The ethics of conducting a co-operative inquiry with vulnerable people.

PubMed

Tee, Stephen R; Lathlean, Judith A

2004-09-01

Mental health services users have been calling for greater participation in clinical research. Participation in this context means research 'with' rather than 'on' groups of people. Conducting a co-operative inquiry involving the participation of vulnerable individuals as co-researchers, in particular those with a history of mental health problems, places an obligation on researchers to articulate and justify sound ethical procedures. The aim of this paper is to consider how the ethical issues encountered when conducting participative research with vulnerable people can be addressed in the implementation of a co-operative inquiry with users of mental health services. The study was based on personal reflection and a critical review of associated literature obtained from a database search using Boolean logic. The findings, presented under the headings of the four prima facie moral principles, suggest the need for researchers using participative approaches to demonstrate the humanistic attributes required for engaging and working with people over a period of time. These include building and maintaining trusting relationships, assessing competence to participate, managing interpersonal and group dynamics and making complex collaborative decisions about participants' continued participation in a study. When using a co-operative inquiry approach involving vulnerable individuals, researchers need to demonstrate clearly how a balance between autonomy and paternalism will be achieved, how risks will be anticipated and managed and how fairness will be maintained throughout all procedures. Researchers using participative approaches need to have developed a level of personal insight and self-awareness through access to supervision which focuses on sources of unintended manipulation and interpersonal dynamics that may arise at the inception of a study and throughout its course. Researchers and ethics committees have a shared responsibility to ensure that vulnerable people are appropriately engaged to maintain the advancement of user knowledge which informs nursing practice.

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

Living donation and cosmetic surgery: a double standard in medical ethics?

PubMed

Testa, Giuliano; Carlisle, Erica; Simmerling, Mary; Angelos, Peter

2012-01-01

The commitment of transplant physicians to protect the physical and psychological health of potential donors is fundamental to the process of living donor organ transplantation. It is appropriate that strict regulations to govern an individual's decision to donate have been developed. Some may argue that adherence to such regulations creates a doctor-patient relationship that is rooted in paternalism, which is in drastic contrast with a doctor-patient relationship that is rooted in patients' autonomy, characteristic of most other operative interventions. In this article we analyze the similarities between cosmetic plastic surgery and living donor surgery as examples of surgeries governed by different ethical principles. It is interesting that, while the prevailing ethical approach in living donor surgery is based on paternalism, the ethical principle guiding cosmetic surgery is respect for patients' autonomy. The purpose of this article is not to criticize either practice, but to suggest that, given the similarities between the two procedures, both operative interventions should be guided by the same ethical principle: a respect for patients' autonomy. We further suggest that if living organ donation valued donors' autonomy as much as cosmetic plastic surgery does, we might witness a wider acceptance of and increase in living organ donation.

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.

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

PubMed

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

2015-05-08

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

Ethical 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.

Ill-placed democracy: ethics consultations and the moral status of voting.

PubMed

Fiester, Autumn M

2011-01-01

As groups around the country begin to craft standards for clinical ethics consultations, one focus of that work is the proper procedure for conducting ethics consults. From a recent empirical look into the workings of ethics consult services (ECSs), one worrisome finding is that some ECSs rely on a committee vote when making a recommendation. This article examines the practice of voting and its moral standing as a procedural strategy for arriving at a clinical ethics recommendation. I focus here on the type of clinical ethics conflicts that are most likely to lead an ECS to vote, namely, conflicts involving ethical uncertainty--or, in the Greek, aporia. I argue that in cases of aporia, voting on an ethics conflict is not a morally justifiable procedure. Then on the same grounds that I use to show that voting is ethically problematic, I raise broader concerns about the common practice of making recommendations by other procedures. In contrast to the standard approach of adjudicating between moral claims, I argue that ECSs can best resolve aporetic conflict through the process of clinical ethics mediation.

Ethics in American health 1: ethical approaches to health policy.

PubMed

Ruger, Jennifer Prah

2008-10-01

I trace the evolution of ethical approaches to health policy in the United States and examine a number of critical unresolved issues pertaining to the current set of frameworks. Several themes emerge. First, fair procedures claim more attention than substantive and procedural principles. Second, in the case of public deliberation, more focus has been placed on factors such as procedural mechanisms than on understanding how individuals and groups value different aspects of health and agree on health-related decisions. Third, the nation needs workable frameworks to guide collective choices about valuable social ends and their trade-offs; purely procedural strategies are limited in illuminating overarching health policy and ethics questions. There is a need to integrate consequential and procedural approaches to health ethics and policy.

Overreaction to External Attacks on Computer Systems Could Be More Harmful than the Viruses Themselves.

ERIC Educational Resources Information Center

King, Kenneth M.

1988-01-01

Discussion of the recent computer virus attacks on computers with vulnerable operating systems focuses on the values of educational computer networks. The need for computer security procedures is emphasized, and the ethical use of computer hardware and software is discussed. (LRW)

Ethics in American Health 1: Ethical Approaches to Health Policy

PubMed Central

2008-01-01

I trace the evolution of ethical approaches to health policy in the United States and examine a number of critical unresolved issues pertaining to the current set of frameworks. Several themes emerge. First, fair procedures claim more attention than substantive and procedural principles. Second, in the case of public deliberation, more focus has been placed on factors such as procedural mechanisms than on understanding how individuals and groups value different aspects of health and agree on health-related decisions. Third, the nation needs workable frameworks to guide collective choices about valuable social ends and their trade-offs; purely procedural strategies are limited in illuminating overarching health policy and ethics questions. There is a need to integrate consequential and procedural approaches to health ethics and policy. PMID:18703449

Ethics of fertility preservation for prepubertal children: should clinicians offer procedures where efficacy is largely unproven?

PubMed Central

McDougall, Rosalind J; Gillam, Lynn; Delany, Clare; Jayasinghe, Yasmin

2018-01-01

Young children with cancer are treated with interventions that can have a high risk of compromising their reproductive potential. ‘Fertility preservation’ for children who have not yet reached puberty involves surgically removing and cryopreserving reproductive tissue prior to treatment in the expectation that strategies for the use of this tissue will be developed in the future. Fertility preservation for prepubertal children is ethically complex because the techniques largely lack proven efficacy for this age group. There is professional difference of opinion about whether it is ethical to offer such ‘experimental’ procedures. The question addressed in this paper is: when, if ever, is it ethically justifiable to offer fertility preservation surgery to prepubertal children? We present the ethical concerns about prepubertal fertility preservation, drawing both on existing literature and our experience discussing this issue with clinicians in clinical ethics case consultations. We argue that offering the procedure is ethically justifiable in certain circumstances. For many children, the balance of benefits and burdens is such that the procedure is ethically permissible but not ethically required; when the procedure is medically safe, it is the parents’ decision to make, with appropriate information and guidance from the treating clinicians. We suggest that clinical ethics support processes are necessary to assist clinicians to engage with the ethical complexity of prepubertal fertility preservation and describe the framework that has been integrated into the pathway of care for patients and families attending the Royal Children’s Hospital in Melbourne, Australia. PMID:29084865

Ethics in clinical drug trial research in private practice.

PubMed

Beran, R G; Beran, M E

2006-09-01

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

Research ethics committee auditing: the experience of a university hospital.

PubMed

Marchetti, Daniela; Spagnolo, Angelico; Cicerone, Marina; Cascini, Fidelia; La Monaca, Giuseppe; Spagnolo, Antonio G

2013-09-01

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.

[Medical ethics under the bioethics' point of view: the moral surgical practice].

PubMed

Antonio, Eliana Maria Restum; Fontes, Tereza Maria Pereira

2011-01-01

The professional practice of medicine today has a strong biological approach due to the increasing specialization of medical science. Often, science itself does not help to address and resolve a particular situation of a medical professional, and this is where human and social sciences, and especially other disciplines such as bioethics, can give a more humane and socialist approach, by systematically studying human behavior in the field of life and health sciences, considering moral values and principles. As part of this study, the segment that is limited to the analysis of ethical conflicts arising from the practice of medicine and patient care is known as medical ethics. Medical ethics, in the context of surgery, involves the integration of the surgical patient with the nature of the surgeon, influenced by his training and experience, his sensitivity to identify what is right. Ethics should not only be in the procedure, the surgery itself or in what happens in an operating room or even in the exercise of surgery as a specialty. Ethics must be in the life and conduct of the surgeon, so that all life and professional acts should be ethically valid.

Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative.

PubMed

Ouwe Missi Oukem-Boyer, Odile; Munung, Nchangwi Syntia; Tangwa, Godfrey B

2016-05-13

Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee (REC) for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures of operation. Guidelines for elaborating standard operating procedures (SOPs) for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments. In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization (WHO)'s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee (ERCC) of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO's guidelines and to the other SOPs. Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed (65 and 102 pages), while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols. We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing.

Ethics of fertility preservation for prepubertal children: should clinicians offer procedures where efficacy is largely unproven?

PubMed

McDougall, Rosalind J; Gillam, Lynn; Delany, Clare; Jayasinghe, Yasmin

2018-01-01

Young children with cancer are treated with interventions that can have a high risk of compromising their reproductive potential. 'Fertility preservation' for children who have not yet reached puberty involves surgically removing and cryopreserving reproductive tissue prior to treatment in the expectation that strategies for the use of this tissue will be developed in the future. Fertility preservation for prepubertal children is ethically complex because the techniques largely lack proven efficacy for this age group. There is professional difference of opinion about whether it is ethical to offer such 'experimental' procedures. The question addressed in this paper is: when, if ever, is it ethically justifiable to offer fertility preservation surgery to prepubertal children? We present the ethical concerns about prepubertal fertility preservation, drawing both on existing literature and our experience discussing this issue with clinicians in clinical ethics case consultations. We argue that offering the procedure is ethically justifiable in certain circumstances. For many children, the balance of benefits and burdens is such that the procedure is ethically permissible but not ethically required; when the procedure is medically safe, it is the parents' decision to make, with appropriate information and guidance from the treating clinicians. We suggest that clinical ethics support processes are necessary to assist clinicians to engage with the ethical complexity of prepubertal fertility preservation and describe the framework that has been integrated into the pathway of care for patients and families attending the Royal Children's Hospital in Melbourne, Australia. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Teaching Ethics in Civil Procedure Courses.

ERIC Educational Resources Information Center

Matasar, Richard A.

1989-01-01

Civil procedure courses are ideal for connecting doctrine and ethics because procedural rules strain constantly to balance competing interests. A University of Iowa course includes at least one significant moral discussion during each general doctrinal unit. (MSE)

Biobanking of different body fluids within the frame of IVF-a standard operating procedure to improve reproductive biology research.

PubMed

Schenk, Michael; Huppertz, Berthold; Obermayer-Pietsch, Barbara; Kastelic, Darja; Hörmann-Kröpfl, Martina; Weiss, Gregor

2017-02-01

The aim of the present study was to develop a standard operating procedure (SOP) for the collection, transport, and storage of human cumulus cells, follicular fluid, blood serum, seminal plasma, embryo culture supernatant, and embryo culture supernatant control obtained within the IVF process under approved protocols and written informed consent from participating patients. The SOP was developed at the Kinderwunsch Institut Schenk, Dobl, Austria, together with Biobank Graz of the Medical University of Graz, Austria. The SOP provides comprehensive details of laboratory procedures and sampling of the different fluids within the IVF process. Furthermore, information on sample coding, references of involved laboratory techniques (e.g., oocyte retrieval with a Steiner-TAN needle), ethical approvals, and biobanking procedures are presented. The result of the present study is a standard operating procedure. The SOP ensures a professional way for collection and scientific use of IVF samples by the Kinderwunsch Institut Schenk, Dobl, Austria, and Biobank Graz of the Medical University of Graz, Austria. It can be used as a template for other institutions to unify specimen collection procedures in the field of reproductive health research.

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

PubMed

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

2014-02-01

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

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2015-04-14

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

A procedural, pragmatist account of ethical objectivity.

PubMed

Roth, Amanda

2013-06-01

This article offers a procedural, pragmatist account of objectivity in the domain of the good that is inspired by pragmatic and feminist critiques of objectivity in philosophy of science and epistemology. I begin by asking first what we want to capture--or ought to want to capture--with a notion of ethical objectivity and in answer to this question I identify four "points" to ethical objectivity: undergirding the possibility of mistakenness, making genuine disagreement possible, making sense of our appreciation of the ethical perspectives of others, and making possible a sense of ethical improvement or learning. I then lay out a process-based account of objectivity in ethics that makes good on the four points I have identified. Finally, I consider worries related to convergence, bias, and ontology and defend the procedural, pragmatist account in light of those potential objections.

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

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

PubMed

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

2018-01-01

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

48 CFR 1503.500-71 - Procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... for: (1) A written code of business ethics and conduct and an ethics training program for all employees; (2) Periodic reviews of company business practices, procedures, policies and internal controls...

Current significant challenges in the decommissioning and environmental remediation of radioactive facilities: A perspective from outside the nuclear industry.

PubMed

Gil-Cerezo, V; Domínguez-Vilches, E; González-Barrios, A J

2017-05-01

This paper presents the results of implementing an extrajudicial environmental mediation procedure in the socioenvironmental conflict associated with routine operation of the El Cabril Disposal Facility for low- and medium- activity radioactive waste (Spain). We analyse the socio-ethical perspective of this facility's operation with regard to its nearby residents, detailing the structure and development of the environmental mediation procedure through the participation of society and interested parties who are or may become involved in such a conflict. The research, action, and participation method was used to apply the environmental mediation procedure. This experience provides lessons that could help improve decision-making processes in nuclear or radioactive facility decommissioning projects or in environmental remediation projects dealing with ageing facilities or with those in which nuclear or radioactive accidents/incidents may have occurred. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Civil, criminal and ethical liability of medical doctors].

PubMed

Udelsmann, Artur

2002-01-01

In the last years doctors have been the target of a growing number of civil, criminal law suits, as well as ethical procedures. Medicine is a widely targeted career, not only owing to its inherent risks, but also owing to a mistaken approach of the Judiciary Power about the obligations of medical doctors. Decisions of the Medical Board in ethical procedures have an impact in civil and criminal justice and therefore should be followed closely. The purpose of this review is to provide a wide view from a doctor-lawyer perspective of cases involving civil, criminal liability of anesthesiologists as well as ethical procedures against them, in an effort to make them comprehensible to doctors. After a brief historical introduction civil liability foundations and legal articles are examined. Responsibilities of doctors, hospitals and health insurance providers are discussed separately, as well as reparation mechanisms. Crimes possible to occur during medical practice and respective penalties are described; the direct relationship between crime and civil reparation is demonstrated. The administrative nature of ethical procedure is described, emphasizing that the legal character of its penalties often serve as grounds for civil and criminal justice decisions. Prevention is still the best medicine. Good medical practice and a good medical-patient relationship are still the best ways to minimize lawsuits and their repercussions. Doctors should have some knowledge of juridical mechanisms in lawsuits and ethical procedures, but should not take defense initiatives without prior consultation of an attorney. Civil, criminal and ethical liability of physicians.

Review of Instructional Approaches in Ethics Education.

PubMed

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

2017-06-01

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

ICRP Publication 138: Ethical Foundations of the System of Radiological Protection.

PubMed

Cho, K-W; Cantone, M-C; Kurihara-Saio, C; Le Guen, B; Martinez, N; Oughton, D; Schneider, T; Toohey, R; ZöLzer, F

2018-02-01

Despite a longstanding recognition that radiological protection is not only a matter of science, but also ethics, ICRP publications have rarely addressed the ethical foundations of the system of radiological protection explicitly. The purpose of this publication is to describe how the Commission has relied on ethical values, either intentionally or indirectly, in developing the system of radiological protection with the objective of presenting a coherent view of how ethics is part of this system. In so doing, it helps to clarify the inherent value judgements made in achieving the aim of the radiological protection system as underlined by the Commission in Publication 103. Although primarily addressed to the radiological protection community, this publication is also intended to address authorities, operators, workers, medical professionals, patients, the public, and its representatives (e.g. NGOs) acting in the interest of the protection of people and the environment. This publication provides the key steps concerning the scientific, ethical, and practical evolutions of the system of radiological protection since the first ICRP publication in 1928. It then describes the four core ethical values underpinning the present system: beneficence/ non-maleficence, prudence, justice, and dignity. It also discusses how these core ethical values relate to the principles of radiological protection, namely justification, optimisation, and limitation. The publication finally addresses key procedural values that are required for the practical implementation of the system, focusing on accountability, transparency, and inclusiveness. The Commission sees this publication as a founding document to be elaborated further in different situations and circumstances.

Battlefield ethics training: integrating ethical scenarios in high-intensity military field exercises.

PubMed

Thompson, Megan M; Jetly, Rakesh

2014-01-01

There is growing evidence that modern missions have added stresses and ethical complexities not seen in previous military operations and that there are links between battlefield stressors and ethical lapses. Military ethicists have concluded that the ethical challenges of modern missions are not well addressed by current military ethics educational programs. Integrating the extant research in the area, we propose that scenario-based operational ethics training in high-intensity military field training settings may be an important adjunct to traditional military ethics education and training. We make the case as to why this approach will enhance ethical operational preparation for soldiers, supporting their psychological well-being as well as mission effectiveness.

Battlefield ethics training: integrating ethical scenarios in high-intensity military field exercises

PubMed Central

Thompson, Megan M.; Jetly, Rakesh

2014-01-01

There is growing evidence that modern missions have added stresses and ethical complexities not seen in previous military operations and that there are links between battlefield stressors and ethical lapses. Military ethicists have concluded that the ethical challenges of modern missions are not well addressed by current military ethics educational programs. Integrating the extant research in the area, we propose that scenario-based operational ethics training in high-intensity military field training settings may be an important adjunct to traditional military ethics education and training. We make the case as to why this approach will enhance ethical operational preparation for soldiers, supporting their psychological well-being as well as mission effectiveness. PMID:25206947

Human and animal research guidelines: aligning ethical constructs with new scientific developments.

PubMed

Ferdowsian, Hope

2011-10-01

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. © 2011 Blackwell Publishing Ltd.

32 CFR 776.84 - Ethics investigation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 5 2011-07-01 2011-07-01 false Ethics investigation. 776.84 Section 776.84... Complaint Processing Procedures § 776.84 Ethics investigation. (a) Whenever an ethics investigation is... ethics investigation: (1) To request a hearing before the investigating officer (IO); (2) To inspect all...

32 CFR 776.84 - Ethics investigation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Ethics investigation. 776.84 Section 776.84... Complaint Processing Procedures § 776.84 Ethics investigation. (a) Whenever an ethics investigation is... ethics investigation: (1) To request a hearing before the investigating officer (IO); (2) To inspect all...

32 CFR 776.84 - Ethics investigation.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Ethics investigation. 776.84 Section 776.84... Complaint Processing Procedures § 776.84 Ethics investigation. (a) Whenever an ethics investigation is... ethics investigation: (1) To request a hearing before the investigating officer (IO); (2) To inspect all...

32 CFR 776.84 - Ethics investigation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 5 2014-07-01 2014-07-01 false Ethics investigation. 776.84 Section 776.84... Complaint Processing Procedures § 776.84 Ethics investigation. (a) Whenever an ethics investigation is... ethics investigation: (1) To request a hearing before the investigating officer (IO); (2) To inspect all...

32 CFR 776.84 - Ethics investigation.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 5 2013-07-01 2013-07-01 false Ethics investigation. 776.84 Section 776.84... Complaint Processing Procedures § 776.84 Ethics investigation. (a) Whenever an ethics investigation is... ethics investigation: (1) To request a hearing before the investigating officer (IO); (2) To inspect all...

25 CFR 700.509 - Duties of the designated agency ethics official.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 2 2011-04-01 2011-04-01 false Duties of the designated agency ethics official. 700.509... RELOCATION PROCEDURES Employee Responsibility and Conduct § 700.509 Duties of the designated agency ethics official. The Designated Agency Ethics Official shall coordinate and manage the agency's ethics program...

25 CFR 700.509 - Duties of the designated agency ethics official.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Duties of the designated agency ethics official. 700.509... RELOCATION PROCEDURES Employee Responsibility and Conduct § 700.509 Duties of the designated agency ethics official. The Designated Agency Ethics Official shall coordinate and manage the agency's ethics program...

25 CFR 700.509 - Duties of the designated agency ethics official.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 2 2013-04-01 2013-04-01 false Duties of the designated agency ethics official. 700.509... RELOCATION PROCEDURES Employee Responsibility and Conduct § 700.509 Duties of the designated agency ethics official. The Designated Agency Ethics Official shall coordinate and manage the agency's ethics program...

25 CFR 700.509 - Duties of the designated agency ethics official.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 2 2012-04-01 2012-04-01 false Duties of the designated agency ethics official. 700.509... RELOCATION PROCEDURES Employee Responsibility and Conduct § 700.509 Duties of the designated agency ethics official. The Designated Agency Ethics Official shall coordinate and manage the agency's ethics program...

25 CFR 700.509 - Duties of the designated agency ethics official.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 2 2014-04-01 2014-04-01 false Duties of the designated agency ethics official. 700.509... RELOCATION PROCEDURES Employee Responsibility and Conduct § 700.509 Duties of the designated agency ethics official. The Designated Agency Ethics Official shall coordinate and manage the agency's ethics program...

5 CFR 2634.1001 - Overview.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT ETHICS EXECUTIVE BRANCH FINANCIAL DISCLOSURE... Ethics before selling the property. This subpart describes the circumstances when an eligible person may obtain a Certificate of Divestiture and establishes the procedure that the Office of Government Ethics...

Ethics-sensitivity of the Ghana national integrated strategic response plan for pandemic influenza.

PubMed

Laar, Amos; DeBruin, Debra

2015-05-07

Many commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza (NISPPI). We critically analyzed the Ghana NISPPI's sensitivity to ethics issues to determine how well it reflects ethical commitments and principles identified in our review of global pandemic preparedness literature, existing pandemic plans, and relevant ethics frameworks. This paper reveals that important ethical issues have not been addressed in the Ghana NISPPI. Several important ethical issues are unanticipated, unacknowledged, and unplanned for. These include guidelines on allocation of scarce resources, the duties of healthcare workers, ethics-sensitive operational guidelines/protocols, and compensation programs. The NISPPI also pays scant attention to use of vaccines and antivirals, border issues and cooperation with neighboring countries, justification for delineated actions, and outbreak simulations. Feedback and communication plans are nebulous, while leadership, coordination, and budgeting are quite detailed. With respect to presentation, the NISPPI's text is organized around five thematic areas. While each area implicates ethical issues, NISPPI treatment of these areas consistently fails to address them. Our analysis reveals a lack of consideration of ethics by the NISPPI. We contend that, while the plan's content and fundamental assumptions provide support for implementation of the delineated public health actions, its consideration of ethical issues is poor. Deficiencies include a failure to incorporate guidelines that ensure fair distribution of scarce resources and a lack of justification for delineated procedures. Until these deficiencies are recognized and addressed, Ghana runs the risk of rolling out unjust and ethically indefensible actions with real negative effects in the event of a pandemic. Soliciting inputs from the public and consultation with ethicists during the next revision of the NISPPI will be useful in addressing these issues.

Ethics in an operations management course.

PubMed

Rudnicka, Ewa A

2005-10-01

Graduates of the management major at the University of Pittsburgh at Greensburg find employment in a variety of organizations. As future managers with employees from different professions, students expressed an interest in discussing ethics cases in the operations management class. The semester starts with students familiarizing themselves with various professional and corporate codes of ethics. Throughout the semester a number of short ethics' cases in operations' areas such as inventory management, scheduling, facility location, and product design are introduced to illustrate ethical issues that a manager and his/her employees might face. Students prepare individual responses before the in-class discussions. The semester ends with a long group ethics case discussion and formal case presentations. In the end-of-semester survey, students responded very favorably to an ethics component in the operations management class.

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…

“Reality Surgery” — A Research Ethics Perspective on the Live Broadcast of Surgical Procedures

PubMed Central

Williams, Judson B.; Mathews, Robin; D'Amico, Thomas A.

2013-01-01

In recent years, the live broadcasting of medical and surgical procedures has gained worldwide popularity. While the practice has appropriately been met with concerns for patient safety and privacy, many physicians tout the merits of real time viewing as a form of investigation, accelerating the process leading to adoption or abolition of newer techniques or technologies. This view introduces a new series of ethical considerations that need to be addressed. As such, this article considers, from a research ethics perspective, the use of live surgical procedure broadcast for investigative purposes. PMID:21292217

[Global aspects of medical ethics: conditions and possibilities].

PubMed

Neitzke, G

2001-01-01

A global or universal code of medical ethics seems paradoxical in the era of pluralism and postmodernism. A different conception of globalisation will be developed in terms of a "procedural universality". According to this philosophical concept, a code of medical ethics does not oblige physicians to accept certain specific, preset, universal values and rules. It rather obliges every culture and society to start a culture-sensitive, continuous, and active discourse on specific issues, mentioned in the codex. This procedure might result in regional, intra-cultural consensus, which should be presented to an inter-cultural dialogue. To exemplify this procedure, current topics of medical ethics (spiritual foundations of medicine, autonomy, definitions concerning life and death, physicians' duties, conduct within therapeutic teams) will be discussed from the point of view of western medicine.

Everyday Ethics: Reflections on Practice

ERIC Educational Resources Information Center

Rossman, Gretchen B.; Rallis, Sharon F.

2010-01-01

This introductory article frames the contributions for this issue on everyday ethics--moments that demand moral considerations and ethical choices that researchers encounter. We discuss concerns raised within the research community about the tendency to observe merely obligatory ethical procedures as outlined in Human Subjects Review regulations.…

Ethical dilemmas of recording and reviewing neonatal resuscitation.

PubMed

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

2018-05-01

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

Ethics committees in India: Facing the challenges!

PubMed

Kadam, Rashmi; Karandikar, Shashikant

2012-04-01

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

Operational Ethics: Just War and Implications for Contemporary American Warfare

DTIC Science & Technology

2003-05-22

will mutually share those values.12 Today, those values are manifested in the secular society in the form of ethics and basic human morality, what is...Approved for Public Release; Distribution is Unlimited Operational Ethics : Just War and Implications for Contemporary American Warfare A Monograph...a denkschrift through which the author hopes to inspire discussions on operational ethics among professional officers and civilian proponents of

Is the concept of ethics misplaced in the migration of Indian trained dentists to Australia? The need for better international co-operation in dentistry.

