The ethics of patenting human embryonic stem cells.

PubMed

Chapman, Audrey R

2009-09-01

Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison's intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns.

Forensic genetics and ethical, legal and social implications beyond the clinic

PubMed Central

Cho, Mildred K; Sankar, Pamela

2008-01-01

Data on human genetic variation help scientists to understand human origins, susceptibility to illness and genetic causes of disease. Destructive episodes in the history of genetic research make it crucial to consider the ethical and social implications of research in genomics, especially human genetic variation. The analysis of ethical, legal and social implications should be integrated into genetic research, with the participation of scientists who can anticipate and monitor the full range of possible applications of the research from the earliest stages. The design and implementation of research directs the ways in which its results can be used, and data and technology, rather than ethical considerations or social needs, drive the use of science in unintended ways. Here we examine forensic genetics and argue that all geneticists should anticipate the ethical and social issues associated with nonmedical applications of genetic variation research. PMID:15510102

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.

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/

The practice of nursing research: getting ready for 'ethics' and the matter of character.

PubMed

Sellman, Derek

2016-03-01

Few would argue with the idea that nursing research should be conducted ethically yet obtaining ethical approval is considered by many to have become unnecessarily burdensome. This brief article investigates the idea that there might be a relationship between the level of perceived burdensomeness of the research ethics application process on the one hand and the character of the nurse-researcher on the other. Given that nurses are required to be other-regarding, a nurse who undertakes research primarily for self-regarding reasons would seem to be acting in ways inconsistent with the aims of nursing as set out in nursing codes. It is suggested that the self-regarding nurse-researcher may find the ethics application process more burdensome than the other-regarding nurse-researcher who, it is further suggested, is engaged with nursing research as a practice in the technical sense in which that term has been developed by the philosopher Alasdair MacIntyre. © 2015 John Wiley & Sons Ltd.

Intrinsic ethics regarding integrated assessment models for climate management.

PubMed

Schienke, Erich W; Baum, Seth D; Tuana, Nancy; Davis, Kenneth J; Keller, Klaus

2011-09-01

In this essay we develop and argue for the adoption of a more comprehensive model of research ethics than is included within current conceptions of responsible conduct of research (RCR). We argue that our model, which we label the ethical dimensions of scientific research (EDSR), is a more comprehensive approach to encouraging ethically responsible scientific research compared to the currently typically adopted approach in RCR training. This essay focuses on developing a pedagogical approach that enables scientists to better understand and appreciate one important component of this model, what we call intrinsic ethics. Intrinsic ethical issues arise when values and ethical assumptions are embedded within scientific findings and analytical methods. Through a close examination of a case study and its application in teaching, namely, evaluation of climate change integrated assessment models, this paper develops a method and case for including intrinsic ethics within research ethics training to provide scientists with a comprehensive understanding and appreciation of the critical role of values and ethical choices in the production of research outcomes.

Proportional ethical review and the identification of ethical issues

PubMed Central

Hunter, D

2007-01-01

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. PMID:17400625

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 ethics of HIV research in developing nations.

PubMed

Resnik, David B

1998-10-01

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

Ethical evaluation of research proposals by ethics panels advising the European Commission.

PubMed

Kolar, Roman

2004-06-01

Ethical principles with regard to animal experimentation are referred to in European Union (EU) legislation and other official documents. Therefore, applications for funding of research under the EU's research programme may undergo an ethical review that is carried out by so-called ethics panels, consisting of experts chosen by the European Commission. The work of these panels differs substantially from that of other ethical committees, as they exist on the institutional, local, regional or national level. Their main purpose is not to decide whether a proposed research can be regarded legal, and therefore should be endorsed or licensed; instead, it is to help the Commission in prioritising its funding. The panels may examine other ethical aspects than those of animal experimentation or animal welfare alone, such as the use of human volunteers. This is reflected by the composition of the panels. Their decisions are normally based on consensus. Even though these decisions may refer to EU legislation, the criteria applied are not restricted to those provided by this legislation. Nevertheless, the various aspects of the Commission's ethical evaluation system (e.g. formal and practical basic conditions, information content of applications, type of decisions taken, lacking of any quality control) offers opportunities for improvement.

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

PubMed

Ezzat, Hanna; Ross, Sue; von Dadelszen, Peter; Morris, Tara; Liston, Robert; Magee, Laura A

2010-07-30

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. 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. 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. 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.

Application of a Sensemaking Approach to Ethics Training in the Physical Sciences and Engineering

NASA Astrophysics Data System (ADS)

Kligyte, Vykinta; Marcy, Richard T.; Waples, Ethan P.; Sevier, Sydney T.; Godfrey, Elaine S.; Mumford, Michael D.; Hougen, Dean F.

2008-06-01

Integrity is a critical determinant of the effectiveness of research organizations in terms of producing high quality research and educating the new generation of scientists. A number of responsible conduct of research (RCR) training programs have been developed to address this growing organizational concern. However, in spite of a significant body of research in ethics training, it is still unknown which approach has the highest potential to enhance researchers' integrity. One of the approaches showing some promise in improving researchers' integrity has focused on the development of ethical decision-making skills. The current effort proposes a novel curriculum that focuses on broad metacognitive reasoning strategies researchers use when making sense of day-to-day social and professional practices that have ethical implications for the physical sciences and engineering. This sensemaking training has been implemented in a professional sample of scientists conducting research in electrical engineering, atmospheric and computer sciences at a large multi-cultural, multi-disciplinary, and multi-university research center. A pre-post design was used to assess training effectiveness using scenario-based ethical decision-making measures. The training resulted in enhanced ethical decision-making of researchers in relation to four ethical conduct areas, namely data management, study conduct, professional practices, and business practices. In addition, sensemaking training led to researchers' preference for decisions involving the application of the broad metacognitive reasoning strategies. Individual trainee and training characteristics were used to explain the study findings. Broad implications of the findings for ethics training development, implementation, and evaluation in the sciences are discussed.

Application of a sensemaking approach to ethics training in the physical sciences and engineering.

PubMed

Kligyte, Vykinta; Marcy, Richard T; Waples, Ethan P; Sevier, Sydney T; Godfrey, Elaine S; Mumford, Michael D; Hougen, Dean F

2008-06-01

Integrity is a critical determinant of the effectiveness of research organizations in terms of producing high quality research and educating the new generation of scientists. A number of responsible conduct of research (RCR) training programs have been developed to address this growing organizational concern. However, in spite of a significant body of research in ethics training, it is still unknown which approach has the highest potential to enhance researchers' integrity. One of the approaches showing some promise in improving researchers' integrity has focused on the development of ethical decision-making skills. The current effort proposes a novel curriculum that focuses on broad metacognitive reasoning strategies researchers use when making sense of day-to-day social and professional practices that have ethical implications for the physical sciences and engineering. This sensemaking training has been implemented in a professional sample of scientists conducting research in electrical engineering, atmospheric and computer sciences at a large multi-cultural, multi-disciplinary, and multi-university research center. A pre-post design was used to assess training effectiveness using scenario-based ethical decision-making measures. The training resulted in enhanced ethical decision-making of researchers in relation to four ethical conduct areas, namely data management, study conduct, professional practices, and business practices. In addition, sensemaking training led to researchers' preference for decisions involving the application of the broad metacognitive reasoning strategies. Individual trainee and training characteristics were used to explain the study findings. Broad implications of the findings for ethics training development, implementation, and evaluation in the sciences are discussed.

The Ethics of Doing Ethics.

PubMed

Hansson, Sven Ove

2017-02-01

Ethicists have investigated ethical problems in other disciplines, but there has not been much discussion of the ethics of their own activities. Research in ethics has many ethical problems in common with other areas of research, and it also has problems of its own. The researcher's integrity is more precarious than in most other disciplines, and therefore even stronger procedural checks are needed to protect it. The promotion of some standpoints in ethical issues may be socially harmful, and even our decisions as to which issues we label as "ethical" may have unintended and potentially harmful social consequences. It can be argued that ethicists have an obligation to make positive contributions to society, but the practical implications of such an obligation are not easily identified. This article provides an overview of ethical issues that arise in research into ethics and in the application of such research. It ends with a list of ten practical proposals for how these issues should be dealt with.

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.

The Dawning of the Ethics of Environmental Robots.

PubMed

van Wynsberghe, Aimee; Donhauser, Justin

2017-10-23

Environmental scientists and engineers have been exploring research and monitoring applications of robotics, as well as exploring ways of integrating robotics into ecosystems to aid in responses to accelerating environmental, climatic, and biodiversity changes. These emerging applications of robots and other autonomous technologies present novel ethical and practical challenges. Yet, the critical applications of robots for environmental research, engineering, protection and remediation have received next to no attention in the ethics of robotics literature to date. This paper seeks to fill that void, and promote the study of environmental robotics. It provides key resources for further critical examination of the issues environmental robots present by explaining and differentiating the sorts of environmental robotics that exist to date and identifying unique conceptual, ethical, and practical issues they present.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

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

Confessions of an Ethics Committee Chair

ERIC Educational Resources Information Center

Halse, Christine

2011-01-01

This essay examines the possibilities of being/becoming an ethical researcher in the academy. It tackles this task through the lens of an ethics application by Mary [pseudonym], a PhD student in sociology whose research thesis was investigating the reasons why married men with children use prostitutes. Two analyses are offered of Mary's story. The…

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.

Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

PubMed Central

2011-01-01

Background Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards. Methods We examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs). Results We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites. Conclusion The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. PMID:21235768

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

Ethical principles of informed consent: exploring nurses' dual role of care provider and researcher.

PubMed

Judkins-Cohn, Tanya M; Kielwasser-Withrow, Kiersten; Owen, Melissa; Ward, Jessica

2014-01-01

This article describes the ethical principles of autonomy, beneficence, and justice within the nurse researcher-participant relationship as these principles relate to the informed consent process for research. Within this process, the nurse is confronted with a dual role. This article describes how nurses, who are in the dual role of care provider and researcher, can apply these ethical principles to their practice in conjunction with the American Nurses Association's code of ethics for nurses. This article also describes, as an element of ethical practice, the importance of using participant-centered quality measures to aid informed decision making of participants in research. In addition, the article provides strategies for improving the informed consent process in nursing research. Finally, case scenarios are discussed, along with the application of ethical principles within the awareness of the dual role of the nurse as care provider and researcher. Copyright 2014, SLACK Incorporated.

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.

The ethical framework for performing research with rare inherited neurometabolic disease patients.

PubMed

Giannuzzi, Viviana; Devlieger, Hugo; Margari, Lucia; Odlind, Viveca Lena; Ragab, Lamis; Bellettato, Cinzia Maria; D'Avanzo, Francesca; Lampe, Christina; Cassis, Linda; Cortès-Saladelafont, Elisenda; Cazorla, Ángels Garcia; Barić, Ivo; Cvitanović-Šojat, Ljerka; Fumić, Ksenija; Dali, Christine I; Bartoloni, Franco; Bonifazi, Fedele; Scarpa, Maurizio; Ceci, Adriana

2017-03-01

The need for performing clinical trials to develop well-studied and appropriate medicines for inherited neurometabolic disease patients faces ethical concerns mainly raising from four aspects: the diseases are rare; include young and very young patients; the neurological impairment may compromise the capability to provide 'consent'; and the genetic nature of the disease leads to further ethical implications. This work is intended to identify the ethical provisions applicable to clinical research involving these patients and to evaluate if these cover the ethical issues. Three searches have been performed on the European regulatory/legal framework, the literature and European Union-funded projects. The European legal framework offers a number of ethical provisions ruling the clinical research on paediatric, rare, inherited diseases with neurological symptoms. In the literature, relevant publications deal with informed consent, newborn genetic screenings, gene therapy and rights/interests of research participants. Additional information raised from European projects on sharing patients' data from different countries, the need to fill the gap of the regulatory framework and to improve information to stakeholders and patients/families. Several recommendations and guidelines on ethical aspects are applicable to the inherited neurometabolic disease research in Europe, even though they suffer from the lack of a common ethical approach. What is Known: • When planning and conducting clinical trials, sponsors and researchers know that clinical trials are to be performed according to well-established ethical rules, and patients should be aware about their rights. • In the cases of paediatric patients, vulnerable patients unable to provide consent, genetic diseases' further rules apply. What is New: • This work discusses which ethical rules apply to ensure protection of patient's rights if all the above-mentioned features coexist. • This work shows available data and information on how these rules have been applied.

Connections and Tensions between University and School Districts: Research Review Boards and School-Based Research

ERIC Educational Resources Information Center

Tilley, Susan A.; Killins, Janet; Van Oosten, Deborah

2005-01-01

Currently researchers connected to university contexts who conduct research involving human participants must receive approval from a research ethics board, and in the case of school-based research, from school district authorities. This article focuses on the ethics review of school-based research. Applications submitted to a research ethics…

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

Application of Ethical Principles to Research using Public Health Data in The Global South: Perspectives from Africa.

PubMed

Anane-Sarpong, Evelyn; Wangmo, Tenzin; Sankoh, Osman; Tanner, Marcel; Elger, Bernice Simone

2018-06-01

Existing ethics guidelines, influential literature and policies on ethical research generally focus on real-time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data (RUPD) raise new challenges to their application. Unlike traditional research, RUPD is population-based, aligned to public health activities, and often reliant on pre-collected longitudinal data. These characteristics, when considered in relation to the generally lower protective ethico-legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South. © 2016 John Wiley & Sons Ltd.

[A framework for evaluating ethical issues of public health initiatives: practical aspects and theoretical implications].

PubMed

Petrini, Carlo

2015-01-01

The "Framework for the Ethical Conduct of Public Health Initiatives", developed by Public Health Ontario, is a practical guide for assessing the ethical implications of evidence-generating public health initiatives, whether research or non-research activities, involving people, their biological materials or their personal information. The Framework is useful not only to those responsible for determining the ethical acceptability of an initiative, but also to investigators planning new public health initiatives. It is informed by a theoretical approach that draws on widely shared bioethical principles. Two considerations emerge from both the theoretical framework and its practical application: the line between practice and research is often blurred; public health ethics and biomedical research ethics are based on the same common heritage of values.

Psychiatric research: what ethical concerns do LRECs encounter? A postal survey. Local research ethics committees.

PubMed

Osborn, D P J; Fulford, K W M

2003-02-01

Psychiatric research can occasionally present particular ethical dilemmas, but it is not clear what kind of problems local research ethics committees (LRECs) actually experience in this field. We aimed to assess the type of problems that committees encounter with psychiatric research, using a postal survey of 211 LRECs. One hundred and seven (51%) of those written to replied within the time limit. Twenty eight (26%) experienced few problems with psychiatric applications. Twenty six (24%) emphasised the value of a psychiatric expert on the committee. The most common issues raised were informed consent (n=64, 60%) and confidentiality (n=17, 16%). The use of placebos (and washout periods) (n=18, 17%), the validity of psychiatric questionnaires (n=16, 15%) and overuse of psychiatric "jargon" (n=14, 13%) in psychiatric applications also raised concern. Our results suggest that LRECs have specific concerns regarding methodology, consent, and confidentiality in psychiatric research, and that they find psychiatric input invaluable.

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.

Virtue Ethics and Rural Professional Healthcare Roles

ERIC Educational Resources Information Center

Crowden, Andrew

2010-01-01

Because rural populations are at risk not only for clinically disparate care but also ethically disparate care, there is a need to enhance scholarship, research, and teaching about rural health care ethics. In this paper an argument for the applicability of a virtue ethics framework for professionals in rural healthcare is outlined. The argument…

Ethical aspects of aging research.

PubMed

Seppet, Enn; Pääsuke, Mati; Conte, Maria; Capri, Miriam; Franceschi, Claudio

2011-12-01

During the last 50-60 years, due to development of medical care and hygienically safe living conditions, the average life span of European citizens has substantially increased, with a rapid growth of the population older than 65 years. This trend places ever-growing medical and economical burden on society, as many of the older subjects suffer from age-related diseases and frailty. Coping with these problems requires not only appropriate medical treatment and social support but also extensive research in many fields of aging-from biology to sociology, with involvement of older people as the research subjects. This work anticipates development and application of ethical standards suited to dynamic advances in aging research. The aim of this review is to update the knowledge in ethical requirements toward recruitment of older research subjects, obtaining of informed consent, collection of biological samples, and use of stem cells in preclinical and clinical settings. It is concluded that application of adequate ethical platform markedly facilitates recruitment of older persons for participation in research. Currently, the basic ethical concepts are subjected to extensive discussion, with participation of all interested parties, in order to guarantee successful research on problems of human aging, protect older people from undesired interference, and afford their benefits through supporting innovations in research, therapy, and care.

From bench to bedside and to health policies (and back): ethics in translational research.

PubMed

Petrini, Carlo

2014-01-01

The medical aim of translational research is to smooth the transition of discoveries made through basic research from the laboratory bench to their diagnostic or therapeutic applications for patients. These applications may be extended to current clinical practice and to health policies. The converse is also important: health policies should provide a point of departure when identifying research priorities. Translational research poses the same ethical problems as trials with human subjects - albeit in different ways. One of the more significant problems is the risk for participants in trials: it is thus necessary to ensure that the risks to which these subjects are exposed are not out of proportion to the expected benefits. Translational research does not require new ethical principles, but existing biomedical principles need to be adjusted to the specific context. The well-being of participants should always be the primary objective; these persons should never be considered as means for the advancement of knowledge or for the improvement of applications.

Providing ethical guidance for collaborative research in developing countries

PubMed Central

Morris, Nina

2015-01-01

Experience has shown that the application of ethical guidelines developed for research in developed countries to research in developing countries can be, and often is, impractical and raises a number of contentious issues. Various attempts have been made to provide guidelines more appropriate to the developing world context; however, to date these efforts have been dominated by the fields of bioscience, medical research and nutrition. There is very little advice available for those seeking to undertake collaborative social science or natural science research in developing countries and what is there tends to be held within disparate sources. Charting the development of a set of ethics documentation for future use by the Ecosystem Services for Poverty Alleviation (ESPA) programme research community, this paper outlines past and present attitudes towards ethics procedures amongst this community and suggests ways in which ethics procedures might be made more relevant and user-friendly to researchers working in this area. PMID:26640509

The ethics of research using electronic mail discussion groups.

PubMed

Kralik, Debbie; Warren, Jim; Price, Kay; Koch, Tina; Pignone, Gino

2005-12-01

The aim of this paper is to identify and discuss the ethical considerations that have confronted and challenged the research team when researchers facilitate conversations using private electronic mail discussion lists. The use of electronic mail group conversations, as a collaborative data generation method, remains underdeveloped in nursing. Ethical challenges associated with this approach to data generation have only begun to be considered. As receipt of ethics approval for a study titled; 'Describing transition with people who live with chronic illness' we have been challenged by many ethical dilemmas, hence we believe it is timely to share the issues that have confronted the research team. These discussions are essential so we can understand the possibilities for research interaction, communication, and collaboration made possible by advanced information technologies. Our experiences in this study have increased our awareness for ongoing ethical discussions about privacy, confidentiality, consent, accountability and openness underpinning research with human participants when generating data using an electronic mail discussion group. We describe how we work at upholding these ethical principles focusing on informed consent, participant confidentiality and privacy, the participants as threats to themselves and one another, public-private confusion, employees with access, hackers and threats from the researchers. A variety of complex issues arise during cyberspace research that can make the application of traditional ethical standards troublesome. Communication in cyberspace alters the temporal, spatial and sensory components of human interaction, thereby challenging traditional ethical definitions and calling to question some basic assumptions about identity and ones right to keep aspects of it confidential. Nurse researchers are bound by human research ethics protocols; however, the nature of research by electronic mail generates moral issues as well as ethical concerns. Vigilance by researchers is required to ensure that data are viewed within the scope of the enabling ethics approval.

[Research ethics: the case with the tule (kuna), Urabbá, Colombia].

PubMed

Alcaraz, Gloria; Correa, Adriana

2006-03-01

An ethical analysis was performed during the development of a research project titled "Culture, nourishment and malaria in the Kuna aboriginals of Urabá, Colombia." This project had 2 objectives; (1) to investigate the prevalence of malaria and its relationship with hypovitaminosis A and nutritional status, and (2) to understand the community's conceptions and practices towards malaria. The current paper summarizes reflections concerning the application of ethical principles and moral values during the course of the malaria research project. Two intercultural relationships were clearly defined: the culture of the Tule (Kuna) Indians, with a traditional medical system, and the culture of the research group, focused on the biomedical model. The rationale and the discussion proposed during the writing of the project proposal was presented as well as the dilemmas that developed during the project within the communities. These problems required rapid decision-making in situations for which the scientists had not been adequately prepared. A need was indicated for application of ethical principles to permeate the analysis throughout the research process in a horizontal manner, such that the human dignity of the participants and the ethnicity of the community are preserved above the purposes of the project. In the research process, mediation between the ethics of conviction and the ethics of consequences must take precedence, with both outcomes tied to an informed consent in place during the process. The establishment of national and local research ethics committees was indicated as necessary to preserve the lifestyle and culture of the ethnic groups. These values were seen as endangered given the trading pressures and health policies in a globalized world.

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.

Oral History Research Ethics: Should Anonymity and Confidentially Issues Be Dealt with on Their Own Merit?

ERIC Educational Resources Information Center

Le Roux, C.

2015-01-01

A primary principle of ethical codes in research involving people is that of informed consent which ensures participants' right to privacy, confidentiality and anonymity. A blanket application of the principle of anonymity to Oral History (OH) research could well be counterproductive to the purported aims of OH research. The research comprised a…

Supporting International Applicants and Promoting an Ethical Model of Global College Admission

ERIC Educational Resources Information Center

Redding, Alexis Brooke

2013-01-01

This article examines the challenges facing the pool of global applicants to US colleges and evaluates the practices of the internationaI IECs who currently fill the void that exists between applicants and admission officers. The author, is a doctoral student at the Harvard Graduate School of Education, where she researches ethical issues in…

[Medical research-ethics applied to social sciences: relevance, limits, issues and necessary adjustments].

PubMed

Desclaux, A

2008-04-01

Social sciences are concretely concerned by the ethics of medical research when they deal with topics related to health, since they are subjected to clearance procedures specific to this field. This raises at least three questions: - Are principles and practices of medical research ethics and social science research compatible? - Are "research subjects" protected by medical research ethics when they participate in social science research projects? - What can social sciences provide to on-going debates and reflexion in this field? The analysis of the comments coming from ethics committees about social science research projects, and of the experience of implementation of these projects, shows that the application of international ethics standards by institutional review boards or ethics committees raises many problems in particular for researches in ethnology anthropology and sociology. These problems may produce an impoverishment of research, pervert its meaning, even hinder any research. They are not only related to different norms, but also to epistemological divergences. Moreover, in the case of studies in social sciences, the immediate and differed risks, the costs, as well as the benefits for subjects, are very different from those related to medical research. These considerations are presently a matter of debates in several countries such as Canada, Brasil, and USA. From another hand, ethics committees seem to have developed without resorting in any manner to the reflexion carried out within social sciences and more particularly in anthropology Still, the stakes of the ethical debates in anthropology show that many important and relevant issues have been discussed. Considering this debate would provide openings for the reflexion in ethics of health research. Ethnographic studies of medical research ethics principles and practices in various sociocultural contexts may also contribute to the advancement of medical ethics. A "mutual adjustment" between ethics of medical research and social sciences is presently necessary: it raises new questions open for debate.

Examination of ethical dilemmas experienced by adult intensive care unit nurses in physical restraint practices.

PubMed

Yönt, Gülendam Hakverdioğlu; Korhan, Esra Akin; Dizer, Berna; Gümüş, Fatma; Koyuncu, Rukiye

2014-01-01

Nurses are more likely to face the dilemma of whether to resort to physical restraints or not and have a hard time making that decision. This is a descriptive study. A total of 55 nurses participated in the research. For data collection, a question form developed by researchers to determine perceptions of ethical dilemmas by nurses in the application of physical restraint was used. A descriptive analysis was made by calculating the mean, standard deviation, and maximum and minimum values. The nurses expressed (36.4%) having difficulty in deciding to use physical restraint. Nurses reported that they experience ethical dilemmas mainly in relation to the ethic principles of nonmaleficence, beneficence, and convenience. We have concluded that majority of nurses working in critical care units apply physical restraint to patients, although they are facing ethical dilemmas concerning harm and benefit principles during the application.

The Epistemological Bias of Ethics Review: Constraining Mental Health Research

ERIC Educational Resources Information Center

Holland, Kate

2007-01-01

This article investigates the concerns of a university research ethics committee in rejecting an application to interview people diagnosed with a mental illness. The committee's concerns included the safety of participants and the author as the researcher, the author's lack of training and clinical expertise, her disclosure of a past diagnosis of…

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 decision making in the conduct of research: role of individual, contextual and organizational factors. Commentary on "Science, human nature, and a new paradigm for ethics education".

PubMed

Langlais, Philip J

2012-09-01

Despite the importance of scientific integrity to the well-being of society, recent findings suggest that training and mentoring in the responsible conduct of research are not very reliable or effective inhibitors of research misbehavior. Understanding how and why individual scientists decide to behave in ways that conform to or violate norms and standards of research is essential to the development of more effective training programs and the creation of more supportive environments. Scholars in business management, psychology, and other disciplines have identified many important factors that affect ethical behavior, including individual, contextual, and organizational factors. Surprisingly little research has been conducted to examine the role of these factors in either the development of ethical decision-making skills, or their applicability to ethical issues commonly encountered in research and other scholarly and professional activities. Interdisciplinary approaches combined with research and discipline relevant paradigms should greatly enhance understanding of the individual contextual and organizational factors involved in ethical and unethical research conduct. Such studies will inform and facilitate the development of more effective ethics education programs in the sciences and engineering professions.

Prevention, communication and equity in environmental epidemiology: ethical issues.

PubMed

Pagliarani, Giovanna; Botti, Caterina

2011-01-01

In environmental epidemiology research, decisions about when and how to intervene requires adequate ethical reflection. In fact, different kinds of issues may arise about: research methods and knowledge production; management of the results in terms of their overall assessments or for the implementation of preventive actions; reclamation intervention. In this contribution we propose to consider three topics we regard as crucial to this ethical debate: the reporting of conclusive research data; the correct application of the precautionary principle; and the environmental equity issues.

Hermeneutic application research - finding a common understanding and consensus on care and caring.

PubMed

Koskinen, Camilla; Nyström, Lisbet

2017-03-01

To clinically and contextually implement the theoretical and factual knowledge of care and caring that has been developed in the last 30 years is seen as a great challenge in caring science research. Emphasis has been put on problem-solving research methodologies and action research in hopes of narrowing the divide between caring theory and clinical practice. Thus, the intention is now to further action research towards a hermeneutic approach and to put emphasis on hermeneutic application where theory and praxis become one through human dialogue. This article highlights hermeneutic application research as an alternative methodology within participatory-oriented research which presents a new opportunity to unite clinical practice and caring theory. The aim is to contribute to the development of the hermeneutical application research design in its epistemological, ontological and ethical perspective, by articulating and clarifying the central foundations in the application. On the basis of Gadamer's hermeneutical thinking and Levinas ethical thinking, the central foundations in the application research are ethics, creation of a hermeneutical room, dialogue and common understanding and appropriation and action. When theoretical understanding turns into praxis, knowledge also becomes activity and theory and practice become one. Application thus realises the basic idea that praxis and theory are one, and thus, theory of caring can only become evident and implemented in a clinical practice through moments when the participants find a common understanding and consensus on the knowledge of care and caring. © 2015 Nordic College of Caring Science.

Ethical considerations in industry-sponsored multiregional clinical trials.

PubMed

Ibia, Ekopimo; Binkowitz, Bruce; Saillot, Jean-Louis; Talerico, Steven; Koerner, Chin; Ferreira, Irene; Agarwal, Anupam; Metz, Craig; Maman, Marianne

2010-01-01

During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 John Wiley & Sons, Ltd.

Improving our application of the health education code of ethics.

PubMed

Marks, Ray; Shive, Steven E

2006-01-01

The Health Education Code of Ethics was designed to provide a framework of shared values within which health education might be practiced. However, an informal survey conducted on a limited sample in November 2004 indicated that ethics and how to apply the code are topics not readily taught formally within all health education programs. There is, however, an expressed interest among health educators in understanding the code and its application. Because of the immense import of ethics, affecting responsible professional conduct at all levels, this article is designed to introduce the topic to health education practitioners who have had little formal exposure to ethics curricula, as well as to faculty who would like to teach this subject. The authors specifically review several resources that might be especially helpful in fostering a better understanding of this essential but often underestimated aspect of health education practice and research, namely, its ethical application.

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

Ethical principles in federal regulations: the case of children and research risks.

PubMed

Williams, P C

1996-04-01

Ethical principles play an important part not only in the promulgation of regulations but also in their application, i.e., enforcement and adjudication. while traditional ethical principles--promotion of welfare, freedom, and fairness--play an important role in both elements of regulation, some other kinds of ethical principles are significant as well. Principles governing the structure of decision processes should shape the structure and actions of agencies; principles of wise application should govern the work of those whose responsibility it is to apply regulatory language to particular situations. These points are demonstrated by investigating a case study: federal regulations designed to protect children involved in scientific research applied to a placebo study of the effects of recombinant human growth hormone on children of extremely short stature.

MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

PubMed

Gysels, Marjolein; Evans, Catherine J; Lewis, Penney; Speck, Peter; Benalia, Hamid; Preston, Nancy J; Grande, Gunn E; Short, Vicky; Owen-Jones, Eleanor; Todd, Chris J; Higginson, Irene J

2013-12-01

There is little guidance on the particular ethical concerns that research raises with a palliative care population. To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

Sustainability in care through an ethical practice model.

PubMed

Nyholm, Linda; Salmela, Susanne; Nyström, Lisbet; Koskinen, Camilla

2018-03-01

While sustainability is a key concept in many different domains today, it has not yet been sufficiently emphasized in the healthcare sector. Earlier research shows that ethical values and evidence-based care models create sustainability in care practice. The aim of this study was to gain further understanding of the ethical values central to the realization of sustainability in care and to create an ethical practice model whereby these basic values can be made perceptible and active in care practice. Part of the ongoing "Ethical Sustainable Caring Cultures" research project, a hermeneutical application research design was employed in this study. Dialogues were used, where scientific researchers and co-researchers were given the opportunity to reflect on ethical values in relation to sustainability in care. An ethical practice model with ethos as its core was created from the results of the dialogues. In the model, ethos is encircled by the ethical values central to sustainability: dignity, responsibility, respect, invitation, and vows. The model can be used as a starting point for ethical conversations that support carers' reflections on the ethical issues seen in day-to-day care work and the work community, allowing ethical values to become visible throughout the entire care culture. It is intended as a tool whereby carers can more deeply understand an organization's common basic values and what they entail in regard to sustainability in care.

Mobile-centric ambient intelligence in health- and homecare-anticipating ethical and legal challenges.

PubMed

Kosta, Eleni; Pitkänen, Olli; Niemelä, Marketta; Kaasinen, Eija

2010-06-01

Ambient Intelligence provides the potential for vast and varied applications, bringing with it both promise and peril. The development of Ambient Intelligence applications poses a number of ethical and legal concerns. Mobile devices are increasingly evolving into tools to orientate in and interact with the environment, thus introducing a user-centric approach to Ambient Intelligence. The MINAmI (Micro-Nano integrated platform for transverse Ambient Intelligence applications) FP6 research project aims at creating core technologies for mobile device based Ambient Intelligence services. In this paper we assess five scenarios that demonstrate forthcoming MINAmI-based applications focusing on healthcare, assistive technology, homecare, and everyday life in general. A legal and ethical analysis of the scenarios is conducted, which reveals various conflicting interests. The paper concludes with some thoughts on drafting ethical guidelines for Ambient Intelligence applications.

Re-focusing the ethical discourse on personalized medicine: a qualitative interview study with stakeholders in the German healthcare system.

PubMed

Schleidgen, Sebastian; Marckmann, Georg

2013-05-24

In recent years, personalized medicine (PM) has become a highly regarded line of development in medicine. Yet, it is still a relatively new field. As a consequence, the discussion of its future developments, in particular of its ethical implications, in most cases can only be anticipative. Such anticipative discussions, however, pose several challenges. Nevertheless, they play a crucial role for shaping PM's further developments. Therefore, it is vital to understand how the ethical discourse on PM is conducted, i.e. on what - empirical and normative - assumptions ethical arguments are based regarding PM's current and future developments. To gather this information, we conducted a qualitative interview study with stakeholders in the German health care system. Our purposive sample included 17 representatives of basic research, clinical research, health economics, regulatory authorities, reimbursement institutions, pharmaceutical industry, patient organizations, as well as clinicians and legal experts involved in PM developments or policy making. We used an interview guide with open-ended questions and analyzed transcriptions of the interviews by means of qualitative content analysis. The respondents addressed a multitude of concerns in the context of research on as well as application of personalized preventive and therapeutic measures both on the individual and on the societal level. Interestingly, regarding future developments of PM the ethical evaluation seemed to follow the rule: the less likely its application, the more problematic a PM measure is assessed. The more likely its application, on the other hand, the less problematic it is evaluated. The results of our study suggest re-focusing the ethical discourse on PM in Germany towards a constructive ethical monitoring which ensures to include only, nevertheless all of the actual and/or potential concerns that are ethically relevant in order to allow balancing them against the actual and potential ethically relevant benefits of PM measures. To render this possible, we propose a strategy for evaluating ethical concerns in the context of PM.

A Situated Practice of Ethics for Participatory Visual and Digital Methods in Public Health Research and Practice: A Focus on Digital Storytelling

PubMed Central

Hill, Amy L.; Flicker, Sarah

2014-01-01

This article explores ethical considerations related to participatory visual and digital methods for public health research and practice, through the lens of an approach known as “digital storytelling.” We begin by briefly describing the digital storytelling process and its applications to public health research and practice. Next, we explore 6 common challenges: fuzzy boundaries, recruitment and consent to participate, power of shaping, representation and harm, confidentiality, and release of materials. We discuss their complexities and offer some considerations for ethical practice. We hope this article serves as a catalyst for expanded dialogue about the need for high standards of integrity and a situated practice of ethics wherein researchers and practitioners reflexively consider ethical decision-making as part of the ongoing work of public health. PMID:23948015

A situated practice of ethics for participatory visual and digital methods in public health research and practice: a focus on digital storytelling.

PubMed

Gubrium, Aline C; Hill, Amy L; Flicker, Sarah

2014-09-01

This article explores ethical considerations related to participatory visual and digital methods for public health research and practice, through the lens of an approach known as "digital storytelling." We begin by briefly describing the digital storytelling process and its applications to public health research and practice. Next, we explore 6 common challenges: fuzzy boundaries, recruitment and consent to participate, power of shaping, representation and harm, confidentiality, and release of materials. We discuss their complexities and offer some considerations for ethical practice. We hope this article serves as a catalyst for expanded dialogue about the need for high standards of integrity and a situated practice of ethics wherein researchers and practitioners reflexively consider ethical decision-making as part of the ongoing work of public health.

The fiduciary obligation of the physician-researcher in phase IV trials

PubMed Central

2014-01-01

Background In this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants. Discussion We first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials. Conclusion The fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. PMID:24507449

42 CFR 52h.5 - Conflict of interest.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH AND DEVELOPMENT CONTRACT PROJECTS § 52h.5 Conflict of interest. (a... Government Ethics Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635), and...

Ethical Issues in Computer-Assisted Language Learning: Perceptions of Teachers and Learners

ERIC Educational Resources Information Center

Wang, Shudong; Heffernan, Neil

2010-01-01

Pedagogical theories and the applications of information technology for language learning have been widely researched in various dimensions. However, ethical issues, such as online privacy and security, and learners' personal data disclosure, are not receiving enough research attention. The perceptions and attitudes from those who participate in…

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

From global bioethics to ethical governance of biomedical research collaborations.

PubMed

Wahlberg, Ayo; Rehmann-Sutter, Christoph; Sleeboom-Faulkner, Margaret; Lu, Guangxiu; Döring, Ole; Cong, Yali; Laska-Formejster, Alicja; He, Jing; Chen, Haidan; Gottweis, Herbert; Rose, Nikolas

2013-12-01

One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved. Copyright © 2013 Elsevier Ltd. All rights reserved.

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.

