promote extrinsic forms of ethics that are exemplified through institutionalized structures such…

Work Values, Cognitive Strategies, and Applicant Reactions in a Structured Pre-Employment Interview for Ethical Integrity.

ERIC Educational Resources Information Center

Pawlowski, Donna R.; Hollwitz, John

2000-01-01

Notes that companies emphasize ethical behavior, and schools and professional groups devote many resources to applied ethics training. Describes initial construct validation of a structured ethical integrity pre-employment interview. Reviews evidence relating to cognitive and impression management strategies used when college students encounter an…

Ethical Issues in Paediatric Practice - Part I: General Principles

PubMed Central

Attard-Montalto, S

2001-01-01

Clinical problems with ethical implications pose an ever increasing dilemma in everyday medical practice, and this is particularly the case with ethical issues involving children and those unable to take their own decisions. In this editorial we shall review some of the general principles that guide medical ethical problems. PMID:22368603