PubMed

Balasubramanian, Madhan; Short, Stephanie D

2011-01-01

The purpose of this article is to discuss the ethics involved in the migration of Indian trained dentists to Australia. It develops from interviews of senior oral health leaders in both the countries to provide evidence that ethics in migration is diluted in practice and to suggest that migratory procedures in both the countries should be reconsidered. There is also an urgent need for more organized bilateral communication and negotiation between the concerned organizations of both the countries (dental councils, immigration departments and research centers) in order to prevent the somewhat irreversible and intensive brain drain of top quality dentists from India to Australia. We would suggest as a starting point better monitoring of the migrants' academic and social background, the nature of the educational investment in India and the nature of the stay in Australia. This new information base could possibly lay the groundwork for more restrictive policies to be introduced both in Australia and India.

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2014 CFR

2014-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

5 CFR 5502.105 - Agency procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

....105 Administrative Personnel DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5502.105 Agency procedures. (a) The designated agency ethics official or, with the concurrence of the designated agency ethics official, each of...

"Reality surgery"--a research ethics perspective on the live broadcast of surgical procedures.

PubMed

Williams, Judson B; Mathews, Robin; D'Amico, Thomas A

2011-01-01

In recent years, the live broadcasting of medical and surgical procedures has gained worldwide popularity. While the practice has appropriately been met with concerns for patient safety and privacy, many physicians tout the merits of real time viewing as a form of investigation, accelerating the process leading to adoption or abolition of newer techniques or technologies. This view introduces a new series of ethical considerations that need to be addressed. As such, this article considers, from a research ethics perspective, the use of live surgical procedure broadcast for investigative purposes. Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Teaching Ethics to High School Students

ERIC Educational Resources Information Center

Pass, Susan; Willingham, Wendy

2009-01-01

Working with two teachers and thirty-four high school seniors, the authors developed procedures and assessments to teach ethics in an American high school civics class. This approach requires high school students to discover an agreement or convergence between Kantian ethics and virtue ethics. The authors also created an instrument to measure…

5 CFR 2600.103 - Office of Government Ethics organization and functions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Office of Government Ethics organization and functions. 2600.103 Section 2600.103 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES ORGANIZATION AND FUNCTIONS OF THE OFFICE OF GOVERNMENT ETHICS § 2600.103 Office of...

Global health and orthopaedic surgery—A call for international morbidity and mortality conferences

PubMed Central

Sheth, Neil P.; Donegan, Derek J.; Foran, Jared R.H.; Sugarman, Jeremy

2014-01-01

Introduction There is a large discrepancy between supply and demand of surgical services in developing countries. This inequality holds true in orthopaedic surgery and the delivery of musculoskeletal care. Intertwined amongst the decision to perform surgical procedures in the developing world are the ethics of doing so – just because one is capable of performing a procedure, should it be done? Presentation of case A 31 year-old female with end-stage joint destruction underwent a left total hip replacement by a foreign orthopaedic team in Tanzania. She had a favorable outcome for 8 months, but is now diagnosed with tuberculosis and a deep space infection in her prosthetic left hip – an unsolvable problem in the developing world. Discussion This case demonstrates the ethical challenges that can be created from performing surgical procedures in the developing world without concomitant access to appropriate patient follow-up or resources for treating post-operative complications. While the current system is inadequate to manage the burden of disease, these inadequacies may be exacerbated at times by post-operative complications resulting from well-intentioned surgical missions. Conclusion This case illustrates many difficulties in caring for individuals in the developing world, raising several questions: (1) How can complications be prevented in the future? (2) What are possible ways of managing complications with resources at hand once it occurs? (3) What resources are needed to minimize patient? Ideally an international forum can help provide descriptions of issues and problems that are encountered so as to increase awareness and identify potential solutions. PMID:25524304

Topectomy versus leukotomy: J. Lawrence Pool's contribution to psychosurgery.

PubMed

Holland, Ryan; Kopel, David; Carmel, Peter W; Prestigiacomo, Charles J

2017-09-01

Surgery of the mind has a rather checkered past. Though its history begins with the prehistoric trephination of skulls to allow "evil spirits" to escape, the early- to mid-20th century saw a surge in the popularity of psychosurgery. The 2 prevailing operations were topectomy and leukotomy for the treatment of certain mental illnesses. Although they were modified and refined by several of their main practitioners, the effectiveness of and the ethics involved with these operations remained controversial. In 1947, Dr. J. Lawrence Pool and the Columbia-Greystone Associates sought to rigorously investigate the outcomes of specific psychosurgical procedures. Pool along with R. G. Heath and John Weber believed that nonexcessive bifrontal cortical ablation could successfully treat certain mental illnesses without the undesired consequences of irreversible personality changes. They conducted this investigation at the psychiatric hospital at Greystone Park near Morristown, New Jersey. Despite several encouraging findings of the Columbia-Greystone project, psychosurgery practices began to decline significantly in the 1950s. The uncertainty of results and ethical debates related to side effects made these procedures unpopular. Further, groups such as the National Association for the Advancement of Colored People and the American Civil Liberties Union condemned the use of psychosurgery, believing it to be an inhumane form of treatment. Today, there are strict guidelines that must be adhered to when evaluating a patient for psychosurgery procedures. It is imperative for the neurosurgery community to remember the history of psychosurgery to provide the best possible current treatment and to search for better future treatments for a particularly vulnerable patient population.

Challenges in biobank governance in Sub-Saharan Africa

PubMed Central

2013-01-01

Background Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples. Methods A literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found. Results It was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples. Conclusion Collaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines. PMID:24025667

Challenges in biobank governance in Sub-Saharan Africa.

PubMed

Staunton, Ciara; Moodley, Keymanthri

2013-09-11

Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples. A literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found. It was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples. Collaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.

From Nuremberg to bioethics: an educational project for students of dentistry and dental prosthesis

PubMed Central

Marinozzi, Silvia; Corbellini, Gilberto; Ottolenghi, Livia; Ripari, Francesca; Pizzuti, Antonio; Pezzetti, Marcello; Gaj, Fabio

2013-01-01

Summary In the lessons of medical-scientific methodologies of the medical faculty at the Sapienza University of Rome, basic notions on the ethical and deontologic aspects characterizing the history of the medical profession are provided, including the formulation and application of bioethical principles to clinics and biomedical research. Within such framework, an educational project has been initiated on the historical origin of the current normative and juridic dispositions in the regulation of experimental biomedical research and the relationship between health operators and patients, with particular attention to the procedure, the meaning the value either professional or deontologic, of ethics and the legality of the informed consensus. Emphasis is put on medical and experimental abuses that occurred in Germany during the nazi regime. PMID:23741533

The ethical allocation of scarce resources in surgery: implants and cost

PubMed Central

Gross, Michael

1997-01-01

This paper is a discussion of the factors involved in instituting a bulk purchasing program for surgical supplies. An improved understanding of the surgical procedure of joint arthroplasty must relate to the variability in surgical methods that achieve patient outcomes. An understanding of the outcomes in relation to the expected duration of the success of an implant and the high costs associated with a revision earlier than expected must be factored into the budget and costs of implants. The ethical implications of choosing one implant over another are considered. A more uniform outcome assessment with respect to surgical activities is needed and potential savings related to other operating-room costs must be examined. Optimizing the implant to patient requirements is the goal within the framework of current fiscal constraints. PMID:9416251

Ethical Issues in Rural Programs for Behavior Analysis for Students with Disabilities

ERIC Educational Resources Information Center

Young-Pelton, Cheryl A.; Dotson, Tyler D.

2017-01-01

Procedures derived from the field of applied behavior analysis (ABA) have extensive research support for use with students with disabilities, such as autism spectrum disorder, intellectual disability, and emotional and behavioral disorders. These procedures should be implemented within the parameters of professional and ethical guidelines to…

Avoiding Scandal and Headlines with Ethics and Accountability

ERIC Educational Resources Information Center

Haubold, Glen; Throneberry, Angela

2010-01-01

Procedures, financial controls and reports, and leadership are the three major components that "set the tone" for an effective, accountable, and ethical organization. Procedures must be formally documented instead of passed down verbally on the premise that "we've always done it this way." Meaningful management reports should be developed and…

Oocyte cryopreservation beyond cancer: tools for ethical reflection.

PubMed

Linkeviciute, Alma; Peccatori, Fedro A; Sanchini, Virginia; Boniolo, Giovanni

2015-08-01

This article offers physicians a tool for structured ethical reflection on challenging situations surrounding oocyte cryopreservation in young healthy women. A systematic literature review offers a comprehensive overview of the ethical debate surrounding the practice. Ethical Counseling Methodology (ECM) offers a practical approach for addressing ethical uncertainties. ECM consists of seven steps: (i) case presentation; (ii) analysis of possible implications; (iii) presentation of ethical question(s); (iv) explanation of ethical terms; (v) presentation of the ethical arguments in favor of and against the procedure; (vi) examination of the individual patient's beliefs and wishes; and (vii) conclusive summary. The most problematic aspects in the ethical debate include the distinction between medical and non-medical use of oocyte cryopreservation, safety and efficiency of the procedure, and marketing practices aimed at healthy women. Female empowerment and enhanced reproductive choices (granted oocyte cryopreservation is a safe and efficient technique) are presented as ethical arguments supporting the practice, while ethical reservations towards oocyte cryopreservation are based on concerns about maternal and fetal safety and wider societal implications. Oocyte cryopreservation is gaining popularity among healthy reproductive age women. However, despite promised benefits it also involves risks that are not always properly communicated in commercialized settings. ECM offers clinicians a tool for structured ethical analysis taking into consideration a wide range of implications, various ethical standpoints, and patients' perceptions and beliefs.

An Analysis of Ethics Laws, Compliance with Ethical Standards, and Ethical Core Competency within the Department of the Army

DTIC Science & Technology

2016-06-15

laws and ethical principles above private gain. (2) Employees shall not hold financial interests that conflict with the conscientious...applying ethical principles to decision-making. We analyze the DA ethics training courses, policies, and procedures. The project explores the...leveraging the Enterprises buying power to obtain goods and services more efficiently. Ms. Lyons earned her Bachelor of Science degree in Accounting in

Methods to identify and address the ethical issues associated with managed care.

PubMed

Lundy, Courtnee

2006-01-01

There are many benefits of managed care, such as its focus on disease prevention and health promotion, its integration of healthcare services to minimize inefficiencies, and its ability to restrict healthcare costs; however, there are also some ethical concerns that arise from managing care. In the context of managed care, ethics is a method for examining conflicts of values and obligations where there are competing interests, each of which presents a reasonably justified position. The principles of procedural, commutative, and general justice are particularly applicable to the ethical issues associated with managed care. Through a review of relevant literature, this paper will examine different methods and principles of justice to consider in establishing an ethical managed care organization and it will offer some examples of plans that have established policies to meet their ethical goals. By setting common goals, plans and enrollees can minimize ethical conflicts and collaborate to ensure that plans consistently use just procedures to ensure that quality care is available.

Intelligent monitoring of critical pathological events during anesthesia.

PubMed

Gohil, Bhupendra; Gholamhhosseini, Hamid; Harrison, Michael J; Lowe, Andrew; Al-Jumaily, Ahmed

2007-01-01

Expert algorithms in the field of intelligent patient monitoring have rapidly revolutionized patient care thereby improving patient safety. Patient monitoring during anesthesia requires cautious attention by anesthetists who are monitoring many modalities, diagnosing clinically critical events and performing patient management tasks simultaneously. The mishaps that occur during day-to-day anesthesia causing disastrous errors in anesthesia administration were classified and studied by Reason [1]. Human errors in anesthesia account for 82% of the preventable mishaps [2]. The aim of this paper is to develop a clinically useful diagnostic alarm system for detecting critical events during anesthesia administration. The development of an expert diagnostic alarm system called ;RT-SAAM' for detecting critical pathological events in the operating theatre is presented. This system provides decision support to the anesthetist by presenting the diagnostic results on an integrative, ergonomic display and thus enhancing patient safety. The performance of the system was validated through a series of offline and real-time testing in the operation theatre. When detecting absolute hypovolaemia (AHV), moderate level of agreement was observed between RT-SAAM and the human expert (anesthetist) during surgical procedures. RT-SAAM is a clinically useful diagnostic tool which can be easily modified for diagnosing additional critical pathological events like relative hypovolaemia, fall in cardiac output, sympathetic response and malignant hyperpyrexia during surgical procedures. RT-SAAM is currently being tested at the Auckland City Hospital with ethical approval from the local ethics committees.

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project—study protocol for a nationwide prospective cohort study

PubMed Central

Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

2016-01-01

Introduction Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. Methods and analysis The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Ethics and dissemination Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. Results Outcome will be published in a scientific journal. Trial registration number NTR5374; Pre-results. PMID:27036141

Institutional ethics policies on medical end-of-life decisions: a literature review.

PubMed

Lemiengre, Joke; de Casterlé, Bernadette Dierckx; Van Craen, Katleen; Schotsmans, Paul; Gastmans, Chris

2007-10-01

The responsibility of healthcare administrators for handling ethically sensitive medical practices, such as medical end-of-life decisions (MELDs), within an institutional setting has been receiving more attention. The overall aim of this paper is to thoroughly examine the prevalence, content, communication, and implementation of written institutional ethics policies on MELDs by means of a literature review. Major databases (Pubmed, Cinahl, PsycINFO, Cochrane Library, FRANCIS, and Philosopher's Index) and reference lists were systematically searched for all relevant papers. Inclusion criteria for relevance were that the study was empirically based and that it focused on the prevalence, content, communication, or implementation of written institutional ethics policies concerning MELDs. Our search yielded 19 studies of American, Canadian, Dutch and Belgian origin. The majority of studies dealt with do-not-resuscitate (DNR) policies (prevalence: 10-89%). Only Dutch and Belgian studies dealt with policies on pain and symptom control (prevalence: 15-19%) and policies on euthanasia (prevalence: 30-79%). Procedural and technical aspects were a prime focus, while the defining of the specific roles of involved parties was unclear. Little attention was given to exploring ethical principles that question the ethical function of policies. In ethics policies on euthanasia, significant consideration was given to procedures that dealt with conscientious objections of physicians and nurses. Empirical studies about the implementation of ethics policies are scarce. With regard to providing support for physicians and nurses, DNR and euthanasia policies expressed support by primarily providing technical and procedural guidelines. Further research is needed whether and in which way written institutional ethics policies on MELDs could contribute to better end-of-life care.

The ethics of placebo-controlled trials: a comparison of inert and active placebo controls.

PubMed

Edward, Sarah J L; Stevens, Andrew J; Braunholtz, David A; Lilford, Richard J; Swift, Teresa

2005-05-01

Because of the recent and controversial example of sham surgery for the evaluation of fetal tissue transplants for Parkinson's disease, there is renewed interest in the ethics of using "active" placebos in surgical trials, where otherwise there are no inert procedures available, and in pharmacological trials, where there are inert substances, but where patients may guess to which arm they have been allocated. This paper seeks to clarify the ethical arguments surrounding the use of active placebos in trials, and to set up a notation for assessing the ethics of trials more generally. We first establish an framework by which ethics committees can analyze such trials. We examine (1) the scientific value of the research; (2) the expected risks and benefits to individual patients, and (3) the voluntary nature of consent. We then contrast the implications of this framework for inert and active placebo-controlled trials, respectively. In particular, we analyze their relative expected utility using three main utility factors, namely, treatment effects, placebo effects, and altruism. We conclude that, when the intervention is already widely available, active placebo trials rely more heavily on altruism than do inert placebo trials and, when the intervention is restricted, this excess reliance may not be needed. What our analysis provides is the explicit justification for the apparent caution of Institutional Review Boards or ethics committees when reviewing sham operations, especially when the expected harm is not trivial and the risk of exploitation is high.

[Ethical Evaluation of Non-Therapeutic Male Circumcision].

PubMed

İzgi, M Cumhur

2015-01-01

Elective circumcision for nonmedical reasons is a surgical approach which is historically long standing and accepted as the most performed procedure. The necessity of the procedure is usually for religious and traditional reasons alongside some medical ground related benefits to enable its social acceptability. The discussion of the subject from the aspect of ethics becomes necessary as there is no consensus about the benefits or harmfulness of nonmedical circumcision. Fundamental ethical discussions about circumcision, which contradicts legal acceptance criteria of any medical application, are related to the basic concepts of the existence of an individual such as sovereignty, the loss of bodily integrity, and privacy. The recent legal processes and the fact that the European Council and the American Academy of Pediatrics have put the issue on their agenda have increased the necessity of these ethical evaluations. The responsibility of consideration and evaluation of ethical permission of every circumcision procedure, besides discussing the necessity of circumcision for improvement and protection of health rests on the shoulders of the physicians because the dignity and intellectual identity of the profession require so.

Ethical issues with informed consent from potential living kidney donors.

PubMed

Petrini, C

2010-05-01

Living organ donation and participation in clinical research trials have several features in common from an ethical perspective. The primary similarity is risk justification: the risk of harm to living organ donors and clinical research participants is justified by a resulting benefit to one or more other individuals. Some authors hold that organ donation and clinical trial participation are full-fledged duties. Such an implicit likening of the two leads to several considerations regarding informed consent in each situation. Informed consent raises ethical concerns in every medical context, and some of those concerns, such as competence, understanding, autonomy, and free or voluntary choice, are uniquely relevant to living organ donation and clinical trial participation. Most countries regulate informed consent procedures for living organ donation in great detail, and although informed consent procedures for clinical trial participation are somewhat less detailed, their rules are subject to review by ethics committees. It would be constructive for research participation informed consent procedures and living organ donation informed consent procedures to learn from one another. Copyright (c) 2009 Elsevier Inc. All rights reserved.

Innovations in research ethics governance in humanitarian settings.

PubMed

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

2015-02-26

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

Ethical Relativism and Behavior Therapy.

ERIC Educational Resources Information Center

Kitchener, Richard F.

1980-01-01

Argues that behavior therapists are really ethical relativists and sometimes ethical skeptics. Ethical naturalism found in operant behavior therapy does entail ethical relativism. Other authors respond to these views. (Author)

Ethics committees in India: Facing the challenges!

PubMed Central

Kadam, Rashmi; Karandikar, Shashikant

2012-01-01

The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves. PMID:22701820

Ethical issues evolving from patients’ perspectives on compulsory screening for syphilis and voluntary screening for cervical cancer in Kenya

PubMed Central

2014-01-01

Background Public health aims to provide universal safety and progressive opportunities to populations to realise their highest level of health through prevention of disease, its progression or transmission. Screening asymptomatic individuals to detect early unapparent conditions is an important public health intervention strategy. It may be designed to be compulsory or voluntary depending on the epidemiological characteristics of the disease. Integrated screening, including for both syphilis and cancer of the cervix, is a core component of the national reproductive health program in Kenya. Screening for syphilis is compulsory while it is voluntary for cervical cancer. Participants’ perspectives of either form of screening approach provide the necessary contextual information that clarifies mundane community concerns. Methods Focus group discussions with female clients screened for syphilis and cancer of the cervix were conducted to elicit their perspectives of compulsory and voluntary screening. The discussions were audiotaped, transcribed and thematic content analysis performed manually to explore emerging ethics issues. Results The results indicate that real ethical challenges exist in either of the approaches. Also, participants were more concerned about the benefits of the procedure and whether their dignity is respected than the compulsoriness of screening per se. The implication is for the policy makers to clarify in the guidelines how to manage ethical challenges, while at the operational level, providers need to be judicious to minimize potential harms participants and families when screening for disease in women. Conclusions The context for mounting screening as a public health intervention and attendant ethical issues may be more complex than hitherto perceived. Interpreting emerging ethics issues in screening requires more nuanced considerations of individuals’ contextual experiences since these may be contradictory to the policy position. In considering mounting screening for Syphilis and cervical cancer as a public heal intervention, the community interests and perspectives should be inculcated into the program. Population lack of information on procedures may influence adversely the demand for screening services by the individuals at risk or the community as a collective agent. PMID:24678613

5 CFR 2610.104 - Proceedings covered.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 2610.104 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES... part applies to adversary administrative adjudications conducted by the Office of Government Ethics... Ethics in Government Act of 1978, section 402(f)(2), 5 U.S.C. app., and subpart E of part 2638 of this...

Going beyond Procedure: Engaging with the Ethical Complexities of Being an Embedded Researcher

ERIC Educational Resources Information Center

Rowley, Harriet

2014-01-01

This article is a reflection upon the ethical dimension of my work and practice as an embedded researcher during my doctorate. To begin with, I describe my experiences of gaining ethical approval from The University of Manchester while also highlighting some of the concerns that were raised by the ethics board. This leads me to recognise how the…

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.

Does uncontrolled cardiac death for organ donation raise ethical questions? An opinion survey.

PubMed

Goudet, V; Albouy-Llaty, M; Migeot, V; Pain, B; Dayhot-Fizelier, C; Pinsard, M; Gil, R; Beloucif, S; Robert, R

2013-11-01

Organ donation after uncontrolled cardiac death raises complex ethical issues. We conducted a survey in a large hospital staff population, including caregivers and administrators, to determine their ethical viewpoints regarding organ donation after uncontrolled cardiac death. Multicenter observational survey using a questionnaire, including information on the practical modalities of the procedure. Respondents were asked to answer 15 detailed ethical questions corresponding to different ethical issues raised in the literature. Ethical concerns was defined when respondents expressed ethical concerns in their answers to at least three of nine specifically selected ethical questions. One thousand one hundred ninety-six questionnaires were received, and 1057 could be analysed. According to our definition, 573 respondents out of 1057 (54%) had ethical concerns with regard to donation after cardiac death and 484 (46 %) had no ethical concerns. Physicians (55%) and particularly junior intensivists (65%) tended to have more ethical issues than nurses (52%) and hospital managers (37%). Junior intensivists had more ethical issues than senior intensivists (59%), emergency room physicians (46%) and transplant specialists (43%). Only 46% of hospital-based caregivers and managers appear to accept easily the legitimacy of organ donation after cardiac death. A significant number of respondents especially intensivists, expressed concerns over the dilemma between the interests of the individual and those of society. These results underline the need to better inform both healthcare professionals and the general population to help to the development of such procedure. © 2013 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Are psychoanalytic billing practices ethical?

PubMed

Blackmon, W D

1993-01-01

The changing climate of "health care reform" and increased third-party intrusion into psychotherapy are raising challenges over the ethics of traditional psychoanalytic practices such as billing for missed sessions. The practice of billing for missed sessions is an integral part of some analytic psychotherapies and forms the basis of the field of operation of many therapies. When used in this way, the billing practices are unique in medicine in that only these therapies use billing as a part of treatment. This practice is used for a variety of practical reasons but especially to emphasize to patients that the therapy occurs in their internal lives and addresses the symbols they use in organizing their world view. The symbolic use of a time commitment and the obligation to pay for that commitment are necessary so as not to present the patient with a contaminated field of operation. In this way the practice is similar to many other areas of medicine, such as surgeries that are viewed as global procedures whose billing allows for time that is not actually spent in contact with patients. This paper discusses the clinical rationale for the ability to bill for missed sessions and its ethics in terms of the newer language of utilization review. By laying down the principle of billing as a practice parameter for an open-ended bundled service that is billed globally the author translates the practice into more modern utilization-review terminology.

Ethical issues in HIV prevention research with people who inject drugs.

PubMed

Sugarman, Jeremy; Rose, Scott M; Metzger, David

2014-04-01

Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal, and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk of acquiring HIV so as to minimize harm to participants in research. To describe how we addressed some of these ethical challenges during the course of a large-scale multinational randomized HIV prevention trial involving PWIDs, which was successfully completed. The ethical issues encountered during the life cycle of the trial were cataloged by the principal investigator, study coordinator, and ethicist working on the trial. Relevant study documents were then reviewed to provide pertinent details. The ethical issues unique to the trial were then described. Before implementation, the trial faced particularly complex challenges related to the vulnerability of PWIDs, where HIV seroincidence rates in the population were high and legal policies and stigma regarding injection drug use was severe. Accordingly, a rapid policy assessment was commissioned, and a series of community engagement activities were conducted. During the trial, in addition to using careful standard operating procedures regarding all aspects of trial conduct and extensive staff training, the trial standardized informed consent procedures and assessed them. Furthermore, social harms were monitored along with physical harms and adverse events. Following the decision to close the study, it was critical to develop an orderly and safe process for closing it. The issue of post-trial access to the study medication and a complex intervention also surfaced for consideration. The issues described in this article are necessarily limited to how they manifested themselves within the context of a particular trial that was conducted in two countries. In addition, other stakeholders may have divergent views on the ethical issues described and may also have identified additional ethical issues that would warrant examination. Adopting similar approaches to addressing ethical issues in future research promises to facilitate this work so that needed strategies to prevent HIV infection among PWIDs can be safely and appropriately tested. Future trials enrolling PWIDs who are at risk of detainment should identify ways of mapping closely their experiences and perceptions in order to better apprehend some of the ethical issues at stake. In addition, scholarly and policy work needs to address the ethical issues related to post-trial access to multi-modal interventions that may be desired by participants, but are not shown to be effective in achieving the primary outcomes of the study.

The ethics of uterus transplantation.

PubMed

Catsanos, Ruby; Rogers, Wendy; Lotz, Mianna

2013-02-01

Human uterus transplantation (UTx) is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies (ART) and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as face and limb grafts, and shares some of the ethical concerns raised by these non-life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx. © 2011 Blackwell Publishing Ltd.

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

5 CFR 2608.101 - Scope and purpose.

Code of Federal Regulations, 2010 CFR

2010-01-01

....101 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES TESTIMONY BY OGE... when you submit a demand or request to an employee of the Office of Government Ethics (OGE) to produce... disclosure of official records and information. (b) The Office of Government Ethics intends these provisions...

Ethical considerations of transparency, informed consent, and nudging in a patient with paediatric aortic stenosis and symptomatic left ventricular endocardial fibroelastosis.

PubMed

Mavroudis, Constantine D; Cook, Thomas; Jacobs, Jeffrey P; Mavroudis, Constantine

2016-12-01

A 9-year-old boy who was born with bicuspid aortic stenosis underwent two unsuccessful aortic valvuloplasty interventions, and by 2 years of age he developed restrictive cardiomyopathy caused by left ventricular endocardial fibroelastosis and diastolic dysfunction. The attending cardiologist referred the patient to a high-volume, high-profile congenital cardiac surgical programme 1000 miles away that has a team with considerable experience with left ventricular endocardial fibroelastosis resection and a reputation of achieving good results. Owing to problems with insurance coverage, the parents sought other options for the care of their child in their home state. Dr George Miller is a well-respected local congenital and paediatric cardiac surgeon with considerable experience with the Ross operation as well as with right ventricular endocardial fibroelastosis resection. When talking with Dr Miller, he implied that there is little difference between right ventricular endocardial fibroelastosis and left ventricular endocardial fibroelastosis resection, and stated that he would perform the operation with low mortality based on his overall experience. Dr Miller stated that the local institution could provide an equivalent surgical procedure with comparable outcomes, without the patient and family having to travel out of state. A fundamental dilemma that often arises in clinical surgical practice concerns the conduct of assessing and performing new procedures, especially in rare cases, for which the collective global experience is scant. Although Dr Miller has performed right ventricular endocardial fibroelastosis resection, this procedure differs from left ventricular endocardial fibroelastosis resection, and he cannot be sure that he will indeed be able to perform the procedure better than the high-volume surgeon. This ethical situation is best understood in terms of the principles of respect for patient autonomy, beneficence, non-maleficence, and justice. The tension between the imperatives of beneficence and the obligation to respect the autonomy of the patient by acting only with the patient's best interest in mind is discussed.