Beyond human subjects: risk, ethics, and clinical development of nanomedicines.

PubMed

Kimmelman, Jonathan

2012-01-01

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena. © 2012 American Society of Law, Medicine & Ethics, Inc.

An evaluation of a data linkage training workshop for research ethics committees.

PubMed

Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A

2015-03-04

In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

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.

Implementing and Evaluating a Chemistry Course in Chemical Ethics and Civic Responsibility

ERIC Educational Resources Information Center

McClure, Craig P.; Lucius, Aaron L.

2010-01-01

An upper-level undergraduate course that explores ethics in chemistry and the impact of chemical innovations on society has been developed. Goals of this course were to promote student recognition of ethical considerations in chemical innovations and chemical research and demonstrate the link between the application of chemical innovations and the…

[How to Understand "Clinical Ethics" and "Research Ethics" in Clinical Settings--Incorporation of IRB, REC, and CEC in Hospital Organizations].

PubMed

Ita, Koichiro

2016-02-01

As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both research and clinical ethics. Quite frequently, ethical problems in clinical settings cannot be addressed by the simple application of good will, hard work, and perseverance by medical personnel. The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have jointly published "Ethical Guidelines for Clinical Studies;" however, clear guidelines (legal, ministerial, or governmental) outlining the expectations regarding clinical ethics do not exist. All medical personnel face deep ethical dilemmas. In these instances, if the fulfillment of 'ethics' relies solely on the capacity of personnel to apply their own individual moral efforts, the result will be burn-out among these workers who have a strong sense of responsibility. In order to avoid this, a system which comprises multiple physicians, nurses, and other personnel must be established, allowing collaboration when an appropriate response is required. A major factor supporting this approach is the offering of Clinical Ethics Consultations.

Research ethics for a globalised world: the revised CIOMS international guidelines.

PubMed

Ehni, Hans-Jöerg; Wiesing, Urban

2017-01-01

On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way. The guidelines combine key principles with a guide to their application based on the state of the art in research ethics. Thus they represent a timely and indispensable orientation for researchers, ethics committees, and other stakeholders in health-related research.

Medical ethics research between theory and practice.

PubMed

ten Have, H A; Lelie, A

1998-06-01

The main object of criticism of present-day medical ethics is the standard view of the relationship between theory and practice. Medical ethics is more than the application of moral theories and principles, and health care is more than the domain of application of moral theories. Moral theories and principles are necessarily abstract, and therefore fail to take account of the sometimes idiosyncratic reality of clinical work and the actual experiences of practitioners. Suggestions to remedy the illness of contemporary medical ethics focus on re-establishing the connection between the internal and external morality of medicine. This article discusses the question how to develop a theoretical perspective on medical ethical issues that connects philosophical reflection with the everyday realities of medical practice. Four steps in a comprehensive approach of medical ethics research are distinguished: (1) examine health care contexts in order to obtain a better understanding of the internal morality of these practices; this requires empirical research; (2) analyze and interpret the external morality governing health care practices; sociological study of prevalent values, norms, and attitudes concerning medical-ethical issues is required; (3) creation of new theoretical perspectives on health care practices; Jensen's theory of healthcare practices will be useful here; (4) develop a new conception of bioethics that illuminates and clarifies the complex interaction between the internal and external morality of health care practices. Hermeneutical ethics can be helpful for integrating the experiences disclosed in the empirical ethical studies, as well as utilizing the insights gained from describing the value-contexts of health care practices. For a critical and normative perspective, hermeneutical ethics has to examine and explain the moral experiences uncovered, in order to understand what they tell us.

[Update of the work of the ethics research in evaluating genetic research and its role as an external ethics committee biobank].

PubMed

Alfonso Farnós, Iciar; Hernández Gil, Arantza; Rodríguez Velasco, María

2013-01-01

Research on human genome and its applications open great perspectives to improve human beings' health. However, these advances must never endanger the respect of dignity, freedom and rights of the participants in medical research, assuring prohibition of any way of discrimination because of genetic features. The Independent Research Boards (IRB), responsible for safeguarding rights, safety and well-being of the subjects taking part in the biomedical research, assess independently submitted genetic studies, clinical trials whose primary objective is obtaining genetic information and genetic sub-studies of clinical trials with drugs. Biobanks, as safeguarding means to preserve biological samples in suitable quality conditions, must be assigned to two external committees, a scientific one and an ethics one. External ethics committees of biobanks have to make the ethical assessment of the submissions of samples transfers and associated data, in order to carry out research projects. On the other hand, they have to advise biobanks on the compliance of ethical and legal principles, which, in many committees, has turned into the performance of informed consent forms which are in accordance with current laws.

On using ethical principles of community-engaged research in translational science.

PubMed

Khodyakov, Dmitry; Mikesell, Lisa; Schraiber, Ron; Booth, Marika; Bromley, Elizabeth

2016-05-01

The transfer of new discoveries into both clinical practice and the wider community calls for reliance on interdisciplinary translational teams that include researchers with different areas of expertise, representatives of health care systems and community organizations, and patients. Engaging new stakeholders in research, however, calls for a reconsideration or expansion of the meaning of ethics in translational research. We explored expert opinion on the applicability of ethical principles commonly practiced in community-engaged research (CEnR) to translational research. To do so, we conducted 2 online, modified-Delphi panels with 63 expert stakeholders who iteratively rated and discussed 9 ethical principles commonly used in CEnR in terms of their importance and feasibility for use in translational research. The RAND/UCLA appropriateness method was used to analyze the data and determine agreement and disagreement among participating experts. Both panels agreed that ethical translational research should be "grounded in trust." Although the academic panel endorsed "culturally appropriate" and "forthcoming with community about study risks and benefits," the mixed academic-community panel endorsed "scientifically valid" and "ready to involve community in interpretation and dissemination" as important and feasible principles of ethical translational research. These findings suggest that in addition to protecting human subjects, contemporary translational science models need to account for the interests of, and owe ethical obligations to, members of the investigative team and the community at large. Copyright © 2016 Elsevier Inc. All rights reserved.

On Using Ethical Principles of Community-Engaged Research in Translational Science

PubMed Central

Mikesell, Lisa; Schraiber, Ron; Booth, Marika; Bromley, Elizabeth

2015-01-01

The transfer of new discoveries into both clinical practice and the wider community calls for reliance on interdisciplinary translational teams that include researchers with different areas of expertise, representatives of healthcare systems and community organizations, and patients. Engaging new stakeholders in research, however, calls for a re-consideration or expansion of the meaning of ethics in translational research. We explored expert opinion on the applicability of ethical principles commonly practiced in community-engaged research (CEnR) to translational research. To do so, we conducted two online, modified-Delphi panels with 63 expert stakeholders who iteratively rated and discussed nine ethical principles commonly used in CEnR in terms of their importance and feasibility for use in translational research. The RAND/UCLA Appropriateness Method was used to analyze the data and determine agreement and disagreement among participating experts. Both panels agreed that ethical translational research should be “grounded in trust.” While the academic panel endorsed “culturally appropriate” and “forthcoming with community about study risks and benefits,” the mixed academic-community panel endorsed “scientifically valid” and “ready to involve community in interpretation and dissemination” as important and feasible principles of ethical translational research. These findings suggest that in addition to protecting human subjects, contemporary translational science models need to account for the interests of, and owe ethical obligations to, members of the investigative team and the community at large. PMID:26773561

From bench to bedside and to health policies: ethics in translational research.

PubMed

Petrini, C

2011-01-01

Translation of biomedical research knowledge to effective clinical treatment is essential to the public good. The first level of translation ("from bench to bedside") corresponds to efficacy studies under controlled conditions with careful attention to internal validity (clinical research). The second level is the translation of results from clinical studies into everyday clinical practice and health decision making. The article summarises the ethical issues involved in the translation of biomedical research advances to clinical applications and to clinical practice. In particular, the article synthesizes theory from clinical ethics, operational design, and philosophy to examine the unique bioethical issues raised by the recent focus on translational research. In this framework safety of study participants and balancing of risk due to treatment with the potential benefits of the research are crucial: in clinical research there is a danger that the emphasis on advancements in scientific knowledge might prevail over the protection of the people who participate in research. These issues involve basic scientists, clinicians and bioethicists because of their application to comparative effectiveness research, clinical trials and evidence-based medicine, as well basic biomedical research.

The Just War Theory and the ethical governance of research.

PubMed

Malsch, Ineke

2013-06-01

This article analyses current trends in and future expectations of nanotechnology and other key enabling technologies for security as well as dual use nanotechnology from the perspective of the ethical Just War Theory (JWT), interpreted as an instrument to increase the threshold for using armed force for solving conflicts. The aim is to investigate the relevance of the JWT to the ethical governance of research. The analysis gives rise to the following results. From the perspective of the JWT, military research should be evaluated with different criteria than research for civil or civil security applications. From a technological perspective, the boundaries between technologies for civil and military applications are fuzzy. Therefore the JWT offers theoretical grounds for making clear distinctions between research for military, civil security and other applications that are not obvious from a purely technological perspective. Different actors bear responsibility for development of the technology than for resorting to armed force for solving conflicts or for use of weapons and military technologies in combat. Different criteria should be used for moral judgment of decisions made by each type of actor in each context. In addition to evaluation of potential consequences of future use of the weapons or military technologies under development, the JWT also prescribes ethical evaluation of the inherent intent and other foreseeable consequences of the development itself of new military technologies.

Accessible Genetics Research Ethics Education (AGREE): A Web-Based Program for IRBs and Investigators

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

Sugarman, Jeremy; Lee, Linda

The primary objective of this project was to design and evaluate a series of web-based educational modules on genetics research ethics for members of Institutional Review Boards and investigators to facilitate the development and oversight of important research that is sensitive to the relevant ethical, legal and social issues. After a needs assessment was completed in March of 2003, five online educational modules on the ethics of research in genetics were developed, tested, and made available through a host website for AGREE: http://agree.mc.duke.edu/index.html. The 5 modules are: (1) Ethics and Genetics Research in Populations; (2) Ethics in Behavioral Genetics Research;more » (3) Ethical Issues in Research on Gene-Environment Interactions; (4) Ethical Issues in Reproductive Genetics Research; and (5) Ethical Issues in Diagnostic and Therapeutic Research. The development process adopted a tested approach used at Duke University School of Medicine in providing education for researchers and IRB members, supplementing it with expert input and a rigorous evaluation. The host website also included a description of the AGREE; short bios on the AGREE Investigators and Expert Advisory Panel; streaming media of selected presentations from a conference, Working at the Frontiers of Law and Science: Applications of the Human Genome held October 2-3, 2003, at the University of North Carolina at Chapel Hill; and links to online resources in genomics, research ethics, ethics in genomics research, and related organizations. The web site was active beginning with the posting of the first module and was maintained throughout the project period. We have also secured agreement to keep the site active an additional year beyond the project period. AGREE met its primary objective of creating web-based educational modules related to the ethical issues in genetics research. The modules have been disseminated widely. While it is clearly easier to judge the quality of the educational experience than to evaluate the impact of an educational program on research, the AGREE modules have been met with very positive feedback on the part of users.« less

Creating a Controlled Vocabulary for the Ethics of Human Research: Towards a Biomedical Ethics Ontology

PubMed Central

Koepsell, David; Arp, Robert; Fostel, Jennifer; Smith, Barry

2009-01-01

Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology (BMEO) would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, creating a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. PMID:19374479

German Ethics Council on genetic diagnostics: trend setting?

PubMed

Buechner, Bianca

2014-06-01

On 30 April 2013, the German Ethics Council ('Council') published its opinion on 'The future of genetic diagnostics--from research to clinical application' ('the Opinion'). The Council was asked by the German government to discuss the future of genetic diagnostic methods in relation to the current applicable laws and regulations as well as the ethical stand points. The Council's 23 recommendations show that the existing regulations in Germany, and indirectly on a European level, lack in protecting consumers sufficiently. Consumer protection built the major focus of the Council's opinion. However, the opinion misses a critical overall analysis of genetic testing and, for example, the potential misuse of genetic test results by insures or the risk of disclosure toward employers. The Council missed an opportunity to discuss which barriers are necessary from a legal and ethical perspective but which still do not prohibit genetic testing and research.

Outcome of a research ethics training workshop among clinicians and scientists in a Nigerian university.

PubMed

Ajuwon, Ademola J; Kass, Nancy

2008-01-24

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants. Three in-depth interviews and one focus group discussion were conducted to assess the training needs of participants. A research ethics training workshop was then conducted with College of Medicine faculty. A 23-item questionnaire that assessed knowledge of research ethics, application of principles of ethics, operations of the Institutional Review Board (IRB) and ethics reasoning was developed to be a pre-post test evaluation of the training workshop. Ninety-seven workshop participants completed the questionnaire before and after the workshop; 59 of them completed a second post-test questionnaire one month after the workshop. The trainees came from a multi-disciplinary background including medicine, nursing, pharmacy, social science and laboratory science. The mean scores for knowledge of the principles of research ethics rose from 0.67 out of 3 points at pre-test to 2.25 at post-test (p < 0.05). Also, 42% correctly mentioned one international guideline or regulation at pretest, with most of those knowing of the Declaration of Helsinki. Trainees' knowledge of the operations of an IRB increased from 6.05 at pre-test to 6.29 at post test out of 7 points. Overall, participants retained much of the knowledge acquired from the workshop one month after its completion. The training improved participants' knowledge of principles of research ethics, international guidelines and regulations and operations of IRBs. It thus provided an opportunity for research ethics capacity development among academic staff in a developing country institution.

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.

The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines.

PubMed

Bracken-Roche, Dearbhail; Bell, Emily; Macdonald, Mary Ellen; Racine, Eric

2017-02-07

The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines. We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability. Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis. Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

Research governance: new hope for ethics committees?

PubMed

Frew, Deborah; Martlew, Ainsley

2007-01-01

For many years there has been discussion regarding the problems confronting our current ethics review system. Commentators have identified numerous issues that threaten the sustainability of Australia's voluntary HREC system. Various ad hoc solutions to these problems have been posed, but have not resulted in any significant advances. However, in recent years, discourse regarding research governance has become prominent in the Australian research environment. The application of research governance principles is gaining momentum amongst the regulators of research, including research institutions and their governing bureaucracies. We argue that this is potentially the most significant development in several years towards creating a sustainable HREC system in Australia. The recognition by research institutions and their governing bureaucracies that the responsibility for overall research governance lies with them, rather than solely with their HRECs, is leading to a range of initiatives which should significantly lessen the burden on Australian ethics committees, and improve their ability to undertake their core task of reviewing the ethical aspects of research proposals.

Blending genetics and sociocultural historical inquiry: ethics, culture, and human subjects protection in international cross cultural research.

PubMed

Sampson, Deborah A; Caldwell, Dennis; Taylor, Andre D; Taylor, Jacquelyn Y

2013-03-01

In this paper, we examine the implementation and difficulties when conducting genetics research in a rural, traditional West African culture within the frame of the United States' grounded research ethics. Research challenges are highlighted by Western researchers following U.S. Institutional Review Board (IRB) guidelines and practices in a non-Western country. IRB concepts are culture bound in Western ideals that may not have synchronicity and compatibility with non-Western cultures. Differences in sociocultural norms, traditions, language, and geography were influencing factors that can affect application of IRB principles. Suggestions for change are offered, which will potentially aid researchers considering application of IRB requirements when conducting research in non-Westernized, non-industrialized countries.

Blending Genetics and Sociocultural Historical Inquiry: Ethics, Culture, and Human Subjects Protection in International Cross Cultural Research

PubMed Central

Sampson, Deborah A.; Caldwell, Dennis; Taylor, Andre D.; Taylor, Jacquelyn Y.

2013-01-01

In this paper, we examine the implementation and difficulties when conducting genetics research in a rural, traditional West African culture within the frame of the United States’ grounded research ethics. Research challenges are highlighted by Western researchers following U.S. Institutional Review Board (IRB) guidelines and practices in a non-Western country. IRB concepts are culture bound in Western ideals that may not have synchronicity and compatibility with non-Western cultures. Differences in sociocultural norms, traditions, language, and geography were influencing factors that can affect application of IRB principles. Suggestions for change are offered, which will potentially aid researchers considering application of IRB requirements when conducting research in non-Westernized, non-industrialized countries. PMID:23482512

Sport Education as a Pedagogical Application for Ethical Development in Physical Education and Youth Sport

ERIC Educational Resources Information Center

Harvey, Stephen; Kirk, David; O'Donovan, Toni M.

2014-01-01

The purpose of this paper is to consider four pedagogical applications within the Sport Education model to examine the ways in which a young person can become a literate sports person and develop ethical behaviour through engagement in physical education and youth sport. Through a systematic review of the Sport Education research literature we…

Integrating anticipated nutrigenomics bioscience applications with ethical aspects.

PubMed

Lévesque, Lise; Ozdemir, Vural; Gremmen, Bart; Godard, Béatrice

2008-03-01

Nutrigenomics is a subspecialty of nutrition science which aims to understand how gene-diet interactions influence individuals' response to food, disease susceptibility, and population health. Yet ethical enquiry into this field is being outpaced by nutrigenomics bioscience. The ethical issues surrounding nutrigenomics face the challenges of a rapidly evolving field which bring forward the additional dimension of crossdisciplinary integrative research between social and biomedical sciences. This article outlines the emerging nutrigenomics definitions and concepts and analyzes the existing ethics literature concerning personalized nutrition and presents "points to consider" over ethical issues regarding future nutrigenomics applications. The interest in nutrigenomics coincides with a shift in emphasis in medicine and biosciences toward prevention of future disease susceptibilities rather than treatment of already established disease. Hence, unique ethical issues emerge concerning the extent to which nutrigenomics can alter our relation to food, boundaries between health and disease, and the folklore of medical practice. Nutrigenomics can result in new social values, norms, and responsibilities for both individuals and societies. Nutrigenomics is not only another new application of "-omics" technologies in the context of gene-diet interactions. Nutrigenomics may fundamentally change the way we perceive human illness while shifting the focus and broadening the scope of health interventions from patients to healthy individuals. In resource- and time-limited healthcare settings, this creates unique ethical dilemmas and distributive justice issues. Ethical aspects of nutrigenomics applications should be addressed proactively, as this new science develops and increasingly coalesces with other applications of genomics in medicine and public health.

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.

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

Nanomedicine: Techniques, Potentials, and Ethical Implications

PubMed Central

Ebbesen, Mette; Jensen, Thomas G.

2006-01-01

Nanotechnology is concerned with materials and systems whose structures and components exhibit novel physical, chemical, and biological properties due to their nanoscale size. This paper focuses on what is known as nanomedicine, referring to the application of nanotechnology to medicine. We consider the use and potentials of emerging nanoscience techniques in medicine such as nanosurgery, tissue engineering, and targeted drug delivery, and we discuss the ethical questions that these techniques raise. The ethical considerations involved in nanomedicine are related to risk assessment in general, somatic-cell versus germline-cell therapy, the enhancement of human capabilities, research into human embryonic stem cells and the toxicity, uncontrolled function and self-assembly of nanoparticles. The ethical considerations associated with the application of nanotechnology to medicine have not been greatly discussed. This paper aims to balance clear ethical discussion and sound science and so provide nanotechnologists and biotechnologists with tools to assess ethical problems in nanomedicine. PMID:17489016

[Public health, genetics and ethics].

PubMed

Kottow, Miguel H

2002-10-01

Genetics research has shown enormous developments in recent decades, although as yet with only limited clinical application. Bioethical analysis has been unable to deal with the vast problems of genetics because emphasis has been put on the principlism applied to both clinical and research bioethics. Genetics nevertheless poses its most complex moral dilemmas at the public level, where a social brand of ethics ought to supersede the essentially interpersonal perspective of principlism. A more social understanding of ethics in genetics is required to unravel issues such as research and clinical explorations, ownership and patents, genetic manipulation, and allocation of resources. All these issues require reflection based on the requirements of citizenry, consideration of common assets, and definition of public policies in regulating genetic endeavors and protecting the society as a whole Bioethics has privileged the approach to individual ethical issues derived from genetic intervention, thereby neglecting the more salient aspects of genetics and social ethics.

Ethics in Evaluating a Sociotechnical Intervention With Socially Isolated Older Adults.

PubMed

Waycott, Jenny; Morgans, Amee; Pedell, Sonja; Ozanne, Elizabeth; Vetere, Frank; Kulik, Lars; Davis, Hilary

2015-11-01

The purpose of this article is to consider how ethical principles can inform the effective design and implementation of technology-based interventions that aim to promote the well-being of socially isolated older adults. We evaluated a new iPad application with small groups of older adults. In this article, we reflect on the ethical issues encountered at each stage of the research process. Drawing on the ethical principles of beneficence, research merit and integrity, justice, and respect, we identify key issues to consider in the future design and implementation of social isolation interventions that use new technologies. Key issues include (a) providing sufficient support to facilitate ongoing social interactions, (b) managing older adults' expectations, (c) providing encouragement without coercion, and (d) responding to individual needs. We conclude that it is important to report on ethical challenges incurred when evaluating social isolation interventions to inform future research in this important area. © The Author(s) 2015.

Realising the technological promise of smartphones in addiction research and treatment: An ethical review.

PubMed

Capon, Hannah; Hall, Wayne; Fry, Craig; Carter, Adrian

2016-10-01

Smartphone technologies and mHealth applications (or apps) promise unprecedented scope for data collection, treatment intervention, and relapse prevention when used in the field of substance abuse and addiction. This potential also raises new ethical challenges that researchers, clinicians, and software developers must address. This paper aims to identify ethical issues in the current uses of smartphones in addiction research and treatment. A search of three databases (PubMed, Web of Science and PsycInfo) identified 33 studies involving smartphones or mHealth applications for use in the research and treatment of substance abuse and addiction. A content analysis was conducted to identify how smartphones are being used in these fields and to highlight the ethical issues raised by these studies. Smartphones are being used to collect large amounts of sensitive information, including personal information, geo-location, physiological activity, self-reports of mood and cravings, and the consumption of illicit drugs, alcohol and nicotine. Given that detailed information is being collected about potentially illegal behaviour, we identified the following ethical considerations: protecting user privacy, maximising equity in access, ensuring informed consent, providing participants with adequate clinical resources, communicating clinically relevant results to individuals, and the urgent need to demonstrate evidence of safety and efficacy of the technologies. mHealth technology offers the possibility to collect large amounts of valuable personal information that may enhance research and treatment of substance abuse and addiction. To realise this potential researchers, clinicians and app-developers must address these ethical concerns to maximise the benefits and minimise risks of harm to users. Copyright © 2016 Elsevier B.V. All rights reserved.

Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach.

PubMed

Dumez, Birgit; Van Damme, Karel; Casteleyn, Ludwine

2008-06-05

Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework.These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP).

Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach

PubMed Central

Dumez, Birgit; Van Damme, Karel; Casteleyn, Ludwine

2008-01-01

Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed. This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework. These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP). PMID:18541073

Ethical issues when using social media for health outside professional relationships.

PubMed

DeCamp, Matthew

2015-04-01

Social media have the potential to revolutionize health and healthcare, but fulfilling this potential requires attention to the ethical issues social media may raise. This article reviews the major ethical issues arising when social media are used for research, public health, mobile health applications, and global health. It focuses on social media use outside fiduciary relationships between healthcare professionals and patients. Emphasis is given to the potential of social media in these contexts, the ethical issues relatively unique to each, and where possible how existing ethical principles and frameworks could help navigate these issues. In some cases social media create the circumstance for particular ethical issues but also facilitate managing them, such as in informed consent for research. In other cases, disagreement exists about whether social media - despite their potential - should be used for certain purposes, such as in public health surveillance (where confidentiality represents a significant ethical concern). In still others, ethical uncertainty exists about how social media will affect ethical issues, such as inequality in global health. As social media technologies continue to develop, identifying and managing the ethical issues they raise will be critical to their success in improving health while preserving fundamental ethical values.

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.

The Asilomar Survey: Stakeholders' Opinions on Ethical Issues Related to Brain-Computer Interfacing.

PubMed

Nijboer, Femke; Clausen, Jens; Allison, Brendan Z; Haselager, Pim

2013-01-01

Brain-Computer Interface (BCI) research and (future) applications raise important ethical issues that need to be addressed to promote societal acceptance and adequate policies. Here we report on a survey we conducted among 145 BCI researchers at the 4 th International BCI conference, which took place in May-June 2010 in Asilomar, California. We assessed respondents' opinions about a number of topics. First, we investigated preferences for terminology and definitions relating to BCIs. Second, we assessed respondents' expectations on the marketability of different BCI applications (BCIs for healthy people, BCIs for assistive technology, BCIs-controlled neuroprostheses and BCIs as therapy tools). Third, we investigated opinions about ethical issues related to BCI research for the development of assistive technology: informed consent process with locked-in patients, risk-benefit analyses, team responsibility, consequences of BCI on patients' and families' lives, liability and personal identity and interaction with the media. Finally, we asked respondents which issues are urgent in BCI research.

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.

Ethics and Epistemology in Big Data Research.

PubMed

Lipworth, Wendy; Mason, Paul H; Kerridge, Ian; Ioannidis, John P A

2017-12-01

Biomedical innovation and translation are increasingly emphasizing research using "big data." The hope is that big data methods will both speed up research and make its results more applicable to "real-world" patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications and raise questions about the very possibility of big data research achieving its goals.

Ethical Applications of Technology in HRD

ERIC Educational Resources Information Center

Lin, Hong

2006-01-01

Human resource development (HRD) professionals are increasingly incorporating technology into their work activities. However, research that examines the ethics in the use of technology by HRD professionals is still underrepresented in the literature. This article first conducts a PEST (political, economic, social-cultural, and technological)…

Does clinical equipoise apply to cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research. PMID:21569349

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.

Outer Limits of Biotechnologies: A Jewish Perspective

PubMed Central

Loike, John D.; Kadish, Alan

2018-01-01

A great deal of biomedical research focuses on new biotechnologies such as gene editing, stem cell biology, and reproductive medicine, which have created a scientific revolution. While the potential medical benefits of this research may be far-reaching, ethical issues related to non-medical applications of these technologies are demanding. We analyze, from a Jewish legal perspective, some of the ethical conundrums that society faces in pushing the outer limits in researching these new biotechnologies. PMID:29406847

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).

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.

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.

Educational Neuroethics: A Contribution from Empirical Research

ERIC Educational Resources Information Center

Zocchi, Meghan; Pollack, Courtney

2013-01-01

In recent years, educational neuroscience has begun to move into the limelight, suggesting an increased importance on the ethical considerations of educational neuroscience work, or "educational neuroethics." In a departure from previous work on educational neuroethics, this article focuses on the ethical considerations that are applicable to…

Evaluating institutional capacity for research ethics in Africa: a case study from Botswana.

PubMed

Hyder, Adnan A; Zafar, Waleed; Ali, Joseph; Ssekubugu, Robert; Ndebele, Paul; Kass, Nancy

2013-07-30

The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form of a case study from an institution in Africa. We adapted the Octagon model originally used by the Swedish International Development Cooperation Agency to assess an organization along eight domains in research ethics: basic values and identity; structure and organization; ability to carry out activities; relevance of activities to stated goals; capacity of staff and management; administrative, financing and accounting systems; its relations with target groups; and the national context. We used a mixed methods approach to collect empirical data at the University of Botswana from March to December 2010. The overall shape of the external evaluation Octagon suggests that strengths of the University of Botswana are in the areas of structure, relevance, production and identity; while the university still needs more work in the areas of systems of finance, target groups, and environment. The Octagons also show the similarities and discrepancies between the 'external' and 'internal' evaluations and provide an opportunity for exploration of these different assessments. For example, the discrepant score for 'identity' between internal and external evaluations allows for an exploration of what constitutes a strong identity for research ethics at the University of Botswana and how it can be strengthened. There is a general lack of frameworks for evaluating research ethics capacity in LMICs. We presented an approach that stresses evaluation from both internal and external perspectives. This case study highlights the university's rapid progress in developing research ethics capacity and points to some notable areas for improvement. We believe that such an empirically-driven and participatory assessment allows a more holistic measurement and promotion of institutional capacity strengthening for research ethics in LMICs.

Evaluating institutional capacity for research ethics in Africa: a case study from Botswana

PubMed Central

2013-01-01

Background The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form of a case study from an institution in Africa. Methods We adapted the Octagon model originally used by the Swedish International Development Cooperation Agency to assess an organization along eight domains in research ethics: basic values and identity; structure and organization; ability to carry out activities; relevance of activities to stated goals; capacity of staff and management; administrative, financing and accounting systems; its relations with target groups; and the national context. We used a mixed methods approach to collect empirical data at the University of Botswana from March to December 2010. Results The overall shape of the external evaluation Octagon suggests that strengths of the University of Botswana are in the areas of structure, relevance, production and identity; while the university still needs more work in the areas of systems of finance, target groups, and environment. The Octagons also show the similarities and discrepancies between the 'external' and 'internal' evaluations and provide an opportunity for exploration of these different assessments. For example, the discrepant score for 'identity' between internal and external evaluations allows for an exploration of what constitutes a strong identity for research ethics at the University of Botswana and how it can be strengthened. Conclusions There is a general lack of frameworks for evaluating research ethics capacity in LMICs. We presented an approach that stresses evaluation from both internal and external perspectives. This case study highlights the university's rapid progress in developing research ethics capacity and points to some notable areas for improvement. We believe that such an empirically-driven and participatory assessment allows a more holistic measurement and promotion of institutional capacity strengthening for research ethics in LMICs. PMID:23899301

Ethics in the Information Exploitation and Manipulation Age

ERIC Educational Resources Information Center

Snow, Richard; Snow, Mary

2007-01-01

Purpose: The purpose of this paper is to elaborate the need to educate and encourage students to seek an ethical realm in which the researcher not only accurately analyses and documents a problem, but also actually advocates involvement to mitigate negative impacts. Design/methodology/approach: Geographic information systems (GIS) applications are…

Progress in animal experimentation ethics: a case study from a Brazilian medical school and from the international medical literature.

PubMed

Ramalli, Edvaldo Luiz; Ho, Wanli; Alves, Mônica; Rocha, Eduardo Melani

2012-09-01

This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

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.

Chinese insurance agents in "bad barrels": a multilevel analysis of the relationship between ethical leadership, ethical climate and business ethical sensitivity.

PubMed

Zhang, Na; Zhang, Jian

2016-01-01

The moral hazards and poor public image of the insurance industry, arising from insurance agents' unethical behavior, affect both the normal operation of an insurance company and decrease applicants' confidence in the company. Contrarily, these scandals may demonstrate that the organizations were "bad barrels" in which insurance agents' unethical decisions were supported or encouraged by the organization's leadership or climate. The present study brings two organization-level factors (ethical leadership and ethical climate) together and explores the role of ethical climate on the relationship between the ethical leadership and business ethical sensitivity of Chinese insurance agents. Through the multilevel analysis of 502 insurance agents from 56 organizations, it is found that organizational ethical leadership is positively related to the organizational ethical climate; organizational ethical climate is positively related to business ethical sensitivity, and organizational ethical climate fully mediates the relationship between organizational ethical leadership and business ethical sensitivity. Organizational ethical climate plays a completely mediating role in the relationship between organizational ethical leadership and business ethical sensitivity. The integrated model of ethical leadership, ethical climate and business ethical sensitivity makes several contributions to ethics theory, research and management.

BNCI systems as a potential assistive technology: ethical issues and participatory research in the BrainAble project.

PubMed

Carmichael, Clare; Carmichael, Patrick

2014-01-01

This paper highlights aspects related to current research and thinking about ethical issues in relation to Brain Computer Interface (BCI) and Brain-Neuronal Computer Interfaces (BNCI) research through the experience of one particular project, BrainAble, which is exploring and developing the potential of these technologies to enable people with complex disabilities to control computers. It describes how ethical practice has been developed both within the multidisciplinary research team and with participants. The paper presents findings in which participants shared their views of the project prototypes, of the potential of BCI/BNCI systems as an assistive technology, and of their other possible applications. This draws attention to the importance of ethical practice in projects where high expectations of technologies, and representations of "ideal types" of disabled users may reinforce stereotypes or drown out participant "voices". Ethical frameworks for research and development in emergent areas such as BCI/BNCI systems should be based on broad notions of a "duty of care" while being sufficiently flexible that researchers can adapt project procedures according to participant needs. They need to be frequently revisited, not only in the light of experience, but also to ensure they reflect new research findings and ever more complex and powerful technologies.

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.

Placebos in clinical practice and research.

PubMed Central

De Deyn, P P; D'Hooge, R

1996-01-01

The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given. PMID:8798935

Challenges in the Ethical Review of Peer Support Interventions

PubMed Central

Simmons, David; Bunn, Christopher; Nakwagala, Fred; Safford, Monika M.; Ayala, Guadalupe X.; Riddell, Michaela; Graffy, Jonathan; Fisher, Edwin B.

2015-01-01

PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the “4+1 ethical framework” (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees’ reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of “light touch” consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support. PMID:26304976

Marketing Approval of Ethical Kampo Medicines.

PubMed

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

Moral Stress, Moral Practice, and Ethical Climate in Community-Based Drug-Use Research: Views From the Front Line

PubMed Central

Fisher, Celia B.; True, Gala; Alexander, Leslie; Fried, Adam L.

2016-01-01

Background The role of front-line researchers, those whose responsibilities include face-to-face contact with participants, is critical to ensuring the responsible conduct of community-based drug use research. To date, there has been little empirical examination of how front-line researchers perceive the effectiveness of ethical procedures in their real-world application and the moral stress they may experience when adherence to scientific procedures appears to conflict with participant protections. Methods This study represents a first step in applying psychological science to examine the work-related attitudes, ethics climate, and moral dilemmas experienced by a national sample of 275 front-line staff members whose responsibilities include face-to-face interaction with participants in community-based drug-use research. Using an anonymous Web-based survey we psychometrically evaluated and examined relationships among six new scales tapping moral stress (frustration in response to perceived barriers to conducting research in a morally appropriate manner); organizational ethics climate; staff support; moral practice dilemmas (perceived conflicts between scientific integrity and participant welfare); research commitment; and research mistrust. Results As predicted, front-line researchers who evidence a strong commitment to their role in the research process and who perceive their organizations as committed to research ethics and staff support experienced lower levels of moral stress. Front-line researchers who were distrustful of the research enterprise and frequently grappled with moral practice dilemmas reported higher levels of moral stress. Conclusion Applying psychometrically reliable scales to empirically examine research ethics challenges can illuminate specific threats to scientific integrity and human subjects protections encountered by front-line staff and suggest organizational strategies for reducing moral stress and enhancing the responsible conduct of research. PMID:27795869

Moral Stress, Moral Practice, and Ethical Climate in Community-Based Drug-Use Research: Views From the Front Line.

PubMed

Fisher, Celia B; True, Gala; Alexander, Leslie; Fried, Adam L

2013-01-01

The role of front-line researchers, those whose responsibilities include face-to-face contact with participants, is critical to ensuring the responsible conduct of community-based drug use research. To date, there has been little empirical examination of how front-line researchers perceive the effectiveness of ethical procedures in their real-world application and the moral stress they may experience when adherence to scientific procedures appears to conflict with participant protections. This study represents a first step in applying psychological science to examine the work-related attitudes, ethics climate, and moral dilemmas experienced by a national sample of 275 front-line staff members whose responsibilities include face-to-face interaction with participants in community-based drug-use research. Using an anonymous Web-based survey we psychometrically evaluated and examined relationships among six new scales tapping moral stress (frustration in response to perceived barriers to conducting research in a morally appropriate manner); organizational ethics climate; staff support; moral practice dilemmas (perceived conflicts between scientific integrity and participant welfare); research commitment; and research mistrust. As predicted, front-line researchers who evidence a strong commitment to their role in the research process and who perceive their organizations as committed to research ethics and staff support experienced lower levels of moral stress. Front-line researchers who were distrustful of the research enterprise and frequently grappled with moral practice dilemmas reported higher levels of moral stress. Applying psychometrically reliable scales to empirically examine research ethics challenges can illuminate specific threats to scientific integrity and human subjects protections encountered by front-line staff and suggest organizational strategies for reducing moral stress and enhancing the responsible conduct of research.

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

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

Questions about environmental ethics: toward a research agenda with a focus on public policy

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

Deknatel, C.Y.