[Toward a practical ethic].

PubMed

Vanbelle, Guido

2007-01-01

The relationship between ethics and philosophy and jurisdiction is described; different kinds of ethics are presented. The increasing pressure of liberal points of view has boosted the ethics of utility. The ethics of care oppose a too rational utilitarianism, taking into consideration relationships such as the caregiver-patient relationship. In the multicultural society ethics of care and virtue ethics are being criticised for not giving universal answers to ethical dilemmas. Can one still define "doing good"? Is "doing good" so culturally biased that it no longer provides the basis for ethical conduct? An accurate procedural assessment of values, sometimes interpreted quite differently in different cultures, could be a tool to judge values in a less relativistic way.

The ethics of smart cities and urban science

PubMed Central

2016-01-01

Software-enabled technologies and urban big data have become essential to the functioning of cities. Consequently, urban operational governance and city services are becoming highly responsive to a form of data-driven urbanism that is the key mode of production for smart cities. At the heart of data-driven urbanism is a computational understanding of city systems that reduces urban life to logic and calculative rules and procedures, which is underpinned by an instrumental rationality and realist epistemology. This rationality and epistemology are informed by and sustains urban science and urban informatics, which seek to make cities more knowable and controllable. This paper examines the forms, practices and ethics of smart cities and urban science, paying particular attention to: instrumental rationality and realist epistemology; privacy, datafication, dataveillance and geosurveillance; and data uses, such as social sorting and anticipatory governance. It argues that smart city initiatives and urban science need to be re-cast in three ways: a re-orientation in how cities are conceived; a reconfiguring of the underlying epistemology to openly recognize the contingent and relational nature of urban systems, processes and science; and the adoption of ethical principles designed to realize benefits of smart cities and urban science while reducing pernicious effects. This article is part of the themed issue ‘The ethical impact of data science’. PMID:28336794

The ethics of smart cities and urban science.

PubMed

Kitchin, Rob

2016-12-28

Software-enabled technologies and urban big data have become essential to the functioning of cities. Consequently, urban operational governance and city services are becoming highly responsive to a form of data-driven urbanism that is the key mode of production for smart cities. At the heart of data-driven urbanism is a computational understanding of city systems that reduces urban life to logic and calculative rules and procedures, which is underpinned by an instrumental rationality and realist epistemology. This rationality and epistemology are informed by and sustains urban science and urban informatics, which seek to make cities more knowable and controllable. This paper examines the forms, practices and ethics of smart cities and urban science, paying particular attention to: instrumental rationality and realist epistemology; privacy, datafication, dataveillance and geosurveillance; and data uses, such as social sorting and anticipatory governance. It argues that smart city initiatives and urban science need to be re-cast in three ways: a re-orientation in how cities are conceived; a reconfiguring of the underlying epistemology to openly recognize the contingent and relational nature of urban systems, processes and science; and the adoption of ethical principles designed to realize benefits of smart cities and urban science while reducing pernicious effects.This article is part of the themed issue 'The ethical impact of data science'. © 2016 The Author(s).

Problems in deceptive medical procedures: an ethical and legal analysis of the administration of placebos

PubMed Central

Simmons, Beth

1978-01-01

The use of placebos in therapy or research poses ethical questions. What are the benefits and the costs in ethical terms of condoning deception of the patient or subject? What does the deception mean for the patient's or subject's right to give informed consent to his treatment? Doctors are rightly expected to disclose to their patient facts which would in their judgement best enable him to give informed consent to treatment. On occasion, the degree of this disclosure may be limited by the need to avoid hazarding the success of treatment of an unstable patient whose condition threatens his life, but doctors should have no right to withhold information just to prevent a patient refusing consent to therapy. No such limitation should apply in experiments where full disclosure must operate to enable the subject to give his informed consent. The potential medical benefits for the patient of placebo therapy have to be weighed against all the ethical costs of the deception and dishonesty involved, including the longer term repercussions on doctor/patient trust: similar ethical costs may arise in experiments involving the use of placebos without disclosure of this as a possibility to the subject. Deception is ethically degrading to both parties not only being a breach of trust, but denying the moral autonomy of the patient or subject to make his own choice. The writer concludes that placebos should be used only with full disclosure and consent whether in therapy or in research, and that this need not impede the success of either. PMID:739513

[The ethical reflection approach, a source of wellbeing at work].

PubMed

Bréhaux, Karine; Grésyk, Bénédicte

2014-01-01

Clinical nursing practice, beyond its application to care procedures, can be expressed in terms of ethical added value in the support of patients. In Reims university hospital, where a clinical ethics and care think-tank was created in June 2010, the ethical reflection approach is encouraged in order to reemphasise the global meaning of care as a source of wellbeing at work.

77 FR 61519 - Commission's Rules of Practice and Procedure

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

...) is designed to expedite consultation with the Director of the Office of Government Ethics, as... from section 207 in 1989 (Pub. L. 101-194 Ethics Reform Act) and replaced with a section on exceptions... Ethics (OGE) and to the Criminal Division, Department of Justice substantiated information regarding...

5 CFR 2604.102 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES FREEDOM OF INFORMATION ACT RULES... the Ethics in Government Act of 1978, 5 U.S.C. appendix, OGE will process a request for those records..., OGE will consider the request under the FOIA and this rule, provided that the special Ethics Act...

5 CFR 2604.102 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES FREEDOM OF INFORMATION ACT RULES... the Ethics in Government Act of 1978, 5 U.S.C. appendix, OGE will process a request for those records..., OGE will consider the request under the FOIA and this rule, provided that the special Ethics Act...

Donor Selection for Allogenic Hemopoietic Stem Cell Transplantation: Clinical and Ethical Considerations

PubMed Central

Pascale, Natascha; La Russa, Raffaele; Liso, Arcangelo; Salerno, Monica

2017-01-01

Allogenic hematopoietic progenitor cell transplantation (allo-HSCT) is an established treatment for many diseases. Stem cells may be obtained from different sources: mobilized peripheral blood stem cells, bone marrow, and umbilical cord blood. The progress in transplantation procedures, the establishment of experienced transplant centres, and the creation of unrelated adult donor registries and cord blood banks gave those without an human leucocyte antigen- (HLA-) identical sibling donor the opportunity to find a donor and cord blood units worldwide. HSCT imposes operative cautions so that the entire donation/transplantation procedure is safe for both donors and recipients; it carries with it significant clinical, moral, and ethical concerns, mostly when donors are minors. The following points have been stressed: the donation should be excluded when excessive risks for the donor are reasonable, donors must receive an accurate information regarding eventual adverse events and health burden for the donors themselves, a valid consent is required, and the recipient's risks must be outweighed by the expected benefits. The issue of conflict of interest, when the same physician has the responsibility for both donor selection and recipient care, is highlighted as well as the need of an adequate insurance protection for all the parties involved. PMID:28680446

Ethical and Animal Welfare Considerations in Relation to Species Selection for Animal Experimentation.

PubMed

Webster, John

2014-12-03

Ethical principles governing the conduct of experiments with animals are reviewed, especially those relating to the choice of species. Legislation requires that the potential harm to animals arising from any procedure should be assessed in advance and justified in terms of its possible benefit to society. Potential harms may arise both from the procedures and the quality of the animals' lifetime experience. The conventional approach to species selection is to use animals with the "lowest degree of neurophysiological sensitivity". However; this concept should be applied with extreme caution in the light of new knowledge. The capacity to experience pain may be similar in mammals, birds and fish. The capacity to suffer from fear is governed more by sentience than cognitive ability, so it cannot be assumed that rodents or farm animals suffer less than dogs or primates. I suggest that it is unethical to base the choice of species for animal experimentation simply on the basis that it will cause less distress within society. A set of responsibilities is outlined for each category of moral agent. These include regulators, operators directly concerned with the conduct of scientific experiments and toxicology trials, veterinarians and animal care staff; and society at large.

Global Ethics in a High School Curriculum.

ERIC Educational Resources Information Center

Sappir, Susan

1998-01-01

Raphi Amram, the late director of Israel's Society for Excellence Through Education, founded the Ethics in Science and Humanities Program operating in Israel and five other countries. Though the ethics program currently operates only in high schools serving high-achieving or gifted students, founders emphasize the universality of its appeal.…

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

Surgical “Placebo” Controls

PubMed Central

Tenery, Robert; Rakatansky, Herbert; Riddick, Frank A.; Goldrich, Michael S.; Morse, Leonard J.; O’Bannon, John M.; Ray, Priscilla; Smalley, Sherie; Weiss, Matthew; Kao, Audiey; Morin, Karine; Maixner, Andrew; Seiden, Sam

2002-01-01

Objective To set ethical guidelines on the use of surgical placebo controls in the design of surgical trials. Background Data Ethical concerns recently arose from surgical trials where subjects in the control arm underwent surgical procedures that had the appearance of a therapeutic intervention, but during which the essential therapeutic maneuver was omitted. Although there are ethical guidelines on the use of a placebo in drug trials, little attention has been paid to the use of a surgical placebo control in surgical trials. Methods The Council on Ethical and Judicial Affairs developed ethical guidelines based on a wide literature search and consultation with experts. Results Surgical placebo controls should be limited to studies of new surgical procedures aimed at treating diseases that are not amenable to other surgical therapies, and are reasonably anticipated to be susceptible to substantial placebo effects. If the standard nonsurgical treatment is efficacious and acceptable to the patient, then it must be offered as part of the study design. Conclusions Surgical placebo controls should be used only when no other trial design will yield the requisite data and should always be accompanied by a rigorous informed consent process and a careful consideration of the related risks and benefits. The recommended ethical guidelines were adopted as AMA ethics policy and are now incorporated in the AMA’s Code of Medical Ethics. PMID:11807373

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.

Teaching Business Ethics or Teaching Business Ethically?

ERIC Educational Resources Information Center

Stablein, Ralph

2003-01-01

Notes that one of the most important contexts for ethical decision-making is the nature and operation of "contemporary capitalisms." Suggests that rather than issuing a call for teaching business ethics, the author emphasizes the need for more ethical business teaching. (SG)

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

A model of a code of ethics for tissue banks operating in developing countries.

PubMed

Morales Pedraza, Jorge

2012-12-01

Ethical practice in the field of tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of tissues for transplantation. This model of a Code of Ethics has been prepared with the purpose of being used for the elaboration of a Code of Ethics for tissue banks operating in the Latin American and the Caribbean, Asia and the Pacific and the African regions in order to guide the day-to-day operation of these banks. The purpose of this model of Code of Ethics is to assist interested tissue banks in the preparation of their own Code of Ethics towards ensuring that the tissue bank staff support with their actions the mission and values associated with tissue banking.

Exploring perceptions and experiences of Bolivian health researchers with research ethics.

PubMed

Sullivan, Sarah; Aalborg, Annette; Basagoitia, Armando; Cortes, Jacqueline; Lanza, Oscar; Schwind, Jessica S

2015-04-01

In Bolivia, there is increasing interest in incorporating research ethics into study procedures, but there have been inconsistent application of research ethics practices. Minimal data exist regarding the experiences of researchers concerning the ethical conduct of research. A cross-sectional study was administered to Bolivian health leaders with research experience (n = 82) to document their knowledge, perceptions, and experiences of research ethics committees and infrastructure support for research ethics. Results showed that 16% of respondents reported not using ethical guidelines to conduct their research and 66% indicated their institutions did not consistently require ethics approval for research. Barriers and facilitators to incorporate research ethics into practice were outlined. These findings will help inform a comprehensive rights-based research ethics education program in Bolivia. © The Author(s) 2015.

Extensive Training Is Insufficient to Produce the Work-Ethic Effect in Pigeons

ERIC Educational Resources Information Center

Vasconcelos, Marco; Urcuioli, Peter J.

2009-01-01

Zentall and Singer (2007a) hypothesized that our failure to replicate the work-ethic effect in pigeons (Vasconcelos, Urcuioli, & Lionello-DeNolf, 2007) was due to insufficient overtraining following acquisition of the high- and low-effort discriminations. We tested this hypothesis using the original work-ethic procedure (Experiment 1) and one…

Ethical environment: reports of practicing nurses.

PubMed

McDaniel, C

1998-06-01

Reports from the development of the Ethics Environment Questionnaire identify three critical features for ethical environments in health care settings of registered nurses. They are the ability of nurses to engage in discussions about patient care, support from administrators, and the development of policies-procedures that support their practice. Implications for clinical practicing nurses are explored.

An Ethical Review of Euthanasia and Physician-assisted Suicide

PubMed Central

BANOVIĆ, Božidar; TURANJANIN, Veljko; MILORADOVIĆ, Anđela

2017-01-01

Background: In the majority of countries, active direct euthanasia is a forbidden way of the deprivation of the patients’ life, while its passive form is commonly accepted. This distinction between active and passive euthanasia has no justification, viewed through the prism of morality and ethics. Therefore, we focused on attention on the moral and ethical implications of the aforementioned medical procedures. Methods: Data were obtained from the Clinical Hospital Center in Kragujevac, collected during the first half of the 2015. The research included 88 physicians: 57 male physicians (representing 77% of the sample) and 31 female physicians (23% of the sample). Due to the nature, subject and hypothesis of the research, the authors used descriptive method and the method of the theoretical content analysis. Results: A slight majority of the physicians (56, 8%) believe that active euthanasia is ethically unacceptable, while 43, 2% is for another solution (35, 2% took a viewpoint that it is completely ethically acceptable, while the remaining 8% considered it ethically acceptable in certain cases). From the other side, 56, 8% of respondents answered negatively on the ethical acceptability of the physician-assisted suicide, while 33% of them opted for a completely ethic viewpoint of this procedure. Out of the remaining 10, 2% opted for the ethical acceptability in certain cases. Conclusion: Physicians in Serbia are divided on this issue, but a group that considers active euthanasia and physician-assisted suicide as ethically unacceptable is a bit more numerous. PMID:28451551

Active parental consent in school-based research. An examination of ethical and methodological issues.

PubMed

Esbensen, F A; Deschenes, E P; Vogel, R E; West, J; Arboit, K; Harris, L

1996-12-01

To date, most school-based research has used passive parental consent. However, the Family Privacy Protection Act of 1995 aims to change these requirements. The proposed legislation requires written parental consent if minors are to be asked "sensitive" questions as part of any program or activity funded in whole or in part by the federal government. This act is representative of a growing trend toward restricting research involving minors. Whether or not this act is passed by Congress, two lines of concern are highlighted by this legislation. The first deals with ethical issues surrounding consent procedures. For instance, are parental rights compromised when active consent is not mandated? A second line of inquiry pertains to the effect of active consent procedures on response rates and sample bias. In this article, the authors discuss ethical issues surrounding passive and active consent procedures and then report response rates from two projects in which active consent procedures were implemented.

[Accreditation of Independent Ethics Committees].

PubMed

Ramiro Avilés, Miguel A

According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Ethics in the Work Environment: Applied Bioethics in the Hospital for Delta's Nursing Students.

ERIC Educational Resources Information Center

Plackowski, Linda C.

In 1979, Delta College, in Michigan, established a bioethics requirement for all nursing students. This paper describes a project to teach one of the required ethics course to local hospitals to observe students while they work and discuss ethical dilemmas as they arose. Introductory sections discuss project rationale and procedures, indicating…

Clinical and Ethical Implications for Teacher-Training in Behavior Modification.

ERIC Educational Resources Information Center

Brion-Meisels, Linda

The ethical issues concerning the use of behavioral procedures are founded on concerns relating to behavioral control. One major recurring ethical issue is that of coercion. The focus of this paper centers on the question: Ought behavioral programs to be employed even when they might be against the volition of the participant? A theoretical and…

True or False, Process or Procedure: Parrhesia and a Consideration of Humanism, Subjectivity, and Ethics within Educational Research

ERIC Educational Resources Information Center

Roof, David; Polush, Elena

2016-01-01

This paper seeks to examine ethics, humanism, and the concept of "parrhesia" ("pa???s?a") in the context of educational research. More specifically, it surveys Foucault's lectures on ethics to explore a framework for educational research that disrupts subjectivity and traditional forms of humanism while retaining a relational…

Statistics and Ethics in Surgery and Anesthesia

ERIC Educational Resources Information Center

Gilbert, John P.; And Others

1977-01-01

Analyzes 46 medical research papers on the effects of innovative versus standard surgical procedures on the health of patients. Results reveal that innovations generally reduce complications. The ethics of experimental surgery are also discussed. (CP)

Optimising experimental research in respiratory diseases: an ERS statement.

PubMed

Bonniaud, Philippe; Fabre, Aurélie; Frossard, Nelly; Guignabert, Christophe; Inman, Mark; Kuebler, Wolfgang M; Maes, Tania; Shi, Wei; Stampfli, Martin; Uhlig, Stefan; White, Eric; Witzenrath, Martin; Bellaye, Pierre-Simon; Crestani, Bruno; Eickelberg, Oliver; Fehrenbach, Heinz; Guenther, Andreas; Jenkins, Gisli; Joos, Guy; Magnan, Antoine; Maitre, Bernard; Maus, Ulrich A; Reinhold, Petra; Vernooy, Juanita H J; Richeldi, Luca; Kolb, Martin

2018-05-01

Experimental models are critical for the understanding of lung health and disease and are indispensable for drug development. However, the pathogenetic and clinical relevance of the models is often unclear. Further, the use of animals in biomedical research is controversial from an ethical perspective.The objective of this task force was to issue a statement with research recommendations about lung disease models by facilitating in-depth discussions between respiratory scientists, and to provide an overview of the literature on the available models. Focus was put on their specific benefits and limitations. This will result in more efficient use of resources and greater reduction in the numbers of animals employed, thereby enhancing the ethical standards and translational capacity of experimental research.The task force statement addresses general issues of experimental research (ethics, species, sex, age, ex vivo and in vitro models, gene editing). The statement also includes research recommendations on modelling asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, lung infections, acute lung injury and pulmonary hypertension.The task force stressed the importance of using multiple models to strengthen validity of results, the need to increase the availability of human tissues and the importance of standard operating procedures and data quality. Copyright ©ERS 2018.

Jewish ethics and xenotransplantation.

PubMed

Mathieu, Richard

2016-07-01

Although exclusively secular approaches to xenotransplantation are methodologically necessary to establish a fundamental verdict on its theoretical ethical acceptability, it is nevertheless pragmatically appropriate to take into account specifically religious positions, as religion is a factor relevant to societal acceptability. Apart from the aspect of societal acceptability, Jewish bioethics, like other religiously embedded ethics, may enrich the broader ethical discourse on xenotransplantation, as some of its principles-pikuach nefesh being the most prominent one-are plausible even in the framework of secular ethics. This paper first explores concepts of normativity in Jewish ethics before identifying specific ethical issues in Jewish bioethics and possible resolutions offered within the framework of Jewish ethics, and then finally examine the implications for the broader debate on xenotransplantation. Religions in general and Judaism in specific cannot and should not be systematically excluded from ethical debates, not only because they may provide helpful input, but also because religion, religiousness and the affiliation to a religion can be crucial factors regarding the societal acceptability of specific medical technologies and procedures as they may be important aspects of an individual's identity. The principles of Jewish bioethics may be compelling to those who do not necessarily share the specifically religious prerequisites on which Jewish ethics is established. Among these rather cogent concepts is the status of natural law and naturalness, which is far more open to medical technologies and procedures deemed as unnatural and thus morally wrong by other religious parties in public discourse. Jewish ethics has strong tendencies toward supporting xenotransplantation given a certain criteria is met. No categorical bans on xenotransplantation can be established on the grounds of Halacha. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The challenges and effects of globalisation on forensic dentistry.

PubMed

Bernitz, Herman

2009-08-01

This paper deals with the challenges faced by forensic dentists in a world in which globalisation has become a reality. People travelling across the globe on a daily basis become victims of violent crime, terrorist attacks, human displacement, natural and man made disasters. This has forced colleagues in the profession to participate in joint operations exposing inadequacies which need urgent attention. Forensic dentists practise in isolation creating their own rules and regulations oblivious to the greater global community. No international protocols exist for the many procedures practised by the profession. Possible solutions to the complex problems are offered. These include co-operation with colleagues around the globe while striving for the highest levels of quality control, standardisation, reliability, impartiality, reproducibility and ethical accountability.

Pastoral care in hospitals: a literature review.

PubMed

Proserpio, Tullio; Piccinelli, Claudia; Clerici, Carlo Alfredo

2011-01-01

This literature review investigates the potential contribution of the pastoral care provided in hospitals by hospital chaplains, as part of an integrated view of patient care, particularly in institutions dealing with severe disease. A search was conducted in the Medline database covering the last 10 years. Ninety-eight articles were considered concerning the modern hospital chaplains' relationships and the principal procedures and practices associated with their roles, i.e., their relations with the scientific world, with other religious figures in the community, with other faiths and religious confessions, with other public health professionals and operators, with colleagues in professional associations and training activities, and with the hospital organization as a whole, as well as their patient assessment activities and the spiritual-religious support they provide, also for the patients' families. Improvements are needed on several fronts to professionalize the pastoral care provided in hospitals and modernize the figure of the hospital chaplain. These improvements include better relations between modern chaplains and the hospital organization and scientific world; more focus on a scientific approach to their activities and on evaluating the efficacy of pastoral care activities; greater clarity in the definition of the goals, methods and procedures; the design of protocols and a stance on important ethical issues; respect for the various faiths, different cultures and both religious and nonreligious or secularized customs; greater involvement in the multidisciplinary patient care teams, of which the hospital chaplains are an integral part; stronger integration with public health operators and cooperation with the psychosocial professions; specific training on pastoral care and professional certification of chaplains; and the development of shared ethical codes for the profession.

Medicine and technology. Remarks on the notion of responsibility in the technology-assisted health care.

PubMed

Kwiatkowski, Waldemar

2018-06-01

The introduction of the modern diagnostic and therapeutic procedures to the medical practice provided a new challenge for the medicine. The art of medicine, with its default purpose of acting for the benefit of health, is therefore required to derive from technological progress effectively and rationally. As a result, the medical ethics has been engaged with the rules of economy and management of deficit medical procedures as well as their rational and fair distribution. The above suggests, that medics, given these recourses, should approach each patient with a consideration to their therapeutic rights. However, the physicians cannot just concentrate on the good of one particular patient, but must take into account joint responsibility for the good of a potential patient. This makes medical ethical dilemmas similar to the ethical issues of business. The notion of responsibility is the key for discriminating these two kinds of ethics.

Dentists versus auto mechanics: are there ethical differences?

PubMed

Riley, Crystal

2013-01-01

The different ethical perspectives of dentists and auto mechanics include primary concern, billing procedures, advertising, emergency care, the level of autonomy granted to their patients/ clients, the amount of disclosure given to their patients/clients, the ability to judge the work of others, and the freedom to pursue romantic relationships with their patients/clients. In analyzing these differences, one finds dentists to have much greater ethical obligations than auto mechanics. There are subtle differences between the ethical expectations of Canadian and United States dentists.

Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives.

PubMed

Altavilla, A; Manfredi, C; Baiardi, P; Dehlinger-Kremer, M; Galletti, P; Pozuelo, A Alemany; Chaplin, J; Ceci, A

2012-01-01

To evaluate the impact of the new European paediatric regulatory framework on the activities of Ethics Committees operating in Europe and to assess their involvement and interest in paediatric research. Task-force in Europe for Drug Development for the Young Network of Excellence and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials project set up an inventory of Ethics Committees existing in Europe and conducted a survey on their approach to paediatric trials. Ethics Committees operating in 22 European Countries participated in this survey. Results showed a high lack of knowledge, understanding and awareness of the current European paediatric regulatory framework and a lack of involvement of Ethics Committees in paediatric research, especially in terms of training and education, demonstrated also by the decreasing number of Ethics Committees answering exhaustively to the whole questionnaire. The majority of participating Ethics Committees expressed interest in future initiatives related to paediatric research. Despite a limited knowledge and understanding of the current paediatric regulatory framework, a significant number of Ethics Committees operating in Europe show interest in initiatives related to paediatric research. Networking may be an essential tool to be used to enhance Ethics Committees role in supporting paediatric research. Any initiative should be undertaken at European level in collaboration with European Union Institutions. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

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

Contracts to devolve health services in fragile states and developing countries: do ethics matter?

PubMed

Jayasinghe, S

2009-09-01

Fragile states and developing countries increasingly contract out health services to non-state providers (NSPs) (such as non-governmental organisations, voluntary sector and private sector). The paper identifies ethical issues when contracts involve devolution of health services to NSPs and proposes procedures to prevent or resolve these ethical dilemmas. Ethical issues were identified by examining processes of contracting out. Health needs could be used to select areas to be contracted out and to identify service needs. Health needs comprise "disease-burden-related needs", "health-service needs", and "urgency of health-service needs". The mix of services should include an analysis of cost-effectiveness. NSPs should be selected fairly, without bias, and conflicts of interest during their work must be avoided. The population's views must be respected and accountability structures established. Devolved health services should ensure equity of access to healthcare. The services ought to be sustainable and evaluated objectively. Of these issues, conflicts of interest among NSPs and sustainability of health services have not attracted attention in the literature on ethics of health policy. Fair procedures could address these ethical issues-for example, public consultation on issues; decisions based on the public consultation and made on evidence; principles of decisions stated and reasonable; decisions given adequate publicity; a mechanism established to challenge decisions; assurance that mechanisms meet the above conditions; and regular review of the policies. These procedures are complemented by improving self-governance of NSPs, countries' development of guidelines for devolving health services, and measures to educate the public of the client countries on these issues.

Public health ethics theory: review and path to convergence.

PubMed

Lee, Lisa M

2012-01-01

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

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

PubMed Central

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

2014-01-01

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

National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.

PubMed

Barchi, Francis; Little, Madison T

2016-10-22

Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.

[Bioethical analysis of the use of newly dead patients in medical learning].

PubMed

Gomes, Andréia Patrícia; Rego, Sergio; Palácios, Marisa; Siqueira-Batista, Rodrigo

2010-01-01

The purpose of this article is to carry out, a discussion on the subject of bioethics and cadavers based upon a critic review of literature. A review of literature, was made with a survey of articles between 1977 and 2007 in the sites 'Biblioteca Virtual de Saúde', PubMed and SciElo, utilizing the keywords: newly deceased patients, newly dead patients, simulators,. This was complemented by a critical evaluation of books published in the area of ethics and bioethics. The possibility to develop learning without orientation by a supervisor is doubtful.. The utilization of newly dead for learning invasive procedures is very frequent and seldom admitted. These procedures, are usually, carried out secretly, without the knowledge and consent of the family. The ethical aspects of these practices are not discussed in the practical medical education. It essential that the ethics of use of recent deceased become a necessary content of graduate education. Performance of these procedures by students should always be authorized by family members. The simulators meet the requirements of training. Discussions about the ethical and bioethical aspects cannot be separated from practical considerations during the students learning time.

Flowers for Algernon: The ethics of human experimentation on the intellectually disabled.

PubMed

Ghoshal, Nishan; Wilkinson, Paul O

2017-09-01

Flowers for Algernon is a novel written in 1966 by Daniel Keyes. Since its publication, it has received significant critical acclaim, earning a Nebula science-fiction award, and was also adapted into a feature film. Set in the 1960s, the novel follows the story of Charlie Gordon, an intellectually disabled man who lives a simple but happy life working a cleaning job at a local bakery. Charlie's life, however, faces an abrupt change when he is offered the opportunity to participate in a novel surgical procedure to improve his intellect. Although he doesn't fully understand the risks of the operation, consent is provided on his behalf by his estranged sister and Charlie undergoes the experiment. The experiment is a success and Charlie develops intellectually at an alarming pace, soon surpassing the experimenters themselves. The rest of the book follows the, not all positive, changes that this intellect brings to Charlie's life. The novel is set in a time when American scientific experimentation could often occur without fully informed consent. This article explores the ethical side of such experiments like the one performed on Charlie, namely if it is morally right to perform a potentially dangerous experimental procedure on someone who doesn't fully understand the risks, even if it will potentially help them.

[Path analysis of the Influence of Hospital Ethical Climate Perceived by Nurses on Supervisor Trust and Organizational Effectiveness].

PubMed

Noh, Yoon Goo; Jung, Myun Sook

2016-12-01

The purpose of this study was to analyze the paths of influence that a hospital's ethical climate exerts on nurses' organizational commitment and organizational citizenship behavior, with supervisor trust as the mediating factor, and verify compatibility of the models in hospital nurses. The sample consisted of 374 nurses recruited from four hospitals in 3 cities in Korea. The measurements included the Ethical Climate Questionnaire, Supervisor Trust Questionnaire, Organizational Commitment Questionnaire and Organizational Citizenship Behavior Questionnaire. Ethical Climate Questionnaire consisted of 6 factors; benevolence, personal morality, company rules and procedures, laws and professional codes, self-interest and efficiency. Data were analysed using SPSS version 18.0 and AMOS version 18.0. Supervisor trust was explained by benevolence and self-interest (29.8%). Organizational commitment was explained by benevolence, supervisor trust, personal morality, and rules and procedures (40.4%). Organizational citizenship behavior was explained by supervisor trust, laws and codes, and benevolence (21.8%). Findings indicate that managers need to develop a positive hospital ethical climate in order to improve nurses' trust in supervisors, organizational commitment and organizational citizenship behavior.

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

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

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

12-hour shifts: an ethical dilemma for the nurse executive.

PubMed

Lorenz, Susan G

2008-06-01

Flexible work hours, including 12-hour shifts, have become a common scheduling option for nurses. The author explores whether 12-hour shifts are an ethical scheduling option for nurses because recent research suggests that 12-hour shifts are a potential hazard to patients. A multistep model for ethical decision making, reflecting the concept of procedural justice, is used to examine this issue.

An Educational Program of Engineering Ethics and Its Dissemination Activity

NASA Astrophysics Data System (ADS)

Muramatsu, Ryujiro; Nagashima, Shigeo

Education on ethics for corporate employees, especially for engineers, seems to become increasingly important for most of companies in Japan, because some affairs or scandals caused by ethical problem in many companies were likely to subject them to operational disadvantages. Even in Hitachi, Ltd., we have worked on education of engineering ethics for two years. In this paper, we describe some activities of committees on engineering ethics, an e-learning training course which is usable on our intranet e-learning system, and a short-term in-house training course operated regularly in our training institute. And we also refer to its dissemination activities to employees in each division and some subsidiaries.

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.

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.

An implementation framework for the feedback of individual research results and incidental findings in research.

PubMed

Thorogood, Adrian; Joly, Yann; Knoppers, Bartha Maria; Nilsson, Tommy; Metrakos, Peter; Lazaris, Anthoula; Salman, Ayat

2014-12-23

This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance of a finding, re-identifying the affected participant, and communicating the finding. Re-identification requires researchers to break the code in place to protect participant identities. Coding systems replace personal identifiers with a numerical code. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third "linkage" database. A trusted and independent intermediary, the "keyholder", controls access to this linkage database. Procedural guidelines for the return of individual research results and incidental findings are lacking. This article outlines a procedural framework for the three steps of feedback: assessment, re-identification, and communication. This framework clarifies the roles of the researcher, Research Ethics Board, and keyholder in the process. The framework also addresses challenges posed by coding systems. Breaking the code involves privacy risks and should only be carried out in clearly defined circumstances. Where a double coding system is used, the keyholder plays an important role in balancing the benefits of individual feedback with the privacy risks of re-identification. Feedback policies should explicitly outline procedures for the assessment of findings, and the re-identification and contact of participants. The responsibilities of researchers, the Research Ethics Board, and the keyholder must be clearly defined. We provide general guidelines for keyholders involved in feedback. We also recommend that Research Ethics Boards should not be directly involved in the assessment of individual findings. Hospitals should instead establish formal, interdisciplinary clinical advisory committees to help researchers determine whether or not an uncertain finding should be returned.

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

Ethics guidelines for research with the recently dead.

PubMed

Pentz, Rebecca D; Cohen, Cynthia B; Wicclair, Mark; DeVita, Michael A; Flamm, Anne Lederman; Youngner, Stuart J; Hamric, Ann B; McCabe, Mary S; Glover, Jacqueline J; Kittiko, Winona J; Kinlaw, Kathy; Keller, James; Asch, Adrienne; Kavanagh, John J; Arap, Wadih

2005-11-01

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

[Dimensions of work ethic as predictors of strategies to cope with stress].

PubMed

Grabowski, Damian; Pollak, Anita; Czerw, Agnieszka

2017-10-17

The article presents the mutual relations between the components of work ethic and the strategies of coping with stress used by employees of different branches. Work ethic was presented as a syndrome of the following attitudes: perceiving work as a moral value, treating work as a central value in life, and the belief in the importance of hard work that leads to success. This ethic also consists of the following components: unwillingness to waste time, disapproval of spare time (anti-leisure), willingness to delay gratification, willingness to act honestly at work (morality/ethic), and being independent (self-reliance). Coping strategies were presented as 3 dimensions (obtained by application of factor analysis of the questionnaire scales COPE (Coping Orientations to Problems Experienced)): proactive cognitive operations, avoidance of action and seeking support. The study conducted on 360 employees of different branches shows that the dimensions of the work ethic are moderately related to strategies emphasizing proactive cognitive operations and poorly related to seeking support and avoidance of action. At the same time, the relations between work ethic and avoidance of action are negative (higher work ethic is linked with lower tendency to avoid action). Predictors of proactive cognitive operations are unwillingness to waste time, treating work as a central value in life, willingness to act honestly at work (morality/ethic) and being independent (self-reliance). Med Pr 2017;68(6):711-724. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

The Effect of Self-Directed Work Teams on Work Ethic

ERIC Educational Resources Information Center

Petty, Gregory C.; Lim, Doo Hun; Yoon, Seung Won; Fontan, Johnny

2008-01-01

This study examined the work ethic of manufacturing machine operators between self-directed work teams and traditional work groups using four work ethic subscales: dependable, considerate, ambitious, and cooperative (Dawson, [1999]; Petty, [1991]). Differences in measured work ethic scores were also compared across six demographic variables: age,…

Evidence, Ethics, and Values: A Framework for Health Promotion

PubMed Central

Rychetnik, Lucie; Dietetics, PGradDip; Lloyd, Beverley; Kerridge, Ian H.; Baur, Louise; Bauman, Adrian; Hooker, Claire; Zask, Avigdor

2011-01-01

We propose a new approach to guide health promotion practice. Health promotion should draw on 2 related systems of reasoning: an evidential system and an ethical system. Further, there are concepts, values, and procedures inherent in both health promotion evidence and ethics, and these should be made explicit. We illustrate our approach with the exemplar of intervention in weight, and use a specific mass-media campaign to show the real-world dangers of intervening with insufficient attention to ethics and evidence. Both researchers and health promotion practitioners should work to build the capacities required for evidential and ethical deliberation in the health promotion profession. PMID:21233436

Surgical ethics and the challenge of surgical innovation.

PubMed

Angelos, Peter

2014-12-01

Surgical ethics as a specific discipline is relatively new to many. Surgical ethics focuses on the ethical issues that are particularly important to the care of surgical patients. Informed consent for surgical procedures, the level of responsibility that surgeons feel for their patients' outcomes, and the management of surgical innovation are specific issues that are important in surgical ethics and are different from other areas of medicine. The future of surgical progress is dependent on surgical innovation, yet the nature of surgical innovation raises specific concerns that challenge the professionalism of surgeons. These concerns will be considered in the following pages. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

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).

Everyday ethics and help-seeking in early rheumatoid arthritis

PubMed Central

Townsend, A.; Adam, P.; Cox, S.M.; Li, L.C.

2018-01-01

Background Sociological understandings of chronic illness have revealed tensions and complexities around help-seeking. Although ethics underpins healthcare, its application in the area of chronic illness is limited. Here we apply an ethical framework to interview accounts and identify ethical challenges in the early rheumatoid arthritis (RA) experience. Methods In-depth interviews were conducted with eight participants who had been diagnosed with RA in the 12 months prior to recruitment. Applying the concepts of autonomous decision-making and procedural justice highlighted ethical concerns which arose throughout the help-seeking process. Analysis was based on the constant-comparison approach. Results Individuals described decision-making, illness actions and the medical encounter. The process was complicated by inadequate knowledge about symptoms, common-sense understandings about the GP appointment, difficulties concerning access to specialists, and patient–practitioner interactions. Autonomous decision-making and procedural justice were compromised. The accounts revealed contradictions between the policy ideals of active self-management, patient-centred care and shared decision-making, and the everyday experiences of individuals. Conclusions For ethical healthcare there is a need for: public knowledge about early RA symptoms; more effective patient–practitioner communication; and increased support during the wait between primary and secondary care. Healthcare facilities and the government may consider different models to deliver services to people requiring rheumatology consults. PMID:20610465

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2606.102 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Ethics; System manager means the Office or other agency official who has the authority to decide Privacy... Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES PRIVACY ACT RULES General... information pertains and by whose name or other individual identifier the information is maintained or...

5 CFR 2606.102 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Ethics; System manager means the Office or other agency official who has the authority to decide Privacy... Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES PRIVACY ACT RULES General... information pertains and by whose name or other individual identifier the information is maintained or...

How medical ethical principles are applied in treatment with artificial insemination by donors (AID) in Hunan, China: effective practice at the Reproductive and Genetic Hospital of CITIC-Xiangya

PubMed Central

Li, L; Lu, G

2005-01-01

This paper investigates the efficiency of application of medical ethics principles in the practice of artificial insemination by donors (AID) in China, in a culture characterised by traditional ethical values and disapproval of AID. The paper presents the ethical approach to AID treatment as established by the Reproduction and Genetics Hospital of CITIC-Xiangya (CITIC Hunan-Yale Approach) in the central southern area of China against the social ethical background of China and describes its general features. The CITIC-Xiangya Approach facilitates the implementation of ethical relations between clinicians and patients participating in AID treatment procedures in Hunan-Yale. PMID:15923480

Moral deliberation and nursing ethics cases: elements of a methodological proposal.

PubMed

Schneider, Dulcinéia Ghizoni; Ramos, Flávia Regina Souza

2012-11-01

A qualitative study with an exploratory, descriptive and documentary design that was conducted with the objective of identifying the elements to constitute a method for the analysis of accusations of and proceedings for professional ethics infringements. The method is based on underlying elements identified inductively during analysis of professional ethics hearings judged by and filed in the archives of the Regional Nursing Board of Santa Catarina, Brazil, between 1999 and 2007. The strategies developed were based on the results of an analysis of the findings of fact (occurrences/infractions, causes and outcomes) contained in the records of 128 professional ethics hearings and on the structural elements (statements, rules and practices) identified in five example professional ethics cases. The strategies suggested for evaluating accusations of ethics infringements and the procedures involved in deliberating on ethics hearings constitute a generic proposal that will require adaptation to the context of specific professional ethics accusations.

The quality of Internet advertising in aesthetic surgery: an in-depth analysis.

PubMed

Wong, Wendy W; Camp, Matthew C; Camp, Jennifer S; Gupta, Subhas C

2010-09-01

The aesthetic market is a growing business, as evidenced by the American Society for Aesthetic Plastic Surgery (ASAPS) reporting an increase of 147% in the number of cosmetic procedures performed by members since 1997. This market is consumer-oriented, relying heavily on advertising for survival amid the increasing provider competition. The authors evaluate trends, ethics, and efficacy of Internet advertising in aesthetic surgery. Medical cosmetic providers in Southern California and their Web sites were catalogued through sales lists from manufacturers (Medicis and Allergan) and combined with advertised providers of surgical treatments. Using the ASAPS/American Society of Aesthetic Plastic Surgeons (ASPS) and American Medical Association Codes of Ethics as guidelines, scores were assigned to each Web site and evaluated with the provider's board certification. A geographical analysis determined whether the presence of high numbers of competitors had an impact on the adherence to ethical guidelines for advertising. To examine patient preferences in physician advertising, a survey was conducted online. Board-certified plastic surgeons showed the highest total ethical scores, followed by otolaryngologists, oromaxillofacial surgeons, and ophthalmologists. No decrement in the quality of the advertising was found in densely competitive environments. A consistent correlation was found between superior compliance with ethical guidelines and board certification in plastic surgery. The patient preference survey of 208 individuals demonstrated their desire for a well-trained, board-certified plastic surgeon to perform their cosmetic procedures. Although plastic surgeons demonstrate greater overall compliance with the ASAPS/ASPS Advertising Code of Ethics, they can continue to improve. With the large variety of cosmetic physicians offering the same procedures, maintaining open, honest, and forthright communication with the public is essential.

Moral philosophy in bioethics. Etsi ethos non daretur?

PubMed

Pessina, Adriano

2013-01-01

In this paper I intend to put forward some criticism of the purely procedural model of bioethics, which, in fact, leads to delegating to biopolitics and biolaw the finding of a purely pragmatic solution to the issues for which bioethics was "invented" over forty years ago. This delegating takes place after the transition from the thesis, dear to modernity, whereby in ethics reasoning should avoid any discussion regarding its foundation or ultimate justification (Etsi Deus non daretur) to the contemporary affirmation of a substantial ethical agnosticism, which, in the name of the incommensurability of morals, should construct procedures as if no sole substantial moral were possible (Etsi ethos non daretur) and act as a guarantor of ethical pluralism. These theses will be discussed and an attempt will be made to demonstrate why it is necessary to establish a link between true and good, and how this is possible only by referring to ontology. The conclusion points to the need to propose bioethics explicitly in terms of content that satisfies the presumed axiological neutrality of procedural bioethics, which however, turns out to be theoretically weak and practically unable to protect the ethical pluralism for which it would like to be the guarantor. The conclusion is that only by referring to ontology can bioethics, which is a fully fledged form of moral philosophy, act as a guarantor of pluralism within the truth and oppose the authoritarian tendencies concealed under the liberal guise of ethical agnosticism.

A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

PubMed

Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

2012-03-01

The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

Ethical Problems of Screening for Neural Tube Defects.

ERIC Educational Resources Information Center

Habgood, J. S.

1978-01-01

Among the ethical problems in screening for severe spina bifida in a fetus are deciding who should be screened; whether the procedure, which has medical risks, is justified; and how to deal with the only known solution--abortion. Journal availability: see EC 114 865. (PHR)

5 CFR 2606.207 - Accounting of disclosures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Section 2606.207 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES PRIVACY...) The Office of Government Ethics or the other agency concerned will maintain an accounting of disclosures in cases where records about the data subject are disclosed from OGE's system of records except...

Frameworks for Teaching and Learning Business Ethics within the Global Context: Background of Ethical Theories

ERIC Educational Resources Information Center

White, Judith; Taft, Susan

2004-01-01

In this article, we provide a summary of several major traditional and contemporary philosophical and psychological perspectives on ethical conduct for businesses, along with five different sets of internationally accepted ethical guidelines for corporations operating anywhere in the world. We include examples of corporate codes of conduct from…

Ethical dilemmas in personality assessment courses: using the classroom for in vivo training.

PubMed

Yalof, J; Brabender, V

2001-10-01

In this article, we argue that the student's first lessons in ethical decision making in personality assessment are in those assessment courses that have a practice component. In these courses, the student has an opportunity to experience in vivo how ethical problems are identified, addressed, and resolved. The faculty member's demonstration of a process wherein the ethical principles activated are highlighted and explored, will enable students to internalize a model for addressing future dilemmas. Four particular ethical situations are considered: (a) the students' procurement of personal experience with personality testing, (b) the identification of assessment participants, (c) the development of informed consent procedures for assessment participants, and (d) classroom presentations. This discussion does not provide concrete solutions to ethical problems but offers a consideration of the relevant ethical principles that any adequate solution must encompass.

The biobank for the molecular classification of kidney disease: research translation and precision medicine in nephrology.

PubMed

Muruve, Daniel A; Mann, Michelle C; Chapman, Kevin; Wong, Josee F; Ravani, Pietro; Page, Stacey A; Benediktsson, Hallgrimur

2017-07-26

Advances in technology and the ability to interrogate disease pathogenesis using systems biology approaches are exploding. As exemplified by the substantial progress in the personalized diagnosis and treatment of cancer, the application of systems biology to enable precision medicine in other disciplines such as Nephrology is well underway. Infrastructure that permits the integration of clinical data, patient biospecimens and advanced technologies is required for institutions to contribute to, and benefit from research in molecular disease classification and to devise specific and patient-oriented treatments. We describe the establishment of the Biobank for the Molecular Classification of Kidney Disease (BMCKD) at the University of Calgary, Alberta, Canada. The BMCKD consists of a fully equipped wet laboratory, an information technology infrastructure, and a formal operational, ethical and legal framework for banking human biospecimens and storing clinical data. The BMCKD first consolidated a large retrospective cohort of kidney biopsy specimens to create a population-based renal pathology database and tissue inventory of glomerular and other kidney diseases. The BMCKD will continue to prospectively bank all kidney biopsies performed in Southern Alberta. The BMCKD is equipped to perform molecular, clinical and epidemiologic studies in renal pathology. The BMCKD also developed formal biobanking procedures for human specimens such as blood, urine and nucleic acids collected for basic and clinical research studies or for advanced diagnostic technologies in clinical care. The BMCKD is guided by standard operating procedures, an ethics framework and legal agreements with stakeholders that include researchers, data custodians and patients. The design and structure of the BMCKD permits its inclusion in a wide variety of research and clinical activities. The BMCKD is a core multidisciplinary facility that will bridge basic and clinical research and integrate precision medicine into renal pathology and nephrology.

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.

Dual loyalties: Everyday ethical problems of registered nurses and physicians in combat zones.

PubMed

Lundberg, Kristina; Kjellström, Sofia; Sandman, Lars

2017-01-01

When healthcare personnel take part in military operations in combat zones, they experience ethical problems related to dual loyalties, that is, when they find themselves torn between expectations of doing caring and military tasks, respectively. This article aims to describe how Swedish healthcare personnel reason concerning everyday ethical problems related to dual loyalties between care and military tasks when undertaking healthcare in combat zones. Abductive qualitative design. Participants and research context: Individual interviews with 15 registered nurses and physicians assigned for a military operation in Mali. Ethical considerations: The participants signed up voluntarily, and requirements for informed consent and confidentiality were met. The research was approved by the Regional Ethics Review Board in Gothenburg (D no. 816-14; 24 November 2014). Three main categories emerged: reasons for not undertaking combat duties, reasons for undertaking combat duties and restricted loyalty to military duties, and 14 subcategories. Reasons for not undertaking combat duties were that it was not in their role, not according to ethical codes or humanitarian law or a breach towards patients. Reasons for undertaking combat duties were that humanitarian law does not apply or has to be treated pragmatically or that it is a case of force protection. Shortage of resources and competence were reasons for both doing and not doing military tasks. Under some circumstances, they could imagine undertaking military tasks: when under threat, if unseen or if not needed for healthcare duties. These discrepant views suggest a lack of a common view on what is ethically acceptable or not, and therefore we suggest further normative discussion on how these everyday ethical problems should be interpreted in the light of humanitarian law and ethical codes of healthcare personnel and following this, further training in ethical reflection before going on military operations.

Ethical triage and scarce resource allocation during public health emergencies: tenets and procedures.

PubMed

Kuschner, Ware G; Pollard, John B; Ezeji-Okoye, Stephen C

2007-01-01

Public health emergencies may result in mass casualties and a surge in demand for hospital-based care. Healthcare standards may need to be altered to respond to an imbalance between demands for care and resources. Clinical decisions that involve triage and scarce resource allocation may present unique ethical challenges. To address these challenges, the authors detailed tenets and procedures to guide triage and scarce resource allocation during public health emergencies. The authors propose health care organizations deploy a Triage and Scarce Resource Allocation Team to over-see and guide ethically challenging clinical decision-making during a crisis period. The authors' goal is to help healthcare organizations and clinicians balance public health responsibilities and their duty to individual patients during emergencies in as equitable and humane a manner as possible.

The value of using top-down and bottom-up approaches for building trust and transparency in biobanking.

PubMed

Meslin, Eric M

2010-01-01

With the domestic and international proliferation of biobanks and their associated connections to health information databases, scholarly attention has been turning from the ethical issues arising from the construction of biobanks to the ethical issues that emerge in their operation and management. Calls for greater transparency in governance structures, coupled with stern reminders of the value of maintaining public trust, are seen as critical components in the success of these resources. Two different approaches have been adopted for addressing these types of ethical issues: the first is a 'top-down' approach which focuses on developing policy, procedures, regulations and guidelines to aid decision-makers. The second is a 'bottom-up' approach, which begins with those who are most affected by the issues and attempts to inductively develop consensus recommendations and policy. While both approaches have merit, I argue that more work needs to be done on 'bottom-up' strategies if trust and transparency are to be more than mere slogans. Using 2 case examples from Indiana, the paper summarizes data from a set of surveys we recently conducted that address issues arising from biobanks that provide some insight into issues associated with trust and transparency. Copyright 2010 S. Karger AG, Basel.

Ethical Dilemmas in Financial Reporting Situations and the Preferred Mode of Resolution of Ethical Conflicts as Taken by Certified and Noncertified Management Accountants in Organizations with Perceived Different Ethical Work Climates.

ERIC Educational Resources Information Center

McKenna, John N.

1995-01-01

Responses from 37.7% of 491 chief financial officers surveyed revealed a majority of organizational climates based on law and codes. Most believed their organizations attempted sound financial reporting and ethical operation. Certified accountants perceived a greater likelihood of the occurrence of ethical dilemmas than did noncertified…

Sankofan socio-ethical reflections: the Tuskegee University National Bioethics Center's decade of operation, 1999-2009.

PubMed

Earl, Riggins R

2010-08-01

Primarily, this is a Sankofan socio-ethical analysis of the moral foundation of the Tuskegee University National Bioethics Center's decade of operation. The first section of the study will do the following: a) a Sankofan socio-ethical analysis of the Center's raison d'être; and b) definitions of ethical terms and the social world of the infamous syphilis study. The second section, as a result of the analysis, will address the Center's following challenges: c) the Center's challenge of theory and practice; d) the Center's challenge of moral heritage; and e) the Center's challenge of the future.

Problematic Behavior: What Do CACREP Accredited Program Policies and Procedures Reflect

ERIC Educational Resources Information Center

Brown, Maranda

2011-01-01

Counselor Education programs are ethically obligated by accreditation standards and professional codes of ethics to identify counselors-in-training whose academic, clinical, and personal performance indicate problematic behavior that would potentially prevent them from entering the profession (McAdams, Foster, & Ward, 2007). Despite these…

5 CFR 2600.101 - Mission and history.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Mission and history. 2600.101 Section 2600.101 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES ORGANIZATION AND FUNCTIONS OF THE OFFICE OF GOVERNMENT ETHICS § 2600.101 Mission and history. (a) The Office of...

5 CFR 2600.101 - Mission and history.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Mission and history. 2600.101 Section 2600.101 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES ORGANIZATION AND FUNCTIONS OF THE OFFICE OF GOVERNMENT ETHICS § 2600.101 Mission and history. (a) The Office of...

5 CFR 2600.101 - Mission and history.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Mission and history. 2600.101 Section 2600.101 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES ORGANIZATION AND FUNCTIONS OF THE OFFICE OF GOVERNMENT ETHICS § 2600.101 Mission and history. (a) The Office of...

5 CFR 2600.101 - Mission and history.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Mission and history. 2600.101 Section 2600.101 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES ORGANIZATION AND FUNCTIONS OF THE OFFICE OF GOVERNMENT ETHICS § 2600.101 Mission and history. (a) The Office of...

A common body of care: the ethics and politics of teamwork in the operating theater are inseparable.

PubMed

Bleakley, Alan

2006-06-01

In the operating theater, the micro-politics of practice, such as interpersonal communications, are central to patient safety and are intimately tied with values as well as knowledge and skills. Team communication is a shared and distributed work activity. In an era of "professionalism," that must now encompass "interprofessionalism," a virtue ethics framework is often invoked to inform practice choices, with reference to phronesis or practical wisdom. However, such a framework is typically cast in individualistic terms as a character trait, rather than in terms of a distributed quality that may be constituted through intentionally collaborative practice, or is an emerging property of a complex, adaptive system. A virtue ethics approach is a necessary but not sufficient condition for a collaborative bioethics within the operating theater. There is also an ecological imperative-the patient's entry into the household (oikos) of the operating theater invokes the need for "hospitality" as a form of ethical practice.

Ethical Issues and Codes of Ethics: Views of Adult Education Practitioners in Canada and the United States.