Despite common elements and antecedents of environmental ethics, their implied application to related policy or action is not always clear. An attempt is made to develop a set of questions and a preliminary framework for considering some of the issues raised by environmental ethics as they might appear in public policy. These examples are merely meant to illustrate the questions which surround environmental ethics and to suggest the beginnings of an approach. The goal of this approach is to clarify the properties of environmental ethics and those of specific situations to which ethics might be applied. It may then bemore » easier to say what the meaning, role, and effect of environmental ethics can be. 42 references, 2 figures.« less

Teaching ethics to engineers - a research-based perspective

NASA Astrophysics Data System (ADS)

Bowden, Peter

2010-10-01

This paper describes research underpinning a course, developed in Australia, on ethics for engineers. The methodology used, that of identifying the principal ethical issues facing the discipline and designing the course around these issues, would be applicable to other disciplines and in other countries. The course was based on the assumption that identifying the major ethical issues in the discipline, and subsequently presenting and analysing them in the classroom, would provide the future professional with knowledge of the ethical problems that they were likely to face on graduation. The student has then to be given the skills and knowledge to combat these concerns, should he/she wish to. These findings feed into several components of the course, such as the development of a code of ethics, the role of a professional society or industry association and the role of ethical theory The sources employed to identify the issues were surveys of the literature and about 30 case studies, in Australia and overseas. The issues thus identified were then put before a sample of engineering managers to assess the relevance to the profession.

Culture, context and community: ethical considerations for global nursing research.

PubMed

Harrowing, J N; Mill, J; Spiers, J; Kulig, J; Kipp, W

2010-03-01

High-quality research is essential for the generation of scientific nursing knowledge and the achievement of the Millennium Development Goals. However, the incorporation of Western bioethical principles in the study design may not be suitable, sufficient or relevant to participants in low-income countries and may indeed be harmful and disrespectful. Before engaging in global health studies, nurses must consider carefully the cultural and social context and values of the proposed setting in order to situate the research within the appropriate ethical framework. The purpose of this paper was to examine the ethical principles and considerations that guide health research conducted in international settings using the example of a qualitative study of Ugandan nurses and nurse-midwives by a Canadian researcher. The application of Western bioethical principles with their emphasis on autonomy fails to acknowledge the importance of relevant contextual aspects in the conduct of global research. Because ethics is concerned with how people interact and live together, it is essential that studies conducted across borders be respectful of, and congruent with, the values and needs of the community in which it occurs. The use of a communitarian ethical framework will allow nurse scientists to contribute to the elimination of inequities between those who enjoy prosperity and good health, and those who do not.

Using an ecological ethics framework to make decisions about the relocation of wildlife.

PubMed

McCoy, Earl D; Berry, Kristin

2008-12-01

Relocation is an increasingly prominent conservation tool for a variety of wildlife, but the technique also is controversial, even among conservation practitioners. An organized framework for addressing the moral dilemmas often accompanying conservation actions such as relocation has been lacking. Ecological ethics may provide such a framework and appears to be an important step forward in aiding ecological researchers and biodiversity managers to make difficult moral choices. A specific application of this framework can make the reasoning process more transparent and give more emphasis to the strong sentiments about non-human organisms held by many potential users. Providing an example of the application of the framework may also increase the appeal of the reasoning process to ecological researchers and biodiversity managers. Relocation as a conservation action can be accompanied by a variety of moral dilemmas that reflect the interconnection of values, ethical positions, and conservation decisions. A model that is designed to address moral dilemmas arising from relocation of humans provides/demonstrates/illustrates a possible way to apply the ecological ethics framework and to involve practicing conservationists in the overall decision-making process.

[RESPECT FOR AUTONOMY AND CONFIDENTIALITY, BETWEEN "ETHICAL NORMS' AND "LOCAL MORALITY". AN ANTHROPOLOGICAL ANALYSIS OF ETHICS OF CARE IN ST LUCIA].

PubMed

Meudec, Marie

2015-10-01

This article considers the difficulty of applying ethical norms as part of an anthropological research on moralities and ethics of healing practices in St. Lucia (Caribbean). This reflection is based on the moral evaluations related to obeah, locally conceived as a set of magical, religious and witchcraft practices that helps to manage disease and misfortune. Through the analysis of local conceptions surrounding the ethical notions of autonomy and confidentiality, I call attention to potential nuisance caused by the application of principles of beneficence and respect for the individual. Indeed, local idioms that are moral discretion and self-sufficiency, which can respectively refer to the concepts of autonomy and confidentiality, are, paradoxically, both valued and likely to be associated with dubious morality. I will demonstrate that the fact of applying these principles in all ethnographic relationship may harm interlocutors by increasing, in the case of St. Lucia, the risk of witchcraft accusations and derogatory moral attributions. The anthropological field experience presented here questions the principles of beneficence and respect for the individual as defined in the field of research ethics; it also imposes the need to think about their adaptation to suit local representations. This leads to recommend a pragmatic and emerging ethics of anthropological research/practice.

Simplified Novel Application (SNApp) framework: a guide to developing and implementing second-generation mobile applications for behavioral health research.

PubMed

Fillo, Jennifer; Staplefoote-Boynton, B Lynette; Martinez, Angel; Sontag-Padilla, Lisa; Shadel, William G; Martino, Steven C; Setodji, Claude M; Meeker, Daniella; Scharf, Deborah

2016-12-01

Advances in mobile technology and mobile applications (apps) have opened up an exciting new frontier for behavioral health researchers, with a "second generation" of apps allowing for the simultaneous collection of multiple streams of data in real time. With this comes a host of technical decisions and ethical considerations unique to this evolving approach to research. Drawing on our experience developing a second-generation app for the simultaneous collection of text message, voice, and self-report data, we provide a framework for researchers interested in developing and using second-generation mobile apps to study health behaviors. Our Simplified Novel Application (SNApp) framework breaks the app development process into four phases: (1) information and resource gathering, (2) software and hardware decisions, (3) software development and testing, and (4) study start-up and implementation. At each phase, we address common challenges and ethical issues and make suggestions for effective and efficient app development. Our goal is to help researchers effectively balance priorities related to the function of the app with the realities of app development, human subjects issues, and project resource constraints.

Toward ethical norms and institutions for climate engineering research

NASA Astrophysics Data System (ADS)

Morrow, David R.; Kopp, Robert E.; Oppenheimer, Michael

2009-10-01

Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research progresses beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk-benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established.

Introducing survival ethics into engineering education and practice.

PubMed

Verharen, C; Tharakan, J; Middendorf, G; Castro-Sitiriche, M; Kadoda, G

2013-06-01

Given the possibilities of synthetic biology, weapons of mass destruction and global climate change, humans may achieve the capacity globally to alter life. This crisis calls for an ethics that furnishes effective motives to take global action necessary for survival. We propose a research program for understanding why ethical principles change across time and culture. We also propose provisional motives and methods for reaching global consensus on engineering field ethics. Current interdisciplinary research in ethics, psychology, neuroscience and evolutionary theory grounds these proposals. Experimental ethics, the application of scientific principles to ethical studies, provides a model for developing policies to advance solutions. A growing literature proposes evolutionary explanations for moral development. Connecting these approaches necessitates an experimental or scientific ethics that deliberately examines theories of morality for reliability. To illustrate how such an approach works, we cover three areas. The first section analyzes cross-cultural ethical systems in light of evolutionary theory. While such research is in its early stages, its assumptions entail consequences for engineering education. The second section discusses Howard University and University of Puerto Rico/Mayagüez (UPRM) courses that bring ethicists together with scientists and engineers to unite ethical theory and practice. We include a syllabus for engineering and STEM (Science, Technology, Engineering and Mathematics) ethics courses and a checklist model for translating educational theory and practice into community action. The model is based on aviation, medicine and engineering practice. The third and concluding section illustrates Howard University and UPRM efforts to translate engineering educational theory into community action. Multidisciplinary teams of engineering students and instructors take their expertise from the classroom to global communities to examine further the ethicality of prospective technologies and the decision-making processes that lead to them.

Balancing Ethical Pros and Cons of Stem Cell Derived Gametes.

PubMed

Segers, Seppe; Mertes, Heidi; de Wert, Guido; Dondorp, Wybo; Pennings, Guido

2017-07-01

In this review we aim to provide an overview of the most important ethical pros and cons of stem cell derived gametes (SCD-gametes), as a contribution to the debate about reproductive tissue engineering. Derivation of gametes from stem cells holds promising applications both for research and for clinical use in assisted reproduction. We explore the ethical issues connected to gametes derived from embryonic stem cells (both patient specific and non-patient specific) as well as those related to gametes derived from induced pluripotent stem cells. The technology of SCD-gametes raises moral concerns of how reproductive autonomy relates to issues of embryo destruction, safety, access, and applications beyond clinical infertility.

Ethical considerations in investigating youth alcohol norms and behaviours: a case for mature minor consent.

PubMed

Hildebrand, J; Maycock, B; Comfort, J; Burns, S; Adams, E; Howat, P

2015-12-01

Mature minor consent only became available in Australia in 2007. There is neither an explicitly defined protocol, nor a clear definition evident in the literature relating to use of the mature minor concept in health research. Due to difficulties in defining fixed age ranges to varying levels of maturity and vulnerability, there is a lack of clarity surrounding when it might be reasonable and ethical to apply for or grant a waiver for parental consent. This paper describes the challenges faced and solutions created when gaining approval for use of mature minor consent in a respondent-driven sampling (RDS) study to explore the social norms and alcohol consumption among 14-17-year-old adolescents (n = 1012) in the community. The University's Human Research Ethics Committee granted mature minor consent for this study, and the techniques applied enabled recruitment of adolescents from community-based settings through use of RDS to achieve the required sample. This paper has relevance for research that requires a waiver for parental consent; it presents a case study for assessing mature minors and makes recommendations on how ethical guidelines can be improved to assist human research ethics application processes.

[About the genesis of the first Polish local research ethics committee].

PubMed

Paprocka-Lipinska, Anna

2014-12-01

From the moment in which the development of medicine became necessary experimental research involving human subjects, the question arose about the ethical limits and limitations of the experiment. The turning point was the year 1947. The Nuremberg Code was formulated after the disclosure of pseudo-medical experiments involving human subjects during the Second World War. In 1964, the medical world accepted the Declaration of Helsinki, which, however, did not prevent abuses and it became necessary to appoint independent ethics committees supervising and enforcing the application of ethics in biomedical experiments. In Poland in the 60's and 70's started a discussion on the ethical rules related to conduct of research involving humans. The initiators of the appointment of bioethics committees were professors of medicine, inspiring experiences of their Western colleagues. It was difficult for reasons of political ideologies to convince the authorities to use the best of western solutions. This paper attempts to describe the circumstances connected with the appointment in 1979 at the Medical University of Gdansk, the first Polish bioethics committee.

[Ethical considerations about research with women in situations of violence].

PubMed

Rafael, Ricardo de Mattos Russo; Soares de Moura, Anna Tereza Miranda

2013-01-01

This essay aims at reflecting on the ethical and methodological principles involved in research with women in situation of violence. The text raises the discussion of the application of the principles of beneficence and non-maleficence during researches involving this issue, pointing to recommendations towards privacy, autonomy and immediate contributions for volunteers. Then, taking as theoretical reference the principles of justice and equity, the authors propose a debate on methodological aspects involved in protection of respondents, with a view at improving the quality of the data obtained and possible social contributions.

[Ethical aspects of biological sample banks].

PubMed

Cambon-Thomsen, A; Rial-Sebbag, E

2003-02-01

Numerous activities in the domain of epidemiology require the constitution or the use of biological sample banks. Such biobanks raise ethical issues. A number of recommendations are applicable to this field, in France and elsewhere. Major principles applicable to biobanks include the respect of person's autonomy, the respect of human body, the respect of confidentiality. These principles are translated into practices through the following procedures: relevant information to the persons regarding their sample management prior to informed consent, opinion of an independent ethics committee, actual implementation of conditions for protecting samples and data. However, although those principles may appear quite simple and obvious, in the context of a largely international practice of research and given the large variety of biobanks, it is not always obvious for researchers to find their way. The attitudes vary between countries, there are numerous texts for various types of biobanks, the same texts raise different interpretations in different institutions, there are new ethical opinions expressed, and mainly the novelty of questions raised by the uses of samples that are possible today, especially in genetics, and were not foreseeable at the time of sampling make the field difficult in practice. This article reviews the types of biobanks, the relevant ethical issues. It also underlines the still unclear or ambiguous situations using some examples of practical situations.

In Defense of a Social Value Requirement for Clinical Research

PubMed Central

Wendler, David; Rid, Annette

2017-01-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present paper assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. PMID:28060427

In Defense of a Social Value Requirement for Clinical Research.

PubMed

Wendler, David; Rid, Annette

2017-02-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

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.

Lessons from Adult Education: Identifying and Exploring Emerging Ethical Issues in Technologically Enhanced Performance

ERIC Educational Resources Information Center

Mabry, Christie Knittel; O'Driscoll, Tony

2003-01-01

Technologically Enhanced Performance (TEP) is the application of technology to improve the performance of knowledge workers. TEP is both an intellectual and ideological complement to the field of Adult Education. As such, much can be learned about ethical issues associated with implementing TEP from the established research and literature base in…

Ethics and methods for biological rhythm research on animals and human beings.

PubMed

Portaluppi, Francesco; Smolensky, Michael H; Touitou, Yvan

2010-10-01

This article updates the ethical standards and methods for the conduct of high-quality animal and human biological rhythm research, which should be especially useful for new investigators of the rhythms of life. The editors of Chronobiology International adhere to and endorse the Code of Conduct and Best Practice Guidelines of the Committee On Publication Ethics (COPE), which encourages communication of such updates at regular intervals in the journal. The journal accepts papers representing original work, no part of which was previously submitted for publication elsewhere, except as brief abstracts, as well as in-depth reviews. The majority of research papers published in Chronobiology International entails animal and human investigations. The editors and readers of the journal expect authors of submitted manuscripts to have made an important contribution to the research of biological rhythms and related phenomena using ethical methods/procedures and unbiased, accurate, and honest reporting of findings. Authors of scientific papers are required to declare all potential conflicts of interest. The journal and its editors endorse compliance of investigators to the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, relating to the conduct of ethical research on laboratory and other animals, and the principles of the Declaration of Helsinki of the World Medical Association, relating to the conduct of ethical research on human beings. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the protocols and methods conform to ethical standards. Authors are expected to show mastery of the basic methods and procedures of biological rhythm research and proper statistical assessment of data, including the appropriate application of time series data analyses, as briefly reviewed in this article. The journal editors strive to consistently achieve high standards for the research of original and review papers reported in Chronobiology International, and current examples of expectations are presented herein.

Ethical aspects of using medical social media in healthcare applications.

PubMed

Denecke, Kerstin

2014-01-01

The advances in internet and mobile technologies and their increased use in healthcare led to the development of a new research field: health web science. Many research questions are addressed in that field, starting from analysing social-media data, to recruiting participants for clinical studies and monitoring the public health status. The information provided through this channel is unique in a sense that there is no other written source of experiences from patients and health carers. The increased usage and analysis of health web data poses questions on privacy, and ethics. Through a literature review, the current awareness on ethical issues in the context of public health monitoring and research using medical social media data is determined. Further, considerations on the topic were collected from members of the IMIA Social Media Working group.

[Non-medical applications for brain MRI: Ethical considerations].

PubMed

Sarrazin, S; Fagot-Largeault, A; Leboyer, M; Houenou, J

2015-04-01

The recent neuroimaging techniques offer the possibility to better understand complex cognitive processes that are involved in mental disorders and thus have become cornerstone tools for research in psychiatry. The performances of functional magnetic resonance imaging are not limited to medical research and are used in non-medical fields. These recent applications represent new challenges for bioethics. In this article we aim at discussing the new ethical issues raised by the applications of the latest neuroimaging technologies to non-medical fields. We included a selection of peer-reviewed English medical articles after a search on NCBI Pubmed database and Google scholar from 2000 to 2013. We screened bibliographical tables for supplementary references. Websites of governmental French institutions implicated in ethical questions were also screened for governmental reports. Findings of brain areas supporting emotional responses and regulation have been used for marketing research, also called neuromarketing. The discovery of different brain activation patterns in antisocial disorder has led to changes in forensic psychiatry with the use of imaging techniques with unproven validity. Automated classification algorithms and multivariate statistical analyses of brain images have been applied to brain-reading techniques, aiming at predicting unconscious neural processes in humans. We finally report the current position of the French legislation recently revised and discuss the technical limits of such techniques. In the near future, brain imaging could find clinical applications in psychiatry as diagnostic or predictive tools. However, the latest advances in brain imaging are also used in non-scientific fields raising key ethical questions. Involvement of neuroscientists, psychiatrists, physicians but also of citizens in neuroethics discussions is crucial to challenge the risk of unregulated uses of brain imaging. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Health data research in New Zealand: updating the ethical governance framework.

PubMed

Ballantyne, Angela; Style, Rochelle

2017-10-27

Demand for health data for secondary research is increasing, both in New Zealand and worldwide. The New Zealand government has established a large research database, the Integrated Data Infrastructure (IDI), which facilitates research, and an independent ministerial advisory group, the Data Futures Partnership (DFP), to engage with citizens, the private sector and non-government organisations (NGOs) to facilitate trusted data use and strengthen the data ecosystem in New Zealand. We commend these steps but argue that key strategies for effective health-data governance remain absent in New Zealand. In particular, we argue in favour of the establishment of: (1) a specialist Health and Disability Ethics Committee (HDEC) to review applications for secondary-use data research; (2) a public registry of approved secondary-use research projects (similar to a clinical trials registry); and (3) detailed guidelines for the review and approval of secondary-use data research. We present an ethical framework based on the values of public interest, trust and transparency to justify these innovations.

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.

Animal models in biological and biomedical research - experimental and ethical concerns.

PubMed

Andersen, Monica L; Winter, Lucile M F

2017-09-04

Animal models have been used in experimental research to increase human knowledge and contribute to finding solutions to biological and biomedical questions. However, increased concern for the welfare of the animals used, and a growing awareness of the concept of animal rights, has brought a greater focus on the related ethical issues. In this review, we intend to give examples on how animals are used in the health research related to some major health problems in Brazil, as well as to stimulate discussion about the application of ethics in the use of animals in research and education, highlighting the role of National Council for the Control of Animal Experimentation (Conselho Nacional de Controle de Experimentação Animal - CONCEA) in these areas. In 2008, Brazil emerged into a new era of animal research regulation, with the promulgation of Law 11794, previously known as the Arouca Law, resulting in an increased focus, and rapid learning experience, on questions related to all aspects of animal experimentation. The law reinforces the idea that animal experiments must be based on ethical considerations and integrity-based assumptions, and provides a regulatory framework to achieve this. This review describes the health research involving animals and the current Brazilian framework for regulating laboratory animal science, and hopes to help to improve the awareness of the scientific community of these ethical and legal rules.

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.

Who is the research subject in cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met. PMID:21791064

Human rights, cultural pluralism, and international health research.

PubMed

Marshall, Patricia A

2005-01-01

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry.

Ethical and social implications of genetic testing for communication disorders.

PubMed

Arnos, Kathleen S

2008-01-01

Advances in genetics and genomics have quickly led to clinical applications to human health which have far-reaching consequences at the individual and societal levels. These new technologies have allowed a better understanding of the genetic factors involved in a wide range of disorders. During the past decade, incredible progress has been made in the identification of genes involved in the normal process of hearing. The resulting clinical applications have presented consumers with new information and choices. Many of the same gene identification techniques are increasingly being applied to the investigation of complex disorders of speech and language. In parallel with gene identification, studies of the legal, ethical and psychosocial impacts of the clinical application of these advances and their influence on specific behaviors of individuals with communication disorders are paramount, but often lag behind. These studies will help to ensure that new technologies are introduced into clinical practice in a responsible manner. As a result of this activity, the participant will be able to (1) explain the differences between Mendelian and complex forms of inheritance and why these differences complicate the ethical impact of genetic testing, (2) explain how publicly funded genome research through the Human Genome Project, the International HapMap Project and others have examined the ethical, legal and social implications of genome research, (3) list some of the ethical complexities of prenatal, newborn and predictive testing for various genetic disorders and (4) discuss the importance of evidence-based practice to the development of public policy for the introduction and clinical use of genetic tests.

Ethical and social implications of genetic testing for communication disorders

PubMed Central

Arnos, Kathleen S.

2013-01-01

Advances in genetics and genomics have quickly led to clinical applications to human health which have far-reaching consequences at the individual and societal levels. These new technologies have allowed a better understanding of the genetic factors involved in a wide range of disorders. During the past decade, incredible progress has been made in the identification of genes involved in the normal process of hearing. The resulting clinical applications have presented consumers with new information and choices. Many of the same gene identification techniques are increasingly being applied to the investigation of complex disorders of speech and language. In parallel with gene identification, studies of the legal, ethical and psychosocial impacts of the clinical application of these advances and their influence on specific behaviors of individuals with communication disorders are paramount, but often lag behind. These studies will help to ensure that new technologies are introduced into clinical practice in a responsible manner. Learning outcomes As a result of this activity, the participant will be able to (1) explain the differences between Mendelian and complex forms of inheritance and why these differences complicate the ethical impact of genetic testing, (2) explain how publicly funded genome research through the Human Genome Project, the International HapMap Project and others have examined the ethical, legal and social implications of genome research, (3) list some of the ethical complexities of prenatal, newborn and predictive testing for various genetic disorders and (4) discuss the importance of evidence-based practice to the development of public policy for the introduction and clinical use of genetic tests. PMID:18452941

Using an ecological ethics framework to make decisions about the relocation of wildlife

USGS Publications Warehouse

McCoy, E.D.; Berry, K.

2008-01-01

Relocation is an increasingly prominent conservation tool for a variety of wildlife, but the technique also is controversial, even among conservation practitioners. An organized framework for addressing the moral dilemmas often accompanying conservation actions such as relocation has been lacking. Ecological ethics may provide such a framework and appears to be an important step forward in aiding ecological researchers and biodiversity managers to make difficult moral choices. A specific application of this framework can make the reasoning process more transparent and give more emphasis to the strong sentiments about non-human organisms held by many potential users. Providing an example of the application of the framework may also increase the appeal of the reasoning process to ecological researchers and biodiversity managers. Relocation as a conservation action can be accompanied by a variety of moral dilemmas that reflect the interconnection of values, ethical positions, and conservation decisions. A model that is designed to address moral dilemmas arising from relocation of humans provides/demonstrates/illustrates a possible way to apply the ecological ethics framework and to involve practicing conservationists in the overall decision-making process. ?? 2008 Springer Science+Business Media B.V.

Ethics education in the consulting engineering environment: where do we start?

PubMed

Elder, Keith E

2004-04-01

As a result of in-house discussions stimulated by previous Gonzaga engineering ethics conferences, Coffman Engineers began the implementation of what is to be a company-wide ethics training program. While preparing a curriculum aimed at consulting engineers, we found very little guidance as to how to proceed with most available literature being oriented towards the academic environment. We consulted a number of resources that address the teaching of engineering ethics in higher education, but questioned their applicability for the Consulting Engineering environment. This lack of guidance led us to informal research into the ethical knowledge and attitudes of both consulting engineers and engineering students. Some of our findings were unexpected, and suggest that a simpler approach to teaching ethics to working professionals might be preferred to that typically promoted in higher education.

Constructing an ethical framework for embryo donation to research: is it time for a restricted consent policy?

PubMed

Ehrich, Kathryn; Farsides, Bobbie; Williams, Clare; Scott, Rosamund

2011-06-01

An Ethics & Policy Workshop was held with 20 invited UK stakeholders to consider whether embryo donors should be able to restrict the future use of human embryonic stem cells (hESCs) created from their embryos. Participants cited tensions between pure altruism and a more reciprocal basis for donation; and between basic research (in which genetic material would never form part of another living being) and treatment applications. Two restriction models were suggested to acknowledge specific ethical issues raised by hESCs' use in research and treatments: (1) a two tier system: hESCs with unrestricted consent could go to the UK Stem Cell Bank; those with restricted consent could be used in individual labs which could guarantee to honour the restrictions, and Bank deposit would not be required. (2) a three category system: restrictions could include (i) basic hESC research; (ii) hESC research and treatment; no gamete derivation (iii) 'unrestricted' hESC research and treatment.

Substance use disorder genetic research: investigators and participants grapple with the ethical issues.

PubMed

Coors, Marilyn E; Raymond, Kristen M

2009-04-01

This qualitative research examined the ethical concerns regarding the psychosocial issues, research design and implementation, and application of psychiatric genetic research on substance use disorders (SUD) from multiple perspectives. A literature review of the bioethics literature related to psychiatric genetics and focus groups explored the ethical implications of SUD genetic research. Twenty-six National Institute on Drug Abuse funded principal investigators in the field of psychiatric genetic research, nine adolescent patients in residential SUD treatment, and 10 relatives of patients participated in focus groups (held separately). The focus groups were recorded, transcribed, and the content was analyzed. The themes that emerged from the literature and the focus group transcripts were organized by using NVIVO7, a software package designed to manage, analyze, and compare narrative data. Investigators and the literature expressed similar concerns regarding the ethical concerns associated with psychiatric genetic research including violation of privacy, misunderstanding about psychiatric genetics, stigmatization, commercialization, discrimination, eugenics, consequences of research on illegal behavior, unforeseen consequences, altered notion of individual responsibility, and others. Patients and their relatives showed little familiarity with the ethical issues as identified by professionals and little concern regarding most of the potential risks. The exception was apprehension associated with potential criminal justice uses of stored genetic information, in particular enforced therapy and stigmatization, which elicited some concern from all perspectives. The challenge for further research is to identify risks and benefits of SUD research that are germane in a behaviorally disinhibited population and devise effective tools to communicate information to participants through an improved informed consent process.

Substance Use Disorder Genetic Research: Investigators and Participants Grapple with the Ethical Issues

PubMed Central

Raymond, Kristen M.

2009-01-01

Objective This qualitative research examined the ethical concerns regarding the psychosocial issues, research design and implementation, and application of psychiatric genetic research on substance use disorders (SUD) from multiple perspectives. Method A literature review of the bioethics literature related to psychiatric genetics and focus groups explored the ethical implications of SUD genetic research. Twenty-six National Institute on Drug Abuse (NIDA) funded principal investigators in the field of psychiatric genetic research, 9 adolescent patients in residential SUD treatment, and 10 relatives of patients participated in focus groups (held separately). The focus groups were recorded, transcribed, and the content was analyzed. The themes that emerged from the literature and the focus group transcripts were organized using NVIVO7, a software package designed to manage, analyze and compare narrative data. Results Investigators and the literature expressed similar concerns regarding the ethical concerns associated with psychiatric genetic research including violation of privacy, misunderstanding about psychiatric genetics, stigmatization, commercialization, discrimination, eugenics, consequences of research on illegal behavior, unforeseen consequences, altered notion of individual responsibility, and others. Patients and their relatives demonstrated little familiarity with the ethical issues as identified by professionals and little concern regarding most of the potential risks. The exception was apprehension associated with potential criminal justice uses of stored genetic information and enforced therapy, which elicited some concern from all perspectives. Conclusions The challenge for further research is to identify risks and benefits of SUD research that are germane in a behaviorally disinhibited population and devise effective tools to communicate information to participants through an improved informed consent process. PMID:19668113

A four-part working bibliography of neuroethics: part 3 - "second tradition neuroethics" - ethical issues in neuroscience.

PubMed

Martin, Amanda; Becker, Kira; Darragh, Martina; Giordano, James

2016-09-19

Neuroethics describes several interdisciplinary topics exploring the application and implications of engaging neuroscience in societal contexts. To explore this topic, we present Part 3 of a four-part bibliography of neuroethics' literature focusing on the "ethics of neuroscience." To complete a systematic survey of the neuroethics literature, 19 databases and 4 individual open-access journals were employed. Searches were conducted using the indexing language of the U.S. National Library of Medicine (NLM). A Python code was used to eliminate duplications in the final bibliography. This bibliography consists of 1137 papers, 56 books, and 134 book chapters published from 2002 through 2014, covering ethical issues in neuroimaging, neurogenetics, neurobiomarkers, neuro-psychopharmacology, brain stimulation, neural stem cells, neural tissue transplants, pediatric-specific issues, dual-use, and general neuroscience research issues. These works contain explanations of recent research regarding neurotechnology, while exploring ethical issues in future discoveries and use.

Research ethics in the context of humanitarian emergencies.

PubMed

O'Mathúna, Dónal

2015-02-01

Research is needed to make responses to disasters and humanitarian emergencies more evidence-based. Such research must also adhere to the generally accepted principles of research ethics. While research into health interventions used in disasters raises distinctive ethical concerns, seven ethical principles developed for clinical research are applied here to disaster research. Practical examples from disaster settings are used to demonstrate how these ethical principles can be applied. This reveals that research ethics needs to be seen as much more than a mechanism to obtain ethical approval for research. Research ethics involves ethical principles and governance frameworks, but must also consider the role of ethical virtues in research. Virtues are essential to ensure that researchers do what they believe is ethically right and resist what is unethical. Research ethics that truly protects participants and promotes respect needs to include training in ethical virtues to ensure disaster research is carried out to the highest ethical standards. This article is based on a presentation at the Evidence Aid Symposium on 20 September 2014, in Hyderabad, India. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

Monitoring ethical, legal, and social issues in developing population genetic databases.

PubMed

Austin, Melissa A; Harding, Sarah E; McElroy, Courtney E

2003-01-01

To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally. Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research. We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable. The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.

Balancing Ethics and Quality in Educational Research--The Ethical Matrix Method

ERIC Educational Resources Information Center

Tangen, Reidun

2014-01-01

This paper addresses ethical issues in educational research with a focus on the interplay between research ethics and both internal and external quality of research. Research ethics is divided into three domains: (1) ethics "within" the research community; (2) ethics concerning relationships with "individuals and groups directly…

75 FR 2553 - Moving Into the Future-New Dimensions and Strategies for Women's Health Research for the National...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-15

... cardiovascular health issues, including the following: pregnancy and cardiovascular disease research and ethical considerations; cardiovascular disease in elderly and frail elderly women--optimal management and research; microvascular disease, biomechanics, and application of new technologies to cardiovascular research; stem cells...

Quality in applied science

NASA Astrophysics Data System (ADS)

Sten, T.

1993-12-01

Science is in many senses a special kind of craft and only skilled craftsmen are able to distinguish good work from bad. Due to the variation in approaches, methods and even philosophical basis, it is nearly impossible to derive a general set of quality criteria for scientific work outside specific research traditions. Applied science introduces a new set of quality criteria having to do with the application of results in practical situations and policy making. A scientist doing basic research relates mainly to the scientific community of which he is a member, while in applied contract research the scientist has to consider the impact of his results both for the immediate users and upon interest groups possibly being affected. Application thus raises a whole new set of requirements having to do with business ethics, policy consequences and societal ethics in general.

Co-design and implementation research: challenges and solutions for ethics committees.

PubMed

Goodyear-Smith, Felicity; Jackson, Claire; Greenhalgh, Trisha

2015-11-16

Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with vulnerable communities. Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada.

Ethics, Risk and Benefits Associated with Different Applications of Nanotechnology: a Comparison of Expert and Consumer Perceptions of Drivers of Societal Acceptance.

PubMed

Gupta, N; Fischer, A R H; Frewer, L J

Examining those risk and benefit perceptions utilised in the formation of attitudes and opinions about emerging technologies such as nanotechnology can be useful for both industry and policy makers involved in their development, implementation and regulation. A broad range of different socio-psychological and affective factors may influence consumer responses to different applications of nanotechnology, including ethical concerns. A useful approach to identifying relevant consumer concerns and innovation priorities is to develop predictive constructs which can be used to differentiate applications of nanotechnology in a way which is meaningful to consumers. This requires elicitation of attitudinal constructs from consumers, rather than measuring attitudes assumed to be important by the researcher. Psychological factors influencing societal responses to 15 applications of nanotechnology drawn from different application areas (e.g. medicine, agriculture and environment, food, military, sports, and cosmetics) were identified using repertory grid method in conjunction with generalised Procrustes analysis. The results suggested that people differentiate nanotechnology applications based on the extent to which they perceive them to be beneficial, useful, necessary and important. The benefits may be offset by perceived risks focusing on fear and ethical concerns. Compared to an earlier expert study on societal acceptance of nanotechnology, consumers emphasised ethical issues compared to experts but had less concern regarding potential physical contact with the product and time to market introduction. Consumers envisaged fewer issues with several applications compared to experts, in particular food applications.

Biomarkers of PTSD: military applications and considerations.

PubMed

Lehrner, Amy; Yehuda, Rachel

2014-01-01

Although there are no established biomarkers for posttraumatic stress disorder (PTSD) as yet, biological investigations of PTSD have made progress identifying the pathophysiology of PTSD. Given the biological and clinical complexity of PTSD, it is increasingly unlikely that a single biomarker of disease will be identified. Rather, investigations will more likely identify different biomarkers that indicate the presence of clinically significant PTSD symptoms, associate with risk for PTSD following trauma exposure, and predict or identify recovery. While there has been much interest in PTSD biomarkers, there has been less discussion of their potential clinical applications, and of the social, legal, and ethical implications of such biomarkers. This article will discuss possible applications of PTSD biomarkers, including the social, legal, and ethical implications of such biomarkers, with an emphasis on military applications. Literature on applications of PTSD biomarkers and on potential ethical and legal implications will be reviewed. Biologically informed research findings hold promise for prevention, assessment, treatment planning, and the development of prophylactic and treatment interventions. As with any biological indicator of disorder, there are potentially positive and negative clinical, social, legal, and ethical consequences of using such biomarkers. Potential clinical applications of PTSD biomarkers hold promise for clinicians, patients, and employers. The search for biomarkers of PTSD should occur in tandem with an interdisciplinary discussion regarding the potential implications of applying biological findings in clinical and employment settings.

[Ethical issues of new communication and information technologies applied in medicine].

PubMed

Tougourti, M Nejib; Ben Hamouda, Ibtissem; Hamza, Mohsen

2008-05-01

The fast development of New Communication and Information Technologies (NTIC) and their use in increasingly numerous fields in medicine; raised new ethical issues. The aim of this paper is to highlight ethical and deontological guidelines for health professionals and physicians which must guide their use of the NTIC. A research in the Anglophone and French medical literature and on the Internet, using various key words related to ethics and medical computing. Ethical issues are mainly related to the property, the access and the use of the broad data bases of medical records, the legal obligations and ethics which must govern the course of a teleconsultation or a therapeutic remote intervention and the rules which must define the relationship between the teleconsultants and their patients. The use, increasingly frequent, of various expert systems of decision-making and/or of expertise in various clinical settings, also, poses ethical problems relating to the reliability of such systems, the qualifications necessary for their application and the responsibility for their development, maintenance and use. Medical Information available on the Internet, of a very unequal and not controlled quality, raises many questions about the responsibility for the medical professionals in the education for the patients and their warning against sometimes erroneous information published on the Web. The ethical rules of research on the Internet must also be clearly formulated and diffused among the researchers. The general principles in front of an ethical problem related to the use of the NTIC remain based on the interest of the patient, the absence of a harmful effect, the respect of the professional secrecy and the safeguarding of the quality of the care and its conformity to the most recent scientific data.

Human Subjects Research and the Physics Classroom

NASA Astrophysics Data System (ADS)

Kubitskey, Beth W.; Thomsen, Marshall

2012-09-01

Physics Education Research is a form of social science research in that it uses human subjects. As physicists we need to be aware of the ethical and legal ramifications of performing this research, taking into account the fundamental differences between working with substances and working with people. For several decades, the federal government has regulated research involving human subjects. With current procedures, a proposal soliciting federal funds for a research project involving human subjects will be flagged by the applicants institution and checked for compliance with appropriate regulations. However, there is a large body of Physics Education Research that is not federally funded and thus may not be flagged. Nevertheless, there are ethical standards that apply to this research. This paper outlines the preliminary considerations for conducting such research.

Consistency in decision making by research ethics committees: a controlled comparison.

PubMed

Angell, E; Sutton, A J; Windridge, K; Dixon-Woods, M

2006-11-01

There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of kappa = 0.286 (95% confidence interval -0.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as "slight". The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.

Ethical and Safety Issues of Stem Cell-Based Therapy.

PubMed

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells.