ERIC Educational Resources Information Center

Gordon, Wanda; Sork, Thomas J.

2001-01-01

Replicating an Indiana study, 261 responses from British Columbia adult educators revealed a high degree of support for codes of ethics and identified ethical dilemmas in practice. Half currently operated under a code. Responses to whether codes should have a regulatory function were mixed. (Contains 44 references.) (SK)

Grand Canyon Skywalk: Views of Law and Ethics

ERIC Educational Resources Information Center

Willey, Lorrie; Burke, Debra D.

2015-01-01

The intersection of law and ethics provides students with a view of how people are expected to conduct themselves legally and how that conduct also should meet ethical standards, although legal and ethical behavior may or may not be synonymous. The story of the development and operation of the Grand Canyon Skywalk is a tale of dreams, schemes, and…

The Effect of Self-Directed Work Teams on Work Ethic

ERIC Educational Resources Information Center

Lim, Doo Hun; Petty, Gregory; Fontan, Johnny; Yoon, Seung Won

2008-01-01

The purpose of this study was to compare work ethic of manufacturing machine operators between a self-directed work team and a traditional work team based on four work ethic subscales and identify differences in work ethic based on six demographic factors. The major findings from the study indicated there were significant differences in the work…

A day in the life of a junior doctor: everyday ethical encounters.

PubMed

Quarini, Catherine J

2010-11-01

This paper presents a hypothetical 'day in the life' of junior doctors working on a busy hospital ward. It illustrates the fact that, although the everyday ethical encounters faced by doctors are generally not as dramatic as some of the ethical issues discussed at medical school, the underlying principles, such as consent, confidentiality and resource allocation, are highly relevant to daily practice. After presenting some of the ethical challenges faced by junior doctors, from patients confused by poor explanations to inadequate consent procedures, the paper ends with suggestions on how to improve the situation.

Self-assessment of clinical nurse mentors as dimensions of professional development and the capability of developing ethical values at nursing students: A correlational research study.

PubMed

Skela-Savič, Brigita; Kiger, Alice

2015-10-01

Providing adequate training for mentors, fostering a positive mentorship culture and establishing the necessary operational procedures for ensuring mentorship quality are the keys to effective clinical mentoring of nursing students. The purpose of the research was to explain different dimensions of clinical mentors' professional development and their capability of developing ethical values in nursing students. A non-experimental quantitative research design was employed. Data were collected by means of a questionnaire administered to the population of clinical mentors (N=143). The total number of questions was 36. Descriptive statistics were used, and bivariate analysis, factor analysis, correlation analysis and linear regression analysis were performed. The professional development of clinical nurse mentors was explained (R(2)=0.256) by career advancement (p=0.000), research and learning (p=0.024) and having a career development plan (p=0.043). Increased professional self-confidence (R(2)=0.188) was explained by career advancement (p=0.000) and the time engaged in record keeping (p=0.028). Responsibility for the development of ethical values in nursing students (R(2)=0.145) was explained by the respondents' level of education (p=0.020) and research and learning (p=0.024). Applying ethical principles and norms into practice (R(2)=0.212) was explained by self-assessed knowledge in ethics (p=0.037) and research and learning (p=0.044). Clinical nurse mentors tended to lack a career development plan, had low work time spent on research and insufficiently participated in education and training activities, which turned out to be significant explanatory factors of their professional development and their capability of developing ethical values in nursing students. The research showed that nursing and higher education managers often failed to assume responsibility for the professional development of clinical nurse mentors. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

Ethical dilemmas in pediatric and adolescent psychogenic nonepileptic seizures.

PubMed

Cole, Cristie M; Falcone, Tatiana; Caplan, Rochelle; Timmons-Mitchell, Jane; Jares, Kristine; Ford, Paul J

2014-08-01

To date, only a very narrow window of ethical dilemmas in psychogenic nonepileptic seizures (PNES) has been explored. Numerous distinct ethical dilemmas arise in diagnosing and treating pediatric and adolescent patients with PNESs. Important ethical values at stake include trust, transparency, confidentiality, professionalism, autonomy of all stakeholders, and justice. In order to further elucidate the ethical challenges in caring for this population, an ethical analysis of the special challenges faced in four specific domains is undertaken: (1) conducting and communicating a diagnosis of PNESs, (2) advising patients about full transparency and disclosure to community including patients' peers, (3) responding to requests to continue antiepileptic drugs, and (4) managing challenges arising from school policy and procedure. An analysis of these ethical issues is essential for the advancement of best care practices that promote the overall well-being of patients and their families. Copyright © 2014 Elsevier Inc. All rights reserved.

Ethical Dilemmas in Pediatric and Adolescent Psychogenic Non-Epileptic Seizures

PubMed Central

Cole, Cristie M.; Falcone, Tatiana; Caplan, Rochelle; Timmons-Mitchell, Jane; Jares, Kristine; Ford, Paul J.

2014-01-01

To date only a very narrow window of ethical dilemmas in psychogenic non-epileptic seizures (PNES) have been explored. Numerous distinct ethical dilemmas arise in diagnosing and treating pediatric and adolescent patients with PNES. Important ethical values at stake include trust, transparency, confidentiality, professionalism, autonomy of all stakeholders and justice. In order to further elucidate the ethical challenges in caring for this population, an ethical analysis of the special challenges faced in four specific domains is undertaken: (1) conducting and communicating a diagnosis of PNES; (2) advising patients about full transparency and disclosure to community including patients’ peers; (3) responding to requests to continue anti-epileptic drugs; and (4) managing challenges arising from school policy and procedure. An analysis of these ethical issues is essential for the advancement of best care practices that promote the overall well-being of patients and their families. PMID:25022823

5 CFR 2610.309 - Agency review.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF THE EQUAL... initial decision on the application shall become a final decision of the Office of Government Ethics 30... (or his or her designee, if any). If review is taken, the Office will issue a final decision on the...

24 CFR 180.315 - Standards of conduct.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND BUSINESS OPPORTUNITY CONSOLIDATED HUD HEARING PROCEDURES FOR CIVIL RIGHTS MATTERS Parties § 180... integrity and in an ethical manner. (b) The ALJ may exclude parties or their representatives for refusal to... orderly and ethical conduct, failure to act in good faith, or violations of the prohibitions against ex...

78 FR 45198 - Federal Acquisition Regulation; Submission for OMB Review; Anti-Kickback Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... INFORMATION CONTACT: Ms. Cecelia L. Davis, Procurement Analyst, Office of Governmentwide Acquisition Policy..., Contractor Business Ethics Compliance Program and Disclosure Requirements. Response: It is important to... business. In the normal course of business, a company that is concerned about ethical behavior will take...

Temporal Withdrawal Behaviors in an Educational Policy Context

ERIC Educational Resources Information Center

Rosenblatt, Zehava; Shapira-Lishchinsky, Orly

2017-01-01

Purpose: The purpose of this paper is to investigate the differential relations between two teacher withdrawal behaviors: work absence and lateness, and two types of school ethics: organizational justice (distributive, procedural) and ethical climate (formal, caring), all in the context of school turbulent environment. Design/methodology/approach:…

Postmortem procedures in the emergency department: using the recently dead to practise and teach.

PubMed Central

Iserson, K V

1993-01-01

In generations past, it was common practice for doctors to learn lifesaving technical skills on patients who had recently died. But this practice has lately been criticised on religious, legal, and ethical grounds, and has fallen into disuse in many hospitals and emergency departments. This paper uses four questions to resolve whether doctors in emergency departments should practise and teach non-invasive and minimally invasive procedures on the newly dead: Is it ethically and legally permissible to practise and teach non-invasive and minimally invasive procedures on the newly dead emergency-department patient? What are the alternatives or possible consequences of not practising non-invasive and minimally invasive procedures on newly dead patients? Is consent from relatives required? Should doctors in emergency departments allow or even encourage this use of newly dead patients? PMID:8331644

Lost in Translation? Ethical Challenges of Implementing a New Diagnostic Procedure.

PubMed

Schmitz, Dagmar

2016-01-01

Since cell-free DNA (cfDNA) fragments of placental origin can be isolated and analyzed from the blood of pregnant women. Applications of this finding have been developed and implemented in clinical care pathways worldwide at an unprecedented pace and manner. Implementation patterns, however, exhibit considerable insufficiencies. Different "motors" of implementation processes, like the market or various regulatory institutions, can be identified at a national level. Each "motor" entails characteristic ethical challenges which are exemplified impressively by a rising number of case reports.Empirical data demonstrate that there are significant "losses" in the respective translational processes, especially when the results from clinical research are to be translated into the clinical reality of NIPT (the so called "second roadblock" (T2)). These "losses" are perceived in the fields of knowledge transfer, professional standardization and ethical debate. Recommendations of professional organizations often fail to reach general practitioners. Blindsided by the new diagnostic procedure in their clinical practice, professionals in prenatal care express their insecurities with regard to its handling. Ethical debate appears to adhere to pre-existing (and partly already proven to be insufficient) normative frameworks for prenatal testing. While all of these deficits are typical for the implementation processes of many new molecular diagnostic procedures, especially in NIPT, they show a high variability between different nations.A critical assessment of the preferred strategy of implementation against the background of already existing national ethical frameworks is indispensable, if potential adverse effects are to be diminished. The described translational losses seem to be significantly reducible by granting the translational process in roadblock T2 more time.

Moral, Ethical and Legal Considerations with the Use of Drugs for Performance Maintenance in the Canadian Forces

DTIC Science & Technology

2009-10-01

Operations (Science, Technology and Ethics) (Amelioration des performances humaines dans les operations militaires de l’OTAN (Science, Technologie et Ethique...Virtually all sovereign nations have at some time in their history administered capital punishment for religious, cultural, and political beliefs

Ethical issues in engineering models: an operations researcher's reflections.

PubMed

Kleijnen, J

2011-09-01

This article starts with an overview of the author's personal involvement--as an Operations Research consultant--in several engineering case-studies that may raise ethical questions; e.g., case-studies on nuclear waste, water management, sustainable ecology, military tactics, and animal welfare. All these case studies employ computer simulation models. In general, models are meant to solve practical problems, which may have ethical implications for the various stakeholders; namely, the modelers, the clients, and the public at large. The article further presents an overview of codes of ethics in a variety of disciples. It discusses the role of mathematical models, focusing on the validation of these models' assumptions. Documentation of these model assumptions needs special attention. Some ethical norms and values may be quantified through the model's multiple performance measures, which might be optimized. The uncertainty about the validity of the model leads to risk or uncertainty analysis and to a search for robust models. Ethical questions may be pressing in military models, including war games. However, computer games and the related experimental economics may also provide a special tool to study ethical issues. Finally, the article briefly discusses whistleblowing. Its many references to publications and websites enable further study of ethical issues in modeling.

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

PubMed

Mertz, Marcel; Kahrass, Hannes; Strech, Daniel

2016-10-03

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

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

PubMed

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

2015-12-01

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

Viewpoint of Science Council of Japan

NASA Astrophysics Data System (ADS)

Ikeda, Syunsuke

The Science Council of Japan (SCJ) is an academic body that represents Japanese 700,000 scientists. The activity of SCJ is changing rapidly, in which the science associated with society is increasingly important. In this context, the engineering education for ethics is treated at SCJ. The importance of engineering ethics was first recognized at the 5th division of 17th term (1999-2001) of SCJ, in which education for engineering ethics based on the analysis of ethical problems occurred in Japan is recommended and it asked the engineering societies to establish the code of ethics. Following this proposal, SCJ founded a committee to treat the problem at 18th and 19th terms. The committee proposed a procedure to prevent misconduct associated with scientific activities and the importance of education of science and engineering ethics especially for young students at tertiary education.

CF Training for Moral and Ethical Decision Making in an Operational Context

DTIC Science & Technology

2006-08-16

operational experience and providing strong mentorship; evaluating and promoting individuals who consistently demonstrate high ethical conduct...they can gain first-hand operational experience. As one SME stated, “program planners need to walk a mile in soldier’s shoes . That will make them a...understanding of how their work can more effectively contribute to actual CF performance , and will provide program development efforts with the gravity of

Development of the Ethical and Legal Issues in Counseling Self-Efficacy Scale

ERIC Educational Resources Information Center

Mullen, Patrick R.; Lambie, Glenn W.; Conley, Abigail H.

2014-01-01

The authors present the development of the Ethical and Legal Issues in Counseling Self-Efficacy Scale (ELICSES). The purpose of this article is threefold: (a) present a rationale for the ELICSES, (b) review statistical analysis procedures used to develop the ELICSES, and (c) offer implications for future research and counselor education.

Reducing theft and embezzlement by encouraging ethical behavior.

PubMed

Weinstock, Donna

2010-01-01

Medical practices are often faced with employee embezzlement and theft. To protect themselves and their practices, physicians should have in place policies and procedures for identifying and handling unethical behaviors by employees. This article will deal with the need to set guidelines for what is considered ethical and professional conduct in the office.

5 CFR 5501.111 - Awards tendered to employees of the National Institutes of Health.

Code of Federal Regulations, 2013 CFR

2013-01-01

... HUMAN SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5501.111 Awards tendered to employees of the National Institutes of Health. (a... approved in writing in advance in accordance with procedures specified by the designated agency ethics...

5 CFR 5501.111 - Awards tendered to employees of the National Institutes of Health.

Code of Federal Regulations, 2011 CFR

2011-01-01

... HUMAN SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5501.111 Awards tendered to employees of the National Institutes of Health. (a... approved in writing in advance in accordance with procedures specified by the designated agency ethics...

5 CFR 5501.111 - Awards tendered to employees of the National Institutes of Health.

Code of Federal Regulations, 2012 CFR

2012-01-01

... HUMAN SERVICES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES § 5501.111 Awards tendered to employees of the National Institutes of Health. (a... approved in writing in advance in accordance with procedures specified by the designated agency ethics...

Ethical Learning and the University: Listening to the Voices of Leaders

ERIC Educational Resources Information Center

Maldonado, Nancy; Lacey, Candace H.; Thompson, Steve D.

2007-01-01

This qualitative study investigated perceptions of contemporary leaders regarding moral and ethical learning and the role of higher education. There were three steps in the data collection procedures: a survey of graduate students, open-ended interviews with the selected leaders, and document content analysis. Participants were asked whether they…

"My Lesson Plan Was Perfect Until I Tried to Teach": Care Ethics into Practice in Classroom Management

ERIC Educational Resources Information Center

Rabin, Colette; Smith, Grinell

2016-01-01

As teacher educators, the authors developed an assignment focused on care ethics to prepare teacher candidates to design classroom-management procedures aimed at cultivating caring community. The teacher candidates revised traditional classroom-management processes, such as class rules, into cocreated norms. They also designed original management…

A Double Standard and Dubious Ethics in Determining Quality Teaching

ERIC Educational Resources Information Center

Reardon, R. Martin

2016-01-01

"Double Standard" was created by the actors who appeared in the accompanying video in spring 2014, as part fulfillment of the requirements for a master's-level class highlighting ethics in education for future educational administrators. A double standard comes into focus as an incoming middle school principal establishes procedures she…

76 FR 76205 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Relating...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

... relating to codes of ethics. This Rule requires investment advisers to adopt a code of ethics that reflects... securities laws. Accordingly, procedures designed to prevent the communication and misuse of non-public... securities of large, medium and small capitalization companies across the globe including developed countries...

Extensive Training Is Insufficient to Produce The Work-Ethic Effect In Pigeons

PubMed Central

Vasconcelos, Marco; Urcuioli, Peter J

2009-01-01

Zentall and Singer (2007a) hypothesized that our failure to replicate the work-ethic effect in pigeons (Vasconcelos, Urcuioli, & Lionello-DeNolf, 2007) was due to insufficient overtraining following acquisition of the high- and low-effort discriminations. We tested this hypothesis using the original work-ethic procedure (Experiment 1) and one similar to that used with starlings (Experiment 2) by providing at least 60 overtraining sessions. Despite this extensive overtraining, neither experiment revealed a significant preference for stimuli obtained after high effort. Together with other findings, these data support our contention that pigeons do not reliably show a work-ethic effect. PMID:19230517

[Responsibilities of ethics committees].

PubMed

von Bergmann, K

1999-01-15

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

[Responsibilities of ethics committees].

PubMed

von Bergmann, K

2000-05-01

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

An overview on ethical issues about sperm donation.

PubMed

Gong, Dan; Liu, Yu-Lin; Zheng, Zhong; Tian, Yi-Fei; Li, Zheng

2009-11-01

Beyond the scientific progress in assisted reproductive technologies (ART), it is necessary to discuss the ethical considerations behind these advances. Ethical issues concerning sperm donation have been considered and discussed by government and non-governmental agencies, the public, media and academic institutions in many countries. Recommendations and guidelines concerning sperm donation issues vary from country to country and between professional groups within countries. This paper attempts to present an overview of findings and reports from various agencies concerning the ethics of sperm donation. The following topics are considered: limiting the number of donor offspring; minimizing risk of infection and genetics from sperm donors; age requirements for sperm donors; and anonymity versus non-anonymity of sperm donors. The diversity of policies shows that each country has its unique set of guidelines tailored toward its own specific needs. Similarly, countries designing their own procedures and guidelines concerning reproductive medicine must tailor them toward their own needs and practical considerations. In Mainland China, the anonymous policy for sperm donation should still be carried out, and the number of donor offspring should be revaluated. ART procedures must be conducted in a way that is respectful of those involved. Ethical principles must respect the interests and welfare of persons who will be born as well as the health and psychosocial welfare of all participants, including sperm donors.

Business Ethics. Digest Number 98-1.

ERIC Educational Resources Information Center

Akhavan, Kambiz

Discussion of business ethics rests on rather ambiguous grounds. What one person considers highly unethical can be legitimate in another person's eye. Many businesses operate under tenets that, although not illegal, most people would consider unethical. Having the ability to distinguish between ethical and unethical practices does not guarantee…

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

PubMed

Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

2016-04-01

Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. Outcome will be published in a scientific journal. NTR5374; Pre-results. 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/

International Ethical Dilemmas Confronting Australian Managers: Implications for the Training and Development of Employees Working Overseas

ERIC Educational Resources Information Center

Pedigo, Kerry; Marshall, Verena

2004-01-01

Globalisation has seen diverse cultures becoming increasingly entwined and interdependent as business organisations operate in a borderless world. When organisations operate internationally they often find that countries differ in what is considered wrong or right. The objectives of the research were to identify cross-cultural ethical dilemmas…

Donor motivations, associated risks and ethical considerations of oocyte donation.

PubMed

Boutelle, Amy L

2014-01-01

Three decades after the first reported successful cases, oocyte donation continues to grow in popularity and regard as an established method to aid women in achieving their reproductive goals. As a result of the increased demand for donated oocytes, many young women in the U.S. volunteer to undergo complex medical procedures to donate their oocytes in return for financial compensation. To best care for these women before, during and after donation, it is important to explore donor characteristics and motivations, discuss the safety of the donation procedure and examine the ethical issues related to this process. © 2014 AWHONN.

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.

Ethical aspects of capsule endoscopy.

PubMed

Niv, Yaron

2008-01-01

Capsule endoscopy is the most recent innovation in gastrointestinal endoscopy. The capsule contains a video camera that photographs the bowel for 8 h after the capsule has been orally ingested and transmits the images for interpretation to a computerized workstation. Ethical considerations of the use of capsule endoscopy should cover the following main issues: justification of the procedure, its potential benefits and harm, and patient autonomy. Capsule endoscopy has several advantages over traditional endoscopy. The procedure is painless, does not require sedation, is easy to perform and for the first time enables exploration of the entire small bowel at high magnification. However, the clinician cannot control its passive advance along the bowel. In addition, the examination may be incomplete, as the capsule reaches the cecum in only 80% of cases. This paper discusses the problems related to the new endoscopic procedure, the diagnostic yield in comparison with other procedures, proper indications for the procedure, outcome and complications. Copyright 2008 S. Karger AG, Basel.

Ethical Problems in the Practice of Organization Development.

ERIC Educational Resources Information Center

Wooten, Kevin C.; White, Louis P.

1983-01-01

This article discusses forces that affect the professional ethics of organizational development (OD). Both driving forces and restraining forces have influenced the current status of OD ethics. These forces have operated since the emergence of OD itself, and their fluctuating intensity results in the dynamic nature of the OD profession. (SSH)

Ethics, standards, and procedures of animal and human chronobiology research.

PubMed

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

2006-01-01

The majority of research papers published in Chronobiology International report the findings of investigations conducted on laboratory animals and human beings. The editors and the readers of the journal expect the authors of submitted manuscripts to have made an important contribution to biological rhythm and related research through the ethical conduct of investigations and unbiased and accurate reporting of findings. Authors of scientific papers are required to disclose any potential conflict of interest. The journal accepts only papers that are original work, no part of which has been submitted for publication elsewhere, except as brief abstracts. The journal and its editors endorse the compliance of investigators to the principles of the Declaration of Helsinki of the World Medical Association, which relate to the conduct of ethical research on human beings, and the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, which relate to the conduct of ethical research on laboratory and other animals. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the investigative methods conform to the standards of good research practice. This article updates the ethical policies, standards, and procedures for manuscripts submitted to Chronobiology International that involve human and animal biological rhythm research, both from the perspective of the criteria of quality chronobiology investigation and from the perspective of humane and ethical research on human beings and animals.

[Indication: scientific and ethical basis of medical practice].

PubMed

Neitzke, G

2014-02-01

The medical indication provides a rational foundation for treatment decisions. An indication can be defined as the reasonable professional judgement that a medical procedure is suitable and useful to reach a specific therapeutic goal with a certain probability. An indication includes empirical, causal and purposive considerations and justifications, and a scrutiny of the individual case. This ensures that medical aspects of the patient, therapeutic goals and evidence-based knowledge are integrated and represented in the indication. An indication justifies a treatment proposal to the patient, which may only be carried out after a procedure of informed consent. Indications can be considered as the ethical basis of treatment decisions and as the heart of professionalism: indications should be used as a professional tool to protect against irrational therapeutic expectations, while ensuring the patient's right for reasonable treatment. In health care that is increasingly shaped by economic constraints, conscientious indications ensure the professional and ethical basis of medical treatment decisions.

Ethical guidelines for the evaluation of living organ donors

PubMed Central

Wright, Linda; Faith, Karen; Richardson, Robert; Grant, David

2004-01-01

Transplantation is an effective, life-prolonging treatment for organ failure. Demand has steadily increased over the past decade, creating a shortage in the supply of organs. In addition, the number of deceased organ donors has reached a plateau. Living-donor transplantation is increasingly an option, influenced by favourable clinical outcomes and increased waiting times at most transplant centres across North America. Living-donor kidney transplants have exceeded deceased-donor transplant rates at some centres. Organ donations from living donors have challenged transplant programs to develop a framework for determining donor acceptability. After a multidisciplinary consensus-building process of discussion and debate, the Multi-Organ Transplant Program of the University Health Network in Toronto has developed ethical guidelines for these procedures. These proposed guidelines address ethical concerns related to selection criteria and procedures, voluntariness, informed consent and disclosure of risks and benefits to both donor and recipient. PMID:15646438

The virtue ethics approach to bioethics.

PubMed

Holland, Stephen

2011-05-01

This paper discusses the viability of a virtue-based approach to bioethics. Virtue ethics is clearly appropriate to addressing issues of professional character and conduct. But another major remit of bioethics is to evaluate the ethics of biomedical procedures in order to recommend regulatory policy. How appropriate is the virtue ethics approach to fulfilling this remit? The first part of this paper characterizes the methodology problem in bioethics in terms of diversity, and shows that virtue ethics does not simply restate this problem in its own terms. However, fatal objections to the way the virtue ethics approach is typically taken in bioethics literature are presented in the second section of the paper. In the third part, a virtue-based approach to bioethics that avoids the shortcomings of the typical one is introduced and shown to be prima facie plausible. The upshot is an inviting new direction for research into bioethics' methodology. © 2009 Blackwell Publishing Ltd.

Implications of the ethical-legal framework for adolescent HIV vaccine trials--report of a consultative forum.

PubMed

Slack, Catherine; Strode, Ann; Grant, Catherine; Milford, Cecilia

2005-09-01

The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants.

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

PubMed

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

2016-07-01

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

The ethical use of paradoxical interventions in psychotherapy.

PubMed Central

Foreman, D M

1990-01-01

The purpose of this paper is to establish ethical guidelines for the use of paradoxical interventions in psychotherapy. These are defined as interventions which are counterintuitive, coercive, and which require non-observance by the client. Arguments are developed to show that such interventions are associated with a psychology that understands individuals solely in terms of their relationship: a 'strong interactionist' position. Ethical principles consistent with such a position are considered, and from these it is derived that: paradox is an ethical technique with resistive patients; it requires consent; its content should be consistent with general ethical principles, especially those of beneficence and non-maleficence; non-paradoxical techniques should be preferred when possible; and it should not be used as an assessment procedure. It is concluded that research is needed to explore the effect of such ethical guidelines of effectiveness, though preliminary impressions are encouraging. PMID:2287016

Analysis of medical confidentiality from the islamic ethics perspective.

PubMed

Tavaokkoli, Saeid Nazari; Nejadsarvari, Nasrin; Ebrahimi, Ali

2015-04-01

Confidentiality is one of the old rules of the medical profession. While emphasizing the necessity of confidentiality in religious teachings, disclosure of other's secrets to commit sin deserves punishment hereafter known. Today, progress in medical science and invention of new diagnostic and therapeutic procedures, as well as the extent of information and disclosure of the secrets of the patients, have provided more than ever. After explaining the concepts and principles of confidentiality in medical ethics, the Islamic-oriented Virtue Ethics, in a comparative review, share the differences in these two sets of ethical review and explain the issue of confidentiality. In professional medical ethics, only the behaviors of health staff are evaluated and moral evaluation of the features cannot be evaluated, but in Islamic ethics, the moral evaluation of the features that are sensual, confidentiality is more stable, without any external supervision will maintain its efficiency.

Ethics and environmental decision making

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

Nelson, R.J.

The subject of environmental ethics trends to be dominated by the idea that the right environmental actions require a change in the value systems of many people. The author argues that the rebirth approach is perverse in that moral attitudes are not easily changed by moral suasion. A properly ethical approach must begin where we are, as moderately moral people desiring the best for all. The real ethical problem is to develop procedures for collectively defining environmental ends that will be fair to the parties participating in the decision process. This idea is essentially utilitarian, and depends on the maximizationmore » of expected social utility. This type of environmental ethics is contrasted with current theories of social choice in welfare economics and with Rawls' theory of justice as fairness. 26 references.« less

5 CFR 2634.404 - Summary of procedures for creation of a qualified trust.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Summary of procedures for creation of a qualified trust. 2634.404 Section 2634.404 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT... Trusts § 2634.404 Summary of procedures for creation of a qualified trust. (a) Consultation with the...