Ethical and Safety Issues of Stem Cell-Based Therapy

PubMed Central

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells. PMID:29333086

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.

PubMed

Addissie, Adamu; Davey, Gail; Newport, Melanie J; Addissie, Thomas; MacGregor, Hayley; Feleke, Yeweyenhareg; Farsides, Bobbie

2014-05-02

Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting

PubMed Central

2014-01-01

Background Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. PMID:24885049

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.

Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

PubMed

Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

2018-06-01

There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

Big Data and Dementia: Charting the Route Ahead for Research, Ethics, and Policy

PubMed Central

Ienca, Marcello; Vayena, Effy; Blasimme, Alessandro

2018-01-01

Emerging trends in pervasive computing and medical informatics are creating the possibility for large-scale collection, sharing, aggregation and analysis of unprecedented volumes of data, a phenomenon commonly known as big data. In this contribution, we review the existing scientific literature on big data approaches to dementia, as well as commercially available mobile-based applications in this domain. Our analysis suggests that big data approaches to dementia research and care hold promise for improving current preventive and predictive models, casting light on the etiology of the disease, enabling earlier diagnosis, optimizing resource allocation, and delivering more tailored treatments to patients with specific disease trajectories. Such promissory outlook, however, has not materialized yet, and raises a number of technical, scientific, ethical, and regulatory challenges. This paper provides an assessment of these challenges and charts the route ahead for research, ethics, and policy. PMID:29468161

Big Data and Dementia: Charting the Route Ahead for Research, Ethics, and Policy.

PubMed

Ienca, Marcello; Vayena, Effy; Blasimme, Alessandro

2018-01-01

Emerging trends in pervasive computing and medical informatics are creating the possibility for large-scale collection, sharing, aggregation and analysis of unprecedented volumes of data, a phenomenon commonly known as big data. In this contribution, we review the existing scientific literature on big data approaches to dementia, as well as commercially available mobile-based applications in this domain. Our analysis suggests that big data approaches to dementia research and care hold promise for improving current preventive and predictive models, casting light on the etiology of the disease, enabling earlier diagnosis, optimizing resource allocation, and delivering more tailored treatments to patients with specific disease trajectories. Such promissory outlook, however, has not materialized yet, and raises a number of technical, scientific, ethical, and regulatory challenges. This paper provides an assessment of these challenges and charts the route ahead for research, ethics, and policy.

Email Surveys in Educational Research: Ethical and Net-Cultural Concerns

ERIC Educational Resources Information Center

Nguyen, Chi Hong

2007-01-01

The growth of the Internet and the increasing application of electronic mail in many aspects of business and educational research have urged researchers to reach different individuals across geographical borders with an obvious reduction of costs and time. While the use of email surveys in educational research, as this paper mainly argues, offers…

Data linkage capabilities in Australia: practical issues identified by a Population Health Research Network 'Proof of Concept project'.

PubMed

Mitchell, Rebecca J; Cameron, Cate M; McClure, Rod J; Williamson, Ann M

2015-08-01

To describe the practical issues that need to be overcome to conduct national data linkage projects in Australia and propose recommendations to improve efficiency. Review of the processes, documentation and applications required to conduct national data linkage in Australia. The establishment of state and national data linkage centres in Australia has placed Australia at the forefront of research linking health-related administrative data collections. However, improvements are needed to reduce the clerical burden on researchers, simplify the process of obtaining ethics approval, improve data accessibility, and thus improve the efficiency of data linkage research. While a sound state and national data linkage infrastructure is in place, the current complexity, duplication and lack of cohesion undermines any attempts to conduct research involving national record linkage in a timely manner. Data linkage applications and Human Research Ethics Committee approval processes need to be streamlined and duplication removed, in order to reduce the administrative and financial burden on researchers if national data linkage research is to be viable. © 2015 Public Health Association of Australia.

Coupled Ethical–Epistemic Analysis of Public Health Research and Practice: Categorizing Variables to Improve Population Health and Equity

PubMed Central

Katikireddi, S. Vittal; Valles, Sean A

2015-01-01

The categorization of variables can stigmatize populations, which is ethically problematic and threatens the central purpose of public health: to improve population health and reduce health inequities. How social variables (e.g., behavioral risks for HIV) are categorized can reinforce stigma and cause unintended harms to the populations practitioners and researchers strive to serve. Although debates about the validity or ethical consequences of epidemiological variables are familiar for specific variables (e.g., ethnicity), these issues apply more widely. We argue that these tensions and debates regarding epidemiological variables should be analyzed simultaneously as ethical and epistemic challenges. We describe a framework derived from the philosophy of science that may be usefully applied to public health, and we illustrate its application. PMID:25393193

Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

PubMed

Fadare, Joseph O; Porteri, Corinna

2010-03-01

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

The ethics of promulgating principles of research ethics: the problem of diversion effects

PubMed Central

Wertheimer, Alan

2015-01-01

There is an important distinction between ethical standards for the conduct of research with human subjects and the ethics of promulgating principles of research ethics. Those who promulgate ethical standards for the conduct of research have an ethical responsibility to consider the consequences to which those promulgations give rise. In particular, they must consider whether their promulgations will give researchers incentives not to conduct research or not to conduct research in locales in which participants would benefit from participation. I first show how such ‘diversion effects’ are possible and then examine four principles of research ethics in that light. I then consider several objections to the argument that those who promulgate principles of research ethics should consider diversion effects. PMID:25937934

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.

Ethical, legal, social, and policy issues in the use of genomic technology by the U.S. Military

PubMed Central

Mehlman, Maxwell J.; Li, Tracy Yeheng

2014-01-01

Advances in genomic science are attracting the interest of the U.S. military for their potential to improve medical care for members of the military and to aid in military recruitment, training, specialization, and mission accomplishment. While researchers have explored the ethical, legal, and social issues raised by the use of genomic science in a wide variety of contexts, there has been virtually no examination of these issues in connection with the use of genomics by the military. This article identifies potential uses of genomic science by the military, proposes an applicable ethical and legal framework, and applies the framework to provide ethical and legal guidance for military decision-makers. PMID:25937933

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

Ethical limitations in patenting biotechnological inventions.

PubMed

Lugagnani, V

1999-01-01

In order to connect ethical considerations with practical limits to patentability, the moral judgement should possibly move from the exploitation of the invention to the nature and/or objectives of Research and Development (R&D) projects which have produced it: in other words, it appears quite reasonable and logical that Society is not rewarding unethical R&D activities by granting intellectual property rights. As far as biotechnology R&D is concerned, ethical guidance can be derived from the 1996 Council of EuropeOs OConvention for the protection of human rights and dignity of the human being with regard to the application of biology and medicineO, whose Chapter V - Scientific research - provides guidelines on: i. protection of persons undergoing research (e.g. informed consent); ii. protection of persons not able to consent to research; iii. research on embryos in vitro. As far as the specific point of patenting biotechnology inventions is concerned, the four exclusions prescribed by Directive 98/44/EC (i.e. human cloning, human germ-line gene therapy, use of human embryos for commercial purposes, unjustified animal suffering for medical purposes) are all we have in Europe in terms of ethical guidance to patentability. In Italy, in particular, we certainly need far more comprehensive legislation, expressing SocietyOs demand to provide ethical control of modern biotechnology. However it is quite difficult to claim that ethical concerns are being raised by currently awarded biotechnology patents related to living organisms and material thereof; they largely deal with the results of genomic R&D, purposely and usefully oriented toward improving health-care and agri-food processes, products and services. ONo patents on lifeOO can be an appealing slogan of militants against modern biotechnology, but it is far too much of an over-simplified abstraction to become the Eleventh Commandment our Society.

Ethical challenges in resuscitation.

PubMed

Mentzelopoulos, Spyros D; Slowther, Anne-Marie; Fritz, Zoe; Sandroni, Claudio; Xanthos, Theodoros; Callaway, Clifton; Perkins, Gavin D; Newgard, Craig; Ischaki, Eleni; Greif, Robert; Kompanje, Erwin; Bossaert, Leo

2018-06-01

A rapidly evolving resuscitation science provides more effective treatments to an aging population with multiple comorbidites. Concurrently, emergency care has become patient-centered. This review aims to describe challenges associated with the application of key principles of bioethics in resuscitation and post-resuscitation care; propose actions to address these challenges; and highlight the need for evidence-based ethics and consensus on ethical principles interpretation. Following agreement on the article's outline, subgroups of 2-3 authors provided narrative reviews of ethical issues concerning autonomy and honesty, beneficence/nonmaleficence and dignity, justice, specific practices/circumstances such as family presence during resuscitation, and emergency research. Proposals for addressing ethical challenges were also offered. Respect for patient autonomy can be realized through honest provision of information, shared decision-making, and advance directives/care planning. Essential prerequisites comprise public and specific healthcare professionals' education, appropriate regulatory provisions, and allocation of adequate resources. Regarding beneficence/nonmaleficence, resuscitation should benefit patients, while avoiding harm from futile interventions; pertinent practice should be based on neurological prognostication and patient/family-reported outcomes. Regarding dignity, aggressive life-sustaining treatments against patients preferences should be avoided. Contrary to the principle of justice, resuscitation quality may be affected by race/income status, age, ethnicity, comorbidity, and location (urban versus rural or country-specific/region-specific). Current evidence supports family presence during resuscitation. Regarding emergency research, autonomy should be respected without hindering scientific progress; furthermore, transparency of research conduct should be promoted and funding increased. Major ethical challenges in resuscitation science need to be addressed through complex/resource-demanding interventions. Such actions require support by ongoing/future research.

Ethics of the electrified mind: Defining issues and perspectives on the principled use of brain stimulation in medical research and clinical care

PubMed Central

Cabrera, Laura Y.; Evans, Emily L.; Hamilton, Roy H.

2013-01-01

In recent years, non-pharmacologic approaches to modifying human neural activity have gained increasing attention. One of these approaches is brain stimulation, which involves either the direct application of electrical current to structures in the nervous system or the indirect application of current by means of electromagnetic induction. Interventions that manipulate the brain have generally been regarded as having both the potential to alleviate devastating brain-related conditions and the capacity to create unforeseen and unwanted consequences. Hence, although brain stimulation techniques offer considerable benefits to society, they also raise a number of ethical concerns. In this paper we will address various dilemmas related to brain stimulation in the context of clinical practice and biomedical research. We will survey current work involving deep brain stimulation (DBS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). We will reflect upon relevant similarities and differences between them, and consider some potentially problematic issues that may arise within the framework of established principles of medical ethics: nonmaleficence and beneficence, autonomy, and justice. PMID:23733209

Research Ethics Capacity Building in Sub-Saharan Africa: A Review of NIH Fogarty-Funded Programs 2000–2012

PubMed Central

Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A.; Meslin, Eric M.

2014-01-01

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program. PMID:24782070

Research ethics capacity building in Sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012.

PubMed

Ndebele, Paul; Wassenaar, Douglas; Benatar, Solomon; Fleischer, Theodore; Kruger, Mariana; Adebamowo, Clement; Kass, Nancy; Hyder, Adnan A; Meslin, Eric M

2014-04-01

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

Ethical Issues in Neuromarketing: "I Consume, Therefore I am!".

PubMed

Ulman, Yesim Isil; Cakar, Tuna; Yildiz, Gokcen

2015-10-01

Neuromarketing is a recent interdisciplinary field which crosses traditional boundaries between neuroscience, neuroeconomics and marketing research. Since this nascent field is primarily concerned with improving marketing strategies and promoting sales, there has been an increasing public aversion and protest against it. These protests can be exemplified by the reactions observed lately in Baylor School of Medicine and Emory University in the United States. The most recent attempt to stop ongoing neuromarketing research in France is also remarkable. The pertaining ethical issues have been continuously attracting much attention, especially since the number of neuromarketing companies has exceeded 300 world-wide. This paper begins with a brief introduction to the field of neurotechnology by presenting its current capabilities and limitations. Then, it will focus on the ethical issues and debates most related with the recent applications of this technology. The French Parliament's revision of rules on bioethics in 2004 has an exemplary role in our discussion. The proposal by Murphy et al. (2008) has attracted attention to the necessity of ethical codes structuring this field. A code has recently been declared by the Neuromarketing Science and Business Association. In this paper, it is argued that these technologies should be sufficiently discussed in public spheres and its use on humans should be fully carried out according to the ethical principles and legal regulations designed in line with human rights and human dignity. There is an urgent need in the interdisciplinary scientific bodies like ethics committees monitoring the research regarding the scientific and ethical values of nonmaleficence, beneficence, autonomy, confidentiality, right to privacy and protection of vulnerable groups.

Enhancing Research Ethics Capacity in the Middle East: Experience and Challenges of a Fogarty-Sponsored Training Program

PubMed Central

Silverman, Henry; Edwards, Hillary; Shamoo, Adil; Matar, Amal

2014-01-01

we describe the research ethics capacity needs of the countries from the Middle East region. Against this background, we relate the experience of an international training program focused on providing long-term training in research ethics to individuals from low- and middle-income countries in the Middle East area. We describe our pedagogical approach to training, program changes to address challenges faced, and accomplishments of trainees. Many former trainees developed research ethics curricula in their home institutions, established or enhanced their institutions’ research ethics committees, provided leadership to national research ethics systems, and conducted research in research ethics. Based on our analysis, we make recommendations for how trainees can further address current regional research ethics needs in the Middle East and conduct future research. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program. PMID:24384515

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…

Research Ethics Education in Post-Graduate Medical Curricula in I.R. Iran.

PubMed

Nikravanfard, Nazila; Khorasanizadeh, Faezeh; Zendehdel, Kazem

2017-08-01

Research ethics training during post-graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post-graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post-graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 (58%) of the programs. Among the 53 (42%) programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post-graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post-graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted. © 2016 John Wiley & Sons Ltd.

Research in Special Education: Designs, Methods, and Applications. Second Edition

ERIC Educational Resources Information Center

Rumrill, Phillip D., Jr.; Cook, Bryan G.; Wiley, Andrew L.

2011-01-01

The goal of this second edition is to provide a comprehensive overview of the philosophical, ethical, methodological, and analytical fundamentals of social science and educational research, as well as specify aspects of special education research that distinguish it from scientific inquiry in other fields of education and human services. Foremost…

Does medical education erode medical trainees' ethical attitude and behavior?

PubMed Central

Yavari, Neda

2016-01-01

In the last few years, medical education policy makers have expressed concern about changes in the ethical attitude and behavior of medical trainees during the course of their education. They claim that newly graduated physicians (MDs) are entering residency years with inappropriate habits and attitudes earned during their education. This allegation has been supported by numerous research on the changes in the attitude and morality of medical trainees. The aim of this paper was to investigate ethical erosion among medical trainees as a serious universal problem, and to urge the authorities to take urgent preventive and corrective action. A comparison with the course of moral development in ordinary people from Kohlberg’s and Gilligan's points of view reveals that the growth of ethical attitudes and behaviors in medical students is stunted or even degraded in many medical schools. In the end, the article examines the feasibility of teaching ethics in medical schools and the best approach for this purpose. It concludes that there is considerable controversy among ethicists on whether teaching ethical virtues is plausible at all. Virtue-based ethics, principle-based ethics and ethics of care are approaches that have been considered as most applicable in this regard. PMID:28050246

Research ethics board approval for an international thromboprophylaxis trial.

PubMed

Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

2012-06-01

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

Nursing students' understanding of factors influencing ethical sensitivity: A qualitative study.

PubMed

Borhani, Fariba; Abbaszadeh, Abbas; Mohsenpour, Mohaddeseh

2013-07-01

Ethical sensitivity is considered as a component of professional competency of nurses. Its effects on improvement of nurses' ethical performance and the therapeutic relationship between nurses and patients have been reported. However, very limited studies have evaluated ethical sensitivity. Since no previous Iranian research has been conducted in this regard, the present study aimed to review nursing students' understanding of effective factors on ethical sensitivity. This qualitative study was performed in Kerman, Iran, during 2009. It used semi-structured individual interviews with eight MSc nursing students to assess their viewpoints. It also included two focus groups. Purposive sampling was continued until data saturation. Data were analyzed using manifest content analysis. The students' understanding of factors influencing ethical sensitivity were summarized in five main themes including individual and spiritual characteristics, education, mutual understanding, internal and external controls, and experience of an immoral act. The findings of this study create a unique framework for sensitization of nurses in professional performance. The application of these factors in human resource management is reinforcement of positive aspects and decrease in negative aspects, in education can use for educational objectives setting, and in research can designing studies based on this framework and making related tools. It is noteworthy that presented classification was influenced by students themselves and mentioned to a kind of learning activity by them.

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,…

Research Integrity and Research Ethics in Professional Codes of Ethics: Survey of Terminology Used by Professional Organizations across Research Disciplines.

PubMed

Komić, Dubravka; Marušić, Stjepan Ljudevit; Marušić, Ana

2015-01-01

Professional codes of ethics are social contracts among members of a professional group, which aim to instigate, encourage and nurture ethical behaviour and prevent professional misconduct, including research and publication. Despite the existence of codes of ethics, research misconduct remains a serious problem. A survey of codes of ethics from 795 professional organizations from the Illinois Institute of Technology's Codes of Ethics Collection showed that 182 of them (23%) used research integrity and research ethics terminology in their codes, with differences across disciplines: while the terminology was common in professional organizations in social sciences (82%), mental health (71%), sciences (61%), other organizations had no statements (construction trades, fraternal social organizations, real estate) or a few of them (management, media, engineering). A subsample of 158 professional organizations we judged to be directly involved in research significantly more often had statements on research integrity/ethics terminology than the whole sample: an average of 10.4% of organizations with a statement (95% CI = 10.4-23-5%) on any of the 27 research integrity/ethics terms compared to 3.3% (95% CI = 2.1-4.6%), respectively (P<0.001). Overall, 62% of all statements addressing research integrity/ethics concepts used prescriptive language in describing the standard of practice. Professional organizations should define research integrity and research ethics issues in their ethics codes and collaborate within and across disciplines to adequately address responsible conduct of research and meet contemporary needs of their communities.

What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

PubMed

Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

2017-06-01

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

[Applying Ethics, Placating Ethics, or Applying ourselves to Ethics? A Critical View of Environmental Ethics as Applied Ethics].

PubMed

Serani Merlo, Alejandro

2016-01-01

There is actually a pervasive tendency to consider environmental ethics and bioethics as specific cases pertaining to a supposed kind of ″applied ethics″. Application can be understood in two different meanings: a concrete sense, as in technical applications, and a psychological meaning, as when we mentally apply ourselves to a task. Ethics has been always thought as a practical knowledge, in a ″praxical″ sense and not in a ″poietic″ one. Ethics has to do with ″ends″ not with ″means″; in this sense ethics is ″useless″. Since ethics has to do with the ultimate meaning of things, ethical choices give meaning to all practical activities. In that sense ethics instead of being useless must be considered as ″over-useful″ (Maritain). Nowadays politics tend to instrumentalize ethics in order to political objectives. The consequence has been the reconceptualization of specific ethics as applied ethics. Environmental ethics and bioethics are then submitted to politics following the logic of technical applications. Environmental ethics and bioethics considered as applied ethics are at risk to becoming not only useless, but also meaningless.

Ethical considerations in community oral health.

PubMed

Naidoo, Sudeshni

2015-05-01

As the public's oral health care needs increase in complexity, there is renewed attention to the ethical dimensions of community oral health decision making and the development of public health ethics in teaching and research in dentistry. Despite their reduction globally, oral diseases persist with a particular distribution pattern that is a reflection of the increasingly widespread inequality in access to community oral health preventive and dental care. This is due to differences in the appropriateness, availability, accessibility, and acceptability of oral health education and the care provided. This article provides an overview of community oral health from an ethical perspective, including the importance of equity, human rights, and social justice in providing oral health care to the underserved. The need for a paradigm shift from highly technical and individualistic dental training curricula is discussed, together with the need to instill a holistic approach to ethical and social responsibility in new dental graduates. It concludes with some possible strategies, using the overarching principles of ethics and bioethics that are applicable to practice among vulnerable populations.

Research ethics and approval process: A guide for new GP researchers.

PubMed

Liaw, Siaw-Teng; Tam, Chun Wah Michael

2015-06-01

The underlying moral principles and values, and the virtues held as desirable for a researcher, should be reflected upon and embedded in the research. The foundation step is to download the National Health and Medical Research Council's (NHMRC's) National Statement on Ethical Conduct in Human Research and the NHMRC's Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research to use as references. This paper draws on the experience of The Royal Australian College of General Practitioners' (RACGP's) National Research and Evaluation Ethics Committee to provide an eight-step approach to the research ethics process. The researcher should use the research ethics process as an opportunity to foster and guide the development and conduct of ethical research.

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…

A Research Agenda for Humanitarian Health Ethics

PubMed Central

Hunt, Matthew; Schwartz, Lisa; Pringle, John; Boulanger, Renaud; Nouvet, Elysée; O'Mathúna, Dónal; Arya, Neil; Bernard, Carrie; Beukeboom, Carolyn; Calain, Philippe; de Laat, Sonya; Eckenwiler, Lisa; Elit, Laurie; Fraser, Veronique; Gillespie, Leigh-Anne; Johnson, Kirsten; Meagher, Rachel; Nixon, Stephanie; Olivier, Catherine; Pakes, Barry; Redwood-Campbell, Lynda; Reis, Andreas; Renaldi, Teuku; Singh, Jerome; Smith, Maxwell; Von Schreeb, Johan

2014-01-01

This paper maps key research questions for humanitarian health ethics: the ethical dimensions of healthcare provision and public health activities during international responses to situations of humanitarian crisis. Development of this research agenda was initiated at the Humanitarian Health Ethics Forum (HHE Forum) convened in Hamilton, Canada in November 2012. The HHE Forum identified priority avenues for advancing policy and practice for ethics in humanitarian health action. The main topic areas examined were: experiences and perceptions of humanitarian health ethics; training and professional development initiatives for humanitarian health ethics; ethics support for humanitarian health workers; impact of policies and project structures on humanitarian health ethics; and theoretical frameworks and ethics lenses. Key research questions for each topic area are presented, as well as proposed strategies for advancing this research agenda. Pursuing the research agenda will help strengthen the ethical foundations of humanitarian health action. PMID:25687273

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.

Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues

PubMed Central

Harper, Barbara; Stone, Dave; O’Neill, Catherine; Berger, Patricia; Harris, Stuart; Donatuto, Jamie

2011-01-01

Background: When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers. Objectives: In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health–related or natural-resource–related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements. Discussion: Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control. Conclusions: Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource–related IPR considerations. PMID:21890450

A surety engineering framework to reduce cognitive systems risks.

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

Caudell, Thomas P.; Peercy, David Eugene; Caldera, Eva O.

Cognitive science research investigates the advancement of human cognition and neuroscience capabilities. Addressing risks associated with these advancements can counter potential program failures, legal and ethical issues, constraints to scientific research, and product vulnerabilities. Survey results, focus group discussions, cognitive science experts, and surety researchers concur technical risks exist that could impact cognitive science research in areas such as medicine, privacy, human enhancement, law and policy, military applications, and national security (SAND2006-6895). This SAND report documents a surety engineering framework and a process for identifying cognitive system technical, ethical, legal and societal risks and applying appropriate surety methods to reducemore » such risks. The framework consists of several models: Specification, Design, Evaluation, Risk, and Maturity. Two detailed case studies are included to illustrate the use of the process and framework. Several Appendices provide detailed information on existing cognitive system architectures; ethical, legal, and societal risk research; surety methods and technologies; and educing information research with a case study vignette. The process and framework provide a model for how cognitive systems research and full-scale product development can apply surety engineering to reduce perceived and actual risks.« less

Conducting research with tribal communities: sovereignty, ethics, and data-sharing issues.

PubMed

Harding, Anna; Harper, Barbara; Stone, Dave; O'Neill, Catherine; Berger, Patricia; Harris, Stuart; Donatuto, Jamie

2012-01-01

When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers. In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health-related or natural-resource-related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements. Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control. Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource-related IPR considerations.

When "Research Ethics" Become "Everyday Ethics": The Intersection of Inquiry and Practice in Practitioner Research

ERIC Educational Resources Information Center

Mockler, Nicole

2014-01-01

The act of engaging in sound and ethical practitioner research, regardless of context, encourages and indeed demands an alignment between the ethical framework employed in the research enterprise and the "everyday ethics" of practice. This paper explores the ethical dimensions of what Cochran-Smith and Lytle have termed the dialectic of…

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

Emerging ethical perspectives in the clustered regularly interspaced short palindromic repeats genome-editing debate

PubMed Central

Camporesi, Silvia; Cavaliere, Giulia

2016-01-01

This paper provides an overview of the ethical issues in the international clustered regularly interspaced short palindromic repeats (CRISPR) genome editing debate from March 2015 to September 2016. We present the regulatory framework for embryo research in the UK, and explain why CRISPR is not a significant break with the past. We discuss the ethical issues arising from CRISPR applications beyond human embryos, namely the use of gene drive-engineered mosquitoes to eradicate diseases, engineering nonhuman animals to harvest organs for human transplant and engineering crops. We discuss the experiments that have demonstrated the technical feasibility of cultivating embryos in vitro for up to 14 days, and possibly beyond this limit, and the ethical issues arising from the proposal to extend the limit beyond 14 days. PMID:28757883

Emerging ethical perspectives in the clustered regularly interspaced short palindromic repeats genome-editing debate.

PubMed

Camporesi, Silvia; Cavaliere, Giulia

2016-11-01

This paper provides an overview of the ethical issues in the international clustered regularly interspaced short palindromic repeats (CRISPR) genome editing debate from March 2015 to September 2016. We present the regulatory framework for embryo research in the UK, and explain why CRISPR is not a significant break with the past. We discuss the ethical issues arising from CRISPR applications beyond human embryos, namely the use of gene drive-engineered mosquitoes to eradicate diseases, engineering nonhuman animals to harvest organs for human transplant and engineering crops. We discuss the experiments that have demonstrated the technical feasibility of cultivating embryos in vitro for up to 14 days, and possibly beyond this limit, and the ethical issues arising from the proposal to extend the limit beyond 14 days.

Research Ethics: Researchers Consider How Best to Prevent Misconduct in Research in Malaysian Higher Learning Institutions Through Ethics Education.

PubMed

Olesen, Angelina Patrick; Amin, Latifah; Mahadi, Zurina

2018-05-01

The purpose of this study is to encourage and highlight discussion on how to improve the teaching of research ethics in institutions of higher education in Malaysia. Drawing on semi-structured interviews with 21 academics in a research-intensive university in Malaysia, interviewees agreed on the importance of emphasizing the subject of research ethics among students, as well as academics or researchers. This study reveals that participants felt that there is an urgent need to improve the current awareness and knowledge of issues related to misconduct in research among students and academics. The results of this study indicate a need for better teaching on the subject of research ethics in order to prevent misconduct in research. Finally, it concludes with suggestions that there should be a clear definition of research misconduct, to include consequences when engaging in misconduct; a separate research ethics syllabus for pure and social sciences should be conducted; research ethics should be implemented as a core subject, and there should be an early intervention and continuous learning of research ethics, with an emphasis on ethics training.

The three official language versions of the Declaration of Helsinki: what's lost in translation?

PubMed

Carlson, Robert V; van Ginneken, Nadja H; Pettigrew, Luisa M; Davies, Alan; Boyd, Kenneth M; Webb, David J

2007-09-01

The Declaration of Helsinki, the World Medical Association's (WMA's) statement of ethical guidelines regarding medical research, is published in the three official languages of the WMA: English, French and Spanish. A detailed comparison of the three official language versions was carried out to determine ways in which they differed and ways in which the wording of the three versions might illuminate the interpretation of the document. There were many minor linguistic differences between the three versions. However, in paragraphs 1, 6, 29, 30 and in the note of clarification to paragraph 29, there were differences that could be considered potentially significant in their ethical relevance. Given the global status of the Declaration of Helsinki and the fact that it is translated from its official versions into many other languages for application to the ethical conduct of research, the differences identified are of concern. It would be best if such differences could be eliminated but, at the very least, a commentary to explain any differences that are unavoidable on the basis of language or culture should accompany the Declaration of Helsinki. This evidence further strengthens the case for international surveillance of medical research ethics as has been proposed by the WMA.

[Learning objectives achievement in ethics education for medical school students].

PubMed

Chae, Sujin; Lim, Kiyoung

2015-06-01

This study aimed to examine the necessity for research ethics and learning objectives in ethics education at the undergraduate level. A total of 393 fourth-year students, selected from nine medical schools, participated in a survey about learning achievement and the necessity for it. It was found that the students had very few chances to receive systematic education in research ethics and that they assumed that research ethics education was provided during graduate school or residency programs. Moreover, the students showed a relatively high learning performance in life ethics, while learning achievement was low in research ethics. Medical school students revealed low interest in and expectations of research ethics in general; therefore, it is necessary to develop guidelines for research ethics in the present situation, in which medical education mainly focuses on life ethics.

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

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.

Research Integrity and Research Ethics in Professional Codes of Ethics: Survey of Terminology Used by Professional Organizations across Research Disciplines

PubMed Central

Komić, Dubravka; Marušić, Stjepan Ljudevit; Marušić, Ana

2015-01-01

Professional codes of ethics are social contracts among members of a professional group, which aim to instigate, encourage and nurture ethical behaviour and prevent professional misconduct, including research and publication. Despite the existence of codes of ethics, research misconduct remains a serious problem. A survey of codes of ethics from 795 professional organizations from the Illinois Institute of Technology’s Codes of Ethics Collection showed that 182 of them (23%) used research integrity and research ethics terminology in their codes, with differences across disciplines: while the terminology was common in professional organizations in social sciences (82%), mental health (71%), sciences (61%), other organizations had no statements (construction trades, fraternal social organizations, real estate) or a few of them (management, media, engineering). A subsample of 158 professional organizations we judged to be directly involved in research significantly more often had statements on research integrity/ethics terminology than the whole sample: an average of 10.4% of organizations with a statement (95% CI = 10.4-23-5%) on any of the 27 research integrity/ethics terms compared to 3.3% (95% CI = 2.1–4.6%), respectively (P<0.001). Overall, 62% of all statements addressing research integrity/ethics concepts used prescriptive language in describing the standard of practice. Professional organizations should define research integrity and research ethics issues in their ethics codes and collaborate within and across disciplines to adequately address responsible conduct of research and meet contemporary needs of their communities. PMID:26192805

The normative background of empirical-ethical research: first steps towards a transparent and reasoned approach in the selection of an ethical theory.

PubMed

Salloch, Sabine; Wäscher, Sebastian; Vollmann, Jochen; Schildmann, Jan

2015-04-04

Empirical-ethical research constitutes a relatively new field which integrates socio-empirical research and normative analysis. As direct inferences from descriptive data to normative conclusions are problematic, an ethical framework is needed to determine the relevance of the empirical data for normative argument. While issues of normative-empirical collaboration and questions of empirical methodology have been widely discussed in the literature, the normative methodology of empirical-ethical research has seldom been addressed. Based on our own research experience, we discuss one aspect of this normative methodology, namely the selection of an ethical theory serving as a background for empirical-ethical research. Whereas criteria for a good ethical theory in philosophical ethics are usually related to inherent aspects, such as the theory's clarity or coherence, additional points have to be considered in the field of empirical-ethical research. Three of these additional criteria will be discussed in the article: (a) the adequacy of the ethical theory for the issue at stake, (b) the theory's suitability for the purposes and design of the empirical-ethical research project, and (c) the interrelation between the ethical theory selected and the theoretical backgrounds of the socio-empirical research. Using the example of our own study on the development of interventions which support clinical decision-making in oncology, we will show how the selection of an ethical theory as a normative background for empirical-ethical research can proceed. We will also discuss the limitations of the procedures chosen in our project. The article stresses that a systematic and reasoned approach towards theory selection in empirical-ethical research should be given priority rather than an accidental or implicit way of choosing the normative framework for one's own research. It furthermore shows that the overall design of an empirical-ethical study is a multi-faceted endeavor which has to balance between theoretical and pragmatic considerations.

An Argument for Fewer Clinical Trials.

PubMed

Borgerson, Kirstin

2016-11-01

The volume of clinical research is increasing exponentially-far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because "quality" is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in "usual" care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. © 2016 The Hastings Center.

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.

Research Ethics 2.0: New Perspectives on Norms, Values, and Integrity in Genomic Research in Times of Even Scarcer Resources

PubMed Central

Brall, Caroline; Maeckelberghe, Els; Porz, Rouven; Makhoul, Jihad; Schröder-Bäck, Peter

2017-01-01

Research ethics anew gained importance due to the changing scientific landscape and increasing demands and competition in the academic field. These changes are further exaggerated because of scarce(r) resources in some countries on the one hand and advances in genomics on the other. In this paper, we will highlight the current challenges thereof to scientific integrity. To mark key developments in research ethics, we will distinguish between what we call research ethics 1.0 and research ethics 2.0. Whereas research ethics 1.0 focuses on individual integrity and informed consent, research ethics 2.0 entails social scientific integrity within a broader perspective of a research network. This research network can be regarded as a network of responsibilities in which every stakeholder involved has to jointly meet the ethical challenges posed to research. PMID:28288472

Research Ethics 2.0: New Perspectives on Norms, Values, and Integrity in Genomic Research in Times of Even Scarcer Resources.

PubMed

Brall, Caroline; Maeckelberghe, Els; Porz, Rouven; Makhoul, Jihad; Schröder-Bäck, Peter

2017-01-01

Research ethics anew gained importance due to the changing scientific landscape and increasing demands and competition in the academic field. These changes are further exaggerated because of scarce(r) resources in some countries on the one hand and advances in genomics on the other. In this paper, we will highlight the current challenges thereof to scientific integrity. To mark key developments in research ethics, we will distinguish between what we call research ethics 1.0 and research ethics 2.0. Whereas research ethics 1.0 focuses on individual integrity and informed consent, research ethics 2.0 entails social scientific integrity within a broader perspective of a research network. This research network can be regarded as a network of responsibilities in which every stakeholder involved has to jointly meet the ethical challenges posed to research. © 2017 S. Karger AG, Basel.

Health research involving First Nations, Inuit and Métis children and their communities

PubMed Central

Starkes, Jill M; Baydala, Lola T

2014-01-01

Canadian and international guidelines address the ethical conduct of health research in general and the issues affecting Indigenous populations in particular. This statement summarizes, for clinicians and researchers, relevant ethical and practical considerations for health research involving Aboriginal children and youth. While not intended to duplicate findings arising from lengthy collaborative processes, it does highlight ‘wise practices’ that have successfully generated knowledge relevant to, respectful of and useful for Aboriginal children, youth and their communities. Further research on current health issues and inequities should lead to practical, effective and culturally relevant applications. Expanding our knowledge of ways to address the health disparities facing Canada’s Aboriginal children and youth can inform health policy and the provision of services. Community-based participatory research is proposed as a means to achieve this goal. PMID:24596485

Twenty-first Century ethics of medical research involving human subjects: achievements and challenges.

PubMed

Tzamaloukas, Antonios H; Konstantinov, Konstantin N; Agaba, Emmanuel I; Raj, Dominic S C; Murata, Glen H; Glew, Robert H

2008-01-01

The field of ethics in medical research has seen important developments in the last three decades, but it also faces great challenges in the new century. The purposes of this report are to examine the current status of ethics of medical research involving human subjects and the nature of the ethical challenges facing this research, to identify the weakness of the current system of safeguards for ethical research, and to stress the importance of the ethical character of the researcher, which is the safeguard that has the greatest potential for protecting the research subjects. Researchers appreciate the risks of human medical research that create ethical dilemmas and the need for an ethical compromise in order to proceed with the research. The main elements of the compromise, formulated primarily from experiences in the Second World War, include: (1) the dominant position of the ethical principle of autonomy; (2) the demand for a signed informed consent; (3) the likelihood of improving health with the research protocol, which must be approved by a duly appointed supervising committee; and (4) an acceptable risk/benefit ratio. The main weakness of this set of safeguards is the difficulty with obtaining a truly informed consent. The new challenges to ethical medical research stem from certain types of research, such as genetic and stem cell research, and from the increasing involvement of the industry in planning and funding the research studies. Developing medical researchers with an ethical character and knowledge about ethics in medicine may be the most effective safeguard in protecting participants of medical research experiments.

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.

Maori responsiveness in health and medical research: key issues for researchers (part 1).