5 CFR 2634.404 - Summary of procedures for creation of a qualified trust.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Summary of procedures for creation of a qualified trust. 2634.404 Section 2634.404 Administrative Personnel OFFICE OF GOVERNMENT ETHICS GOVERNMENT... Trusts § 2634.404 Summary of procedures for creation of a qualified trust. (a) Consultation with the...

5 CFR 2608.210 - Procedure in the event of an adverse ruling.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2608.210 Section 2608.210 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 2608.210 Procedure in the event...

Ethics and surgical innovation: challenges to the professionalism of surgeons.

PubMed

Angelos, Peter

2013-01-01

The future of surgical progress depends on surgeons finding innovative solutions to their patients' problems. Surgical innovation is critical to advances in surgery. However, surgical innovation also raises a series of ethical issues that challenge the professionalism of surgeons. The very criteria for defining surgical progress have changed as patients may value more than simply reductions in morbidity and mortality. The requirement for informed consent prior to surgery is difficult when an innovative surgical procedure is planned since the risks of the novel operation may not be known. In addition, even if the risks are known in the hands of the innovator, the actual risks to patients when surgeons are learning the new technique are unknown. New techniques often depend on new technology which may be significantly more expensive than traditional techniques. There are no clear criteria to decide which new innovative techniques are going to turn out to be truly beneficial to patients. Many surgical innovations depend on new products which may have been developed as collaborative efforts between surgical device companies and surgeons. Although many currently accepted therapies were developed in this fashion, the collaboration of surgeons and device companies raises the potential for significant harmful conflicts of interest. In the decades to come, careful attention to these and other ethical issues will help to define the future professional standing of surgeons. Copyright © 2013 Elsevier Ltd and Surgical Associates Ltd. All rights reserved.

Monitoring of approved studies: A difficult tightrope walk by Ethics Committees.

PubMed

Davis, Sanish

2018-01-01

Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.

Ethical and Legal Issues Associated with Using Response-to-Intervention to Assess Learning Disabilities

ERIC Educational Resources Information Center

Burns, Matthew K.; Jacob, Susan; Wagner, Angela R.

2008-01-01

The Individuals with Disabilities Education Improvement Act of 2004 allows schools to use a child's response to research-based intervention (RTI) as a part of procedures to identify students with learning disabilities. This paper considers whether RTI-based assessment models meet ethical and legal standards for acceptable assessment practices.…

Investigation of a Technique for Measuring Ethical Development of Students in Business: A Heuristic Example.

ERIC Educational Resources Information Center

DuFrene, Debbie D.; And Others

Administering measures of students' ethical orientation at various points in the education of business students would be helpful in determining the affective impact of the curriculum. Procedures for eliminating item bias and maximizing the validity and reliability of such measures are discussed and illustrated through actual data collected in the…

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

Proximity morality in medical school – medical students forming physician morality "on the job": Grounded theory analysis of a student survey

PubMed Central

Thulesius, Hans O; Sallin, Karl; Lynoe, Niels; Löfmark, Rurik

2007-01-01

Background The value of ethics education have been questioned. Therefore we did a student survey on attitudes about the teaching of ethics in Swedish medical schools. Methods Questionnaire survey on attitudes to ethics education with 409 Swedish medical students participating. We analyzed > 8000 words of open-ended responses and multiple-choice questions using classic grounded theory procedures. Results In this paper we suggest that medical students take a proximity morality stance towards their ethics education meaning that they want to form physician morality "on the job". This involves comprehensive ethics courses in which quality lectures provide "ethics grammar" and together with attitude exercises and vignette reflections nurture tutored group discussions. Goals of forming physician morality are to develop a professional identity, handling diversity of religious and existential worldviews, training students described as ethically naive, processing difficult clinical experiences, and desisting negative role modeling from physicians in clinical or teaching situations, some engaging in "ethics suppression" by controlling sensitive topic discussions and serving students politically correct attitudes. Conclusion We found that medical students have a proximity morality attitude towards ethics education. Rather than being taught ethics they want to form their own physician morality through tutored group discussions in comprehensive ethics courses. PMID:17683618

Hymenoplasty and Muslim Patients: Islamic Ethico-Legal Perspectives.

PubMed

Bawany, Mohammad H; Padela, Aasim I

2017-08-01

Hymenoplasty, commonly called "revirginization," is a controversial procedure that pushes the scope of medical practice to satisfy cultural and/or religious "needs." To outline the sociocultural contexts underlying patient requests for hymenoplasty and present Islamic juridical views on the moral status of hymenoplasty for Muslim patients. Narrative review of the extant bioethics literature and leading Islamic ethico-legal verdicts. We identified "Western" and Islamic bioethical debates on hymenoplasty and the critical concepts that underpin ethical justifications for and against the procedure. From a Western-ethics perspective, the life-saving potential of the procedure is weighed against the role of the surgeon in directly assisting in a deception and in indirectly promoting cultural practices of sexual inequality. From an Islamic bioethical vantage point, jurists offer two opinions. The first is that the surgery is always impermissible. The second is that although the surgery is generally impermissible, it can become licit when the risks of not having postcoital bleeding harm are sufficiently great. Patient requests for hymenoplasty should be approached by surgeons with a willingness to understand patients' social contexts and reasons for pursuing the procedure and are ethically justified by leading Islamic jurists in particular circumstances. This article presents emic and etic perspectives on hymenoplasty in Muslim patients, although our review of the Islamic bioethical stances might have missed some juridical opinions and important considerations. Further, Muslims, even devout ones, might not be beholden to Islamic juridical views on medical procedures and thus physicians should not make assumptions about the rationale for, and ethical views of, patients seeking hymenoplasty. This article provides critical insight into how Muslim patients, and Islamic jurists, evaluate the moral contexts of hymenoplasty. Bawany MH, Padela AI. Hymenoplasty and Muslim Patients: Islamic Ethico-Legal Perspectives. J Sex Med 2017;14:1003-1010. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Documenting moral agency: a qualitative analysis of abortion decision making for fetal indications.

PubMed

Gawron, Lori M; Watson, Katie

2017-02-01

We explored whether the decision-making process of women aborting a pregnancy for a fetal indication fit common medical ethical frameworks. We applied three ethical frameworks (principlism, care ethics, and narrative ethics) in a secondary analysis of 30 qualitative interviews from women choosing 2nd trimester abortion for fetal indications. All 30 women offered reasoning consistent with one or more ethical frameworks. Principlism themes included avoidance of personal suffering (autonomy), and sparing a child a poor quality of life and painful medical interventions (beneficence/non-maleficence). Care ethics reasoning included relational considerations of family needs and resources, and narrative ethics reasoning contextualized this experience into the patient's life story. This population's universal application of commonly accepted medical ethical frameworks supports the position that patients choosing fetal indication abortions should be treated as moral decision-makers and given the same respect as patients making decisions about other medical procedures. These findings suggest recent political efforts blocking abortion access should be reframed as attempts to undermine the moral decision-making of women. Published by Elsevier Inc.

Beyond Research Ethics: Novel Approaches of 3 Major Public Health Institutions to Provide Ethics Input on Public Health Practice Activities.

PubMed

Klingler, Corinna; Barrett, Drue H; Ondrusek, Nancy; Johnson, Brooke R; Saxena, Abha; Reis, Andreas A

2018-02-23

Public health institutions increasingly realize the importance of creating a culture in their organizations that values ethics. When developing strategies to strengthen ethics, institutions will have to take into account that while public health research projects typically undergo thorough ethics review, activities considered public health practice may not be subjected to similar oversight. This approach, based on a research-practice dichotomy, is increasingly being criticized as it does not adequately identify and manage ethically relevant risks to those affected by nonresearch activities. As a reaction, 3 major public health institutions (the World Health Organization, US Centers for Disease Control and Prevention, and Public Health Ontario) have implemented mechanisms for ethics review of public health practice activities. In this article, we describe and critically discuss the different modalities of the 3 approaches. We argue that although further evaluation is necessary to determine the effectiveness of the different approaches, public health institutions should strive to implement procedures to ensure that public health practice adheres to the highest ethical standards.

Do Brazilian scientific journals promote the adherence of Chagas disease researchers to international ethical principles?

PubMed

Malafaia, Guilherme; Guilhem, Dirce; Talvani, André

2013-01-01

The ethical aspects of the Brazilian publications about human Chagas disease (CD) developed between 1996 and 2010 and the policy adopted by Brazilian medical journals were analyzed. Articles were selected on the SciELO Brazil data basis, and the evaluation of ethical aspects was based on the normative contents about ethics in research involving human experimentation according to the Brazilian resolution of the National Health Council no. 196/1996. The editorial policies of the section "Instructions to authors" were analyzed. In the period of 1996-2012, 58.9% of articles involving human Chagas disease did not refer to the fulfillment of the ethical aspects concerning research with human beings. In 80% of the journals, the requirements and confirmation of the information about ethical aspects in the studies of human CD were not observed. Although a failure in this type of service is still observed, awareness has been raised in federal agencies, educational institutions/research and publishing groups to standardize the procedures and ethical requirements for the Brazilian journals, reinforcing the fulfillment of the ethical parameters, according to the resolution of NHC no. 196/1996.

The issue of reinfibulation.

PubMed

Serour, Gamal I

2010-05-01

Reinfibulation is resuturing after delivery or gynecological procedures of the incised scar tissue resulting from infibulation. Despite the global fight against female genital mutilation/cutting (FGM/C), reinfibulation of previously mutilated or circumcised women is still performed in various countries around the world. A good estimate of the prevalence of reinfibulation is difficult to obtain, but it can be inferred that 6.5-10.4million women are likely to have been reinfibulated worldwide. Women who undergo reinfibulation have little influence on the decision-making and are usually persuaded by the midwife or birth attendant to undergo the procedure immediately following labor or gynecological operation. Although medicalization of reinfibulation may reduce its immediate risks, it has no effect on the incidence of long-term risks. Reinfibulation is performed mainly for the financial benefit of the operator, and cultural values that have been perpetuated for generations. Reinfibulation has no benefits and is associated with complications for the woman and the unborn child. Its medicalization violates the medical code of ethics and should be abandoned. International and national efforts should be combined to eradicate this practice. Copyright 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

A large multicenter outcome study of female genital plastic surgery.

PubMed

Goodman, Michael P; Placik, Otto J; Benson, Royal H; Miklos, John R; Moore, Robert D; Jason, Robert A; Matlock, David L; Simopoulos, Alex F; Stern, Bernard H; Stanton, Ryan A; Kolb, Susan E; Gonzalez, Federico

2010-04-01

Female Genital Plastic Surgery, a relatively new entry in the field of Cosmetic and Plastic Surgery, has promised sexual enhancement and functional and cosmetic improvement for women. Are the vulvovaginal aesthetic procedures of Labiaplasty, Vaginoplasty/Perineoplasty ("Vaginal Rejuvenation") and Clitoral Hood Reduction effective, and do they deliver on that promise? For what reason do women seek these procedures? What complications are evident, and what effects are noted regarding sexual function for women and their partners? Who should be performing these procedures, what training should they have, and what are the ethical considerations? This study was designed to produce objective, utilizable outcome data regarding FGPS. 1) Reasons for considering surgery from both patient's and physician's perspective; 2) Pre-operative sexual functioning per procedure; 3) Overall patient satisfaction per procedure; 4) Effect of procedure on patient's sexual enjoyment, per procedure; 5) Patient's perception of effect on her partner's sexual enjoyment, per procedure; 6) Complications. This cross-sectional study, including 258 women and encompassing 341 separate procedures, comes from a group of twelve gynecologists, gynecologic urologists and plastic surgeons from ten centers in eight states nationwide. 104 labiaplasties, 24 clitoral hood reductions, 49 combined labiaplasty/clitoral hood reductions, 47 vaginoplasties and/or perineoplasties, and 34 combined labiaplasty and/or reduction of the clitoral hood plus vaginoplasty/perineoplasty procedures were studied retrospectively, analyzing both patient's and physician's perception of surgical rationale, pre-operative sexual function and several outcome criteria. Combining the three groups, 91.6% of patients were satisfied with the results of their surgery after a 6-42 month follow-up. Significant subjective enhancement in sexual functioning for both women and their sexual partners was noted (p = 0.0078), especially in patients undergoing vaginal tightening/perineal support procedures. Complications were acceptable and not of major consequence. While emphasizing that these female genital plastic procedures are not performed to correct "abnormalities," as there is a wide range of normality in the external and internal female genitalia, both parous and nulliparous, many women chose to modify their vulvas and vaginas. From the results of this large study pooling data from a diverse group of experienced genital plastic surgeons, outcome in both general and sexual satisfaction appear excellent.

ESHRE Task Force on Ethics and Law 21: genetic screening of gamete donors: ethical issues.

PubMed

Dondorp, W; De Wert, G; Pennings, G; Shenfield, F; Devroey, P; Tarlatzis, B; Barri, P; Diedrich, K; Eichenlaub-Ritter, U; Tüttelmann, F; Provoost, V

2014-07-01

This Task Force document explores the ethical issues involved in the debate about the scope of genetic screening of gamete donors. Calls for expanded donor screening arise against the background of both occasional findings of serious but rare genetic conditions in donors or donor offspring that were not detected through present screening procedures and the advent of new genomic technologies promising affordable testing of donors for a wide range of conditions. Ethical principles require that all stakeholders' interests are taken into account, including those of candidate donors. The message of the profession should be that avoiding all risks is impossible and that testing should remain proportional.

Enhancing professionalism using ethics education as part of a dental licensure board's disciplinary action. Part 1. An evidence-based process.

PubMed

Bebeau, Muriel J

2009-01-01

This paper describes a process and procedures for interacting with individuals who have violated the rules of professional conduct and includes descriptions of each of the assessment measures used to conduct a baseline assessment of four ethical capacities that are necessary conditions for reflective, ethical practice. The process and assessment methods are theoretically grounded in Rest's Four Component Model of Morality--a model that asserts that moral failing can result in a deficiency in any one of four abilities or capacities that are necessary for ethical behavior. Following descriptions of five well-validated assessment strategies, a synopsis of an educational intervention is presented.

HIV vaccine trials: critical issues in informed consent.

PubMed

Lindegger, G; Richter, L M

2000-06-01

Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.

Current Canadian Forces Education and Training for Moral and Ethical Decision Making in Operations

DTIC Science & Technology

2010-01-01

default.asp. PIAGET, J. 1932. The moral judgment of the child. London: Kegan Paul, Trench, Trubner and Co. POJMAN, L.P. 2006. Ethics: Discovering right...provided by SME. Syllabus. n.d. Leadership and Ethics. Documentation provided by SME. TETLOCK, P., KRISTEL, O., ELSON, B., GREEN , M. LERNER, J. 2000

Utilizing codes of ethics in health professions education.

PubMed

Dahnke, Michael D

2014-10-01

Codes of ethics abound in health care, the aims and purposes of which are multiple and varied, from operating as a decision making tool to acting as a standard of practice that can be operational in a legal context to providing a sense of elevated seriousness and professionalism within a field of practice. There is some doubt and controversy, however, regarding the value and use of these codes both in professional practice and in the education of healthcare professionals. I intend to review and analyze the various aims and purposes of ethics codes particularly within the study and practice of healthcare in light of various criticisms of codes of ethics. After weighing the strength and import of these criticisms, I plan to explore effective means for utilizing such codes as part of the ethics education of healthcare professionals. While noting significant limitations of this tool, both in practice and in education, I plan to demonstrate its potential usefulness as well, in both generating critical thinking within the study of ethics and as a guide for practice for the professional.

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.

[ICT'S AND ETHICS: AN E-LEARNING EXPERIENCE AT THE FACULTY OF MEDICINE].

PubMed

Bolly, Cécile

2016-01-01

A long-distance training course was implemented to the academic program which teaches ethics to future doctors. Its main objective was to develop students' individual patient care skills to carry out an analysis on ethically problematic situations. Such procedures may seem paradoxical in a training course which aims to develop one's sensitivity to others; it does however help to accommodate the geographical constraints linked to students accessing their practical training (in a country's different hospitals or abroad) and provides students with a introductory course on e-learning organised by their university's learning centre. Said course provided a rigorous structure in view of preparing for this procedure, alternating meetings with work hours via a digital platform: precise and measurable objectives, scripted sequences, clear guidelines, diverse activities. Organising work around 4 progress reports provided students with some reassurance but also a degree of autonomy, reflecting what they will be able to offer their future patients. All interactions suggested by the teacher were successfully carried out via the platform (individually on one hand, in the context of a forum on the other hand) but also using collective supervision for certain students. The advantages of such a procedure have been highlighted by evaluating students' levels of satisfaction (via an online questionnaire), but also levels of personal involvement in their work. One dimension in particular deserves further attention: the place occupied by writing in the study of ethics, as well as patient care in general.

Ethical issues in public health surveillance: a systematic qualitative review.

PubMed

Klingler, Corinna; Silva, Diego Steven; Schuermann, Christopher; Reis, Andreas Alois; Saxena, Abha; Strech, Daniel

2017-04-04

Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent. Ethical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis. Our search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures. This is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

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

PubMed

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

2013-05-01

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

The future (r)evolution of preimplantation genetic diagnosis/human leukocyte antigen testing: ethical reflections.

PubMed

de Wert, Guido; Liebaers, Inge; Van de Velde, Hilde

2007-09-01

There has been increasing support for combining preimplantation genetic diagnosis (PGD) for specific diseases with a test for human leukocyte antigens (HLA) because the generation of HLA-matched umbilical cord blood cells may save the life of a diseased sibling. To date, this procedure has taken place in the context of conceiving another child--PGD/HLA testing type 1. However, it may well become possible to perform PGD/HLA testing outside this context, that is, to select matched embryos from which embryonic stem cells could be derived and used in cell therapy--PGD/HLA testing type 2. A proactive ethical analysis is needed and is presented in this article. Although PGD/HLA testing type 1 can be morally justified, the risks, pitfalls, and practical limitations of this procedure make it necessary to develop alternative strategies. PGD/HLA testing type 2 may provide an alternative strategy. From an ethical point of view, the controversial issue is that this procedure creates embryos purely for instrumental use. However, given the dominant view that the preimplantation embryo has only limited moral value, this alternative may be as morally justified as PGD/HLA testing type 1.

Positioning of Engineer Ethics from the Standpoint of a Company. And the Ethics Education Towards Practice

NASA Astrophysics Data System (ADS)

Sato, Masaki

The purpose of a company is contribution to society by operating activities. Therefore, it has a company principle and “Business ethics” conduct codes in each. On the other hand, many engineers with specialties are performing business toward the same purpose at the same company. And it will produce new inconsistency by introducing “Engineer ethics” and “the ethics of each professional” all at once in the situation of that company. Then, the engineer ethics education in company needs to carry out by arranging company conduct codes and Engineer ethics. This paper proposes what the company ethics education should be from exemplifying results by make activities and engineer ethics education of the corporate ethics observance in the Tokyo Electric Power Co., Inc.

Utilizing Codes of Ethics in Health Professions Education

ERIC Educational Resources Information Center

Dahnke, Michael D.

2014-01-01

Codes of ethics abound in health care, the aims and purposes of which are multiple and varied, from operating as a decision making tool to acting as a standard of practice that can be operational in a legal context to providing a sense of elevated seriousness and professionalism within a field of practice. There is some doubt and controversy,…

A concept analysis of professional commitment in nursing.

PubMed

García-Moyano, Loreto; Altisent, Rogelio; Pellicer-García, Begoña; Guerrero-Portillo, Sandra; Arrazola-Alberdi, Oihana; Delgado-Marroquín, María Teresa

2017-01-01

The concept of professional commitment is being widely studied at present. However, although it is considered an indicator for the most human part of nursing care, there is no clear definition for it, and different descriptors are being used indiscriminately to reference it. The aim of this study is to clarify the concept of professional commitment in nursing through the Rodgers' evolutionary concept analysis process. Systematic search using English and Spanish descriptors and concept analysis. Studies published between 2009 and June 2015, front-to-back analysis of the Nursing Ethics journal and manual check of articles cited in studies related to the Nijmegen Professionalism Scale. The procedure of concept analysis developed by Rodgers was used. Ethical considerations: Although the topic was not labeled as sensitive and subject to ethical approval, its realization was approved by the Ethical Committee of Clinical Research of Aragon (CEICA) approved the study on 18 March 2015 and also careful procedures have been followed according to ethics expressed in the Declaration of Helsinki. A total of 17 published studies. A clear definition of the concept was made, and surrogate terms, concept dimension, differential factors related to the concept, sociocultural variations and consequences for nursing practice were identified. There is a need for continuous advancement in the development of the concept, specific actions to encourage this and the improvement of evaluation methods for its study.

[Coercive procedures in forensic psychiatry : Current treatment practice in forensic psychiatric hospitals from a medical ethics perspective].

PubMed

Jakovljević, A-K; Wiesemann, C

2016-07-01

In 2011 the legal foundations of coercive treatment in German forensic psychiatric clinics were declared to be unconstitutional. In the present study we analyzed the frequency of coercive procedures in forensic psychiatric hospitals before and after 2011, the consequences for medical care as well as the ethical assessments by attending chief physicians. By a questionnaire-based survey of views of attending chief physicians in forensic psychiatric clinics in 2013, data on the current state of patient care were collected and analyzed from an ethical perspective. These were compared with treatment data from a large forensic psychiatric clinic collected over the period 2007-2013. Even after 2011 coercive forms of treatment were applied in forensic psychiatric hospitals. In practice, there is a high degree of legal uncertainty regarding the limits of coercive treatment. Of all patients treated in forensic psychiatric clinics in 2012, on average 13 % had been in isolation at least once, approximately 3 % had been treated under fixation at least once and 2.2 % had been subjected to coercive medical treatment at least once. From an ethical perspective an open debate about the practice of coercive treatment is urgently required. Legal regulations, ethical guidelines and treatment standards have to be developed for the special situation of patient care in forensic psychiatric hospitals.

5 CFR 2610.304 - Reply.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Reply. 2610.304 Section 2610.304 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT Procedures for Considering Applications § 2610.304 Reply. Within 15 days after...

The NHS and market forces in healthcare: the need for organisational ethics.

PubMed

Frith, Lucy

2013-01-01

The NHS in England is an organisation undergoing substantial change. The passage of the Health and Social Care Act 2012, consolidates and builds on previous health policies and introduces further 'market-style' reforms of the NHS. One of the main aspects of these reforms is to encourage private and third sector providers to deliver NHS services. The rationale for this is to foster a more competitive market in healthcare to encourage greater efficiency and innovation. This changing healthcare environment in the English NHS sharpens the need for attention to be paid to the ethical operation of healthcare organisations. All healthcare organisations need to consider the ethical aspects of their operation, whether state or privately run. However, the changes in the type of organisations used to provide healthcare (such as commercial companies) can create new relationships and ethical tensions. This paper will chart the development of organisational ethics as a concern in applied ethics and how it arose in the USA largely owing to changes in the organisation of healthcare financing and provision. It will be argued that an analogous transition is happening in the NHS in England. The paper will conclude with suggestions for the development of organisational ethics programmes to address some of the possible ethical issues raised by this new healthcare environment that incorporates both private and public sector providers.

Ethical considerations in umbilical cord blood banking.

PubMed

Fox, Nathan S; Chervenak, Frank A; McCullough, Laurence B

2008-01-01

Pregnant patients have the option at delivery of having their cord blood collected and stored for future use. At many hospitals, they have the option of donating their cord blood to the public banking system for future use by anyone who is an appropriate match (public banking). Patients also have the option of having their cord blood stored for a fee with a commercial/private company for future use within their family (private banking). Currently, private banking is not recommended by major obstetric and pediatric professional organizations. We applied current evidence of the risks and benefits of private and public cord blood banking and accepted ethical principles to answer the following two related questions: 1) Do obstetricians have an ethical obligation to comply with a request for private banking? and 2) Do obstetricians have an ethical obligation to routinely offer private banking to women who do not request it? The only situation where there is a known benefit to private banking is when public banking is not available and the patient currently has an affected family member who may benefit from cord blood therapy. We conclude that when presented with a request for private banking, obstetricians have an ethical obligation to explain the lack of proven benefit of this procedure. If the patient still requests private banking, it would be appropriate to comply, because there is minimal or no risk to the procedure. However, obstetricians are not ethically obligated to offer private banking, even when public banking is not available, except in the limited circumstance when the patient currently has an affected family member who may benefit from cord blood therapy.

Ethical Credibility of Scientists in Social Research

ERIC Educational Resources Information Center

Petrovic, Ruzica

2017-01-01

In the paper we open the question of the correlation of scientific researchers and the ethical credibility of this engagement. The purpose of this paper is to point out to the significance of the connection between the scientific, especially social researches and the ethical postulates which we use to regulate the way in which they operate. The…

Establishment of medical education upon internalization of virtue ethics: bridging the gap between theory and practice.

PubMed

Madani, Mansoureh; Larijani, Bagher; Madani, Ensieh; Ghasemzadeh, Nazafarin

2017-01-01

During medical training, students obtain enough skills and knowledge. However, medical ethics accomplishes its goals when, together with training medical courses, it guides students behavior towards morality so that ethics-oriented medical practice is internalized. Medical ethics is a branch of applied ethics which tries to introduce ethics into physicians' practice and ethical decisions; thus, it necessitates the behavior to be ethical. Therefore, when students are being trained, they need to be supplied with those guidelines which turn ethical instructions into practice to the extent possible. The current text discusses the narrowing of the gap between ethical theory and practice, especially in the field of medical education. The current study was composed using analytical review procedures. Thus, classical ethics philosophy, psychology books, and related articles were used to select the relevant pieces of information about internalizing behavior and medical education. The aim of the present study was to propose a theory by analyzing the related articles and books. The attempt to fill the gap between medical theory and practice using external factors such as law has been faced with a great deal of limitations. Accordingly, the present article tries to investigate how and why medical training must take internalizing ethical instructions into consideration, and indicate the importance of influential internal factors. Virtue-centered education, education of moral emotions, changing and strengthening of attitudes through education, and the wise use of administrative regulations can be an effective way of teaching ethical practice in medicine.