PubMed

Sporle, Andrew; Koea, Jonathan

2004-08-06

Application for contestable government-research funding and ethical approval requires researchers to outline how their intended research project contributes to Maori development or advancement. When formulating their research proposals, the key issues for researchers are research utility, defining Maori, informed consent, confidentiality, issues with human tissues and genetic material, participant remuneration and recognition (koha), intellectual property, and involvement of local Maori health or social services. The most common Maori responsiveness issues in research applications can be readily approached by researchers who address straightforward methodological concerns, by working through precedents established by peers and colleagues, as well as by working with end-users of their research.

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.

Introduction: international research ethics education.

PubMed

Millum, Joseph; Sina, Barbara

2014-04-01

NIH's Fogarty International Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly changing health research landscape. This collection of papers is the result.

Introduction: International Research Ethics Education

PubMed Central

Millum, Joseph; Sina, Barbara

2016-01-01

NIH's fogarty international Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly changing health research landscape. This collection of papers is the result. PMID:24782067

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.

Emergency response in a global health crisis: epidemiology, ethics, and Ebola application.

PubMed

Salerno, Jennifer; Hlaing, WayWay M; Weiser, Thomas; Striley, Catherine; Schwartz, Lisa; Angulo, Frederick J; Neslund, Verla S

2016-04-01

The link between ethics and epidemiology can go unnoticed in contemporary gatherings of professional epidemiologists or trainees at conferences and workshops, as well as in teaching. Our goal is to provide readers with information about the activities of the College and to provide a broad perspective on a recent major issue in epidemiology. The Ethics Committee of the American College of Epidemiology (ACE) presented a plenary session at the 2015 Annual Meeting in Atlanta, GA, on the complexities of ethics and epidemiology in the context of the 2014-2015 Ebola virus disease outbreak and response in West Africa. This article presents a summary and further discussion of that plenary session. Three main topic areas were presented: clinical trials and ethics in public health emergencies, public health practice, and collaborative work. A number of key ethical concepts were highlighted and discussed in relation to Ebola and the ACE Ethics Guidelines. The Ebola virus disease outbreak is an example of a public health humanitarian crisis from which we hope to better understand the role of professional epidemiologists in public health practice and research and recognize ethical challenges epidemiologists faced. Copyright © 2016 Elsevier Inc. All rights reserved.

[Clinical trials: vulnerability and ethical relativism].

PubMed

Lima, Cristina

2005-01-01

Research in human beings is an important chapter of medical ethics. In recent years, investigation has been taken over by profit driven corporations that must guarantee the medical and commercial application of results. This new model of investigation has generated conflicts of interest in doctor-patient, researcher-subject relationship. The inevitable debate and media reaction has led. These trials of controversial design to regions of the globe where the vulnerability of the populations continues to allow their undertaking. This article includes a historical perspective on experimentation in human beings and the conditions that led to its regulation: the Nuremberg CODE, followed by the Helsinky Declaration in its different versions, and the Belmont Report, that defend the subject according to the ethic of principles used in western medicine. There is then a review of the attempts to change international regulation to reintroduce clinical trials with placebo--which since 1996 is only permitted where there are no therapeutic or diagnostic methods--on populations that would otherwise have no access to treatment. This then leads on to the issue of double standards in medical investigation defended by many investigators and some official entities. The article concludes that it may be prudent to allow local ethical commissions to approve deviation from the established norm if such is necessary to resolve urgent questions of health in the country, but it is unacceptable that any such emergency is used as a reason to reduce the ethical prerequisites, in clinical trials. It also concludes that true urgency is in making available to all who need it the effective products already in existence. Furthermore, that the acceptance of ethical relativism can result in the exploitation of vulnerable third world populations for research programmes that cannot be undertaken in their sponsoring countries due to the ethical restrictions in place.

Ethical Issues of Social Media Usage in Healthcare.

PubMed

Denecke, K; Bamidis, P; Bond, C; Gabarron, E; Househ, M; Lau, A Y S; Mayer, M A; Merolli, M; Hansen, M

2015-08-13

Social media, web and mobile technologies are increasingly used in healthcare and directly support patientcentered care. Patients benefit from disease self-management tools, contact to others, and closer monitoring. Researchers study drug efficiency, or recruit patients for clinical studies via these technologies. However, low communication barriers in socialmedia, limited privacy and security issues lead to problems from an ethical perspective. This paper summarizes the ethical issues to be considered when social media is exploited in healthcare contexts. Starting from our experiences in social-media research, we collected ethical issues for selected social-media use cases in the context of patient-centered care. Results were enriched by collecting and analyzing relevant literature and were discussed and interpreted by members of the IMIA Social Media Working Group. Most relevant issues in social-media applications are confidence and privacy that need to be carefully preserved. The patient-physician relationship can suffer from the new information gain on both sides since private information of both healthcare provider and consumer may be accessible through the Internet. Physicians need to ensure they keep the borders between private and professional intact. Beyond, preserving patient anonymity when citing Internet content is crucial for research studies. Exploiting medical social-media in healthcare applications requires a careful reflection of roles and responsibilities. Availability of data and information can be useful in many settings, but the abuse of data needs to be prevented. Preserving privacy and confidentiality of online users is a main issue, as well as providing means for patients or Internet users to express concerns on data usage.

Ethical Issues of Social Media Usage in Healthcare

PubMed Central

Bamidis, P.; Bond, C.; Gabarron, E.; Househ, M.; Lau, A. Y. S.; Mayer, M. A.; Merolli, M.; Hansen, M.

2015-01-01

Summary Objective Social media, web and mobile technologies are increasingly used in healthcare and directly support patient-centered care. Patients benefit from disease self-management tools, contact to others, and closer monitoring. Researchers study drug efficiency, or recruit patients for clinical studies via these technologies. However, low communication barriers in social-media, limited privacy and security issues lead to problems from an ethical perspective. This paper summarizes the ethical issues to be considered when social media is exploited in healthcare contexts. Methods Starting from our experiences in social-media research, we collected ethical issues for selected social-media use cases in the context of patient-centered care. Results were enriched by collecting and analyzing relevant literature and were discussed and interpreted by members of the IMIA Social Media Working Group. Results Most relevant issues in social-media applications are confidence and privacy that need to be carefully preserved. The patient-physician relationship can suffer from the new information gain on both sides since private information of both healthcare provider and consumer may be accessible through the Internet. Physicians need to ensure they keep the borders between private and professional intact. Beyond, preserving patient anonymity when citing Internet content is crucial for research studies. Conclusion Exploiting medical social-media in healthcare applications requires a careful reflection of roles and responsibilities. Availability of data and information can be useful in many settings, but the abuse of data needs to be prevented. Preserving privacy and confidentiality of online users is a main issue, as well as providing means for patients or Internet users to express concerns on data usage. PMID:26293861

Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

PubMed

Chaudhry, Shazia H; Brehaut, Jamie C; Grimshaw, Jeremy M; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Skea, Zoë C; Zwarenstein, Merrick; Taljaard, Monica

2013-04-01

Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.

[Research ethics committees: a necessary good].

PubMed

Riera, Alejandra V

2013-12-01

The Nuremberg Code, issued as the result of the deliberations of the Nuremberg Trials, which judged the atrocities carried out during Nazi Germany (1933-1945), was the first universal document that defined research ethics principles for human experimentation. This code served as the basis for the subsequent ethical codes and principles used today by the Research Ethics Committees. The Research Ethics Committee is a multidisciplinary body whose primary role is to protect the rights and welfare of research subjects through the review of research protocols, ensuring compliance with internationally and locally accepted ethical guidelines. Worldwide, there have been important improvements in order to promote and regulate bioethics in medical research. In Venezuela, several national organizations have been constituted with the aim of promoting the establishment of ethics committees; however, there has not been a significant progress in the quantity or quality of the functioning of Research Ethics Committees in the country. It is imperative for each research institution to establish and work to improve their ethics committee to ensure the quality of the clinical research conducted, making it adherent to ethical codes, and safeguarding the integrity and credibility of the investigators and the research institutions, and more importantly, the patient's rights.

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.

Ethics Instruction for Future Geoscientists: Essential for Contributions to Good Public Policy

NASA Astrophysics Data System (ADS)

Leinen, M.; Mogk, D. W.

2016-12-01

Geoscientists work in a world of uncertainty in the complex, dynamic, and chaotic Earth system that is fraught with opportunities to become involved in ethical dilemmas. To be effective contributors to the public discourse on Earth science policy, geoscientists must conduct their work according to the highest personal and professional ethical standards. The geosciences as a discipline relies on the fidelity of geoscience data and their interpretations, geoscience concepts and methodologies must be conveyed to policy makers in ways that allow them to make informed decisions, corporations require a workforce that conducts their affairs according to the highest standards, and the general public expects the highest standards of conduct of geoscientists as they underwrite much of the research supported through tax dollars and the applications of this research impacts personal and societal lives. Geoscientists must have the foundations to identify ethical dilemmas in the first instance, and to have the ethical decision-making skills to either prevent, mitigate or otherwise address ethical issues that arise in professional practice. Awareness of ethical issues arises in many dimensions: Ethics and self (engaging self-monitoring and self-regulating behaviors); Ethics and profession (working according to professional standards); Ethics and society (communicating effectively to policy makers and the general public about the underlying science that informs public policy); and, Ethics and Earth (recognizing the unique responsibilities of geoscientists in the stewardship of Earth). To meet these ethical challenges, training of future geoscientists must be done a) at the introductory level as all students should be aware of ethical implications of geoscience concepts as they impact societal issues; undergraduate geoscience majors need to be explicitly trained in the standards and norms of the geoscience community of practice; graduate students need to be fully prepared to deal with ethical issues in future employment in the academy, government agencies or the industry. We have developed a comprehensive website, Teaching Geoethics Across the Geoscience Curriculum to support instruction in ethics at all levels: http://serc.carleton.edu/geoethics/index.html

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

Ethical principles in the work of nurse educator-A cross-sectional study.

PubMed

Salminen, Leena; Stolt, Minna; Metsämäki, Riikka; Rinne, Jenni; Kasen, Anne; Leino-Kilpi, Helena

2016-01-01

The application of ethical principles within the teaching profession and nursing practice forms the core of the nurse educator's professional ethics. However, research focusing on the professional ethics of nurse educators is scarce. To describe ethical principles and issues relating to the work of nurse educators from the perspectives of both nurse educators themselves and nursing students. A descriptive study using cross-sectional data and content analysis. Nursing education program involving students from nine polytechnics in Finland. Nursing students (n=202) and nurse educators (n=342). Data were derived from an online survey, with two open-ended questions: Nursing students and nurse educators were asked to name the three main ethical principles that guide the work of nurse educators and also to describe ethical issues involved in the work. Students most often named professionalism, justice, and equality as the main ethical principles for a nurse educator. Nurse educators considered justice, equality, and honesty as the main ethical principles. The content analysis showed that professionalism and the relationship between educator and student were the key categories for ethical issues as perceived by nursing students. Nursing students most often identified inequality between the nurse educator and nursing student as the ethical issue faced by the nurse educator. Nursing students and nurse educators differed somewhat both in their views of the ethical principles guiding an educator's work and in the ethical issues arising in the work. Copyright © 2015 Elsevier Ltd. All rights reserved.

Is it possible to assess the "ethics" of medical school applicants?

PubMed Central

Lowe, M.; Kerridge, I.; Bore, M.; Munro, D.; Powis, D.

2001-01-01

Questions surrounding the assessment of medical school applicants' morality are difficult but they are nevertheless important for medical schools to consider. It is probably inappropriate to attempt to assess medical school applicants' ethical knowledge, moral reasoning, or beliefs about ethical issues as these all may be developed during the process of education. Attitudes towards ethical issues and ethical sensitivity, however, might be tested in the context of testing for personality attributes. Before any "ethics" testing is introduced as part of screening for admission to medical school it would require validation. We suggest a number of ways in which this might be achieved. Key Words: Ethics • medical school selection • personality PMID:11731605

The Science and Ethics of Induced Pluripotency: What Will Become of Embryonic Stem Cells?

PubMed Central

Zacharias, David G.; Nelson, Timothy J.; Mueller, Paul S.; Hook, C. Christopher

2011-01-01

For over a decade, the field of stem cell research has advanced tremendously and gained new attention in light of novel insights and emerging developments for regenerative medicine. Invariably, multiple considerations come into play, and clinicians and researchers must weigh the benefits of certain stem cell platforms against the costs they incur. Notably, human embryonic stem (hES) cell research has been a source of continued debate, leading to differing policies and regulations worldwide. This article briefly reviews current stem cell platforms, looking specifically at the two existing pluripotent lines available for potential therapeutic applications: hES cells and induced pluripotent stem (iPS) cells. We submit iPS technology as a viable and possibly superior alternative for future medical and research endeavors as it obviates many ethical and resource-related concerns posed by hES cells while prospectively matching their potential for scientific use. However, while the clinical realities of iPS cells appear promising, we must recognize the current limitations of this technology, avoid hype, and articulate ethically acceptable medical and scientific goals. PMID:21719620

Ethical issues for bioscientists in the new millennium.

PubMed

Purchase, Iain F H

2002-02-28

The scientific understanding of biological processes is developing extremely fast, providing opportunities for changing people's lives in many ways-through health care, food and the environment. The speed with which these changes are occurring means that even bioscientists can only keep up with their own narrow field of science. It is not surprising that members of the public are frightened about the rapidity and impact of the changes arising from the biological revolution. These concerns are often expressed in ethical terms. Decision making about the direction of research and its application is becoming more transparent. This means that bioscientists will have to engage in the debate about their work with members of the public, including those who are opposed to it, in order to create acceptance of their work and its products. At the moment, bioscientists are often ill equipped to enter this debate because of their lack of training in ethics and lack of understanding of the impact of ethics on their work. A better understanding of bioethics will be necessary for entering this debate with vigour. A comprehensive ethical analysis is outside the scope of this text. Some of the principal arguments about the ethics of two aspects of bioscience research-genetically modified crops and the use of experimental animals-will be discussed to illustrate a few of the issues that derive from ethical analyses. I hope that this will encourage toxicologists to take a greater interest in bioethics.

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…

Canadian University Ethics Review: Cultural Complications Translating Principles into Practice

ERIC Educational Resources Information Center

Tilley, Susan; Gormley, Louise

2007-01-01

Drawing from educational research conducted in Canada and Mexico, university researchers explore how culture complicates both the ethics review process and the translation of ethical research principles into practice. University researchers in Canadian contexts seek approval from university Research Ethics Boards to conduct research, following…

Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees

ERIC Educational Resources Information Center

Hoecht, Andreas

2011-01-01

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…

Beyond Compliance Checking: A Situated Approach to Visual Research Ethics.

PubMed

Lenette, Caroline; Botfield, Jessica R; Boydell, Katherine; Haire, Bridget; Newman, Christy E; Zwi, Anthony B

2018-03-19

Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous.

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 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.

Experiences, behaviors, and perceptions of registered nurses regarding research ethics and misconduct.

PubMed

Asman, Oren; Melnikov, Semyon; Barnoy, Sivia; Tabak, Nili

2017-01-01

Nurses engaging in research are held to research ethics standards. Research aim: Examine experiences, behaviors, and perceptions of nurses in Israel regarding research ethics and explore possible related factors. An original investigator-designed self-administered questionnaire measured five variables: (a) ethics in research, (b) encountered research misconduct during the course of one's studies, (c) the inclination to fabricate data, (d) the inclination to select or omit data, and (e) knowledge of research misconduct in the workplace. Additionally, demographic data were collected. Participants and research context: The questionnaire was completed by 151 Israeli registered nurses. 10.2% hold a PhD, 34 % hold an MA, 42.2% hold a BA, and 13.6% with no academic degree. Ethical considerations: The study was approved by the University's ethics committee; anonymity and consent of the respondents were respected. Registered nurses' level of studies achieved was significantly associated with a lower inclination to fabricate data, with one exception-PhD nurses were more inclined to fabricate data than nurses with a Master's degree. A trend was found in which a higher level of studies is associated with higher knowledge of research misconduct in the workplace. Results indicate that nurses' perceptions of research ethics change throughout their academic studies, indicating a positive influence of level of studies, research experience, and work experience on ethics perceptions. Nevertheless, PhD nurses showed a greater inclination to actually select, omit, or even fabricate data than MA nurses. This may be related to pressure to publish. PhD nursing programs should include ethics training. Academic faculty members should serve as role models regarding research integrity. Research ethics deserves further emphasis on all levels of nurse education in Israel, as well as in the nurses' code of ethics and related documents. This may positively impact ethical research practices.

Ethical and Social Issues in Health Research Involving Incarcerated People.

PubMed

Coughlin, Steven S; Lewis, Sharon R; Smith, Selina A

2016-01-01

The use of inmates in research in the U.S. was restricted by the recommendations of the National Commission and by federal regulations and guidelines that followed. By the 1980s, many health care officials became concerned about the exclusion of inmates from experimental treatments for human immunodeficiency virus infection (HIV). These developments in ethics occurred in the context of racial/ethnic disparities in health. In this article, ethical considerations in clinical and public health research on HIV in prison and jail settings are considered. Ethical considerations in mental health research are summarized as well as issues pertaining to research involving female inmates. Issues related to oversight of research involving incarcerated people are considered along with the ethics of public health research. The ethics of research involving incarcerated people extends beyond traditional issues in human subjects ethics to include issues within the domains of bioethics and public health ethics.

Ethical and Social Issues in Health Research Involving Incarcerated People

PubMed Central

Coughlin, Steven S.; Lewis, Sharon R.; Smith, Selina A.

2016-01-01

The use of inmates in research in the U.S. was restricted by the recommendations of the National Commission and by federal regulations and guidelines that followed. By the 1980s, many health care officials became concerned about the exclusion of inmates from experimental treatments for human immunodeficiency virus infection (HIV). These developments in ethics occurred in the context of racial/ethnic disparities in health. In this article, ethical considerations in clinical and public health research on HIV in prison and jail settings are considered. Ethical considerations in mental health research are summarized as well as issues pertaining to research involving female inmates. Issues related to oversight of research involving incarcerated people are considered along with the ethics of public health research. The ethics of research involving incarcerated people extends beyond traditional issues in human subjects ethics to include issues within the domains of bioethics and public health ethics. PMID:27133509

Justifiability and Animal Research in Health: Can Democratisation Help Resolve Difficulties?

PubMed

Khoo, Shaun Yon-Seng

2018-02-14

Current animal research ethics frameworks emphasise consequentialist ethics through cost-benefit or harm-benefit analysis. However, these ethical frameworks along with institutional animal ethics approval processes cannot satisfactorily decide when a given potential benefit is outweighed by costs to animals. The consequentialist calculus should, theoretically, provide for situations where research into a disease or disorder is no longer ethical, but this is difficult to determine objectively. Public support for animal research is also falling as demand for healthcare is rising. Democratisation of animal research could help resolve these tensions through facilitating ethical health consumerism or giving the public greater input into deciding the diseases and disorders where animal research is justified. Labelling drugs to disclose animal use and providing a plain-language summary of the role of animals may help promote public understanding and would respect the ethical beliefs of objectors to animal research. National animal ethics committees could weigh the competing ethical, scientific, and public interests to provide a transparent mandate for animal research to occur when it is justifiable and acceptable. Democratic processes can impose ethical limits and provide mandates for acceptable research while facilitating a regulatory and scientific transition towards medical advances that require fewer animals.

A personalist approach to public-health ethics.

PubMed

Petrini, Carlo; Gainotti, Sabina

2008-08-01

First we give an overview of the historical development of public health. Then we present some public-health deontology codes and some ethical principles. We highlight difficulties in defining ethics for public health, with specific reference to three of them that concern: (i) the adaptability to public health of the classical principles of bioethics; (ii) the duty to respect and safeguard the individual while acting within the community perspective that is typical of public health; and (iii) the application-oriented nature of public health and the general lack of attention towards the ethical implications of collective interventions (compared with research). We then mention some proposals drafted from North American bioethics "principles" and utilitarian, liberal and communitarian views. Drawing from other approaches, personalism is outlined as being the theory that offers a consistent set of values and alternative principles that are relevant for public health.

Regulations and Ethical Considerations for Astronomy Education Research III: A Suggested Code of Ethics

NASA Astrophysics Data System (ADS)

Brogt, Erik; Foster, Tom; Dokter, Erin; Buxner, Sanlyn; Antonellis, Jessie

We present an argument for, and suggested implementation of, a code of ethics for the astronomy education research community. This code of ethics is based on legal and ethical considerations set forth by U.S. federal regulations and the existing code of conduct of the American Educational Research Association. We also provide a fictitious research study as an example for working through the suggested code of ethics.

Reflexive Research Ethics for Environmental Health and Justice: Academics and Movement-Building

PubMed Central

Cordner, Alissa; Ciplet, David; Brown, Phil; Morello-Frosch, Rachel

2012-01-01

Community-engaged research on environmental problems has reshaped researcher-participant relationships, academic-community interaction, and the role of community partners in human subjects protection and ethical oversight. We draw on our own and others’ research collaborations with environmental health and justice social movement organizations to discuss the ethical concerns that emerge in community-engaged research. In this paper we introduce the concept of reflexive research ethics: ethical guidelines and decision-making principles that depend on continual reflexivity concerning the relationships between researchers and participants. Seeing ethics in this way can help scientists conduct research that simultaneously achieves a high level of professional conduct and protects the rights, well-being, and autonomy of both researchers and the multiple publics affected by research. We highlight our research with community-based organizations in Massachusetts, California, and Alaska, and discuss the potential impacts of the community or social movement on the research process and the potential impacts of research on community or social movement goals. We conclude by discussing ways in which the ethical concerns that surface in community-engaged research have led to advances in ethical research practices. This type of work raises ethical questions whose answers are broadly relevant for social movement, environmental, and public health scholars. PMID:22690133

An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review.

PubMed

Farajkhoda, Tahmineh

2017-02-01

Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems, designing and establishing convenient collaborative educational courses at different levels.

An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

PubMed Central

Farajkhoda, Tahmineh

2017-01-01

Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems, designing and establishing convenient collaborative educational courses at different levels. PMID:28462397

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.

Brief report.

PubMed

Colnerud, Gunnel

2013-10-01

Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees, and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts, and problems in research. They were all researchers at the postdoctoral level in the fields of medicine, the humanities, education, and the social sciences, who devoted at least 50 percent of their working hours to research. They reported issues they face before, during, and after gathering data. Their range of issues is broader than generally discussed and points to the importance of researchers' ethical sensitivity.

The Human as an Experimental System in Molecular Genetics.

ERIC Educational Resources Information Center

White, Ray; Caskey, C. Thomas

1988-01-01

Discusses insights discovered from research into human biology that are raising possibilities for therapy, prevention of disease, and challenges to society in the form of ethical decisions about the appropriate application of genetic information. (Author/RT)

Research ethics in dissertations: ethical issues and complexity of reasoning.

PubMed

Kjellström, S; Ross, S N; Fridlund, B

2010-07-01

Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations. To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations. Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007. A total of seven ethical topics were identified: ethical approval (94% of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3-5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%). Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions.

Argumentation Based Bioethics Education: Sample Implementation on Genetically Modified Organisms (GMOs) and Genetic Screening Tests

ERIC Educational Resources Information Center

Ozer Keskin, Melike; Keskin Samanci, Nilay; Yaman, Hale

2013-01-01

Nowadays, there is a need in science education to consider scientific research and its applications alongside ethical consensus. Even though classroom debates of value issues have been demonstrated to significantly contribute to the raising of social consciousness and awareness, research shows that neither academics in higher education nor…

An ethic of analysis: an argument for critical analysis of research interviews as an ethical practice.

PubMed

Cloyes, Kristin Gates

2006-01-01

Nursing literature is replete with discussions about the ethics of research interviews. These largely involve questions of method, and how careful study design and data collection technique can render studies more ethical. Analysis, the perennial black box of the research process, is rarely discussed as an ethical practice. In this paper, I introduce the idea that analysis itself is an ethical practice. Specifically, I argue that political discourse analysis of research interviews is an ethical practice. I use examples from my own research in a prison control unit to illustrate what this might look like, and what is at stake.

The ethics of contacting family members of a subject in a genetic research study to return results for an autosomal dominant syndrome.

PubMed

Taylor, Holly A; Wilfond, Benjamin S

2013-01-01

This case explores the ethical landscape around recontacting a subject's relatives to return genetic research results when the informed consent form signed by the original cohort of subjects is silent on whether investigators may share new information with the research subject's family. As a result of rapid advances in genetic technology, methods to identify genetic markers can mature during the life course of a study. In this case, the investigators identified the genetic mutation responsible for the disorder after a number of their original subjects had died. The researchers now have the ability to inform relatives of the subject about their risk of developing the same disease. Mark Rothstein, JD, from the University of Louisville School of Medicine, provides an overview of the medical/scientific, legal, and ethical issues underlying this case. Lauren Milner, PhD, and colleagues at Stanford University explore how the relationship between researcher and subject affect this debate. Seema Shah, JD, and colleagues at the National Institutes of Health and University of California, Los Angeles (UCLA) discuss whether and how requirements of the duty to warn are applicable in this case.

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.

Ethical issues in neuroprosthetics

NASA Astrophysics Data System (ADS)

Glannon, Walter

2016-04-01

Objective. Neuroprosthetics are artificial devices or systems designed to generate, restore or modulate a range of neurally mediated functions. These include sensorimotor, visual, auditory, cognitive affective and volitional functions that have been impaired or lost from congenital anomalies, traumatic brain injury, infection, amputation or neurodevelopmental and neurodegenerative disorders. Cochlear implants, visual prosthetics, deep brain stimulation, brain-computer interfaces, brain-to-brain interfaces and hippocampal prosthetics can bypass, replace or compensate for dysfunctional neural circuits, brain injury and limb loss. They can enable people with these conditions to gain or regain varying degrees of control of thought and behavior. These direct and indirect interventions in the brain raise general ethical questions about weighing the potential benefit of altering neural circuits against the potential harm from neurophysiological and psychological sequelae. Other ethical questions are more specific to the therapeutic goals of particular neuroprosthetics and the conditions for which they are indicated. These include informed consent, agency, autonomy (free will) and identity. Approach. This review is an analysis and discussion of these questions. It also includes consideration of social justice issues such as how to establish and implement fair selection criteria in providing access to neuroprosthetic research and balancing technological innovation with patients’ best interests. Main results. Neuroprosthetics can restore or improve motor and mental functions in bypassing areas of injury or modulating dysregulation in neural circuits. As enabling devices that integrate with these circuits, neuroprosthetics can restore varying degrees of autonomous agency for people affected by neurological and psychiatric disorders. They can also re-establish the connectedness and continuity of the psychological properties they had before injury or disease onset and thereby re-establish their identity. Neuroprosthetics can maximize benefit and minimize harm for people affected by damaged or dysfunctional brains and improve the quality of their lives. Significance. Provided that adequate protections are in place for research subjects and patients, the probable benefit of research into and therapeutic applications of neuroprosthetics outweighs the risk and therefore can be ethically justified. Depending on their neurogenerative potential, there may be an ethical obligation to conduct this research. Advances in neuroscience will generate new ethical and philosophical questions about people and their brains. These questions should shape the evolution and application of novel techniques to better understand and treat brain disorders.

Ethical issues in neuroprosthetics.

PubMed

Glannon, Walter

2016-04-01

Neuroprosthetics are artificial devices or systems designed to generate, restore or modulate a range of neurally mediated functions. These include sensorimotor, visual, auditory, cognitive affective and volitional functions that have been impaired or lost from congenital anomalies, traumatic brain injury, infection, amputation or neurodevelopmental and neurodegenerative disorders. Cochlear implants, visual prosthetics, deep brain stimulation, brain-computer interfaces, brain-to-brain interfaces and hippocampal prosthetics can bypass, replace or compensate for dysfunctional neural circuits, brain injury and limb loss. They can enable people with these conditions to gain or regain varying degrees of control of thought and behavior. These direct and indirect interventions in the brain raise general ethical questions about weighing the potential benefit of altering neural circuits against the potential harm from neurophysiological and psychological sequelae. Other ethical questions are more specific to the therapeutic goals of particular neuroprosthetics and the conditions for which they are indicated. These include informed consent, agency, autonomy (free will) and identity. This review is an analysis and discussion of these questions. It also includes consideration of social justice issues such as how to establish and implement fair selection criteria in providing access to neuroprosthetic research and balancing technological innovation with patients' best interests. Neuroprosthetics can restore or improve motor and mental functions in bypassing areas of injury or modulating dysregulation in neural circuits. As enabling devices that integrate with these circuits, neuroprosthetics can restore varying degrees of autonomous agency for people affected by neurological and psychiatric disorders. They can also re-establish the connectedness and continuity of the psychological properties they had before injury or disease onset and thereby re-establish their identity. Neuroprosthetics can maximize benefit and minimize harm for people affected by damaged or dysfunctional brains and improve the quality of their lives. Provided that adequate protections are in place for research subjects and patients, the probable benefit of research into and therapeutic applications of neuroprosthetics outweighs the risk and therefore can be ethically justified. Depending on their neurogenerative potential, there may be an ethical obligation to conduct this research. Advances in neuroscience will generate new ethical and philosophical questions about people and their brains. These questions should shape the evolution and application of novel techniques to better understand and treat brain disorders.

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.

Uncertain translation, uncertain benefit and uncertain risk: ethical challenges facing first-in-human trials of induced pluripotent stem (ips) cells.

PubMed

Fung, Ronald K F; Kerridge, Ian H

2013-02-01

The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes. © 2011 Blackwell Publishing Ltd.

Ethical muscle and scientific interests: a role for philosophy in scientific research.

PubMed

Kaposy, Chris

2008-03-01

Ethics, a branch of philosophy, has a place in the regulatory framework of human subjects research. Sometimes, however, ethical concepts and arguments play a more central role in scientific activity. This can happen, for example, when violations of research norms are also ethical violations. In such a situation, ethical arguments can be marshaled to improve the quality of the scientific research. I explore two different examples in which philosophers and scientists have used ethical arguments to plead for epistemological improvements in the conduct of research. The first example deals with research dishonesty in pharmaceutical development. The second example is concerned with neuropsychological research using fMRI technology.

Chinese nurses' perceived barriers and facilitators of ethical sensitivity.

PubMed

Huang, Fei Fei; Yang, Qing; Zhang, Jie; Khoshnood, Kaveh; Zhang, Jing Ping

2016-08-01

An overview of ethical sensitivity among Chinese registered nurses is needed to develop and optimize the education programs and interventions to cultivate and improve ethical sensitivity. The study was conducted to explore the barriers to and facilitators of ethical sensitivity among Chinese registered nurses working in hospital settings. A convergent parallel mixed-methods research design was adopted. In the cross-sectional quantitative study, the Chinese Moral Sensitivity Questionnaire-revised version was used to assess the levels of ethical sensitivity among registered nurses, and the scores were correlated with key demographics, training experiences in ethics, and workplace cultural environments (n = 306). In the qualitative study, semi-structured interviews were used to elicit the nurses' perceptions of the barriers and facilitators in nurturing ethical sensitivity (n = 15). The data were collected from February to June 2014. This study was approved by the Institutional Review Boards of Yale University and Central South University. Despite moderately high overall Chinese Moral Sensitivity Questionnaire-revised version scores, the ethical sensitivity among Chinese nurses lags in practice. Barriers to ethical sensitivity include the lack of knowledge related to ethics, lack of working experience as a nurse, the hierarchical organizational climate, and the conformist working attitude. The positive workplace cultural environments and application of ethical knowledge in practice were considered potential facilitators of ethical sensitivity. The findings of this study were compared with studies from other countries to examine the barriers and facilitators of ethical sensitivity in Chinese nurses. This mixed-methods study showed that even though the Chinese nurses have moderately high sensitivity to the ethical issues encountered in hospitals, there is still room for improvement. The barriers to and facilitators of ethical sensitivity identified here offer new and important strategies to support and enhance the nurses' sensitivity to ethical issues. © The Author(s) 2015.

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.

A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.

PubMed

Shah, Pruthak C; Panchasara, Ashwin K; Barvaliya, Manish J; Tripathi, C B

2016-09-01

Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.

Introduction : The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context

PubMed Central

Millum, Joseph; Grady, Christine; Keusch, Gerald; Sina, Barbara

2016-01-01

In response to the increasing need for research ethics expertise in low- and middle-income countries (LMICs), the NIH’s Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. PMID:24384512

Introduction: the Fogarty International Research Ethics Education and Curriculum Development Program in historical context.

PubMed

Millum, Joseph; Grady, Christine; Keusch, Gerald; Sina, Barbara

2013-12-01

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection.

Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

PubMed

De Wert, Guido; Heindryckx, Björn; Pennings, Guido; Clarke, Angus; Eichenlaub-Ritter, Ursula; van El, Carla G; Forzano, Francesca; Goddijn, Mariëtte; Howard, Heidi C; Radojkovic, Dragica; Rial-Sebbag, Emmanuelle; Dondorp, Wybo; Tarlatzis, Basil C; Cornel, Martina C

2018-04-01

Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.

Ethics, Ethical Human Research and Human Research Ethics Committees

ERIC Educational Resources Information Center

Lindorff, Margaret

2010-01-01

Non-medical research involves the same issues of justice, beneficence, and respect for persons that apply to non-medical research. It also may involve risk of harm to participants, and conflicts of interest for researchers. It is therefore not possible to argue that such research should be exempt from ethical review. This paper argues that…

Resources to Support Ethical Practice in Evaluation: An Interview with the Director of the National Center for Research and Professional Ethics

ERIC Educational Resources Information Center

Goodyear, Leslie

2012-01-01

Where do evaluators find resources on ethics and ethical practice? This article highlights a relatively new online resource, a centerpiece project of the National Center for Professional and Research Ethics (NCPRE), which brings together information on best practices in ethics in research, academia, and business in an online portal and center. It…

Theoretical frameworks used to discuss ethical issues in private physiotherapy practice and proposal of a new ethical tool.

PubMed

Drolet, Marie-Josée; Hudon, Anne

2015-02-01

In the past, several researchers in the field of physiotherapy have asserted that physiotherapy clinicians rarely use ethical knowledge to solve ethical issues raised by their practice. Does this assertion still hold true? Do the theoretical frameworks used by researchers and clinicians allow them to analyze thoroughly the ethical issues they encounter in their everyday practice? In our quest for answers, we conducted a literature review and analyzed the ethical theoretical frameworks used by physiotherapy researchers and clinicians to discuss the ethical issues raised by private physiotherapy practice. Our final analysis corpus consisted of thirty-nine texts. Our main finding is that researchers and clinicians in physiotherapy rarely use ethical knowledge to analyze the ethical issues raised in their practice and that gaps exist in the theoretical frameworks currently used to analyze these issues. Consequently, we developed, for ethical analysis, a four-part prism which we have called the Quadripartite Ethical Tool (QET). This tool can be incorporated into existing theoretical frameworks to enable professionals to integrate ethical knowledge into their ethical analyses. The innovative particularity of the QET is that it encompasses three ethical theories (utilitarism, deontologism, and virtue ethics) and axiological ontology (professional values) and also draws on both deductive and inductive approaches. It is our hope that this new tool will help researchers and clinicians integrate ethical knowledge into their analysis of ethical issues and contribute to fostering ethical analyses that are grounded in relevant philosophical and axiological foundations.

Cross-Cultural Considerations in U.S. Research Ethics Education

PubMed Central

Heitman, Elizabeth

2014-01-01

Demand among graduate and postdoctoral trainees for international research experience brings together students and investigators from increasingly diverse cultural backgrounds around the world. Educators in research ethics and scientific integrity need to address the cultural aspects of both science and ethics to help all trainees learn ethical practices for effective collaboration with a diverse array of partners. NIH and NSF’s mandates for instruction in the responsible conduct of research do not specifically address the needs of international trainees or U.S. trainees who undertake research projects abroad. Nonetheless, research ethics educators’ typical focus on policy and professional standards can offer trainees and faculty investigators helpful insights into differing ethical values and priorities in research. Examination of linguistic differences can also reveal important conceptual frameworks that shape ethical practice. New resources for teaching research integrity in cross-cultural settings can be a valuable addition to the development of shared understanding of the goals of scientific research. PMID:25574262

The three official language versions of the Declaration of Helsinki: what's lost in translation?

PubMed Central

Carlson, Robert V; van Ginneken, Nadja H; Pettigrew, Luisa M; Davies, Alan; Boyd, Kenneth M; Webb, David J

2007-01-01

Background The Declaration of Helsinki, the World Medical Association's (WMA's) statement of ethical guidelines regarding medical research, is published in the three official languages of the WMA: English, French and Spanish. Methods A detailed comparison of the three official language versions was carried out to determine ways in which they differed and ways in which the wording of the three versions might illuminate the interpretation of the document. Results There were many minor linguistic differences between the three versions. However, in paragraphs 1, 6, 29, 30 and in the note of clarification to paragraph 29, there were differences that could be considered potentially significant in their ethical relevance. Interpretation Given the global status of the Declaration of Helsinki and the fact that it is translated from its official versions into many other languages for application to the ethical conduct of research, the differences identified are of concern. It would be best if such differences could be eliminated but, at the very least, a commentary to explain any differences that are unavoidable on the basis of language or culture should accompany the Declaration of Helsinki. This evidence further strengthens the case for international surveillance of medical research ethics as has been proposed by the WMA. PMID:17761826

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.

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…

The high road to success: how investing in ethics enhances corporate objectives.

PubMed

Dashefsky, Richard

2003-01-01

There is a growing gap between the tidal wave of information emerging from the Human Genome Project and other molecular biology initiatives, and the clinical research needed to transform these discoveries into new diagnostics and therapeutics. While genomics-based technologies are being rapidly integrated into pharmaceutical R&D, many steps in the experimental process are still reliant on traditional surrogate model systems whose predictive power about human disease is incomplete or inaccurate. There is a growing trend underway in the research community to introduce actual human disease understanding as early as possible into discovery, thereby improving accuracy of results throughout the R&D continuum. Such an approach (known as clinical genomics: the large scale study of genes in the context of actual human disease) requires the availability of large quantities of ethically and legally sourced, high-quality human tissues with associated clinical information.Heretofore, no source could meet all of these requirements. Ardais Corporation was the first to address this need by pioneering a systematized, standardized network for the collection, processing, dissemination and research application of human tissue and associated clinical information, all of which rest on the highest ethical standards. Based on a novel model of collaboration between industry and the academic/medical community, Ardais has created procedures, structures, technologies, and information tools that collectively compromise a new paradigm in the application of human disease to biomedical research. Ardais now serves as a clinical genomics resource to dozens of academic researchers and biopharmaceutical companies, providing products and services to accelerate and improve drug discovery and development.

Ethical clinical translation of stem cell interventions for neurologic disease.

PubMed

Cote, David J; Bredenoord, Annelien L; Smith, Timothy R; Ammirati, Mario; Brennum, Jannick; Mendez, Ivar; Ammar, Ahmed S; Balak, Naci; Bolles, Gene; Esene, Ignatius Ngene; Mathiesen, Tiit; Broekman, Marike L

2017-01-17

The application of stem cell transplants in clinical practice has increased in frequency in recent years. Many of the stem cell transplants in neurologic diseases, including stroke, Parkinson disease, spinal cord injury, and demyelinating diseases, are unproven-they have not been tested in prospective, controlled clinical trials and have not become accepted therapies. Stem cell transplant procedures currently being carried out have therapeutic aims, but are frequently experimental and unregulated, and could potentially put patients at risk. In some cases, patients undergoing such operations are not included in a clinical trial, and do not provide genuinely informed consent. For these reasons and others, some current stem cell interventions for neurologic diseases are ethically dubious and could jeopardize progress in the field. We provide discussion points for the evaluation of new stem cell interventions for neurologic disease, based primarily on the new Guidelines for Stem Cell Research and Clinical Translation released by the International Society for Stem Cell Research in May 2016. Important considerations in the ethical translation of stem cells to clinical practice include regulatory oversight, conflicts of interest, data sharing, the nature of investigation (e.g., within vs outside of a clinical trial), informed consent, risk-benefit ratios, the therapeutic misconception, and patient vulnerability. To help guide the translation of stem cells from the laboratory into the neurosurgical clinic in an ethically sound manner, we present an ethical discussion of these major issues at stake in the field of stem cell clinical research for neurologic disease. © 2016 American Academy of Neurology.

An ethical assessment model for digital disease detection technologies.

PubMed

Denecke, Kerstin

2017-09-20

Digital epidemiology, also referred to as digital disease detection (DDD), successfully provided methods and strategies for using information technology to support infectious disease monitoring and surveillance or understand attitudes and concerns about infectious diseases. However, Internet-based research and social media usage in epidemiology and healthcare pose new technical, functional and formal challenges. The focus of this paper is on the ethical issues to be considered when integrating digital epidemiology with existing practices. Taking existing ethical guidelines and the results from the EU project M-Eco and SORMAS as starting point, we develop an ethical assessment model aiming at providing support in identifying relevant ethical concerns in future DDD projects. The assessment model has four dimensions: user, application area, data source and methodology. The model supports in becoming aware, identifying and describing the ethical dimensions of DDD technology or use case and in identifying the ethical issues on the technology use from different perspectives. It can be applied in an interdisciplinary meeting to collect different viewpoints on a DDD system even before the implementation starts and aims at triggering discussions and finding solutions for risks that might not be acceptable even in the development phase. From the answers, ethical issues concerning confidence, privacy, data and patient security or justice may be judged and weighted.

Phronesis: Beyond the Research Ethics Committee-A Crucial Decision-Making Skill for Health Researchers During Community Research.

PubMed

Greeff, Minrie; Rennie, Stuart

2016-04-01

Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.

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

Failure to Apply for Ethical Approval for Health Studies in Low-Income Countries

PubMed Central

Simkhada, Padam

2015-01-01

On too many occasions researchers conduct public health and/or epidemiological studies in low-income countries without the appropriate in-country ethical approval. This article reflects on some of the underlying reasons for not applying for ethical approval. The piece concludes that we need to start by educating our (junior) researchers and research students about the importance of research ethics. We conclude with a number of recommendations for researchers, scientific journal editors and reviewers and ethical committees in high-income countries to bring the message home to researchers that ethical approval should be sought in low-income countries if and when required! PMID:26913212

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

14 CFR 1207.101 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Cross-references to ethical conduct, financial disclosure, and other applicable regulations. 1207.101 Section 1207.101 Aeronautics and Space...-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the...

14 CFR 1207.101 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Cross-references to ethical conduct, financial disclosure, and other applicable regulations. 1207.101 Section 1207.101 Aeronautics and Space...-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the...

14 CFR 1207.101 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Cross-references to ethical conduct, financial disclosure, and other applicable regulations. 1207.101 Section 1207.101 Aeronautics and Space...-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the...

14 CFR 1207.101 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Cross-references to ethical conduct, financial disclosure, and other applicable regulations. 1207.101 Section 1207.101 Aeronautics and Space...-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the...

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.

Bioteaching Ethics and the Researcher-Teacher: Considerations for Teacher Education.

ERIC Educational Resources Information Center

Lovat, Terence J.

1995-01-01

This article examines the teacher researcher movement, discussing ethical matters related to action research. In the medical domain, biomedical ethics directs human interventions resulting from clinical and research practice. The paper suggests a discipline called "bioteaching ethics" could help direct human interventionary actions of teachers…

Gathering Sensitive Stories

ERIC Educational Resources Information Center

Daley, Kathryn

2012-01-01

Discussions of research ethics are often focused on research ethics guidelines. These guidelines are useful in designing ethical research projects but are not designed to guide the interpersonal interactions that occur once researchers are out in the field. Drawing from Noddings' care theory, this article argues that making ethical decisions when…

43 CFR 20.101 - Cross-references to ethical conduct, financial disclosure and other applicable regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure and other applicable regulations. In addition... Standards of Ethical Conduct for Employees of the Executive Branch, at 5 CFR part 2635; the Department's...

15 CFR 0.735-2 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the Department of Commerce should refer to the executive branch-wide Standards of Ethical Conduct...

15 CFR 0.735-2 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the Department of Commerce should refer to the executive branch-wide Standards of Ethical Conduct...

43 CFR 20.101 - Cross-references to ethical conduct, financial disclosure and other applicable regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure and other applicable regulations. In addition... Standards of Ethical Conduct for Employees of the Executive Branch, at 5 CFR part 2635; the Department's...

43 CFR 20.101 - Cross-references to ethical conduct, financial disclosure and other applicable regulations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure and other applicable regulations. In addition... Standards of Ethical Conduct for Employees of the Executive Branch, at 5 CFR part 2635; the Department's...

15 CFR 0.735-2 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 15 Commerce and Foreign Trade 1 2013-01-01 2013-01-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the Department of Commerce should refer to the executive branch-wide Standards of Ethical Conduct...

15 CFR 0.735-2 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 15 Commerce and Foreign Trade 1 2012-01-01 2012-01-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the Department of Commerce should refer to the executive branch-wide Standards of Ethical Conduct...

43 CFR 20.101 - Cross-references to ethical conduct, financial disclosure and other applicable regulations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 1 2014-10-01 2014-10-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure and other applicable regulations. In addition... Standards of Ethical Conduct for Employees of the Executive Branch, at 5 CFR part 2635; the Department's...

15 CFR 0.735-2 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 15 Commerce and Foreign Trade 1 2014-01-01 2014-01-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure, and other applicable regulations. Employees of the Department of Commerce should refer to the executive branch-wide Standards of Ethical Conduct...

43 CFR 20.101 - Cross-references to ethical conduct, financial disclosure and other applicable regulations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Cross-references to ethical conduct... Cross-references to ethical conduct, financial disclosure and other applicable regulations. In addition... Standards of Ethical Conduct for Employees of the Executive Branch, at 5 CFR part 2635; the Department's...

Getting personal: ethics and identity in global health research.

PubMed

Simon, Christian; Mosavel, Maghboeba

2011-08-01

'Researcher identity' affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen's (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. © 2011 Blackwell Publishing Ltd.

GETTING PERSONAL: ETHICS AND IDENTITY IN GLOBAL HEALTH RESEARCH

PubMed Central

Simon, Christian; Mosavel, Maghboeba

2011-01-01

‘Researcher identity’ affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen’s (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. PMID:21426482

Introducing ethics to chemistry students in a "Research Experiences for Undergraduates" (REU) program.

PubMed

Hanson, Mark J

2015-01-01

A three-day ethics seminar introduced ethics to undergraduate environmental chemistry students in the Research Experiences for Undergraduates (REU) program. The seminar helped students become sensitive to and understand the ethical and values dimensions of their work as researchers. It utilized a variety of resources to supplement lectures and class discussion on a variety of issues. Students learned about the relevance of ethics to research, skills in moral reasoning, and the array of ethical issues facing various aspects of scientific research. © 2015 The International Union of Biochemistry and Molecular Biology.

Ethics creep or governance creep? Challenges for Australian Human Research Ethics Committees (HRECS).

PubMed

Gorman, Susanna M

2011-09-01

Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

Importance of a midterm time horizon for addressing ethical issues integral to nanobiotechnology.

PubMed

Khushf, George

2007-01-01

There is a consensus emerging on the importance of upstream ethical engagement in nanobiotechnology. Such a preventive ethic would anticipate downstream concerns that might arise and mitigate them as part of the research and development process. However, there is an unappreciated tension between the time horizon of upstream ethics and that assumed by most bioethical research. Current standards of high-quality research on ethical issues biases the research in favor of near-term, science-based, results-oriented work. A near-term focus would miss many of the important ethical issues integral to nanobiotechnology and undermine the goals integral to upstream ethical engagement. However, if we move to a far-term time horizon, the ethical debates tend to get too speculative and are no longer disciplined by existing research trajectories. This paper addresses the link between the midterm time horizon necessary for upstream ethics and the form, content, and style of ethical reflection. New paradigm cases, standards, and criteria will be needed for high-quality upstream ethics work in the area of nanobiotechnology.

Reporting ethics committee approval in public administration research.

PubMed

Jordan, Sara R; Gray, Phillip W

2014-03-01

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

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…

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

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.

Spatially explicit data: stewardship and ethical challenges in science.

PubMed

Hartter, Joel; Ryan, Sadie J; Mackenzie, Catrina A; Parker, John N; Strasser, Carly A

2013-09-01

Scholarly communication is at an unprecedented turning point created in part by the increasing saliency of data stewardship and data sharing. Formal data management plans represent a new emphasis in research, enabling access to data at higher volumes and more quickly, and the potential for replication and augmentation of existing research. Data sharing has recently transformed the practice, scope, content, and applicability of research in several disciplines, in particular in relation to spatially specific data. This lends exciting potentiality, but the most effective ways in which to implement such changes, particularly for disciplines involving human subjects and other sensitive information, demand consideration. Data management plans, stewardship, and sharing, impart distinctive technical, sociological, and ethical challenges that remain to be adequately identified and remedied. Here, we consider these and propose potential solutions for their amelioration.

Research Experience and Agreement with Selected Ethics Principles from Canada's "Tri-Council Policy Statement--Ethical Conduct for Research Involving Humans"

ERIC Educational Resources Information Center

Fahy, Pat; Spencer, Bob

2004-01-01

An online survey was conducted of students, instructors, and researchers in distance education regarding principles for the ethical treatment of human research subjects. The study used an online questionnaire based on principles drawn from Canada's "Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans" (TCPS,…

[Ethics as first philosophy: the ethics of responsibility as a rationale for health care].

PubMed

Belli, Laura Florencia; Quadrelli, Silvia

2010-01-01

The origins of bioethics as a discipline arouse from the need to provide an answer to new ethical questions generated as a result of technological advances in the health field and the new arenas in which biomedical research began to develop. Discussions were first focused on the relevance of the applicability of new technologies and the need to redefine a number of concepts related to the beginning and end of life. Then, over the years, this discipline was shaped and reconfigured incorporating issues related to the process of decision making in daily medical care, patient rights, protection of their freedoms and obligations of medical professionals, among others. The purpose of this essay is to reflect upon the ethical foundations of health care, trying to provide an answer to the question "why movide care" in light of the thought of Emmanuel Lévinas.

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.

Ethical considerations when employing fake identities in online social networks for research.

PubMed

Elovici, Yuval; Fire, Michael; Herzberg, Amir; Shulman, Haya

2014-12-01

Online social networks (OSNs) have rapidly become a prominent and widely used service, offering a wealth of personal and sensitive information with significant security and privacy implications. Hence, OSNs are also an important--and popular--subject for research. To perform research based on real-life evidence, however, researchers may need to access OSN data, such as texts and files uploaded by users and connections among users. This raises significant ethical problems. Currently, there are no clear ethical guidelines, and researchers may end up (unintentionally) performing ethically questionable research, sometimes even when more ethical research alternatives exist. For example, several studies have employed "fake identities" to collect data from OSNs, but fake identities may be used for attacks and are considered a security issue. Is it legitimate to use fake identities for studying OSNs or for collecting OSN data for research? We present a taxonomy of the ethical challenges facing researchers of OSNs and compare different approaches. We demonstrate how ethical considerations have been taken into account in previous studies that used fake identities. In addition, several possible approaches are offered to reduce or avoid ethical misconducts. We hope this work will stimulate the development and use of ethical practices and methods in the research of online social networks.

Taking the Ethics of Einstein into the 21st Century

NASA Astrophysics Data System (ADS)

Neuenschwander, Dwight E.

2004-10-01

We are an inquisitive species. Our curiosity about the structure of matter led to the discovery of the nucleus. In the cultural and political environment of the times, how short were the steps from the innocence of discovery to the atomic bombings of Hiroshima and Nagasaki, and the Cold War that followed! If you had been a graduate student in 1942, invited to help build these nuclear weapons, what would you have done? If the choice of how to end World War II had been yours to make instead of President Truman's-invade Japan, or use the new atomic bomb-what would you have decided? The deeper issues did not go away in 1945. They continue to haunt all scientists today, from hydrogen bombs to general manipulation to environmental sustainability. How do intellectual questions about nature lead to potentially horrific applications of knowledge? What are our ethical responsibilities as physicists? What ethical principles should guide scientific research and its applications?

Beyond procedural ethics: foregrounding questions of justice in global health research ethics training for students.

PubMed

Hunt, Matthew R; Godard, Beatrice

2013-07-01

Interest in global health is growing among students across many disciplines and fields of study. In response, an increasing number of academic programmes integrate and promote opportunities for international research, service or clinical placements. These activities raise a range of ethical issues and are associated with important training needs for those who participate. In this paper, we focus on research fieldwork conducted in lower income nations by students from more affluent countries and the ethics preparation they would benefit from receiving prior to embarking on these projects. Global health research is closely associated with questions of justice and equity that extend beyond concerns of procedural ethics. Research takes place in and is shaped by matrices of political, social and cultural contexts and concerns. These realities warrant analysis and discussion during research ethics training. Training activities present an opportunity to encourage students to link global health research to questions of global justice, account for issues of justice in planning their own research, and prepare for 'ethics-in-practice' issues when conducting research in contexts of widespread inequality. Sustained engagement with questions of justice and equity during research ethics training will help support students for involvement in global health research.

Undergraduate healthcare ethics education, moral resilience, and the role of ethical theories.

PubMed

Monteverde, Settimio

2014-06-01

This article combines foundational and empirical aspects of healthcare education and develops a framework for teaching ethical theories inspired by pragmatist learning theory and recent work on the concept of moral resilience. It describes an exemplary implementation and presents data from student evaluation. After a pilot implementation in a regular ethics module, the feasibility and acceptance of the novel framework by students were evaluated. In addition to the regular online module evaluation, specific questions referring to the teaching of ethical theories were added using simple (yes/no) and Likert rating answer formats. At the Bern University of Applied Sciences, a total of 93 students from 2 parallel sub-cohorts of the bachelor's program in nursing science were sent the online survey link after having been exposed to the same modular contents. A total of 62% of all students participated in the survey. The survey was voluntary and anonymous. Students were free to write their name and additional comments. Students consider ethical theories-as taught within the proposed framework-as practically applicable, useful, and transferable into practice. Teaching ethical theories within the proposed framework overcomes the shortcomings described by current research. Students do not consider the mutually exclusive character of ethical theories as an insurmountable problem. The proposed framework is likely to promote the effectiveness of healthcare ethics education. Inspired by pragmatist learning theory, it enables students to consider ethical theories as educative playgrounds that help them to "frame" and "name" the ethical issues they encounter in daily practice, which is seen as an expression of moral resilience. Since it does not advocate a single ethical theory, but is open to the diversity of traditions that shape ethical thinking, it promotes a culturally sensitive, ethically reflected healthcare practice. © The Author(s) 2013.

Ethics issues for HIV/AIDS researchers in international settings - perspectives from the Canadian experience.

PubMed

Gahagan, Jacqueline; Sweeney, Ellen; Worthington, Catherine; Perry, Darryl; Satzinger, Franziska; Rogers, Erin

2008-11-01

In recognition of the level of international HIV/AIDS research being conducted by Canadians, the Canadian Association for HIV Research (CAHR), along with its partners, has developed a resource document to assist researchers in identifying and preparing for the unique ethics issues and challenges that may arise during international HIV/AIDS research. Between 2004 and 2007, face-to-face consultations were undertaken with community and government stakeholders, and interviews were conducted with eight prominent HIV/AIDS researchers with international experience to identify key research ethics challenges and structural, cultural, political, social, and economic factors that may impact HIV/AIDS research ethics in resource-limited settings. These challenges and factors served as the basis for the hypothetical ethics issues case scenarios developed for each of the four research tracks. Ethics issues were identified at every stage of the research process. Key contextual issues included: (1) stigma and culturally-embedded conceptualizations of HIV; (2) local and global politics and economics; (3) gender inequities, power dynamics, and sexual roles; and (4) allocation and availability of resources for research and health services. The final document resulting from the consultation process provides a framework for open dialogue on the complex and interconnected ethics issues researchers may experience in the field of international HIV/AIDS research, and contributes to the HIV/AIDS research field by reinforcing the need for high quality and ethically sound research. This document can be found at http://ethics.cahr-acrv.ca/.

Restoring trust through bioethics education?

PubMed

Salerno, Judith A

2008-06-01

Ethically conducted research involving human participants is a cornerstone of the academic medical research establishment. However, there is public mistrust of clinical research and, as a result, low participation rates in research studies among minorities and in communities where health disparities are glaring. Specific initiatives have been undertaken by the National Institutes of Health (NIH) to restore public confidence in biomedical research and to ensure that research is conducted ethically and responsibly. The T15 program, instituted in 1997, made awards beginning in 1998 to institutions for up to three years to develop, conduct, and evaluate short-term courses on ethical issues in research. A companion solicitation (K01 program) targeted the career development of independent investigators in applied research ethics through mentored scientist development awards in research ethics. Both programs emphasized ethical research involving human participants and outreach to minority scientists. The author asks how the success of these programs should be gauged, especially in light of new--and often unforeseen--ethical challenges that are likely to confront the research community. Participation in some T15 programs indicates that few researchers and practitioners perceived the need to increase their proficiency in analyzing the ethical dimensions of their work. To improve participation and, ultimately, ethical approaches to human participants research, the NIH should foster appreciation for the centrality of bioethics in the biomedical research enterprise. The author calls on the NIH to provide leadership for bioethics by further developing a national agenda for bioethics training and research.

Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals.

PubMed

Sippel, Daniel; Marckmann, Georg; Ndzie Atangana, Etienne; Strech, Daniel

2015-01-01

Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: "confidentiality and information", "interpersonal, relational and behavioral issues", "psychological strain of individuals", and "scarce resources"; B) meso level: "structural issues of medical institutions", "issues with private clinics", "challenges connected to the family", and "issues of education, training and competence"; and C) macro level: "influence of society, culture, religion and superstition", "applicability of western medicine", "structural issues on the political level", and "legal issues". Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into perspective. As many participants reported a lack of awareness of ethical issues amongst other health care professionals in daily clinical practice, we suggest that international organizations and national medical schools should consider infrastructure and tools to improve context-sensitive capacity building in clinical ethics for Sub-Saharan African countries like Gabon.

Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals

PubMed Central

Sippel, Daniel; Marckmann, Georg; Ndzie Atangana, Etienne; Strech, Daniel

2015-01-01

Introduction Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. Materials and Methods In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Results Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: “confidentiality and information”, “interpersonal, relational and behavioral issues”, “psychological strain of individuals”, and “scarce resources”; B) meso level: “structural issues of medical institutions”, “issues with private clinics”, “challenges connected to the family”, and “issues of education, training and competence”; and C) macro level: “influence of society, culture, religion and superstition”, “applicability of western medicine”, “structural issues on the political level”, and “legal issues”. Discussion Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into perspective. As many participants reported a lack of awareness of ethical issues amongst other health care professionals in daily clinical practice, we suggest that international organizations and national medical schools should consider infrastructure and tools to improve context-sensitive capacity building in clinical ethics for Sub-Saharan African countries like Gabon. PMID:26161655

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.

Ethical, Legal and Social Issues related to the health data-warehouses: re-using health data in the research and public health research.

PubMed

Lamas, Eugenia; Barh, Anne; Brown, Dario; Jaulent, Marie-Christine

2015-01-01

Research derived from the application of information and communication technologies in medicine operates in a context involving the globalization of collecting, sharing, storage, transfer and re-use of personal health data. Health data computerization within Clinical Information Systems (as Electronic Healthcare Records) should allow the re-use of health data for clinical research and public health purposes. One of the objects allowing the integration of healthcare and research information systems is the health data-warehouse (DWH). However, ethical-legal frameworks in force are not adapted to these DWHs because they were not conceived for re-using data in a different context than the one of their acquisition. For that matter, access modalities to data-warehouses must ensure the respect of patients' rights: information to the patient, as well as confidentiality and security. Through a bibliography research, some Ethical, legal and Social Issues (ELSI) have been identified: Patients' rights Modalities of implementation of the DWs; Solidarity and common good; Transparency and Trust. Comparative analysis between the Directive 95/46/CE and the "Proposal for regulation on protection of individuals with regard to the processing of personal data" shows that this regulation pretends allowing the re-use of key-coded data when aimed at a scientific purpose. However, since this new regulation does not align with the ethical and legal requirements at an operational level, a Code of practice on secondary use of Medical Data in scientific Research Projects has been developed at the European Level. This Code provides guidance for Innovative Medicine Initiative (IMI) and will help to propose practical solutions to overcome the issue of the re-use of data for research purposes.

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.

From environmental to ecological ethics: toward a practical ethics for ecologists and conservationists.

PubMed

Minteer, Ben A; Collins, James P

2008-12-01

Ecological research and conservation practice frequently raise difficult and varied ethical questions for scientific investigators and managers, including duties to public welfare, nonhuman individuals (i.e., animals and plants), populations, and ecosystems. The field of environmental ethics has contributed much to the understanding of general duties and values to nature, but it has not developed the resources to address the diverse and often unique practical concerns of ecological researchers and managers in the field, lab, and conservation facility. The emerging field of "ecological ethics" is a practical or scientific ethics that offers a superior approach to the ethical dilemmas of the ecologist and conservation manager. Even though ecological ethics necessarily draws from the principles and commitments of mainstream environmental ethics, it is normatively pluralistic, including as well the frameworks of animal, research, and professional ethics. It is also methodologically pragmatic, focused on the practical problems of researchers and managers and informed by these problems in turn. The ecological ethics model offers environmental scientists and practitioners a useful analytical tool for identifying, clarifying, and harmonizing values and positions in challenging ecological research and management situations. Just as bioethics provides a critical intellectual and problem-solving service to the biomedical community, ecological ethics can help inform and improve ethical decision making in the ecology and conservation communities.

Grant Patents on Animals? An Ethical and Legal Battle Looms.

ERIC Educational Resources Information Center

Wheeler, David L.

1987-01-01

Rulings on applications for animal patents being considered by the U.S. Patent and Trademark Office could profoundly influence university patent and research income. Many animal-rights advocates have expressed philosophical objections to genetic engineering of animals. (MLW)

14 CFR § 1207.101 - Cross-references to ethical conduct, financial disclosure, and other applicable regulations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Cross-references to ethical conduct, financial disclosure, and other applicable regulations. § 1207.101 Section § 1207.101 Aeronautics and... Cross-references to ethical conduct, financial disclosure, and other applicable regulations. Employees...

Retreat from Nuremberg: can we prevent unethical medical research?

PubMed

Horner, J S

1999-09-01

The prosecution of doctors guilty of appalling human rights abuses at Nuremberg was achieved on the mistaken premise that the research community already had a code of conduct which, if applied, would have made such abuses impossible. In fact, not only was there no such code but when the 'Nuremberg Code' was published after the trial it continued to be ignored by many doctors for some thirty years afterwards. Indeed its central principle of informed consent has itself been eroded by subsequent international agreements on the ethics of medical research. This review shows that the mechanisms for approval of medical research which have now been promulgated in England and Wales, in practice, are applied on a very variable basis. Research in vulnerable groups unable to give fully informed consent such as children, prisoners and the incompetent elderly require the application of more rigorous standards of ethical control than those currently in operation. The use of vulnerable populations in the developing world and the application of international standards to them is also considered. A number of suggestions for improvements in current procedures in all these areas are put forward. The proposals for the United Kingdom would meet the requirements of the European Convention on bioethical research and the recent government consultation paper on medical treatment and research in incompetent adults.

18 CFR 1300.101 - Cross references to employee ethical conduct standards and other applicable regulations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... employee ethical conduct standards and other applicable regulations. 1300.101 Section 1300.101 Conservation... TENNESSEE VALLEY AUTHORITY § 1300.101 Cross references to employee ethical conduct standards and other...-wide standards of ethical conduct at 5 CFR part 2635 and to the TVA regulations at 5 CFR part 7901...

18 CFR 1300.101 - Cross references to employee ethical conduct standards and other applicable regulations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... employee ethical conduct standards and other applicable regulations. 1300.101 Section 1300.101 Conservation... TENNESSEE VALLEY AUTHORITY § 1300.101 Cross references to employee ethical conduct standards and other...-wide standards of ethical conduct at 5 CFR part 2635 and to the TVA regulations at 5 CFR part 7901...

18 CFR 1300.101 - Cross references to employee ethical conduct standards and other applicable regulations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... employee ethical conduct standards and other applicable regulations. 1300.101 Section 1300.101 Conservation... TENNESSEE VALLEY AUTHORITY § 1300.101 Cross references to employee ethical conduct standards and other...-wide standards of ethical conduct at 5 CFR part 2635 and to the TVA regulations at 5 CFR part 7901...

18 CFR 1300.101 - Cross references to employee ethical conduct standards and other applicable regulations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... employee ethical conduct standards and other applicable regulations. 1300.101 Section 1300.101 Conservation... TENNESSEE VALLEY AUTHORITY § 1300.101 Cross references to employee ethical conduct standards and other...-wide standards of ethical conduct at 5 CFR part 2635 and to the TVA regulations at 5 CFR part 7901...

18 CFR 1300.101 - Cross references to employee ethical conduct standards and other applicable regulations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... employee ethical conduct standards and other applicable regulations. 1300.101 Section 1300.101 Conservation... TENNESSEE VALLEY AUTHORITY § 1300.101 Cross references to employee ethical conduct standards and other...-wide standards of ethical conduct at 5 CFR part 2635 and to the TVA regulations at 5 CFR part 7901...

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.

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.

Real-time Responsiveness for Ethics Oversight During Disaster Research.

PubMed

Eckenwiler, Lisa; Pringle, John; Boulanger, Renaud; Hunt, Matthew

2015-11-01

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises--particularly in resource-poor settings--is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees (RECs). Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like--how it might be conceptualized and utilized--using the concept of real-time responsiveness (RTR). The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. © 2015 John Wiley & Sons Ltd.

Steps to Strengthen Ethics in Organizations: Research Findings, Ethics Placebos, and What Works

PubMed Central

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. PMID:25602131

New Strategies of Control: Academic Freedom and Research Ethics Boards

ERIC Educational Resources Information Center

Lewis, Magda

2008-01-01

This article, detailing the implications of "ethics drift" for critical work in the academy, reports on an ethics challenge to a non-research-based scholarly text. It analyzes how General Research Ethics Boards (GREBs) can threaten academic freedom when they lack a clear definition of "human subject" research, fail to…

40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Code of Federal Regulations, 2013 CFR

2013-07-01

... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...

40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Code of Federal Regulations, 2012 CFR

2012-07-01

... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...

40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Code of Federal Regulations, 2011 CFR

2011-07-01

... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...

40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Code of Federal Regulations, 2014 CFR

2014-07-01

... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...

40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...

Ethical practice in internet research involving vulnerable people: lessons from a self-harm discussion forum study (SharpTalk).

PubMed

Sharkey, Siobhan; Jones, Ray; Smithson, Janet; Hewis, Elaine; Emmens, Tobit; Ford, Tamsin; Owens, Christabel

2011-12-01

The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a 'report' button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them.

Why should ethics approval be required prior to publication of health promotion research?

PubMed

Newson, Ainsley J; Lipworth, Wendy

2015-12-01

Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

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.

Ethical management guidelines for the shanghai disease-based biobank network.

PubMed

Zhu, Shu; Shen, Mingxian; Qiu, Xiangxing; Gan, Rongxing; Hu, Qingli

2015-02-01

The Ethical Management Guidelines for the Shanghai Disease-Based Biobank Network are intended to safeguard the interests of all the participants, to standardize the construction, management, and resource sharing of the Shanghai Disease-based Biobank Network, to promote the development of medical research, and to improve public health and well-being. The guidelines contain seven chapters: General Principles; Informed Consent; Use of Bio-samples from Persons without the Capacity to Consent; Privacy and Confidentiality; Applications of Use of Biological Samples and Data; Intellectual Property and Resource Sharing; and Conflict of Interest.

Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya.

PubMed

Molyneux, Sassy; Tsofa, Benjamin; Barasa, Edwine; Nyikuri, Mary Muyoka; Waweru, Evelyn Wanjiku; Goodman, Catherine; Gilson, Lucy

2016-12-01

There is a growing interest in the ethics of Health Policy and Systems Research (HPSR), and especially in areas that have particular ethical salience across HPSR. Hyder et al (2014) provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential 'solutions' to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications. © 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.

Evaluating Research Ethics Training in the Maryland Sea Grant REU Program

NASA Astrophysics Data System (ADS)

Allen, M. R.; Kumi, G. A.; Kumi, B. C.; Moser, F. C.

2016-02-01

The NSF's Research Experiences for Undergraduates (REU) program is an opportunity to cultivate responsible research practices in researchers at an early stage in their career. However, teaching responsible research conduct and science ethics in this program has been challenging because of a lack of consensus regarding which instructional methods are most effective for educating students about ethical concepts and establishing the process of ethical decision-making. Over the last 15 years, Maryland Sea Grant's REU ethics program has evolved by exploring different teaching models and looking for ways to effectively engage upper level undergraduates throughout their summer experience in ethical responsibility training. Since 2007, we have adopted a concerted experiential learning approach that includes an ethics seminar, role playing, case studies, and reflection. Currently, our summer long ethics training includes: 1) an interactive seminar; 2) a workshop with role playing and case studies; 3) 1-2 readings; and 4) a roundtable discussion with faculty mentors and their mentees to discuss researchers' real-world experiences with ethical dilemmas. Within the last 3 years, we have expanded our student learning outcomes assessments by administering pre- and post-program surveys to assess ethical skills students acquire through the program. Reevaluations administered three and six years after the REU experience will measure long term effectiveness of the training. Results from the first group of students reveal a greater awareness of ethical issues following our summer program. Students show a high level of competence about "black and white" issues (falsification, fabrication, plagiarism), but are more challenged by ethical "gray areas" such as data ownership and authorship. Results suggest many undergraduates come to research programs with basic ethics training, but benefit from our additional focus on complex ethical dilemmas.

Empirical research in medical ethics: how conceptual accounts on normative-empirical collaboration may improve research practice.

PubMed

Salloch, Sabine; Schildmann, Jan; Vollmann, Jochen

2012-04-13

The methodology of medical ethics during the last few decades has shifted from a predominant use of normative-philosophical analyses to an increasing involvement of empirical methods. The articles which have been published in the course of this so-called 'empirical turn' can be divided into conceptual accounts of empirical-normative collaboration and studies which use socio-empirical methods to investigate ethically relevant issues in concrete social contexts. A considered reference to normative research questions can be expected from good quality empirical research in medical ethics. However, a significant proportion of empirical studies currently published in medical ethics lacks such linkage between the empirical research and the normative analysis. In the first part of this paper, we will outline two typical shortcomings of empirical studies in medical ethics with regard to a link between normative questions and empirical data: (1) The complete lack of normative analysis, and (2) cryptonormativity and a missing account with regard to the relationship between 'is' and 'ought' statements. Subsequently, two selected concepts of empirical-normative collaboration will be presented and how these concepts may contribute to improve the linkage between normative and empirical aspects of empirical research in medical ethics will be demonstrated. Based on our analysis, as well as our own practical experience with empirical research in medical ethics, we conclude with a sketch of concrete suggestions for the conduct of empirical research in medical ethics. High quality empirical research in medical ethics is in need of a considered reference to normative analysis. In this paper, we demonstrate how conceptual approaches of empirical-normative collaboration can enhance empirical research in medical ethics with regard to the link between empirical research and normative analysis.

Empirical research in medical ethics: How conceptual accounts on normative-empirical collaboration may improve research practice

PubMed Central

2012-01-01

Background The methodology of medical ethics during the last few decades has shifted from a predominant use of normative-philosophical analyses to an increasing involvement of empirical methods. The articles which have been published in the course of this so-called 'empirical turn' can be divided into conceptual accounts of empirical-normative collaboration and studies which use socio-empirical methods to investigate ethically relevant issues in concrete social contexts. Discussion A considered reference to normative research questions can be expected from good quality empirical research in medical ethics. However, a significant proportion of empirical studies currently published in medical ethics lacks such linkage between the empirical research and the normative analysis. In the first part of this paper, we will outline two typical shortcomings of empirical studies in medical ethics with regard to a link between normative questions and empirical data: (1) The complete lack of normative analysis, and (2) cryptonormativity and a missing account with regard to the relationship between 'is' and 'ought' statements. Subsequently, two selected concepts of empirical-normative collaboration will be presented and how these concepts may contribute to improve the linkage between normative and empirical aspects of empirical research in medical ethics will be demonstrated. Based on our analysis, as well as our own practical experience with empirical research in medical ethics, we conclude with a sketch of concrete suggestions for the conduct of empirical research in medical ethics. Summary High quality empirical research in medical ethics is in need of a considered reference to normative analysis. In this paper, we demonstrate how conceptual approaches of empirical-normative collaboration can enhance empirical research in medical ethics with regard to the link between empirical research and normative analysis. PMID:22500496

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

Microbicide research in developing countries: have we given the ethical concerns due consideration?