Establishment of medical education upon internalization of virtue ethics: bridging the gap between theory and practice

PubMed Central

Madani, Mansoureh; Larijani, Bagher; Madani, Ensieh; Ghasemzadeh, Nazafarin

2017-01-01

During medical training, students obtain enough skills and knowledge. However, medical ethics accomplishes its goals when, together with training medical courses, it guides students behavior towards morality so that ethics-oriented medical practice is internalized. Medical ethics is a branch of applied ethics which tries to introduce ethics into physicians’ practice and ethical decisions; thus, it necessitates the behavior to be ethical. Therefore, when students are being trained, they need to be supplied with those guidelines which turn ethical instructions into practice to the extent possible. The current text discusses the narrowing of the gap between ethical theory and practice, especially in the field of medical education. The current study was composed using analytical review procedures. Thus, classical ethics philosophy, psychology books, and related articles were used to select the relevant pieces of information about internalizing behavior and medical education. The aim of the present study was to propose a theory by analyzing the related articles and books. The attempt to fill the gap between medical theory and practice using external factors such as law has been faced with a great deal of limitations. Accordingly, the present article tries to investigate how and why medical training must take internalizing ethical instructions into consideration, and indicate the importance of influential internal factors. Virtue-centered education, education of moral emotions, changing and strengthening of attitudes through education, and the wise use of administrative regulations can be an effective way of teaching ethical practice in medicine. PMID:29282423

Maternal request for caesarean section: an ethical consideration.

PubMed

Selinger, Hannah

2014-12-01

Caesarean section (CS) is a method of delivering a baby through a surgical incision into the abdominal wall. Until recently in the UK, it was preserved as a procedure which was only carried out in certain circumstances. These included if the fetus lay in a breech position or was showing signs of distress leading to a requirement for rapid delivery. CS is perceived as a safe method of delivery due to the recommendation by the National Institute for Health and Care Excellence (NICE) in these situations. As a result, the opportunity for maternal request for CS arose, whereby the mother requests the operation despite no medical indication. There are risks associated with CS, as with all surgery, however, these risks in current and future pregnancies may not be fully understood by the mother. The ethics of exposing mothers to these risks, as well as performing surgery on what is otherwise a healthy patient, become entangled with the demand for patient choice, as well as the increasing financial strain on our healthcare system. The main question to be examined in this essay is whether it is ethical to allow women to choose a CS in the absence of obstetric indication, taking into account the increased risk to the mother and her future offspring in order to potentially decrease the risk to the current baby. Alongside a case report, this analysis will apply Beauchamp and Childress' four principles of biomedical ethics and an exploration of the scientific literature. 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.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

What Is the Relevance of Procedural Fairness to Making Determinations about Medical Evidence?

PubMed

Persad, Govind

2017-02-01

Approaches relying on fair procedures rather than substantive principles have been proposed for answering dilemmas in medical ethics and health policy. These dilemmas generally involve two questions: the epistemological (factual) question of which benefits an intervention will have, and the ethical (value) question of how to distribute those benefits. This article focuses on the potential of fair procedures to help address epistemological and factual questions in medicine, using the debate over antidepressant efficacy as a test case. In doing so, it employs concepts from social epistemology such as testimonial injustice (bias resulting from the exclusion of evidence) and hermeneutical injustice (bias resulting from a prevailing discussion framework's conceptual limitations). This article also explores the relevance of scientific consensus to determinations regarding medical evidence. © 2017 American Medical Association. All Rights Reserved.

Case Management and Rehabilitation Counseling: Procedures and Techniques. Fourth Edition

ERIC Educational Resources Information Center

Roessler, Richard T.; Rubin, Stanford E.

2006-01-01

"Case Management and Rehabilitation Counseling" discusses procedures that are useful to rehabilitation professionals working in many settings. Specifically, this book reviews the finer points relating to diagnosing, arranging services, monitoring program outcomes, arranging for placement, planning for accommodations, ethical decision making,…

Professional Counselors Licensure Preparation Study Session Booklet.

ERIC Educational Resources Information Center

Richardson, Julia K.

This study guide, designed to help counselors prepare for the Virginia Professional Counselor License Application, provides a review of counseling techniques and procedures, evaluation and appraisal procedures, and group theories and techniques. Other topics reviewed in the materials include professional identity, function and ethics, and abnormal…

Research Ethics in the Era of Personalized Medicine: Updating Science's Contract with Society

PubMed Central

Meslin, Eric M.; Cho, Mildred K.

2010-01-01

With the completed sequence of the human genome has come the prospect of substantially improving the quality of life for millions through personalized medicine approaches. Still, any advances in this direction require research involving human subjects. For decades science and ethics have enjoyed an allegiance reflected in a common set of ethical principles and procedures guiding the conduct of research with human subjects. Some of these principles emphasize avoiding harm over maximizing benefit. In this paper we revisit the priority given to these ethical principles – particularly the principles that support a cautious approach to science – and propose a reframing of the ‘social contract’ between science and society that emphasizes reciprocity and meeting public needs. PMID:20805701

Animal experimentation.

PubMed

Kolar, Roman

2006-01-01

Millions of animals are used every year in often times extremely painful and distressing scientific procedures. Legislation of animal experimentation in modern societies is based on the supposition that this is ethically acceptable when certain more or less defined formal (e.g. logistical, technical) demands and ethical principles are met. The main parameters in this context correspond to the "3Rs" concept as defined by Russel and Burch in 1959, i.e. that all efforts to replace, reduce and refine experiments must be undertaken. The licensing of animal experiments normally requires an ethical evaluation process, often times undertaken by ethics committees. The serious problems in putting this idea into practice include inter alia unclear conditions and standards for ethical decisions, insufficient management of experiments undertaken for specific (e.g. regulatory) purposes, and conflicts of interest of ethics committees' members. There is an ongoing societal debate about ethical issues of animal use in science. Existing EU legislation on animal experimentation for cosmetics testing is an example of both the public will for setting clear limits to animal experiments and the need to further critically examine other fields and aspects of animal experimentation.

Ethical issues in newer assisted reproductive technologies: A view from Nigeria.

PubMed

Fadare, J O; Adeniyi, A A

2015-12-01

Infertility is a prevalent condition in many developing countries with significant physical and psychosocial implications. The aim of this study is to discuss briefly the ethics of newer assisted reproductive technology (ART) with special emphasis on the peculiarities in Nigeria. MEDLINE and Google Scholar were searched for English-language articles from January 1990 to July 2014 using the search terms "ethics of ART AND Nigeria," "ethical issues in in vitro fertilization AND Nigeria." Using the above search phrases, a total of 43 articles were retrieved out of which only 5 dealt specifically with the subject matter. The core ethical issues found in the reviewed literature are listed in [Table 1]. Inequitable access to ART due to its high cost, lack of regulatory body, safety of the procedure, and fate of the embryos were the main themes identified from the papers. Surrogacy, sex selection, and gamete donation were additional relevant ethical issues. There is an urgent need for stakeholders in developing countries to formulate cultural and context-specific guidelines to help address some of these ethical dilemmas.

Ethnographic research with adolescent students: situated fieldwork ethics and ethical principles governing human research.

PubMed

Hemmings, Annette

2009-12-01

This paper explores ethical dilemmas in situated fieldwork ethics concerning ethnographic studies of adolescent students. While consequentialist and deontological ethics form the basis of the ethical stances shared by ethnographers and research ethics committees, the interpretation of those principles may diverge in school-based ethnography with adolescent students because of the particular role of the adult ethnographer vis-à-vis developmentally immature adolescents not held legally responsible for many of their actions. School ethnographers attempt to build trust with adolescent participants in order to learn about their hidden cultural worlds, which may involve activities that are very harmful to the youths involved. They face many difficult and sometimes unexpected choices, including whether to intervene and how to represent events and adolescents in published findings. Scenarios with examples drawn from research conducted in public high schools are used to illustrate and explicate dilemmas in formal research and latent insider/outsider roles and relations involving harmful adolescent behaviors, advocacy, and psychological trauma. Also examined are analytical procedures used to construct interpretations leading to representations of research participants in the resulting publication.

'To be or not to be'--an ethical debate on the not-for-resuscitation (NFR) status of a stroke patient.

PubMed

Herbert, C L

1997-03-01

Nursing has been described as a moral endeavour (Seedhouse, 1988; Berger et al., 1991), the art of dealing with ethical issues of right and wrong. Within the nursing literature, ethical issues are a major topic for discussion. Berger et al. (1991) explain that this reflects larger societal concerns about ethics in business, industry and government. The development of advanced technology and life-sustaining treatments such as cardiopulmonary resuscitation (CPR) has heightened the dilemmas of moral decision making. CPR was developed in the 1960s as an emergency life-saving procedure, although it is currently used on anyone who does not have a not-for-resuscitation status (Anon., 1980). In this paper, an ethical issue involving the decision of whether or not to resuscitate a stroke patient is discussed. An overview of the main ethical theories is presented because they provide a framework for an explication of ethical decision-making. The options available to those involved are then discussed in relation to relevant research. Finally, a conclusion is drawn from the ensuing situation.

Evaluating non-disclosure of errors and healthcare organization: a case of bioethics consultation.

PubMed

Colucci, Massimiliano; Aprile, Anna; Pegoraro, Renzo

2015-11-01

Sometimes medical errors should not be disclosed. We report a case of semen samples exchange, during a homologous artificial insemination procedure, where a bioethics consultation was required. The bioethics consultation addressed ethical and legal elements in play, supporting non-disclosure to some of the subjects involved. Through a proper methodology, gathering factual and juridical elements, a consultant can show when a moral dilemma between values and rights-privacy versus fatherhood, in our case-is unsubstantial, in a given context, because of the groundlessness of the value or the right itself. However, being the error elicited by organizational factors, a broader ethical pronouncement was needed. Under such circumstances, ethical evaluation should engage in a sort of 'ethical-based root-cause analysis', linking ethical principles to quality aims and showing the opportunity to integrate ethical methodology in healthcare management. From this perspective, errors may become an incentive to promote high-quality organizations, attending to the central value of person even through the organizational process.

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.

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

PubMed

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

2018-03-01

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

the Army Ethic-Educating and Equipping the Army Mid-Level Leaders in the CGSOC

DTIC Science & Technology

2016-06-10

fundamental motive for teaching ethics in the military is neither to clean up the act of military operations under the gaze of media , nor to make...THE ARMY ETHIC –EDUCATING AND EQUIPPING THE ARMY MID-LEVEL LEADERS IN THE CGSOC A thesis presented to the Faculty of the U.S...10-06-2016 2. REPORT TYPE Master’s Thesis 3. DATES COVERED (From - To) AUG 2015 – JUN 2016 4. TITLE AND SUBTITLE The Army Ethic –Educating and

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

PubMed

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

2018-02-27

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

European public deliberation on brain machine interface technology: five convergence seminars.

PubMed

Jebari, Karim; Hansson, Sven-Ove

2013-09-01

We present a novel procedure to engage the public in ethical deliberations on the potential impacts of brain machine interface technology. We call this procedure a convergence seminar, a form of scenario-based group discussion that is founded on the idea of hypothetical retrospection. The theoretical background of this procedure and the results of five seminars are presented.

A Longitudinal Study of the Predictors of Perceived Procedural Justice in Australian University Staff.

PubMed

Pignata, Silvia; Winefield, Anthony H; Provis, Chris; Boyd, Carolyn M

2016-01-01

This study examined the factors that predict employees' perceptions of procedural justice in university settings. The paper also reviews the ethical aspects of justice and psychological contracts within employment relationships. The study examined the predictors of perceived procedural justice in a two-wave longitudinal sample of 945 employees from 13 universities by applying the Job Demands-Resources theoretical model of stress. The proposed predictors were classified into two categories: Job demands of work pressure and work-home conflict; and job resources of job security, autonomy, trust in senior management, and trust in supervisor. The predictor model also examined job satisfaction and affective organizational commitment, demographic (age, gender, tenure, role) and individual characteristics (negative affectivity, job involvement) as well as Time 1 (T1) perceptions of procedural justice to ensure that tests were rigorous. A series of hierarchical multiple regression analyses found that job satisfaction at T1 was the strongest predictor of perceived procedural justice at Time 2. Employees' trust in senior management, and their length of tenure also positively predicted justice perceptions. There were also differences between academic and non-academic staff groups, as non-academic employees' level of job satisfaction, trust in senior management, and their length of organizational tenure predicted procedural justice perceptions, whereas for academics, only job satisfaction predicted perceived justice. For the "all staff" category, job satisfaction was a dominant and enduring predictor of justice, and employees' trust in senior management also predicted justice. Results highlight the importance of workplace factors in enhancing fair procedures to encourage reciprocity from employees. As perceived procedural justice is also conceptually linked to the psychological contract between employees-employers, it is possible that employees' levels of job satisfaction and perceptions of trust in senior management, relative to other work attitudinal outcomes, may be more effective for improving the broader working environment, and promoting staff morale. This study adds to research on applied business ethics as it focuses on the ethical aspects of perceived procedural justice and highlights the importance of workplace factors in enhancing fair procedures in organizational policy to encourage reciprocity and promote healthy organizational environments.

A Longitudinal Study of the Predictors of Perceived Procedural Justice in Australian University Staff

PubMed Central

Pignata, Silvia; Winefield, Anthony H.; Provis, Chris; Boyd, Carolyn M.

2016-01-01

Purpose: This study examined the factors that predict employees' perceptions of procedural justice in university settings. The paper also reviews the ethical aspects of justice and psychological contracts within employment relationships. Design/Methodology/Approach: The study examined the predictors of perceived procedural justice in a two-wave longitudinal sample of 945 employees from 13 universities by applying the Job Demands-Resources theoretical model of stress. The proposed predictors were classified into two categories: Job demands of work pressure and work-home conflict; and job resources of job security, autonomy, trust in senior management, and trust in supervisor. The predictor model also examined job satisfaction and affective organizational commitment, demographic (age, gender, tenure, role) and individual characteristics (negative affectivity, job involvement) as well as Time 1 (T1) perceptions of procedural justice to ensure that tests were rigorous. Findings: A series of hierarchical multiple regression analyses found that job satisfaction at T1 was the strongest predictor of perceived procedural justice at Time 2. Employees' trust in senior management, and their length of tenure also positively predicted justice perceptions. There were also differences between academic and non-academic staff groups, as non-academic employees' level of job satisfaction, trust in senior management, and their length of organizational tenure predicted procedural justice perceptions, whereas for academics, only job satisfaction predicted perceived justice. For the “all staff” category, job satisfaction was a dominant and enduring predictor of justice, and employees' trust in senior management also predicted justice. Research limitations/implications: Results highlight the importance of workplace factors in enhancing fair procedures to encourage reciprocity from employees. As perceived procedural justice is also conceptually linked to the psychological contract between employees-employers, it is possible that employees' levels of job satisfaction and perceptions of trust in senior management, relative to other work attitudinal outcomes, may be more effective for improving the broader working environment, and promoting staff morale. Originality/value: This study adds to research on applied business ethics as it focuses on the ethical aspects of perceived procedural justice and highlights the importance of workplace factors in enhancing fair procedures in organizational policy to encourage reciprocity and promote healthy organizational environments. PMID:27610093

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.

Do we need a special ethics for research?

PubMed

Hansson, Sven Ove

2011-03-01

Research is subject to more stringent ethical requirements than most other human activities, and a procedure that is otherwise allowed may be forbidden in research. Hence, risk-taking is more restricted in scientific research than in most non-research contexts, and privacy is better protected in scientific questionnaires than in marketing surveys. Potential arguments for this difference are scrutinized. The case in its favour appears to be weak. A stronger case can be made in favour of a difference in the opposite direction: If perilous or otherwise problematic activities have to be performed it is usually better to perform them in a research context where they are properly evaluated so that guidance is obtained for the future. However, retreating from current ethical demands on research is not a desirable direction to go. Instead, research ethics can serve to inspire the introduction of more stringent ethical principles in other social sectors.

Organisational and individual support for nurses' ethical competence: A cross-sectional survey.

PubMed

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

2018-05-01

Nurses' ethical competence has been identified as a significant factor governing high quality of care. However, nurses lack support in dealing with ethical problems, and therefore managerial support for nurses' ethical competence is needed. This study aimed to analyse, from the perspective of nurse and nurse leaders, the level of nurses' and nurse leaders' ethical competence, perceptions of support for nurses' ethical competence at the organisational and individual levels and background factors associated with this support. A descriptive, cross-sectional study design was employed. The Ethical Competence and Ethical Competence Support questionnaires were used to measure the main components. Descriptive statistics and multifactor analysis of variance were used for data analysis. The participants were 298 nurses and 193 nurse leaders working in specialised (48%/52%), primary (43%/36%) or private healthcare (5%/7%) in Finland. Ethical considerations: Ethical approval was obtained from the university ethics committee. Nurses estimated their own ethical competence to be at an average level, whereas nurse leaders estimated their own competence at a high level. Nurses' and nurse leaders' perceptions of provided support for nurses' ethical competence was not at a high level. The positive agreement percentage related to organisational support was 44% among nurses and 51% among nurse leaders. The positive agreement percentage related to individual support was lower, that is, 38% among nurses and 61% among nurse leaders. University education had a positive association with some items of individual support. Despite the findings that ethical competence was estimated at a high level among nurse leaders, perceptions of support for nurses' ethical competence were not at a satisfactory level. At the organisational level, nurse leaders need to inform of ethical procedures and practices in orientation; encourage multidisciplinary ethics discussions and collaboration; and support nurses at an individual level to participate in ethics education, multidisciplinary ethics discussions and in solving ethical problems.

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

21 CFR 314.620 - Withdrawal procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.620 Withdrawal procedures. (a) Reasons to withdraw...

National survey on the indicators of quality in Bioethics of the SEMICYUC in the departments of Intensive Care Medicine in Spain.

PubMed

López Camps, V; García García, M A; Martín Delgado, M C; Añón Elizalde, J M; Masnou Burrallo, N; Rubio Sanchiz, O; Estella García, A; Monzón Marín, J L

2017-12-01

Multiple interventions are performed in critical patients admitted to Intensive Care Units (ICUs). This study explores the presence in the daily practice of ICUs of elements related to the 6 bioethics quality indicators of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units, and the participation of their members in the hospital ethics committees. A multicenter observational study was carried out, using a survey exploring descriptive aspects of the ICUs, with 25 questions related to bioethics quality indicators, and assessing the participation of ICU members in the hospital ethics committees. The ICUs were classified by size (larger or smaller than 10 beds) and type of hospital (public/private-public concerted center, with/without teaching). The 68 analyzed surveys revealed: daily informing of the family (97%), carried out in the information room (82%); end-of-life care protocols (44%); life support limitation form (48.43%); and physical containment protocol (40%). Compliance with the informed consent process referred to different procedures is: tracheostomy (92%), vascular procedures (76%), and extrarenal clearance (25%). The presence of ICU members in the hospital ethics committee is currently frequent (69%). Information supplied to relatives is adequate, although there are ICUs without an information room. Compliance with the informed consent requirements of various procedures is insufficient. The participation of ICU members in the hospital ethics committees is frequent. The results obtained suggest a chance for improvement in the bioethical quality of the ICU. Copyright © 2017 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

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

PubMed

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

2015-08-01

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

Drawing the line in clinical treatment of companion animals: recommendations from an ethics working party.

PubMed

Grimm, Herwig; Bergadano, Alessandra; Musk, Gabrielle C; Otto, Klaus; Taylor, Polly M; Duncan, Juliet Clare

2018-06-09

Modern veterinary medicine offers numerous options for treatment and clinicians must decide on the best one to use. Interventions causing short-term harm but ultimately benefitting the animal are often justified as being in the animal's best interest. Highly invasive clinical veterinary procedures with high morbidity and low success rates may not be in the animal's best interest. A working party was set up by the European College of Veterinary Anaesthesia and Analgesia to discuss the ethics of clinical veterinary practice and improve the approach to ethically challenging clinical cases. Relevant literature was reviewed. The 'best interest principle' was translated into norms immanent to the clinic by means of the 'open question argument'. Clinical interventions with potential to cause harm need ethical justification, and suggest a comparable structure of ethical reflection to that used in the context of in vivo research should be applied to the clinical setting. To structure the ethical debate, pertinent questions for ethical decision-making were identified. These were incorporated into a prototype ethical tool developed to facilitate clinical ethical decision-making. The ethical question 'Where should the line on treatment be drawn' should be replaced by 'How should the line be drawn?' © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed

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

2006-12-04

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

Challenging Operations: An Ethical Framework to Assist Humanitarian Aid Workers in their Decision-making Processes.

PubMed

Clarinval, Caroline; Biller-Andorno, Nikola

2014-06-23

This paper aims to raise awareness regarding ethical issues in the context of humanitarian action, and to offer a framework for systematically and effectively addressing such issues. Several cases highlight ethical issues that humanitarian aid workers are confronted with at different levels over the course of their deployments. The first case discusses a situation at a macro-level concerning decisions being made at the headquarters of a humanitarian organization. The second case looks at meso-level issues that need to be solved at a country or regional level. The third case proposes an ethical dilemma at the micro-level of the individual patient-provider relationship. These real-life cases have been selected to illustrate the ethical dimension of conflicts within the context of humanitarian action that might remain unrecognized in everyday practice. In addition, we propose an ethical framework to assist humanitarian aid workers in their decision-making process. The framework draws on the principles and values that guide humanitarian action and public health ethics more generally. Beyond identifying substantive core values, the framework also includes a ten-step process modelled on tools used in the clinical setting that promotes a transparent and clear decision-making process and improves the monitoring and evaluation of aid interventions. Finally, we recommend organizational measures to implement the framework effectively. This paper uses a combination of public health/clinical ethics concepts and practices and applies them to the decision-making challenges encountered in relief operations in the humanitarian aid context.

Scientific Integrity and Professional Ethics at AGU - The Establishment and Evolution of an Ethics Program at a Large Scientific Society

NASA Astrophysics Data System (ADS)

McPhaden, Michael; Leinen, Margaret; McEntee, Christine; Townsend, Randy; Williams, Billy

2016-04-01

The American Geophysical Union, a scientific society of 62,000 members worldwide, has established a set of scientific integrity and professional ethics guidelines for the actions of its members, for the governance of the union in its internal activities, and for the operations and participation in its publications and scientific meetings. This presentation will provide an overview of the Ethics program at AGU, highlighting the reasons for its establishment, the process of dealing ethical breaches, the number and types of cases considered, how AGU helps educate its members on Ethics issues, and the rapidly evolving efforts at AGU to address issues related to the emerging field of GeoEthics. The presentation will also cover the most recent AGU Ethics program focus on the role for AGU and other scientific societies in addressing sexual harassment, and AGU's work to provide additional program strength in this area.

Ethical Concerns and Procedural Pathways for Patients Who are Incapacitated and Alone: Implications from a Qualitative Study for Advancing Ethical Practice

PubMed Central

Catlin, Casey; Kwak, Jennifer; Wood, Erica; Teaster, Pamela B.

2017-01-01

Adults who are incapacitated and alone, having no surrogates, may be known as “unbefriended.” Decision-making for these particularly vulnerable patients is a common and vexing concern for healthcare providers and hospital ethics committees. When all other avenues for resolving the need for surrogate decision-making fail, patients who are incapacitated and alone may be referred for “public guardianship” or guardianship of last resort. While an appropriate mechanism in theory, these programs are often under-staffed and under-funded, laying the consequences of inadequacies on the healthcare system and the patient him or herself. We describe a qualitative study of professionals spanning clinical, court, and agency settings about the mechanisms for resolving surrogate consent for these patients and problems therein within the state of Massachusetts. Interviews found that all participants encountered adults who are incapacitated and without surrogates. Four approaches for addressing surrogate needs were: (1) work to restore capacity; (2) find previously unknown surrogates; (3) work with agencies to obtain surrogates; and (4) access the guardianship system. The use of guardianship was associated with procedural challenges and ethical concerns including delays in care, short term gains for long term costs, inabilities to meet a patient’s values and preferences, conflicts of interest, and ethical discomfort among interviewees. Findings are discussed in the context of resources to restore capacity, identify previously unknown surrogates, and establish improved surrogate mechanisms for this vulnerable population. PMID:28084575

Human-animal chimeras: ethical issues about farming chimeric animals bearing human organs.

PubMed

Bourret, Rodolphe; Martinez, Eric; Vialla, François; Giquel, Chloé; Thonnat-Marin, Aurélie; De Vos, John

2016-06-29

Recent advances in stem cells and gene engineering have paved the way for the generation of interspecies chimeras, such as animals bearing an organ from another species. The production of a rat pancreas by a mouse has demonstrated the feasibility of this approach. The next step will be the generation of larger chimeric animals, such as pigs bearing human organs. Because of the dramatic organ shortage for transplantation, the medical needs for such a transgressive practice are indisputable. However, there are serious technical barriers and complex ethical issues that must be discussed and solved before producing human organs in animals. The main ethical issues are the risks of consciousness and of human features in the chimeric animal due to a too high contribution of human cells to the brain, in the first case, or for instance to limbs, in the second. Another critical point concerns the production of human gametes by such chimeric animals. These worst-case scenarios are obviously unacceptable and must be strictly monitored by careful risk assessment, and, if necessary, technically prevented. The public must be associated with this ethical debate. Scientists and physicians have a critical role in explaining the medical needs, the advantages and limits of this potential medical procedure, and the ethical boundaries that must not be trespassed. If these prerequisites are met, acceptance of such a new, borderline medical procedure may prevail, as happened before for in-vitro fertilization or preimplantation genetic diagnosis.

Ethics and observational studies in medical research: various rules in a common framework

PubMed Central

Claudot, Frédérique; Alla, François; Fresson, Jeanne; Calvez, Thierry; Coudane, Henry; Bonaïti-Pellié, Catherine

2009-01-01

Background Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure), the modalities used for applying the main principles vary from one country to the other. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by United States peer reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC). Methods national legislation case analysis Results In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these researches are neither exempt from scientific opinion nor from ethical and legal authorization. Conclusion We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this paper was to encourage public bodies, scientific journals, and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language. PMID:19336436

Ethical Concerns and Procedural Pathways for Patients Who are Incapacitated and Alone: Implications from a Qualitative Study for Advancing Ethical Practice.

PubMed

Moye, Jennifer; Catlin, Casey; Kwak, Jennifer; Wood, Erica; Teaster, Pamela B

2017-06-01

Adults who are incapacitated and alone, having no surrogates, may be known as "unbefriended." Decision-making for these particularly vulnerable patients is a common and vexing concern for healthcare providers and hospital ethics committees. When all other avenues for resolving the need for surrogate decision-making fail, patients who are incapacitated and alone may be referred for "public guardianship" or guardianship of last resort. While an appropriate mechanism in theory, these programs are often under-staffed and under-funded, laying the consequences of inadequacies on the healthcare system and the patient him or herself. We describe a qualitative study of professionals spanning clinical, court, and agency settings about the mechanisms for resolving surrogate consent for these patients and problems therein within the state of Massachusetts. Interviews found that all participants encountered adults who are incapacitated and without surrogates. Four approaches for addressing surrogate needs were: (1) work to restore capacity; (2) find previously unknown surrogates; (3) work with agencies to obtain surrogates; and (4) access the guardianship system. The use of guardianship was associated with procedural challenges and ethical concerns including delays in care, short term gains for long term costs, inabilities to meet a patient's values and preferences, conflicts of interest, and ethical discomfort among interviewees. Findings are discussed in the context of resources to restore capacity, identify previously unknown surrogates, and establish improved surrogate mechanisms for this vulnerable population.