PubMed

Moodley, Keymanthri

2007-09-19

HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally. Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike.

5 CFR 2638.402 - Corrective orders.

Code of Federal Regulations, 2011 CFR

2011-01-01

....402 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS OFFICE OF GOVERNMENT ETHICS AND EXECUTIVE AGENCY ETHICS PROGRAM RESPONSIBILITIES Correction of Executive Branch Agency Ethics... agency ethics program is not in full compliance with the requirements set forth in applicable statutes or...

5 CFR 2638.402 - Corrective orders.

Code of Federal Regulations, 2010 CFR

2010-01-01

....402 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS OFFICE OF GOVERNMENT ETHICS AND EXECUTIVE AGENCY ETHICS PROGRAM RESPONSIBILITIES Correction of Executive Branch Agency Ethics... agency ethics program is not in full compliance with the requirements set forth in applicable statutes or...

5 CFR 2638.402 - Corrective orders.

Code of Federal Regulations, 2014 CFR

2014-01-01

....402 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS OFFICE OF GOVERNMENT ETHICS AND EXECUTIVE AGENCY ETHICS PROGRAM RESPONSIBILITIES Correction of Executive Branch Agency Ethics... agency ethics program is not in full compliance with the requirements set forth in applicable statutes or...

5 CFR 2638.402 - Corrective orders.

Code of Federal Regulations, 2012 CFR

2012-01-01

....402 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS OFFICE OF GOVERNMENT ETHICS AND EXECUTIVE AGENCY ETHICS PROGRAM RESPONSIBILITIES Correction of Executive Branch Agency Ethics... agency ethics program is not in full compliance with the requirements set forth in applicable statutes or...

5 CFR 2638.402 - Corrective orders.

Code of Federal Regulations, 2013 CFR

2013-01-01

....402 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS OFFICE OF GOVERNMENT ETHICS AND EXECUTIVE AGENCY ETHICS PROGRAM RESPONSIBILITIES Correction of Executive Branch Agency Ethics... agency ethics program is not in full compliance with the requirements set forth in applicable statutes or...

Pragmatic ethical basis for radiation protection in diagnostic radiology.

PubMed

Malone, Jim; Zölzer, Friedo

2016-01-01

Medical ethics has a tried and tested literature and a global active research community. Even among health professionals, literate and fluent in medical ethics, there is low recognition of radiation protection principles such as justification and optimization. On the other hand, many in healthcare environments misunderstand dose limitation obligations and incorrectly believe patients are protected by norms including a dose limit. Implementation problems for radiation protection in medicine possibly flow from apparent inadequacies of the International Commission on Radiological Protection (ICRP) principles taken on their own, coupled with their failure to transfer successfully to the medical world. Medical ethics, on the other hand, is essentially global, is acceptable in most cultures, is intuitively understood in hospitals, and its expectations are monitored, even by managements. This article presents an approach to ethics in diagnostic imaging rooted in the medical tradition, and alert to contemporary social expectations. ICRP and the International Radiation Protection Association (IRPA), both alert to growing ethical concerns, organized a series of consultations on ethics for general radiation protection in the last few years. The literature on medical ethics and implicit ICRP ethical values were reviewed qualitatively, with a view to identifying a system that will help guide contemporary behaviour in radiation protection of patients. Application of the system is illustrated in six clinical scenarios. The proposed system is designed, as far as is possible, so as not to be in conflict with the conclusions emerging from the ICRP/IRPA consultations. A widely recognized and well-respected system of medical ethics was identified that has global reach and claims acceptance in all cultures. Three values based on this system are grouped with two additional values to provide an ethical framework for application in diagnostic imaging. This system has the potential to be robust and to reach conclusions that are in accord with contemporary medical, social and ethical thinking. The system is not intended to replace the ICRP principles. Rather, it is intended as a well-informed interim approach that will help judge and analyse situations that arouse ethical concerns in radiology. Six scenarios illustrate the practicality of the value system in alerting one to possible deficits in practice. Five widely recognized values and the basis for them are identified to support the contemporary practice of diagnostic radiology. These are essential to complement the widely used ICRP principles pending further development in the area.

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.

The 'over-researched community': An ethics analysis of stakeholder views at two South African HIV prevention research sites.

PubMed

Koen, Jennifer; Wassenaar, Douglas; Mamotte, Nicole

2017-12-01

Health research in resource-limited, multi-cultural contexts raises complex ethical concerns. The term 'over-researched community' (ORC) has been raised as an ethical concern and potential barrier to community participation in research. However, the term lacks conceptual clarity and is absent from established ethics guidelines and academic literature. In light of the concern being raised in relation to research in low- and middle-income countries (LMICs), a critical and empirical exploration of the meaning of ORC was undertaken. Guided by Emanuel et al.'s (2004) eight principles for ethically sound research in LMICs, this study examines the relevance and meaning of the terms 'over-research' and 'over-researched community' through an analysis of key stakeholder perspectives at two South African research sites. Data were collected between August 2007 and October 2008. 'Over-research' was found to represent a conglomeration of ethical concerns often used as a proxy for standard research ethics concepts. 'Over-research' seemed fundamentally linked to disparate positions and perspectives between different stakeholders in the research interaction, arising from challenges in inter-stakeholder relationships. 'Over-research' might be interpreted to mean exploitation. However, exploitation itself could mean different things. Using the term may lead to obscured understanding of real or perceived ethical concerns, making it difficult to identify and address the underlying concerns. It is recommended that the term be carefully and critically interrogated for clarity when used in research ethics discourse. Because it represents other legitimate concerns, it should not be dismissed without careful exploration. Copyright © 2017 Elsevier Ltd. All rights reserved.

"It's the Way That You Do It": Developing an Ethical Framework for Community Psychology Research and Action.

PubMed

Campbell, Rebecca

2016-12-01

In the 50 years since the 1965 Swampscott conference, the field of community psychology has not yet developed a well-articulated ethical framework to guide research and practice. This paper reviews what constitutes an "ethical framework"; considers where the field of community psychology is at in its development of a comprehensive ethical framework; examines sources for ethical guidance (i.e., ethical principles and standards) across multiple disciplines, including psychology, evaluation, sociology, and anthropology; and recommends strategies for developing a rich written discourse on how community psychology researchers and practitioners can address ethical conflicts in our work. © Society for Community Research and Action 2016.

MOMENTS OF UNCERTAINTY: ETHICAL CONSIDERATIONS AND EMERGING CONTAMINANTS

PubMed Central

Cordner, Alissa; Brown, Phil

2013-01-01

Science on emerging environmental health threats involves numerous ethical concerns related to scientific uncertainty about conducting, interpreting, communicating, and acting upon research findings, but the connections between ethical decision making and scientific uncertainty are under-studied in sociology. Under conditions of scientific uncertainty, researcher conduct is not fully prescribed by formal ethical codes of conduct, increasing the importance of ethical reflection by researchers, conflicts over research conduct, and reliance on informal ethical standards. This paper draws on in-depth interviews with scientists, regulators, activists, industry representatives, and fire safety experts to explore ethical considerations of moments of uncertainty using a case study of flame retardants, chemicals widely used in consumer products with potential negative health and environmental impacts. We focus on the uncertainty that arises in measuring people’s exposure to these chemicals through testing of their personal environments or bodies. We identify four sources of ethical concerns relevant to scientific uncertainty: 1) choosing research questions or methods, 2) interpreting scientific results, 3) communicating results to multiple publics, and 4) applying results for policy-making. This research offers lessons about professional conduct under conditions of uncertainty, ethical research practice, democratization of scientific knowledge, and science’s impact on policy. PMID:24249964

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…

From subject to participant: ethics and the evolving role of community in health research.

PubMed

Bromley, Elizabeth; Mikesell, Lisa; Jones, Felica; Khodyakov, Dmitry

2015-05-01

Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.

From Subject to Participant: Ethics and the Evolving Role of Community in Health Research

PubMed Central

Mikesell, Lisa; Jones, Felica; Khodyakov, Dmitry

2015-01-01

Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research. PMID:25790380

Representation of genomics research among Latin American laymen and bioethics: a inquiry into the migration of knowledge and its impact on underdeveloped communities

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

Fernando Lolas; Carolina Valdebenito; Eduardo Rodríguez

The effects of genetic knowledge beyond the scientific community depend on processes of social construction of risks and benefits, or perils and possibilities, which are different in different communities. In a globalized world, new developments affect societies not capable of technically replicating them and unaware of the very nature of the scientific process. Moral and legal consequences, however, diffuse rapidly and involve groups and persons with scant or no knowledge about the way scientific concepts are developed or perfected. Leading genomics researchers view their field as developing after a sharp break with that worldwide social movement of the 20´s andmore » 30´s known as eugenics and its most radical expression in the Nazi efforts to destroy life “not worth living”. Manipulation, prejudice and mistrust, however, pervade non-expert accounts of current research. Researchers claim that the new knowledge will have a positive impact on medicine and serve as a foundation for informed social policy. Both types of applications depend on informed communities of non-scientists (physicians, policymakers), whose members may well differ on what constitutes burden and what is benefit, depending upon professional socialization and cultural bias. ELSI projects associated with genomic research are notable for the lack of minorities involved and for the absence of comparative analysis of data reception in different world communities. It may be contended also that the critical potential of philosophical or ethical analyses is reduced by their being situated within the scientific process itself and carried out by members of the expert community, thus reducing independence of judgment. The majority of those involved in such studies, by tradition, experience, and formative influences, share the same worldview about the nature of moral dilemmas or the feasibility of intended applications. The global effects of new knowledge when combined with other cultural or religious traditions are thus unknown. These effects are interesting on two accounts. First, even if underdeveloped countries cannot replicate the technical aspects of research, their influence on social practices is not kept within geographical or language barriers. The way they are handled in developed countries may become part of resistances to “ethical imperialism”. Second, these advances have economic consequences. Their full understanding and the creation of a scientific literacy essential for sound ethical analysis demand the creation of “receptive capacity” in developing countries. The morality of genomics research and its applications can be analyzed from two main vantage points. Some traditions stress the ethics of convictions (in Max Weber´s terms, Gesinnungsethik) while others rely on the ethics of responsibility (Verantwortungsethik). In different forms, the latter deals with the consequences of social action, scientific research in this case, and may or may not be related to utilitarian considerations. It may be hypothesized that convictions, mostly of a religious nature, dominate the argumentative preferences in Latin countries and continental European traditions which rely on virtues while responsibility is associated with a discourse based on rights prevalent in countries following the Anglo-Saxon pattern of thought. This finds expression in different legal systems (common law versus codes) and in the language used for deliberation and moral reasoning. Although results of US-based ELSI research may not be transferable to other cultural and economic contexts, they impact other societies and serve as models. Rarely do they apply completely in other settings. In a globalized world, both appropriate understanding of the scientific enterprise and its ethical or economic sustainability demand empirical analysis of the patterns of thought, main beliefs, and reactions toward the new knowledge and its applications. Anecdotal accounts show that expectations may be misleading and inadequate knowledge prevents appropriate appraisal of burdens and benefits in different societies.« less

Ethical Gifts?: An Analysis of Soap-for-data Transactions in Malawian Survey Research Worlds.

PubMed

Biruk, Crystal

2017-09-01

In 2008, thousands of Malawians received soap from an American research project as a gift for survey participation. Soap was deemed an ethical, non-coercive gift by researchers and ethics boards, but took on meanings that expressed recipients' grievances and aspirations. Research participants reframed soap and research benefits as "rights" they are entitled to, wages for "work," and a symbol of exploitation. Enlisting the perspectives of Malawi's ethics board, demographers, Malawian fieldworkers, and research participants, I describe how soap is spoken about and operates in research worlds. I suggest that neither a prescriptive nor a situated frame for ethics-with their investments in standardization and attention to context, respectively-provides answers about how to compensate Malawian research participants. The conclusion gestures toward a reparative framework for thinking ethics that is responsive not just to project-based parameters but also to the histories and political economy in which projects (and ethics) are situated. © 2017 by the American Anthropological Association.

Scientists' perspectives on the ethical issues of stem cell research.

PubMed

Longstaff, Holly; Schuppli, Catherine A; Preto, Nina; Lafrenière, Darquise; McDonald, Michael

2009-06-01

This paper describes findings from an ethics education project funded by the Canadian Stem Cell Network (SCN). The project is part of a larger research initiative entitled "The Stem Cell Research Environment: Drawing the Evidence and Experience Together". The ethics education study began with a series of focus groups with SCN researchers and trainees as part of a "needs assessment" effort. The purpose of these discussions was to identify the main ethical issues associated with stem cell (SC) research from the perspective of the stem cell community. This paper will focus on five prominent themes that emerged from the focus group data including: (1) the source of stem cells; (2) the power of stem cells; (3) working within a charged research environment; (4) the regulatory context; and (5) ethics training for scientists. Additional discussions are planned with others involved in Canadian stem cell research (e.g., research ethics board members, policy makers) to supplement initial findings. These assessment results combined with existing bioethics literature will ultimately inform a web-based ethics education module for the SCN. We believe that our efforts are important for those analyzing the ethical, legal, and social issues (ELSI) in this area because our in depth understanding of stem cell researcher perspectives will enable us to develop more relevant and effective education material, which in turn should help SC researchers address the important ethical challenges in their area.

Ethical modernization: research misconduct and research ethics reforms in Korea following the Hwang affair.

PubMed

Kim, Jongyoung; Park, Kibeom

2013-06-01

The Hwang affair, a dramatic and far reaching instance of scientific fraud, shocked the world. This collective national failure prompted various organizations in Korea, including universities, regulatory agencies, and research associations, to engage in self-criticism and research ethics reforms. This paper aims, first, to document and review research misconduct perpetrated by Hwang and members of his research team, with particular attention to the agencies that failed to regulate and then supervise Hwang's research. The paper then examines the research ethics reforms introduced in the wake of this international scandal. After reviewing American and European research governance structures and policies, policy makers developed a mixed model mindful of its Korean context. The third part of the paper examines how research ethics reform is proactive (a response to shocking scientific misconduct and ensuing external criticism from the press and society) as well as reactive (identification of and adherence to national or international ethics standards). The last part deals with Korean society's response to the Hwang affair, which had the effect of a moral atomic bomb and has led to broad ethical reform in Korean society. We conceptualize this change as ethical modernization, through which the Korean public corrects the failures of a growth-oriented economic model for social progress, and attempts to create a more trustworthy and ethical society.

Applying Cases to Solve Ethical Problems: The Significance of Positive and Process-Oriented Reflection

PubMed Central

Antes, Alison L.; Thiel, Chase E.; Martin, Laura E.; Stenmark, Cheryl K.; Connelly, Shane; Devenport, Lynn D.; Mumford, Michael D.

2015-01-01

This study examined the role of reflection on personal cases for making ethical decisions with regard to new ethical problems. Participants assumed the position of a business manager in a hypothetical organization and solved ethical problems that might be encountered. Prior to making a decision for the business problems, participants reflected on a relevant ethical experience. The findings revealed that application of material garnered from reflection on a personal experience was associated with decisions of higher ethicality. However, whether the case was viewed as positive or negative, and whether the outcomes, process, or outcomes and processes embedded in the experience were examined, influenced the application of case material to the new problem. As expected, examining positive experiences and the processes involved in those positive experiences resulted in greater application of case material to new problems. Future directions and implications for understanding ethical decision-making are discussed. PMID:26257506

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

Some Basics about Ethics.

ERIC Educational Resources Information Center

Dean, Peter J.

1994-01-01

Discussion of ethics focuses on the role of human performance technology professionals in helping corporate ethicists. Highlights include definitions of ethics, morals, values, and business ethics; ethics in academia and in business; and application of the knowledge of ethics to decision-making. (Contains 18 references.) (LRW)

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.

Overview on health research ethics in Egypt and North Africa.

PubMed

Marzouk, Diaa; Abd El Aal, Wafaa; Saleh, Azza; Sleem, Hany; Khyatti, Meriem; Mazini, Loubna; Hemminki, Kari; Anwar, Wagida A

2014-08-01

Developing countries, including Egypt and North African countries, need to improve their quality of research by enhancing international cooperation and exchanges of scientific information, as well as competing for obtaining international funds to support research activities. Research must comply with laws and other requirements for research that involves human subjects. The purpose of this article is to overview the status of health research ethics in Egypt and North African countries, with reference to other Middle Eastern countries. The EU and North African Migrants: Health and Health Systems project (EUNAM) has supported the revision of the status of health research ethics in Egypt and North African countries, by holding meetings and discussions to collect information about research ethics committees in Egypt, and revising the structure and guidelines of the committees, as well as reviewing the literature concerning ethics activities in the concerned countries. This overview has revealed that noticeable efforts have been made to regulate research ethics in certain countries in the Middle East. This can be seen in the new regulations, which contain the majority of protections mentioned in the international guidelines related to research ethics. For most of the internationally registered research ethics committees in North African countries, the composition and functionality reflect the international guidelines. There is growing awareness of research ethics in these countries, which extends to teaching efforts to undergraduate and postgraduate medical students. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Scientific Ethics: A New Approach.

PubMed

Menapace, Marcello

2018-06-04

Science is an activity of the human intellect and as such has ethical implications that should be reviewed and taken into account. Although science and ethics have conventionally been considered different, it is herewith proposed that they are essentially similar. The proposal set henceforth is to create a new ethics rooted in science: scientific ethics. Science has firm axiological foundations and searches for truth (as a value, axiology) and knowledge (epistemology). Hence, science cannot be value neutral. Looking at standard scientific principles, it is possible to construct a scientific ethic (that is, an ethical framework based on scientific methods and rules), which can be applied to all sciences. These intellectual standards include the search for truth (honesty and its derivatives), human dignity (and by reflection the dignity of all animals) and respect for life. Through these it is thence achievable to draft a foundation of a ethics based purely on science and applicable beyond the confines of science. A few applications of these will be presented. Scientific ethics can have vast applications in other fields even in non scientific ones.

Aversive Stimulation -- Criteria for Application.

ERIC Educational Resources Information Center

O'Donnell, Patrick A.; Ohlson, Glenn A.

Criteria for applying aversive stimulation with severely handicapped children are examined, and practical and ethical issues are considered. Factors seen to influence punishment outcomes include timing, intensity, and schedule of reinforcement. Suggested is the need for further research on the comparative effectiveness of positive and negative…

(Un)ethical behavior in organizations.

PubMed

Treviño, Linda Klebe; den Nieuwenboer, Niki A; Kish-Gephart, Jennifer J

2014-01-01

This review spotlights research related to ethical and unethical behavior in organizations. It builds on previous reviews and meta-analyses of the literature on (un)ethical behavior in organizations and discusses recent advances in the field. The review emphasizes how this research speaks to the influence of the organizational context on (un)ethical behavior, proceeding from a more macro to a more micro view on (un)ethical behavior and covering ethical infrastructures, interpersonal influences, individual differences, and cognitive and affective processes. The conclusion highlights opportunities for future research.

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

PubMed

Grunberg, F

1990-06-01

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

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

Assessing the Public’s Views in Research Ethics Controversies: Deliberative Democracy and Bioethics as Natural Allies

PubMed Central

Kim, Scott Y. H.; Wall, Ian F.; Stanczyk, Aimee; Vries, Raymond De

2010-01-01

In a Liberal Democracy, Policy Decisions regarding ethical controversies, including those in research ethics, should incorporate the opinions of its citizens. Eliciting informed and well-considered ethical opinions can be challenging. The issues may not be widely familiar and they may involve complex scientific, legal, historical, and ethical dimensions. Traditional surveys risk eliciting superficial and uninformed opinions that may be of dubious quality for policy formation. We argue that the theory and practice of deliberative democracy (DD) is especially useful in overcoming such inadequacies. We explain DD theory and practice, discuss the rationale for using DD methods in research ethics, and illustrate in depth the use of a DD method for a long-standing research ethics controversy involving research based on surrogate consent. The potential pitfalls of DD and the means of minimizing them as well as future research directions are also discussed. PMID:19919315

Assessing the public's views in research ethics controversies: deliberative democracy and bioethics as natural allies.

PubMed

Kim, Scott Y H; Wall, Ian F; Stanczyk, Aimee; De Vries, Raymond

2009-12-01

In a liberal democracy, policy decisions regarding ethical controversies, including those in research ethics, should incorporate the opinions of its citizens. Eliciting informed and well-considered ethical opinions can be challenging. The issues may not be widely familiar and they may involve complex scientific, legal, historical, and ethical dimensions. Traditional surveys risk eliciting superficial and uninformed opinions that may be of dubious quality for policy formation. We argue that the theory and practice of deliberative democracy (DD) is especially useful in overcoming such inadequacies. We explain DD theory and practice, discuss the rationale for using DD methods in research ethics, and illustrate in depth the use of a DD method for a longstanding research ethics controversy involving research based on surrogate consent. The potential pitfalls of DD and the means of minimizing them as well as future research directions are also discussed.

Ethical challenges embedded in qualitative research interviews with close relatives.

PubMed

Haahr, Anita; Norlyk, Annelise; Hall, Elisabeth Oc

2014-02-01

Nurse researchers engaged in qualitative interviews with patients and spouses in healthcare may often experience being in unforeseen ethical dilemmas. Researchers are guided by the bioethical principles of justice, beneficence, non-maleficence, respect for human rights and respect for autonomy through the entire research process. However, these principles are not sufficient to prepare researchers for unanticipated ethical dilemmas related to qualitative research interviews. We describe and discuss ethically challenging and difficult moments embedded in two cases from our own phenomenological interview studies. We argue that qualitative interviews involve navigation between being guided by bioethics as a researcher, being a therapist/nurse and being a fellow human being or even a friend. The researchers' premises to react to unexpected situations and act in a sound ethical manner must be enhanced, and there is a need for an increased focus on the researchers' ethical preparation and to continually address and discuss cases from their own interviews.

Taking stock of the ethical foundations of international health research: pragmatic lessons from the IU-Moi Academic Research Ethics Partnership.

PubMed

Meslin, Eric M; Were, Edwin; Ayuku, David

2013-09-01

It is a sine qua non that research and health care provided in international settings raise profound ethical questions when different cultural and political values are implicated. Yet ironically, as international health research expands and as research on ethical issues in international health research broadens and deepens, we appear to have moved away from discussing the moral foundations of these activities. For international health research to thrive and lead to the kind of benefits it is capable of, it is helpful to occasionally revisit the foundational premises that justify the enterprise as a whole. We draw on the experience of the Indiana University-Moi University Academic Research Ethics Partnership, an innovative bioethics training program co-located in Indianapolis and Eldoret, Kenya to highlight the changing nature of ethical issues in international health research and the ongoing practical challenges.

The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics.

PubMed

Fisher, Celia B; Yuko, Elizabeth

2015-12-01

The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. © The Author(s) 2015.

Herbal medicine research and global health: an ethical analysis.

PubMed

Tilburt, Jon C; Kaptchuk, Ted J

2008-08-01

Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal medicine research: social value, scientific validity and favourable risk-benefit ratio. Significant challenges exist in determining shared concepts of social value, scientific validity and favourable risk-benefit ratio across international research collaborations. However, we argue that collaborative partnership, including democratic deliberation, offers the context and process by which many of the ethical challenges in international herbal medicine research can, and should be, resolved. By "cross-training" investigators, and investing in safety-monitoring infrastructure, the issues identified by this comprehensive framework can promote ethically sound international herbal medicine research that contributes to global health.

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.

Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.

PubMed

Juritzen, Truls I; Grimen, Harald; Heggen, Kristin

2011-09-01

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics

PubMed Central

Fisher, Celia B.; Yuko, Elizabeth

2018-01-01

The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. PMID:26564944

Legal and ethical issues in research.

PubMed

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-09-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

The ethics of neuromodulation for anorexia nervosa: a focus on rTMS

PubMed Central

2014-01-01

Objective Recently there has been emerging clinical and research interest in the application of deep brain stimulation (DBS) and repetitive transcranial magnetic stimulation (rTMS) to the treatment of anorexia nervosa (AN). To our knowledge, few studies have discussed ethical aspects associated with the increased use of neuromodulation in AN, some of which are quite specific to AN, despite the rapid development and dissemination of these new technologies. Method We provide a brief overview of three published rTMS studies for AN and discuss ethical issues involved in the use of neuromodulation for AN. Results In contrast to neurosurgery or DBS, rTMS is a less invasive technique, with less associated risk, and thus has greater potential to become a more widespread augmentation or add-on therapy for AN. New therapeutic procedures are promising, yet they raise ethical questions regarding informed consent and patient selection. Illness-specific issues surrounding authenticity and autonomy are important to consider, ensuring an ethical approach to treatment for patients with AN. Discussion We argue that ethical investigations for neuromodulation techniques are timely and important, and discussions should go beyond the immediate goals of patient safety, consent, and risk and benefit, to consider broader ethical concepts such as authenticity and autonomy. PMID:24690315

The Hidden Ethics Curriculum in Two Canadian Psychiatry Residency Programs: A Qualitative Study.

PubMed

Gupta, Mona; Forlini, Cynthia; Lenton, Keith; Duchen, Raquel; Lohfeld, Lynne

2016-08-01

The authors describe the hidden ethics curriculum in two postgraduate psychiatry programs. Researchers investigated the formal, informal, and hidden ethics curricula at two demographically different postgraduate psychiatry programs in Canada. Using a case study design, they compared three sources: individual interviews with residents and with faculty and a semi-structured review of program documents. They identified the formal, informal, and hidden curricula at each program for six ethics topics and grouped the topics under two thematic areas. They tested the applicability of the themes against the specific examples under each topic. Results pertaining to one of the themes and its three topics are reported here. Divergences occurred between the curricula for each topic. The nature of these divergences differed according to local program characteristics. Yet, in both programs, choices for action in ethically challenging situations were mediated by a minimum standard of ethics that led individuals to avoid trouble even if this meant their behavior fell short of the accepted ideal. Effective ethics education in postgraduate psychiatry training will require addressing the hidden curriculum. In addition to profession-wide efforts to articulate high-level values, program-specific action on locally relevant issues constitutes a necessary mechanism for handling the impact of the hidden curriculum.

Publication ethics from the ground up.

PubMed

DeTora, Lisa; Foster, Cate; Nori, Mukund; Simcoe, Donna; Skobe, Catherine; Toroser, Dikran

2018-02-01

It is relatively easy to begin policy documents with a general assertion that ethics will be followed. Less obvious is how to ensure that day-to-day activities are consonant with ethical standards. We suggest that using day-to-day publication activities as the driver for building policies and procedures can promote ethical practices from the ground up. Although basic principles of ethical publication practice may seem straightforward to some, for others this information may require explanation, interpretation and context. Effective policy development includes big-picture items as well as more day-to-day tactical responsibilities such as those discussed below. Research questions, disciplinary practices, applications and team structures may vary. Thus, no single publication plan or policy solution is right for all teams. It is up to team members to review guidelines for best practices and find the optimal implementation for their situations. Experts in publication management, planning and writing can help large teams manage publication activities. These experts have an obligation to maintain and enhance their skills continually. A strong acumen in publication best practices will allow these publication professionals to better address any possible ethical dilemmas in the future. © 2018 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Ethics and Research with Undergraduates

ERIC Educational Resources Information Center

Richman, Kenneth A.; Alexander, Leslie B.

2006-01-01

Ethicists, researchers and policy makers have paid increasing attention to the ethical conduct of research, especially research involving human beings. Research performed with and by undergraduates poses a specific set of ethical challenges. These challenges are often overlooked by the research community because it is assumed that undergraduate…

Research Ethics in Sign Language Communities

ERIC Educational Resources Information Center

Harris, Raychelle; Holmes, Heidi M.; Mertens, Donna M.

2009-01-01

Codes of ethics exist for most professional associations whose members do research on, for, or with sign language communities. However, these ethical codes are silent regarding the need to frame research ethics from a cultural standpoint, an issue of particular salience for sign language communities. Scholars who write from the perspective of…

The Ethics of Archival Research

ERIC Educational Resources Information Center

McKee, Heidi A.; Porter, James E.

2012-01-01

What are the key ethical issues involved in conducting archival research? Based on examination of cases and interviews with leading archival researchers in composition, this article discusses several ethical questions and offers a heuristic to guide ethical decision making. Key to this process is recognizing the person-ness of archival materials.…

An Environmental Ethical Conceptual Framework for Research on Sustainability and Environmental Education

ERIC Educational Resources Information Center

Kronlid, David O.; Ohman, Johan

2013-01-01

This article suggests that environmental ethics can have great relevance for environmental ethical content analyses in environmental education and education for sustainable development research. It is based on a critique that existing educational research does not reflect the variety of environmental ethical theories. Accordingly, we suggest an…

What Price Ethics: New Research Directions in Counselor Ethical Behavior

ERIC Educational Resources Information Center

Paradise, Louis V.

1978-01-01

This paper briefly examines research on the ethical behavior of counselors, demonstrating that new directions in this area are needed, and that new research questions must be asked if significant information relating to counseling and ethics is to advance. Areas of inquiry and methods for investigation are suggested. (Author)

Simple Gifts: Ethical Issues in the Conduct of Person-Based Composition Research.

ERIC Educational Resources Information Center

Anderson, Paul V.

1998-01-01

Discusses ethical issues involved with person-based research. Discusses the ethical discourse embodied in the "Nuremberg Code," federal regulations, and the "Belmont Report." Discusses several specific issues in research ethics to illustrate how this discourse provides new ways of thinking about what must be done to treat…

The Ethnographer as "Impresario-Joker" in the (Re)presentation of Educational Research as Performance Art: Towards a Performance Ethic

ERIC Educational Resources Information Center

Bagley, Carl

2009-01-01

The paper reflects critically on the use of arts-based approaches to (re)present ethnographic educational research data, positing that the use of these artistic genres while creating new opportunities for engaging and enacting the complexities of twenty-first century realities also pose new challenges particularly in relation to the application of…

Curriculum and Faculty Development for the Teaching of Academic Research Ethics.

ERIC Educational Resources Information Center

Stern, Judy E.; Elliott, Deni

This report summarizes a three-year project to design a graduate level course in ethics and scientific research at Dartmouth College (New Hampshire). The goals of the project were: (1) to train faculty to teach a course in research ethics, (2) to pilot-teach a graduate course in ethics and scientific research, and (3) to develop teaching materials…

Building research capacity with members of underserved American Indian/Alaskan Native communities: training in research ethics and the protection of human subjects.

PubMed

Jetter, Karen M; Yarborough, Mark; Cassady, Diana L; Styne, Dennis M

2015-05-01

To develop a research ethics training course for American Indian/Alaskan Native health clinic staff and community researchers who would be conducting human subjects research. Community-based participatory research methods were used in facilitated discussions of research ethics centered around topics included in the Collaborative Institutional Training Initiative research ethics course. The community-based participatory research approach allowed all partners to jointly develop a research ethics training program that was relevant for American Indian/Alaskan Native communities. All community and clinic partners were able to pass the Collaborative Institutional Training Initiative course they were required to pass so that they could be certified to conduct research with human subjects on federally funded projects. In addition, the training sessions provided a foundation for increased community oversight of research. By using a collaborative process to engage community partners in research ethics discussions, rather than either an asynchronous online or a lecture/presentation format, resulted in significant mutual learning about research ethics and community concerns about research. This approach requires university researchers to invest time in learning about the communities in which they will be working prior to the training. © 2014 Society for Public Health Education.

Advancing Ethical Neuroscience Research.

PubMed

Borah, B Rashmi; Strand, Nicolle K; Chillag, Kata L

2016-12-01

As neuroscience research advances, researchers, clinicians, and other stakeholders will face a host of ethical challenges. The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has published two reports that provide recommendations on how to advance research endeavors ethically. The commission addressed, among other issues, how to prioritize different types of neuroscience research and how to include research participants who have impaired consent capacity. The Bioethics Commission's recommendations provide a foundation for ethical guidelines as neuroscience research advances and progresses. © 2016 American Medical Association. All Rights Reserved.

Best practice & research in anaesthesiology issue on new approaches in clinical research ethics in clinical research.

PubMed

Schwenzer, Karen J

2011-12-01

The history of ethics in clinical research parallels the history of abuse of human beings. The Nuremberg Code, Declaration of Helsinki, and the Belmont Report laid the foundations for modern research ethics. In the United States, the OHRP and the FDA provide guidelines for the ethical conduct of research. Investigators should be familiar with regulations concerning informed consent, doing research in vulnerable populations, and protection of privacy. Copyright © 2011 Elsevier Ltd. All rights reserved.

Mental health research, ethics and multiculturalism.

PubMed

Bailes, Marion J; Minas, I Harry; Klimidis, Steven

2006-01-01

In this paper we examine ethical issues relevant to conducting mental health research with refugees and immigrant communities that have cultural orientations and social organisation that are substantially different to those of the broader Australian community, and we relate these issues to NH&MRC Guidelines. We describe the development and conduct of a mental health research project carried out recently in Melbourne with the Somali community, focusing on ethical principles involved, and relating these to the NH&MRC National Statement on Ethical Conduct in Research Involving Humans, and the NH&MRC document Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. The experience of conducting mental health research with the Somali community highlights the fact that the principles of inclusion and benefit enunciated in the NH&MRC document Values and Ethics are particularly pertinent when conducting research with refugees and immigrant communities that are culturally distant to those of the broader Australian community. These principles inform issues of research design and consent, as well as guiding respectful engagement with the participating community and communication of the research findings.

The paucity of ethical analysis in allergology

PubMed Central

2013-01-01

While a growing body of research is uncovering the aetiology and effective treatments for allergy, research that assess the broader ethical implications of this disease is lacking significantly. This article will demonstrate both the paucity of academic research concerning ethical implications in allergy and explain why ethical analysis is integral to formulating effective health strategies for allergic disease. An exhaustive literature search of publications in French and English identified less than 35 academic articles focussed on the topic of ethics and allergy; this is a miniscule number when compared to the amount of articles published on ethical issues related to other chronic illnesses, such as obesity. It is important to demonstrate to allergy specialists the need for, and utility of, further incorporating ethical analyses in allergology; the current success of Ethical, Legal, Social Implications (ELSI) research programmes in human genetics and nanotechnology will serve as notable examples. Indeed, future research and innovation in allergy will undoubtedly encounter ethical dilemmas and the allergology community should play a significant role in helping to address these issues. However, incorporating ethical analyses in allergology does not imply that the allergology community must acquire extensive knowledge in bioethics; instead, interdisciplinary research that incorporates expertise from allergology and bioethics would enable allergy specialists to advance critical knowledge development in this largely overlooked domain of study. PMID:23388345

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.

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea

PubMed Central

2013-01-01

Background In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Discussion Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Summary Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered. PMID:23885908

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea.

PubMed

Laman, Moses; Pomat, William; Siba, Peter; Betuela, Inoni

2013-07-26

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered.

Ethical aspects of clinical research with minors.

PubMed

Bos, Wendy; Tromp, Krista; Tibboel, Dick; Pinxten, Wim

2013-07-01

Over the past decades, clinical research has increasingly been subjected to ethical requirements and legal regulation. The specific focus of ethical and legal frameworks on competent adults (which serve as the paradigmatic research subject), however, has created an ambivalent attitude towards pediatric clinical research. On one hand, minors are regarded as a vulnerable population that deserves additional protection against the risks and burdens involved in clinical research. On the other hand, the population of minors should not be denied (or not get timely) access to the benefits of clinical research. In this paper, we will explore the legal regulation and ethical guidance that currently governs pediatric clinical research in the European Union and discuss the future challenges in this field. In addition, we will discuss major ethical concerns in pediatric clinical research, with a focus on the acceptability of research risks and the informed consent process. In the discussion, we will address key concerns in both regulating pediatric clinical research and implementing ethical and legal requirement in the actual pediatric research conduct.

The ethical challenges of animal research.

PubMed

Ferdowsian, Hope R; Gluck, John P

2015-10-01

In 1966, Henry K. Beecher published an article entitled "Ethics and Clinical Research" in the New England Journal of Medicine, which cited examples of ethically problematic human research. His influential paper drew attention to common moral problems such as inadequate attention to informed consent, risks, and efforts to provide ethical justification. Beecher's paper provoked significant advancements in human research policies and practices. In this paper, we use an approach modeled after Beecher's 1966 paper to show that moral problems with animal research are similar to the problems Beecher described for human research. We describe cases that illustrate ethical deficiencies in the conduct of animal research, including inattention to the issue of consent or assent, incomplete surveys of the harms caused by specific protocols, inequitable burdens on research subjects in the absence of benefits to them, and insufficient efforts to provide ethical justification. We provide a set of recommendations to begin to address these deficits.

Knowledge of the Nigerian Code of Health Research Ethics Among Biomedical Researchers in Southern Nigeria.

PubMed

Ogunrin, Olubunmi A; Daniel, Folasade; Ansa, Victor

2016-12-01

Responsibility for protection of research participants from harm and exploitation rests on Research Ethics Committees and principal investigators. The Nigerian National Code of Health Research Ethics defines responsibilities of stakeholders in research so its knowledge among researchers will likely aid ethical conduct of research. The levels of awareness and knowledge of the Code among biomedical researchers in southern Nigerian research institutions was assessed. Four institutions were selected using a stratified random sampling technique. Research participants were selected by purposive sampling and completed a pre-tested structured questionnaire. A total of 102 biomedical researchers completed the questionnaires. Thirty percent of the participants were aware of the National Code though 64% had attended at least one training seminar in research ethics. Twenty-five percent had a fairly acceptable knowledge (scores 50%-74%) and 10% had excellent knowledge of the code (score ≥75%). Ninety-five percent expressed intentions to learn more about the National Code and agreed that it is highly relevant to the ethical conduct of research. Awareness and knowledge of the Code were found to be very limited among biomedical researchers in southern Nigeria. There is need to improve awareness and knowledge through ethics seminars and training. Use of existing Nigeria-specific online training resources is also encouraged.

What is data ethics?

PubMed

Floridi, Luciano; Taddeo, Mariarosaria

2016-12-28

This theme issue has the founding ambition of landscaping data ethics as a new branch of ethics that studies and evaluates moral problems related to data (including generation, recording, curation, processing, dissemination, sharing and use), algorithms (including artificial intelligence, artificial agents, machine learning and robots) and corresponding practices (including responsible innovation, programming, hacking and professional codes), in order to formulate and support morally good solutions (e.g. right conducts or right values). Data ethics builds on the foundation provided by computer and information ethics but, at the same time, it refines the approach endorsed so far in this research field, by shifting the level of abstraction of ethical enquiries, from being information-centric to being data-centric. This shift brings into focus the different moral dimensions of all kinds of data, even data that never translate directly into information but can be used to support actions or generate behaviours, for example. It highlights the need for ethical analyses to concentrate on the content and nature of computational operations-the interactions among hardware, software and data-rather than on the variety of digital technologies that enable them. And it emphasizes the complexity of the ethical challenges posed by data science. Because of such complexity, data ethics should be developed from the start as a macroethics, that is, as an overall framework that avoids narrow, ad hoc approaches and addresses the ethical impact and implications of data science and its applications within a consistent, holistic and inclusive framework. Only as a macroethics will data ethics provide solutions that can maximize the value of data science for our societies, for all of us and for our environments.This article is part of the themed issue 'The ethical impact of data science'. © 2016 The Author(s).

What is data ethics?

PubMed Central

2016-01-01

This theme issue has the founding ambition of landscaping data ethics as a new branch of ethics that studies and evaluates moral problems related to data (including generation, recording, curation, processing, dissemination, sharing and use), algorithms (including artificial intelligence, artificial agents, machine learning and robots) and corresponding practices (including responsible innovation, programming, hacking and professional codes), in order to formulate and support morally good solutions (e.g. right conducts or right values). Data ethics builds on the foundation provided by computer and information ethics but, at the same time, it refines the approach endorsed so far in this research field, by shifting the level of abstraction of ethical enquiries, from being information-centric to being data-centric. This shift brings into focus the different moral dimensions of all kinds of data, even data that never translate directly into information but can be used to support actions or generate behaviours, for example. It highlights the need for ethical analyses to concentrate on the content and nature of computational operations—the interactions among hardware, software and data—rather than on the variety of digital technologies that enable them. And it emphasizes the complexity of the ethical challenges posed by data science. Because of such complexity, data ethics should be developed from the start as a macroethics, that is, as an overall framework that avoids narrow, ad hoc approaches and addresses the ethical impact and implications of data science and its applications within a consistent, holistic and inclusive framework. Only as a macroethics will data ethics provide solutions that can maximize the value of data science for our societies, for all of us and for our environments. This article is part of the themed issue ‘The ethical impact of data science’. PMID:28336805

Beyond procedural ethics: Foregrounding questions of justice in global health research ethics training for students

PubMed Central

Hunt, Matthew R.; Godard, Beatrice

2013-01-01

Interest in global health is growing among students across many disciplines and fields of study. In response, an increasing number of academic programmes integrate and promote opportunities for international research, service or clinical placements. These activities raise a range of ethical issues and are associated with important training needs for those who participate. In this paper, we focus on research fieldwork conducted in lower income nations by students from more affluent countries and the ethics preparation they would benefit from receiving prior to embarking on these projects. Global health research is closely associated with questions of justice and equity that extend beyond concerns of procedural ethics. Research takes place in and is shaped by matrices of political, social and cultural contexts and concerns. These realities warrant analysis and discussion during research ethics training. Training activities present an opportunity to encourage students to link global health research to questions of global justice, account for issues of justice in planning their own research, and prepare for ‘ethicsin-practice’ issues when conducting research in contexts of widespread inequality. Sustained engagement with questions of justice and equity during research ethics training will help support students for involvement in global health research. PMID:23706108

The gap between law and ethics in human embryonic stem cell research: overcoming the effect of U.S. federal policy on research advances and public benefit.

PubMed

Taylor, Patrick L

2005-10-01

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create.

Ethical aspects of genome diversity research: genome research into cultural diversity or cultural diversity in genome research?

PubMed

Ilkilic, Ilhan; Paul, Norbert W

2009-03-01

The goal of the Human Genome Diversity Project (HGDP) was to reconstruct the history of human evolution and the historical and geographical distribution of populations with the help of scientific research. Through this kind of research, the entire spectrum of genetic diversity to be found in the human species was to be explored with the hope of generating a better understanding of the history of humankind. An important part of this genome diversity research consists in taking blood and tissue samples from indigenous populations. For various reasons, it has not been possible to execute this project in the planned scope and form to date. Nevertheless, genomic diversity research addresses complex issues which prove to be highly relevant from the perspective of research ethics, transcultural medical ethics, and cultural philosophy. In the article at hand, we discuss these ethical issues as illustrated by the HGDP. This investigation focuses on the confrontation of culturally diverse images of humans and their cosmologies within the framework of genome diversity research and the ethical questions it raises. We argue that in addition to complex questions pertaining to research ethics such as informed consent and autonomy of probands, genome diversity research also has a cultural-philosophical, meta-ethical, and phenomenological dimension which must be taken into account in ethical discourses. Acknowledging this fact, we attempt to show the limits of current guidelines used in international genome diversity studies, following this up by a formulation of theses designed to facilitate an appropriate inquiry and ethical evaluation of intercultural dimensions of genome research.

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…

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

PubMed Central

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

Evaluation in health promotion: thoughts from inside a human research ethics committee.

PubMed

Allen, Judy; Flack, Felicity

2015-12-01

Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

Research Ethics and Ethical Research: Some Observations from the Global South

ERIC Educational Resources Information Center

Zhang, J. J.

2017-01-01

This paper aims to achieve two objectives. Firstly, it elicits some of the concerns for universal research ethics. It is argued that ethical codes are never universal; they are geographically sensitive. As such, it is important to "develop authentic individual responses to potentially unique circumstances". Secondly, in going beyond a…

For Researchers on Animals, Ethics Training Is Sparse

ERIC Educational Resources Information Center

Keller, Josh

2008-01-01

While the past several decades have brought federal regulations that are designed to make animal research more humane, ethics courses still form only a patchwork across colleges. The amount and types of ethical training available to students vary widely by program and the culture of an institution. Now discussions about animal-research ethics that…

Introducing Ethics to Chemistry Students in a "Research Experiences for Undergraduates" (REU) Program

ERIC Educational Resources Information Center

Hanson, Mark J.

2015-01-01

A three-day ethics seminar introduced ethics to undergraduate environmental chemistry students in the Research Experiences for Undergraduates (REU) program. The seminar helped students become sensitive to and understand the ethical and values dimensions of their work as researchers. It utilized a variety of resources to supplement lectures and…

A code of ethics for evidence-based research with ancient human remains.

PubMed

Kreissl Lonfat, Bettina M; Kaufmann, Ina Maria; Rühli, Frank

2015-06-01

As clinical research constantly advances and the concept of evolution becomes a strong and influential part of basic medical research, the absence of a discourse that deals with the use of ancient human remains in evidence-based research is becoming unbearable. While topics such as exhibition and excavation of human remains are established ethical fields of discourse, when faced with instrumentalization of ancient human remains for research (i.e., ancient DNA extractions for disease marker analyses) the answers from traditional ethics or even more practical fields of bio-ethics or more specific biomedical ethics are rare to non-existent. The Centre for Evolutionary Medicine at the University of Zurich solved their needs for discursive action through the writing of a self-given code of ethics which was written in dialogue with the researchers at the Institute and was published online in Sept. 2011: http://evolutionäremedizin.ch/coe/. The philosophico-ethical basis for this a code of conduct and ethics and the methods are published in this article. © 2015 Wiley Periodicals, Inc.

A Model of Comparative Ethics Education for Social Workers

ERIC Educational Resources Information Center

Pugh, Greg L.

2017-01-01

Social work ethics education models have not effectively engaged social workers in practice in formal ethical reasoning processes, potentially allowing personal bias to affect ethical decisions. Using two of the primary ethical models from medicine, a new social work ethics model for education and practical application is proposed. The strengths…

Willingness of the Local Health Department Workforce to Respond to Infectious Disease Events: Empirical, Ethical, and Legal Considerations

PubMed Central

Rutkow, Lainie; Barnett, Daniel J.

2014-01-01

According to the Institute of Medicine, the local health department workforce is at the hub of the public health emergency preparedness system. A growing body of research has pointed to troubling attitudinal gaps among local health department workers, a vital response cohort, regarding willingness to respond to emergent infectious disease threats, ranging from naturally occurring pandemics to bioterrorism events. A summary of relevant literature on the empirical evidence, ethical norms, and legal standards applicable to the willingness of public health professionals to respond to an infectious disease emergency is presented. Recommendations are proposed for future work to be done to bring the relevant empirical, ethical, and legal considerations together to develop practical guidance for the local response to infectious disease emergencies. PMID:24963648

Ethical questions to ponder in the European stem cell patent debate.

PubMed

Curley, Duncan; Sharples, Andrew

2006-01-01

Patents may be refused in Europe on ethical grounds. Whereas in the past this issue has arisen only infrequently, recent developments in human embryonic stem cell research have given rise to conflicting opinions in Europe as to the approach that should be adopted in relation to patents. The United Kingdom Patent Office has adopted a positive policy towards inventions involving human embryonic stem cells, but the European Patent Office has to date refused to grant patent applications involving similar subject-matter. A series of legal questions on the role of ethics in granting European patents is now to be considered for clarification by the European Patent Office. The answers to these questions should eventually resolve the debate on the patenting of human embryonic stem cells throughout Europe.

A right to confidentiality or a duty to disclose? Ethical guidance for conducting prevention research with children and adolescents.

PubMed

Hiriscau, Ioana E; Stingelin-Giles, Nicola; Stadler, Christina; Schmeck, Klaus; Reiter-Theil, Stella

2014-06-01

Conducting prevention research with children and adolescents raises ethical challenges especially regarding confidentiality. Research with children and adolescents often applies methodologies which aims at the disclosure of sensitive information about practices that impact on adolescent mental and physical health such as sexual activity, smoking, alcohol consumption, illegal drug use, self-damaging and suicidal behaviour (ideation and attempts). The scope of the article is to review normative documents that cover topics relevant for confidentiality when conducting research with children and adolescents. A systematic literature search in MEDLINE was performed to identify relevant international and European guidelines and codes of ethics that cover health, behavioural and social science research. Additionally, the European Research Ethics website was consulted for double check. However, none of the documents aimed at biomedical, behavioural or social research offers concrete support in resolving practical research ethics problems regarding confidentiality. The codes show a lack of clarity in any circumstances in which the researcher might have an obligation to breach confidentiality by disclosing sensitive information. Only little information is given on what kind of disclosed information, if disclosed, might justify breaching confidentiality. The findings prove a need for normative documents to address the ethical questions regarding confidentiality arising in research practice explicitly and specifically. Moreover, further forms of ethical guidance should be developed to support ethical research with children and adolescents.

Operational effectiveness of blended e-learning program for nursing research ethics.

PubMed

Cho, Kap-Chul; Shin, Gisoo

2014-06-01

Since 2006, the Korean Ministry of Education, Science and Technology, and the National Research Foundation of Korea have taken the lead in developing an institutional guideline for research ethics. The purpose was to identify the effectiveness of the Good Research Practice program, developed on a fund granted by the National Research Foundation of Korea, for nurses and nursing students whose knowledge and perception of research ethics were compared before and after the implementation of the Good Research Practice program. This study was conducted to compare the levels of knowledge and perception of research ethics in the participants before and after the program was implemented. The participants included 45 nurses and 69 nursing students from hospitals, colleges of nursing, and the Korean Nurses Association, located in Seoul, Korea. This study was approved by the Institutional Research Board in Korea. Based on the Analysis, Design, Development, Implementation, and Evaluation model, the Good Research Practice program was made up of a total of 30 h of the blended learning both online and off-line. The results of this study showed that there were statistically significant differences in both knowledge and perception of research ethics in nursing students and nurses before and after the program had been implemented. The concepts of professional nursing ethics, moral issues, and bioethics were often confused with one another and not clearly defined. Therefore, the concept and scope of bioethics, moral judgment, and overall nursing ethics should be well defined and conceptualized in the future. This study suggested integrating research ethics education in the nursing curriculum as a required course of study for nursing students and as part of the in-service training program for nurses in order to improve research ethics in nursing research in Korea. © The Author(s) 2013.

Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

PubMed

Ravid, Rivka

2008-09-01

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP's which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, "financial gain" and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

Setting up an ethics of ecosystem research structure based on the precautionary principle.

PubMed

Farmer, Michael C

2013-01-01

Ethical practices in ecological field research differ from those in laboratory research in more than the technical setting and the important distinction between population-level and individual-based concerns. The number of stakeholders affected by the conduct of field research is far larger; private landholders, public water utilities, public land managers, local industries, and communities large and small are only some of those who may be impacted. As research review boards move to establish specific ethical practices for field biologists, the process of identifying appropriate standards will affect the degree to which research will ultimately be disrupted. Standards that lead to research protocols that alienate key interests are not likely to be sustainable. Already, standards that have conflicted with the primary values of a key interest have resulted in disruptions to research and scientific progress. One way to manage this problem of deeply competing interests is to avoid the deepest offenses to any relevant interest group in the design of a proposed study. This is an application of the precautionary principle and is likely to generate a more sustainable balance among competing interests. Unfortunately, this process is also likely to be a never-ending, consensus-seeking process. Fortunately, scientists can have enormous influence on the process if they choose to engage in it early. If scientists use their expertise to function as honest brokers among affected interests, their own interest in scientific research progress is likely to be better met.

Trends in nursing ethics research: Mapping the literature production.

PubMed

Blažun Vošner, Helena; Železnik, Danica; Kokol, Peter; Vošner, Janez; Završnik, Jernej

2017-12-01

There have been a number of debates in the field of nursing ethics. Researchers have focused on various aspects of nursing ethics, such as professional ethics, professional, nursing and ethical values. Within this research, a variety of literature reviews have been conducted, but to the best of our knowledge, bibliometric mapping has not yet been used. This article aims to analyse the production of literature within nursing ethics research. In order to examine publishing patterns, we focused on publishing dynamics, prolific research entities and the most-cited articles. We additionally visualised the content of the literature using a novel mixed-method approach, combining bibliometric analysis and mapping with thematic analysis. Ethical considerations: In our study, ethical review was not required. A total of 1416 information sources were found in the Scopus database. Overall, literature production has increased; however, in recent years, the quantity of published material has begun to decrease. The most prolific countries are the United States, the United Kingdom and Canada, and the most prolific source titles are Nursing Ethics, Journal of Advanced Nursing and Nursing Times. Lately, research in the field of nursing ethics has been focused more on life care (providing for the basic needs of older residents), moral distress and community nursing. The dynamics of research literature production showed an exponential rise in the number of published information sources - a rise which started in the period between 1974 and 1998. Since that period, the trend has stabilised, which might indicate that nursing ethics research is starting a transition to a mature phase. The innovative use of bibliometric analysis and mapping, together with thematic analysis, is a useful tool for analysis of research production in the field of nursing ethics. The results presented can be an excellent starting point for literature reviews and more exhaustive data, information and knowledge seeking.

Ethical dilemmas concerning decision-making within health care leadership: a systematic literature review.

PubMed

Zydziūnaite, Vilma; Suominen, Tarja; Astedt-Kurki, Päivi; Lepaite, Daiva

2010-01-01

The objective was to describe the research methods and research focuses on ethical dilemmas concerning decision-making within health care leadership. The search was conducted on Medline and PubMed databases (1998-2008). The systematic review included 21 selected articles. The ethical dilemmas concerning decision-making within health care leadership are related to three levels: institutional (particular organization), political and local interface (local governmental structure), and national (professional expertise and system). The terms that are used as adequate to the term of "ethical dilemma" are the following: "continuous balancing," "result of resource allocation," "gap between professional obligations and possibilities," "ethically controversial situation," "concern about interactions," "ethical difficulty," "outcome of medical choices," "concern about society access to health care resources," "ethically difficult/challenging situation," "(the consequence of) ethical concern/ethical issue." In qualitative studies, a semi-structured interview and qualitative content analysis are the most commonly applied methods; in quantitative studies, questionnaire surveys are employed. In the research literature, there is a lack of specification according to professional qualification of health care professionals concerning ethical dilemmas by decision-making within health care management/administration. The research on ethical dilemmas in health care leadership, management, and administration should integrate data about levels at which ethical dilemmas occur and investigate ethical dilemmas as complex phenomena because those are attached to decision-making and specific nuances of health care management/administration. In this article, the presented scientific problem requires extensive scientific discussions and research on ethical dilemmas concerning decision-making within health care leadership at various levels.

5 CFR 2638.313 - Agency opinions.

Code of Federal Regulations, 2010 CFR

2010-01-01

....313 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS OFFICE OF GOVERNMENT ETHICS AND EXECUTIVE AGENCY ETHICS PROGRAM RESPONSIBILITIES Formal Advisory Opinion Service § 2638.313 Agency opinions. If the designated agency ethics official issues a written opinion concerning the application of...

Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

PubMed

Dresser, Rebecca

2006-01-01

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

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.

Just regionalisation: rehabilitating care for people with disabilities and chronic illnesses.

PubMed

Secker, Barbara; Goldenberg, Maya J; Gibson, Barbara E; Wagner, Frank; Parke, Bob; Breslin, Jonathan; Thompson, Alison; Lear, Jonathan R; Singer, Peter A

2006-08-29

Regionalised models of health care delivery have important implications for people with disabilities and chronic illnesses yet the ethical issues surrounding disability and regionalisation have not yet been explored. Although there is ethics-related research into disability and chronic illness, studies of regionalisation experiences, and research directed at improving health systems for these patient populations, to our knowledge these streams of research have not been brought together. Using the Canadian province of Ontario as a case study, we address this gap by examining the ethics of regionalisation and the implications for people with disabilities and chronic illnesses. The critical success factors we provide have broad applicability for guiding and/or evaluating new and existing regionalised health care strategies. Ontario is in the process of implementing fourteen Local Health Integration Networks (LHINs). The implementation of the LHINs provides a rare opportunity to address systematically the unmet diverse care needs of people with disabilities and chronic illnesses. The core of this paper provides a series of composite case vignettes illustrating integration opportunities relevant to these populations, namely: (i) rehabilitation and services for people with disabilities; (ii) chronic illness and cancer care; (iii) senior's health; (iv) community support services; (v) children's health; (vi) health promotion; and (vii) mental health and addiction services. For each vignette, we interpret the governing principles developed by the LHINs - equitable access based on patient need, preserving patient choice, responsiveness to local population health needs, shared accountability and patient-centred care - and describe how they apply. We then offer critical success factors to guide the LHINs in upholding these principles in response to the needs of people with disabilities and chronic illnesses. This paper aims to bridge an important gap in the literature by examining the ethics of a new regionalisation strategy with a focus on the implications for people with disabilities and chronic illnesses across multiple sites of care. While Ontario is used as a case study to contextualize our discussion, the issues we identify, the ethical principles we apply, and the critical success factors we provide have broader applicability for guiding and evaluating the development of - or revisions to - a regionalised health care strategy.

A virtue ethics guide to best practices for community-based participatory research.

PubMed

Schaffer, Marjorie A

2009-01-01

Rule ethics, or principled thinking, is important in the analysis of risks and benefits of research and informed consent, but is not completely adequate for guiding ethical responses to communities as research participants and collaborators. Virtue ethics theory can be used to guide actions in relationships, which are foundational to the implementation of community-based participatory research (CBPR). Virtues are strengths of character that contribute to a life of flourishing or well-being for individuals and communities. This article provides an overview of virtue ethics theory, identifies common ethical problems in CBPR, and discusses how professional virtues can be used to guide ethical research practice. The virtues of compassion, courage, honesty, humility, justice, and practical reasoning are defined and applied to ethical practice in the development, implementation, and dissemination of CBPR. Best practices for CBPR that consider the well-being of communities are identified. The virtues of compassion and humility foster inclusiveness and integration of community perspectives in research collaboration. Courage requires researchers to step out of the research safety-net to listen to community member voices and wisdom and share power in research decisions. Honesty requires researchers to communicate realistic expectations for research outcomes, share all findings with the community, and consider community perspectives in research dissemination. Systematic involvement of the community in all steps of the research process represents the virtue of practical reasoning. From a justice perspective, CBPR aims to restore communities rather than take from them.

[Research Ethics in Partnership with Benin : A call for Solidarity].

PubMed

Bergeron, Michel

2017-05-22

Over the last decade, research ethics has developed in Benin partly through a partnership with Quebec. This partnership has evolved using TCPS2, the Canadian framework in research ethics. In doing so, three main values were put forward : respect for human dignity, respect for cultural diversity and solidarity. Over that time period, research ethics in Benin has structured through new Research Ethics Committees (REC) and though participation of those involved in research with human beings. REC members, researchers and students have acquired the needed tools to resolve most of the ethical dilemmas that could arise in the future making it one of the positive results of this partnership. Retrospectively, it has also been a situation where the Van Rensselaer Potter's perspective on bioethics has emerged in a French-speaking context where the spoken language and the French cultural approach is of great importance.

The Most Exciting Thing: Researcher Ethics and Personal Ethics

ERIC Educational Resources Information Center

Ballard, Robert L.

2009-01-01

This autoethnographic chapter explores the thoughts, feelings, desires, and ethical struggles of the author when he rode along with a patrol officer and saw a dead body. Drawing on communication ethics, the author problematizes his ethics, faith, identity, and personal desires. He learns it is important for researchers to consider their personal…

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

PubMed Central

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

2016-01-01

This report describes the development and implementation of a tailored research ethics training that 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, 7 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 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. PMID:27241871

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

Ethics by opinion poll? The functions of attitudes research for normative deliberations in medical ethics.

PubMed

Salloch, Sabine; Vollmann, Jochen; Schildmann, Jan

2014-09-01

Empirical studies on people's moral attitudes regarding ethically challenging topics contribute greatly to research in medical ethics. However, it is not always clear in which ways this research adds to medical ethics as a normative discipline. In this article, we aim to provide a systematic account of the different ways in which attitudinal research can be used for normative reflection. In the first part, we discuss whether ethical judgements can be based on empirical work alone and we develop a sceptical position regarding this point, taking into account theoretical, methodological and pragmatic considerations. As empirical data should not be taken as a direct source for normative justification, we then delineate different ways in which attitudes research can be combined with theoretical accounts of normative justification in the second part of the article. Firstly, the combination of attitudes research with normative-ethical theories is analysed with respect to three different aspects: (a) The extent of empirical data which is needed, (b) the question of which kind of data is required and (c) the ways in which the empirical data are processed within the framework of an ethical theory. Secondly, two further functions of attitudes research are displayed which lie outside the traditional focus of ethical theories: the exploratory function of detecting and characterising new ethical problems, and the field of 'moral pragmatics'. The article concludes with a methodological outlook and suggestions for the concrete practice of attitudinal research in medical ethics. 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.

International variation in ethics committee requirements: comparisons across five Westernised nations

PubMed Central

Goodyear-Smith, Felicity; Lobb, Brenda; Davies, Graham; Nachson, Israel; Seelau, Sheila M

2002-01-01

Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. PMID:11964190

Practicing Research Ethics: Private-Sector Physicians & Pharmaceutical Clinical Trials

PubMed Central

2008-01-01

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians’ relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities. PMID:18353515

Practicing research ethics: private-sector physicians & pharmaceutical clinical trials.

PubMed

Fisher, Jill A

2008-06-01

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.

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.

Legal and ethical issues in research

PubMed Central

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-01-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees. PMID:27729698

Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

PubMed

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

2017-06-28

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster.

Find a NCCAOM Certified Practitioner

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What research ethics should learn from genomics and society research: lessons from the ELSI Congress of 2011.

PubMed

Henderson, Gail E; Juengst, Eric T; King, Nancy M P; Kuczynski, Kristine; Michie, Marsha

2012-01-01

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty--that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted "in the public square." © 2012 American Society of Law, Medicine & Ethics, Inc.

Teaching Ethics When Working with Geocoded Data: A Novel Experiential Learning Approach

ERIC Educational Resources Information Center

van den Bemt, Vera; Doornbos, Julia; Meijering, Louise; Plegt, Marion; Theunissen, Nicky

2018-01-01

Research ethics are not the favourite subject of most undergraduate geography students. However, in the light of increasing mixed-methods research, as well as research using geocodes, it is necessary to train students in the field of ethics. Experiential learning is an approach to teaching that is potentially suitable for teaching ethics. The aim…

Research ethics consultation: ethical and professional practice challenges and recommendations.

PubMed

Sharp, Richard R; Taylor, Holly A; Brinich, Margaret A; Boyle, Mary M; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

2015-05-01

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical and Translational Science Award Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: (1) managing multiple institutional roles and responsibilities, (2) managing sensitive information, and (3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services.

Human research ethics committees in technical universities.

PubMed

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

2014-07-01

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.

Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

PubMed Central

Sharp, Richard R.; Taylor, Holly A.; Brinich, Margaret A.; Boyle, Mary M.; Cho, Mildred; Coors, Marilyn; Danis, Marion; Havard, Molly; Magnus, David; Wilfond, Benjamin

2015-01-01

The complexity of biomedical research has increased considerably in the last decade, as has the pace of translational research. This complexity has generated a number of novel ethical issues for clinical investigators, institutional review boards (IRBs), and other oversight committees. In response, many academic medical centers have created formal research ethics consultation (REC) services to help clinical investigators and IRBs navigate ethical issues in biomedical research. Key functions of a REC service include: assisting with research design and implementation, providing a forum for deliberative exploration of ethical issues, and supplementing regulatory oversight. As increasing numbers of academic research institutions establish REC services, there is a pressing need for consensus about the primary aims and policies that should guide these activities. Establishing clear expectations about the aims and policies of REC services is important if REC programs are to achieve their full potential. Drawing on the experiences of a Clinical Translational Science Award (CTSA) Research Ethics Consultation Working Group, this article describes three major ethical and professional practice challenges associated with the provision of REC: 1) managing multiple institutional roles and responsibilities, 2) managing sensitive information, and 3) communicating with consultation requestors about how these issues are managed. The paper also presents several practical strategies for addressing these challenges and enhancing the quality of REC services. PMID:25607942

Heritage ethics: Toward a thicker account of nursing ethics.

PubMed

Fowler, Marsha D

2016-02-01

The key to understanding the moral identity of modern nursing and the distinctiveness of nursing ethics resides in a deeper examination of the extensive nursing ethics literature and history from the late 1800s to the mid 1960s, that is, prior to the "bioethics revolution". There is a distinctive nursing ethics, but one that falls outside both biomedical and bioethics and is larger than either. Were, there a greater corpus of research on nursing's heritage ethics it would decidedly recondition the entire argument about a distinctive nursing ethics. It would also provide a thicker account of nursing ethics than has been afforded thus far. Such research is dependent upon identifying, locating, accessing and, more importantly, sharing these resources. A number of important heritage ethics sources are identified so that researchers might better locate them. In addition, a bibliography of heritage ethics textbooks and a transcript of the earliest known journal article on nursing ethics in the US are provided. © The Author(s) 2015.

Procedure versus process: ethical paradigms and the conduct of qualitative research.

PubMed

Pollock, Kristian

2012-09-27

Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic 'procedural' resolution. This is not to say that qualitative studies are 'unethical' but that their ethical nature can only be safeguarded through the practice of 'micro-ethics' based on the judgement and integrity of researchers in the field. This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of 'empirical ethics' as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values.

Ethical Issues in mHealth Research Involving Persons Living with HIV/AIDS and Substance Abuse

PubMed Central

Labrique, Alain B.; Kirk, Gregory D.; Westergaard, Ryan P.; Merritt, Maria W.

2013-01-01

We aim to raise awareness and stimulate dialogue among investigators and research ethics committees regarding ethical issues that arise specifically in the design and conduct of mHealth research involving persons living with HIV/AIDS and substance abuse. Following a brief background discussion of mHealth research in general, we offer a case example to illustrate the characteristics of mHealth research involving people living with HIV/AIDS and substance abuse. With reference to a well-established systematic general ethical framework for biomedical research with human participants, we identify a range of ethical issues that have particular salience for the protection of participants in mHealth research on HIV/AIDS and substance abuse. PMID:24171110

Ethical Issues in the Research of Group Work

ERIC Educational Resources Information Center

Goodrich, Kristopher M.; Luke, Melissa

2017-01-01

This article provides a primer for researchers exploring ethical issues in the research of group work. The article begins with an exploration of relevant ethical issues through the research process and current standards guiding its practice. Next, the authors identify resources that group work researchers can consult prior to constructing their…

Ethical Issues in Addressing Inequity in/through ESL Research

ERIC Educational Resources Information Center

Lee, Ena

2011-01-01

This article outlines a researcher's struggles with conducting "ethical" research when her case study reveals racializations faced by a minority teacher in a Canadian ESL program. How might becoming privy to research participants' experiences of inequity in ESL education complicate the notion of research ethics when "doing the right…

Focus on Teaching: Ethics.

ERIC Educational Resources Information Center

Worley, Rebecca B.; Dyrud, Marilyn A.

1998-01-01

Notes that business today is concerned with the translation and application of ethical principles into everyday business life. Offers a list of Web sites on ethics and business ethics at various colleges and universities. (SR)

Unfinished business: ongoing ethical exceptionalism in the oversight of human pluripotent stem cell research in Canada.

PubMed

Baylis, Françoise; Downie, Jocelyn

2012-01-01

In this article, we critically examine the arguments for and against the exceptional status given human pluripotent stem cell research in Canada (through the latest [December 2010] revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), and conclude that this exceptionalism is unwarranted and ethically unsound. In our view, the three federal research granting agencies should honor their longstanding commitment that researchers, research sponsors, and Research Ethics Boards in Canada have access to "a single reference document for all research involving humans conducted under the auspices of institutions eligible for Agency funding." As well, responsibility for the development, interpretation, and implementation of Canada's research ethics guidelines should be under the authority of a single oversight body that is independent of the federal research granting Agencies.

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.

Virtue Ethics in School Counseling: A Framework for Decision Making

ERIC Educational Resources Information Center

Wilczenski, Felicia L.; Cook, Amy L.

2011-01-01

Virtue ethics focus on the motives that guide ethical decision making and action, and as such, are critical to the competent application of the counseling profession's ethical codes. Knowledge of virtue ethics deepens understanding of moral responsibilities and ethical reasoning in professional practice. This paper is an overview of virtue ethics…

Ethics of clinical trials.

PubMed

Iyalomhe, G B S; Imomoh, P A

2007-01-01

Although clinical trials are conducted far more ethically and safer now than they were some decades ago, the elimination of gross abuses has tended to highlight more subtle ethical problems. Therefore, research in man, especially clinical drug trials, must now take into account ethical and legal requirements. This review examines the progress of clinical trial ethics, highlights the major ethical principles and challenges involved in the conduct of clinical trials, and suggests measures to ensure scientifically and ethically sound clinical trials. An internet search and a perusal of the literature on the history of clinical trials, medical ethics and good clinical practice, reveal that apart from laying a general principle, the Oath of Hippocrates did not provide a guide on the specific ethical problems involved in undertaking research, an important arm of advancement in medical knowledge. Hence, to avert continued ethical abuses of subjects during clinical research, the current reference guideliNe--the Helsinki Declaration of 1964 (revised in 1975), was adopted by the World Medical Assembly. It emphasized four major principles: autonomy, nonmaleficience, beneficence and justice. In applying these principles, the researcher must obtain a written free and well informed consent from patients who should be aware of their right to withdraw from trial at any moment. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. He must ethically monitor and assess risks and benefits of the trial throughout its duration and use a fair procedure in selecting research subjects and must respect the concept of inviolability of the human person. Ethical challenges confronting clinical trials include the appropriateness of the proposed research, obtaining free informed consent, use of medications after completion of drug trials, drug toxicities and long-term side effects as well as the release and publication of research result. To improve protection for research subjects and have ethically sound clinical trials, there is need to adhere to global standards and legislations; establish, strengthen and empower regulatory bodies; develop partnership among stakeholders; intensify public enlightenment and train research personnel.

ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH

Cancer.gov

ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH, designed to stimulate dialogue on ethical and regulatory issues in cancer research and promote awareness of developing policies and best practices.

[Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data].

PubMed

de Lecuona, Itziar

2018-05-31

The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Application of Ethics for Providing Telemedicine Services and Information Technology.

PubMed

Langarizadeh, Mostafa; Moghbeli, Fatemeh; Aliabadi, Ali

2017-10-01

Advanced technology has increased the use of telemedicine and Information Technology (IT) in treating or rehabilitating diseases. An increased use of technology increases the importance of the ethical issues involved. The need for keeping patients' information confidential and secure, controlling a number of therapists' inefficiency as well as raising the quality of healthcare services necessitates adequate heed to ethical issues in telemedicine provision. The goal of this review is gathering all articles that are published through 5 years until now (2012-2017) for detecting ethical issues for providing telemedicine services and Information technology. The reason of this time is improvement of telemedicine and technology through these years. This article is important for clinical practice and also to world, because of knowing ethical issues in telemedicine and technology are always important factors for physician and health providers. the required data in this research were derived from published electronic sources and credible academic articles published in such databases as PubMed, Scopus and Science Direct. The following key words were searched for in separation and combination: tele-health, telemedicine, ethical issues in telemedicine. A total of 503 articles were found. After excluding the duplicates (n= 93), the titles and abstracts of 410 articles were skimmed according to the inclusion criteria. Finally, 64 articles remained. They were reviewed in full text and 36 articles were excluded. At the end, 28 articles were chosen which met our eligibility criteria and were included in this study. Ethics has been of a great significance in IT and telemedicine especially the Internet since there are more chances provided for accessing information. It is, however, accompanied by a threat to patients' personal information. Therefore, suggestions are made to investigate ethics in technology, to offer standards and guidelines to therapists. Due to the advancement in technology, access to information has become simpler than the past. This has prompted hackers to seize the opportunity. This research shows that the ethical issues in telemedicine can be investigated from several aspects like technology, doctor-patient relationship, data confidentiality and security, informed consent, patient's and family's satisfaction with telemedicine services. Following ethical issues in telemedicine is a primary aspect of high quality services. In other words, if therapists abide by ethical rules, they can provide better services for patients. Attention to ethical issues in telemedicine guarantees a safer use of the services.