"Low-field" intraoperative MRI: a new scenario, a new adaptation.

PubMed

Iturri-Clavero, F; Galbarriatu-Gutierrez, L; Gonzalez-Uriarte, A; Tamayo-Medel, G; de Orte, K; Martinez-Ruiz, A; Castellon-Larios, K; Bergese, S D

2016-11-01

To describe the adaptation of Cruces University Hospital to the use of intraoperative magnetic resonance imaging (ioMRI), and how the acquisition and use of this technology would impact the day-to-day running of the neurosurgical suite. With the approval of the ethics committee, an observational, prospective study was performed from June 2012 to April 2014, which included 109 neurosurgical procedures with the assistance of ioMRI. These were performed using the Polestar N-30 system (PSN30; Medtronic Navigation, Louisville, CO), which was integrated into the operating room. A total of 159 procedures were included: 109 cranial surgeries assisted with ioMRI and 50 control cases (no ioMRI use). There were no statistical significant differences when anaesthetic time (p=0.587) and surgical time (p=0.792) were compared; however, an important difference was shown in duration of patient positioning (p<0.0009) and total duration of the procedure (p<0.0009) between both groups. The introduction of ioMRI is necessary for most neurosurgical suites; however, a few things need to be taken into consideration when adapting to it. Increase procedure time, the use of specific MRI-safe devices, as well as a checklist for each patient to minimise risks, should be taken into consideration. Published by Elsevier Ltd.

Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial

PubMed Central

2012-01-01

Background Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. Findings In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. Conclusion The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. PMID:22818109

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

PubMed

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

2016-01-01

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

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 and legal constraints to children's participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial.

PubMed

Bwakura-Dangarembizi, Mutsa; Musesengwa, Rosemary; Nathoo, Kusum J; Takaidza, Patrick; Mhute, Tawanda; Vhembo, Tichaona

2012-07-20

Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. In Zimbabwe the parental informed consent document for children participating in clinical research is modeled after Western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.

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

PubMed Central

Hunt, Matthew; Tansey, Catherine M.

2016-01-01

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

Consensus on guidelines for stereotactic neurosurgery for psychiatric disorders

PubMed Central

Nuttin, Bart; Wu, Hemmings; Mayberg, Helen; Hariz, Marwan; Gabriëls, Loes; Galert, Thorsten; Merkel, Reinhard; Kubu, Cynthia; Vilela-Filho, Osvaldo; Matthews, Keith; Taira, Takaomi; Lozano, Andres M; Schechtmann, Gastón; Doshi, Paresh; Broggi, Giovanni; Régis, Jean; Alkhani, Ahmed; Sun, Bomin; Eljamel, Sam; Schulder, Michael; Kaplitt, Michael; Eskandar, Emad; Rezai, Ali; Krauss, Joachim K; Hilven, Paulien; Schuurman, Rick; Ruiz, Pedro; Chang, Jin Woo; Cosyns, Paul; Lipsman, Nir; Voges, Juergen; Cosgrove, Rees; Li, Yongjie; Schlaepfer, Thomas

2014-01-01

Background For patients with psychiatric illnesses remaining refractory to ‘standard’ therapies, neurosurgical procedures may be considered. Guidelines for safe and ethical conduct of such procedures have previously and independently been proposed by various local and regional expert groups. Methods To expand on these earlier documents, representative members of continental and international psychiatric and neurosurgical societies, joined efforts to further elaborate and adopt a pragmatic worldwide set of guidelines. These are intended to address a broad range of neuropsychiatric disorders, brain targets and neurosurgical techniques, taking into account cultural and social heterogeneities of healthcare environments. Findings The proposed consensus document highlights that, while stereotactic ablative procedures such as cingulotomy and capsulotomy for depression and obsessive-compulsive disorder are considered ‘established’ in some countries, they still lack level I evidence. Further, it is noted that deep brain stimulation in any brain target hitherto tried, and for any psychiatric or behavioural disorder, still remains at an investigational stage. Researchers are encouraged to design randomised controlled trials, based on scientific and data-driven rationales for disease and brain target selection. Experienced multidisciplinary teams are a mandatory requirement for the safe and ethical conduct of any psychiatric neurosurgery, ensuring documented refractoriness of patients, proper consent procedures that respect patient's capacity and autonomy, multifaceted preoperative as well as postoperative long-term follow-up evaluation, and reporting of effects and side effects for all patients. Interpretation This consensus document on ethical and scientific conduct of psychiatric surgery worldwide is designed to enhance patient safety. PMID:24444853

Identifying Unique Ethical Challenges of Indigenous Field-Workers: A Commentary on Alexander and Richman's "Ethical Dilemmas in Evaluations Using Indigenous Research Workers"

ERIC Educational Resources Information Center

Smith, Nick L.

2008-01-01

In contrast with nonindigenous workers, to what extent do unique ethical problems arise when indigenous field-workers participate in field studies? Three aspects of study design and operation are considered: data integrity issues, risk issues, and protection issues. Although many of the data quality issues that arise with the use of indigenous…

Practising What We Preach: Justice and Ethical Instruction in Management Education

ERIC Educational Resources Information Center

Robbins, Tina L.; Jeffords, Ben C.

2009-01-01

Building on organizational justice research, we extended the study of classroom justice to management education. In the first study, we identified the criteria that business students use to define distributive, procedural, and interactional fairness. In a second study, we found that management students' perceptions of both procedural and…

Overcoming Barriers to Implementing Outdoor and Environmental Education (Continued): Safety/Legal Liability.

ERIC Educational Resources Information Center

Hanna, Glenda

1994-01-01

A risk management plan for outdoor education programs should include procedures for regular program implementation, as well as rescue, first aid, and accident follow-up procedures. Stresses understanding legal and ethical responsibilities and the importance of sufficient insurance protection. Includes suggestions for dealing with conflicts in…

21 CFR 601.92 - Withdrawal procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Withdrawal procedures. 601.92 Section 601.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.92...

21 CFR 601.92 - Withdrawal procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Withdrawal procedures. 601.92 Section 601.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.92...

21 CFR 601.92 - Withdrawal procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Withdrawal procedures. 601.92 Section 601.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.92...

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.

Sepsis and Critical Illness Research Center investigators: protocols and standard operating procedures for a prospective cohort study of sepsis in critically ill surgical patients

PubMed Central

Loftus, Tyler J; Mira, Juan C; Ozrazgat-Baslanti, Tezcan; Ghita, Gabriella L; Wang, Zhongkai; Stortz, Julie A; Brumback, Babette A; Bihorac, Azra; Segal, Mark S; Anton, Stephen D; Leeuwenburgh, Christiaan; Mohr, Alicia M; Efron, Philip A; Moldawer, Lyle L; Moore, Frederick A; Brakenridge, Scott C

2017-01-01

Introduction Sepsis is a common, costly and morbid cause of critical illness in trauma and surgical patients. Ongoing advances in sepsis resuscitation and critical care support strategies have led to improved in-hospital mortality. However, these patients now survive to enter state of chronic critical illness (CCI), persistent low-grade organ dysfunction and poor long-term outcomes driven by the persistent inflammation, immunosuppression and catabolism syndrome (PICS). The Sepsis and Critical Illness Research Center (SCIRC) was created to provide a platform by which the prevalence and pathogenesis of CCI and PICS may be understood at a mechanistic level across multiple medical disciplines, leading to the development of novel management strategies and targeted therapies. Methods Here, we describe the design, study cohort and standard operating procedures used in the prospective study of human sepsis at a level 1 trauma centre and tertiary care hospital providing care for over 2600 critically ill patients annually. These procedures include implementation of an automated sepsis surveillance initiative, augmentation of clinical decisions with a computerised sepsis protocol, strategies for direct exportation of quality-filtered data from the electronic medical record to a research database and robust long-term follow-up. Ethics and dissemination This study has been registered at ClinicalTrials.gov, approved by the University of Florida Institutional Review Board and is actively enrolling subjects. Dissemination of results is forthcoming. PMID:28765125

Evaluating the Process of Generating a Clinical Trial Protocol

PubMed Central

Franciosi, Lui G.; Butterfield, Noam N.; MacLeod, Bernard A.

2002-01-01

The research protocol is the principal document in the conduct of a clinical trial. Its generation requires knowledge about the research problem, the potential experimental confounders, and the relevant Good Clinical Practices for conducting the trial. However, such information is not always available to authors during the writing process. A checklist of over 80 items has been developed to better understand the considerations made by authors in generating a protocol. It is based on the most cited requirements for designing and implementing the randomised controlled trial. Items are categorised according to the trial's research question, experimental design, statistics, ethics, and standard operating procedures. This quality assessment tool evaluates the extent that a generated protocol deviates from the best-planned clinical trial.

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.

Youth crime and preventive policing in post-war Scotland (c.1945-71).

PubMed

Bartie, Angela; Jackson, Louise A

2011-01-01

This article explores debates concerning the methods and styles used by the police service in its dealings with children and young people in post-war Scotland (in comparison with England). Study of the implementation of Police Juvenile Liaison Schemes is used to consider shifting points of tension as well as cooperation between the police and other occupational groups engaged in work at the nexus of youth justice-welfare. Whilst often characterized as contradictory tendencies, the article demonstrates that a social welfare ethic and a criminal justice ethic were coexistent within the rhetoric and practice of policing, but that they operated in a state of flux. It also argues that styles of policing were subject to change, particularly as the use of discretionary and informal methods was increasingly challenged, as physical violence was increasingly seen as an outmoded recourse for the institutions of criminal justice, and as the policing of youth was increasingly politicized. The post-war period can be characterized in terms of greater levels of public scrutiny, the formalization of processes previously undertaken through informal or semi-formal mechanisms, and attempts (not always successful) to systematize procedures nationally in terms of the Scottish state.

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.

Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

PubMed

Ozarda, Yesim; Ichihara, Kiyoshi; Barth, Julian H; Klee, George

2013-05-01

The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

Chapter 9. Educational process. Recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza epidemic or mass disaster.

PubMed

Richards, Guy A; Sprung, Charles L

2010-04-01

To provide recommendations and standard operating procedures (SOPs) for intensive care unit (ICU) and hospital preparations for an influenza pandemic or mass disaster with focus on education of all stakeholders, specifically the emergency executive control groups, ICU staff and staff co-opted to assist with patient management. Based on a literature review and expert opinion, a Delphi process was used to define the essential topics, including staff education. Key recommendations include: (1) define functional roles and responsibilities of the internal personnel and interface agencies or sectors; (2) determine logistic support and requirements necessary for the effective implementation of the SOPs; (3) determine what is required to maintain the SOPs; (4) recommended training and activities include: (a) personal protection techniques; (b) environmental contamination; (c) medical management; (d) laboratory specimens; (e) alert lists; (f) training of recruited staff; (g) ethical issues; (h) psychosocial issues; (i) dealing with the deceased; (j) policies for restricting visitors; (k) mechanisms for enforcing policies; (5) Training should begin as soon as possible with daily demonstrations followed by supervised practice; (6) identify the staff to participate in training programs, verify that they have participated and evaluate their knowledge subsequently. Judicious planning and adoption of protocols for staff education are necessary to optimize outcomes during a pandemic.

Corruption: Engineers are Victims, Perpetrators or Both?

PubMed

Pecujlija, M; Cosic, I; Nesic-Grubic, L; Drobnjak, S

2015-08-01

This study was conducted in Serbian companies on licensed engineers and in its first part included a total of 336 licensed engineers who voluntarily completed the questionnaires about their ethical orientation and attitudes toward corruption and in the second part 214 engineers who participated in the first survey, who voluntarily evaluated their company's business operations characteristics. This study has clearly shown that there is a direct significant influence of the engineer's ethical orientations and attitudes toward corruption on their evaluation of the characteristics of their respective companies regarding business operations. This research also clearly shows that only engineers with a strong deontological orientation, low ethical subjectivity, and strong readiness to fight corruption, low corruption acceptance and high awareness of corruption can successfully fight corruption, improve the business operations of their companies and make beneficial changes to society. Otherwise, they should be considered as corruption perpetrators, not just as its victims.

Hemostasis of the liver, spleen, and bone achieved by electrocautery greased with lidocaine gel.

PubMed

Petroianu, Andy

2011-02-01

Despite advances in surgical techniques, achieving hemostasis of the liver, spleen, and bone during major surgery, especially after trauma, is still difficult. I describe a new procedure my colleagues and I devised to achieve parenchymatous hemostasis using electrocautery greased with lidocaine gel. After achieving good results in experimental studies and obtaining approval from our ethics committee, we used electrocautery greased with lidocaine gel for hemostasis in the following 36 procedures: multisegmental hepatectomy to remove hepatic tumors (n = 6); partial hepatectomy to allow hepatojejunostomy for intrahepatic biliary obstruction (n = 10); laparoscopic liver biopsy (n = 4); subtotal splenectomy (n = 8; for portal hypertension in 5 patients, splenic ischemia in 2, and Gaucher's disease in 1); laparoscopic splenic biopsy (n = 1); and bone resection (n = 7; as pelvic-femoral resection in 6 patients and to remove a rectal tumor invading the coccyx in 1). This procedure was easy to perform and achieved complete hemostasis of the minor blood vessels in all patients. No postoperative bleeding occurred and the follow-up course was satisfactory. Electrocautery greased with lidocaine gel is an inexpensive, readily available, and efficient method to achieve hemostasis of minor vessels in hepatic, splenic, and bone operations.

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.

Consenting to invasive contraceptives: an ethical analysis of adolescent decision-making authority for long-acting reversible contraception.

PubMed

Behmer Hansen, Rosemary Talbot; Arora, Kavita Shah

2018-06-14

Since USA constitutional precedent established in 1976, adolescents have increasingly been afforded the right to access contraception without first obtaining parental consent or authorisation. There is general agreement this ethically permissible. However, long-acting reversible contraception (LARC) methods have only recently been prescribed to the adolescent population. They are currently the most effective forms of contraception available and have high compliance and satisfaction rates. Yet unlike other contraceptives, LARCs are associated with special procedural risks because they must be inserted and removed by trained healthcare providers. It is unclear whether the unique invasive nature of LARC changes the traditional ethical calculus of permitting adolescent decision-making in the realm of contraception. To answer this question, we review the risk-benefit profile of adolescent LARC use. Traditional justifications for permitting adolescent contraception decision-making authority are then considered in the context of LARCs. Finally, analogous reasoning is used to evaluate potential differences between permitting adolescents to consent for LARC procedures versus for emergency and pregnancy termination procedures. Ultimately, we argue that the invasive nature of LARCs does not override adolescents' unique and compelling need for safe and effective forms of contraception. In fact, LARCs may oftentimes be in the best interest of adolescent patients who wish to prevent unintended pregnancy. We advocate for the specific enumeration of adolescents' ability to consent to both LARC insertion and removal procedures within state policies. Given the provider-dependent nature of LARCs and the stigma regarding adolescent sexuality, special political and procedural safeguards to protect adolescent autonomy are warranted. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Ethical, financial, and policy considerations in hand transplantation.

PubMed

Chang, Jeff; Mathes, David W

2011-11-01

Currently, more than 65 hand transplants have been performed with studies demonstrating favorable cosmetic and functional outcomes and cortical reintegration of the transplanted hand. Due to such favorable outcomes, many view hand transplant as a potential gold standard for treatment of a double amputee. However, ethical debate continues regarding risks and benefits of this nonlifesaving procedure. Clinicians, patients, and society must agree on whether hand transplantation is ethical and affordable. If a decision is made to transplant a hand, this must be performed in a dedicated center that facilitates integration of multiple specialists, ethicists, pharmacists, and rehabilitationists. Copyright © 2011 Elsevier Inc. All rights reserved.

Reflections on the researcher-participant relationship and the ethics of dialogue.

PubMed

Yassour-Borochowitz, Dalit

2004-01-01

Research concerned with human beings is always an interference of some kind, thus posing ethical dilemmas that need justification of procedures and methodologies. It is especially true in social work when facing mostly sensitive populations and sensitive issues. In the process of conducting a research on the emotional life histories of Israeli men who batter their partners, some serious ethical questions were evoked such as (a) Did the participants really give their consent? (b) What are the limits of the researcher-participants relationship and who decides them? (c) For whom is the study beneficial? and (d) To what degree did the methodology fit with the participants? In this article, I discuss the Socratic idea of truth revealed through dialogue and the idea of reciprocity that was developed in Buber's (1949) ethics of dialogue and Habermas' (1990) communicative ethics. The 3 essential conclusions drawn from the ethical questions raised and the discussion of the thinkers that are mentioned previously are (a) dialogical methodology is ethically justified; (b) dynamic interactions give a more holistic perspective of the human nature, thus enriching the field; and (c) through dialogical methodology both researcher and participant profit from growth of knowledge, which is a key for empowerment and change.

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

PubMed

Ito, Chiharu; Natsume, Mikiko

2016-06-01

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

The Top 10 Ethical Challenges in Dental Practice in Indian Scenario: Dentist Perspective

PubMed Central

Kemparaj, Vanishree M.; Panchmal, Ganesh Shenoy; Kadalur, Umashankar Gangadaraiah

2018-01-01

Aim: This exploratory qualitative research is an attempt to assess the health care ethical challenges in dental practice in an Indian scenario. Methodology: Qualitative indepth interview was conducted on 20 dental professionals to assess the ethical challenges prevailing in dental practice in Indian scenario. After obtaining the responses the verbatims were categorized into categories and finally 36 themes emerged. Later from two group of 6 panellists each after conducting focus group discussion the themes of ethical issues occurring in dental practice were ranked based on order of significance impact on the practice, patient and society using Delphi method. Result: The top ten ethical challenges listed by the panellists are inadequate sterilization and waste management in dental clinics, poor knowledge and attitude towards ethics among our dental practitioners, in competence among dental professional, increase in cost of oral health service, poor informed consent process, requirement of consensus about the treatment procedures among dentists, Conflict in Advertising, clustering of dental clinics in urban areas, disagreement with treatment modalities among dentist and patient, poor medical record maintenance among our dental practitioners. Conclusion: The study attempts to bring the prevailing ethical challenges in oral health care practice in Indian scenario. PMID:29599593

When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

PubMed

de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

2011-09-01

For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

Surgical innovation: the ethical agenda: A systematic review.

PubMed

Broekman, Marike L; Carrière, Michelle E; Bredenoord, Annelien L

2016-06-01

The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might particularly enrich the necessary future discussion on surgical innovation: integration of research and practice and a moral emphasis on "learning activities." Future research should evaluate whether the learning health care system and its adjacent moral framework provides ethical guidance for evidence-based surgery.

Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial.

PubMed

de Vries, Bradley; Phipps, Hala; Kuah, Sabrina; Pardey, John; Ludlow, Joanne; Bisits, Andrew; Park, Felicity; Kowalski, David; Hyett, Jon A

2015-08-18

Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate. Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity. Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410). This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies. This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.

Towards a European code of medical ethics. Ethical and legal issues.

PubMed

Patuzzo, Sara; Pulice, Elisabetta

2017-01-01

The feasibility of a common European code of medical ethics is discussed, with consideration and evaluation of the difficulties such a project is going to face, from both the legal and ethical points of view. On the one hand, the analysis will underline the limits of a common European code of medical ethics as an instrument for harmonising national professional rules in the European context; on the other hand, we will highlight some of the potentials of this project, which could be increased and strengthened through a proper rulemaking process and through adequate and careful choice of content. We will also stress specific elements and devices that should be taken into consideration during the establishment of the code, from both procedural and content perspectives. Regarding methodological issues, the limits and potentialities of a common European code of medical ethics will be analysed from an ethical point of view and then from a legal perspective. The aim of this paper is to clarify the framework for the potential but controversial role of the code in the European context, showing the difficulties in enforcing and harmonising national ethical rules into a European code of medical ethics. 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/.

An overview of ethical frameworks in public health: can they be supportive in the evaluation of programs to prevent overweight?

PubMed Central

2010-01-01

Background The prevention of overweight sometimes raises complex ethical questions. Ethical public health frameworks may be helpful in evaluating programs or policy for overweight prevention. We give an overview of the purpose, form and contents of such public health frameworks and investigate to which extent they are useful for evaluating programs to prevent overweight and/or obesity. Methods Our search for frameworks consisted of three steps. Firstly, we asked experts in the field of ethics and public health for the frameworks they were aware of. Secondly, we performed a search in Pubmed. Thirdly, we checked literature references in the articles on frameworks we found. In total, we thus found six ethical frameworks. We assessed the area on which the available ethical frameworks focus, the users they target at, the type of policy or intervention they propose to address, and their aim. Further, we looked at their structure and content, that is, tools for guiding the analytic process, the main ethical principles or values, possible criteria for dealing with ethical conflicts, and the concrete policy issues they are applied to. Results All frameworks aim to support public health professionals or policymakers. Most of them provide a set of values or principles that serve as a standard for evaluating policy. Most frameworks articulate both the positive ethical foundations for public health and ethical constraints or concerns. Some frameworks offer analytic tools for guiding the evaluative process. Procedural guidelines and concrete criteria for solving important ethical conflicts in the particular area of the prevention of overweight or obesity are mostly lacking. Conclusions Public health ethical frameworks may be supportive in the evaluation of overweight prevention programs or policy, but seem to lack practical guidance to address ethical conflicts in this particular area. PMID:20969761

Ethical issues associated with the use of animal experimentation in behavioral neuroscience research.

PubMed

Ohl, Frauke; Meijboom, Franck

2015-01-01

This chapter briefly explores whether there are distinct characteristics in the field of Behavioral Neuroscience that demand specific ethical reflection. We argue that although the ethical issues in animal-based Behavioral Neuroscience are not necessarily distinct from those in other research disciplines using animal experimentation, this field of endeavor makes a number of specific, ethically relevant, questions more explicit and, as a result, may expose to discussion a series of ethical issues that have relevance beyond this field of science. We suggest that innovative research, by its very definition, demands out-of-the-box thinking. At the same time, standardization of animal models and test procedures for the sake of comparability across experiments inhibits the potential and willingness to leave well-established tracks of thinking, and leaves us wondering how open minded research is and whether it is the researcher's established perspective that drives the research rather than the research that drives the researcher's perspective. The chapter finishes by introducing subsequent chapters of this book volume on Ethical Issues in Behavioral Neuroscience.

What Critical Ethical Values Guide Strategic Planning Processes in Health Care Organizations?

PubMed

Kucmanic, Matthew; Sheon, Amy R

2017-11-01

This case explores a fictitious hospital's use of co-creation to make a decision about redesign of inpatient units as a first step in incorporating stakeholder input into creation of governing policies. We apply a "procedural fairness" framework to reveal that conditions required for an ethical decision about space redesign were not met by using clinician and patient focus groups to obtain stakeholder input. In this article, we identify epistemic injustices resulting from this process that could undermine confidence in leadership decisions. Suggestions are offered for incorporating stakeholder input going forward that address prior shortcomings. The result should be conditions that are perceived as procedurally fair and decisions that engender confidence in institutional leadership. © 2017 American Medical Association. All Rights Reserved.

Social networking and online recruiting for HIV research: ethical challenges.

PubMed

Curtis, Brenda L

2014-02-01

Social networking sites and online advertising organizations provide HIV/AIDS researchers access to target populations, often reaching difficult-to-reach populations. However, this benefit to researchers raises many issues for the protections of prospective research participants. Traditional recruitment procedures have involved straightforward transactions between the researchers and prospective participants; online recruitment is a more complex and indirect form of communication involving many parties engaged in the collecting, aggregating, and storing of research participant data. Thus, increased access to online data has challenged the adequacy of current and established procedures for participants' protections, such as informed consent and privacy/confidentiality. Internet-based HIV/AIDS research recruitment and its ethical challenges are described, and research participant safeguards and best practices are outlined.

Social Networking and Online Recruiting for HIV Research: Ethical Challenges

PubMed Central

Curtis, Brenda L.

2015-01-01

Social networking sites and online advertising organizations provide HIV/AIDS researchers access to target populations, often reaching difficult-to-reach populations. However, this benefit to researchers raises many issues for the protections of prospective research participants. Traditional recruitment procedures have involved straightforward transactions between the researchers and prospective participants; online recruitment is a more complex and indirect form of communication involving many parties engaged in the collecting, aggregating, and storing of research participant data. Thus, increased access to online data has challenged the adequacy of current and established procedures for participants’ protections, such as informed consent and privacy/confidentiality. Internet-based HIV/AIDS research recruitment and its ethical challenges are described, and research participant safeguards and best practices are outlined. PMID:24572084

Challenging Operations: An Ethical Framework to Assist Humanitarian Aid Workers in their Decision-making Processes

PubMed Central

Clarinval, Caroline; Biller-Andorno, Nikola

2014-01-01

Introduction: This paper aims to raise awareness regarding ethical issues in the context of humanitarian action, and to offer a framework for systematically and effectively addressing such issues. Methods: Several cases highlight ethical issues that humanitarian aid workers are confronted with at different levels over the course of their deployments. The first case discusses a situation at a macro-level concerning decisions being made at the headquarters of a humanitarian organization. The second case looks at meso-level issues that need to be solved at a country or regional level. The third case proposes an ethical dilemma at the micro-level of the individual patient-provider relationship. Discussion: These real-life cases have been selected to illustrate the ethical dimension of conflicts within the context of humanitarian action that might remain unrecognized in everyday practice. In addition, we propose an ethical framework to assist humanitarian aid workers in their decision-making process. The framework draws on the principles and values that guide humanitarian action and public health ethics more generally. Beyond identifying substantive core values, the framework also includes a ten-step process modelled on tools used in the clinical setting that promotes a transparent and clear decision-making process and improves the monitoring and evaluation of aid interventions. Finally, we recommend organizational measures to implement the framework effectively. Conclusion: This paper uses a combination of public health/clinical ethics concepts and practices and applies them to the decision-making challenges encountered in relief operations in the humanitarian aid context. PMID:24987575

Medical ethics surveillance in the Armed Forces.

PubMed

Pearn, J

2000-05-01

Modern defense services depend on a policy of the vigorous promotion of research to ensure that they retain an advantage in any future operational context. Research involving personnel within the armed forces, however, has certain constraints with respect to contemporary, best-practice medical ethics. Service members are one example of a class of "captive subjects" who require special protection in the context of medical research. (Prisoners, students, children, and the intellectually disabled are other such examples.) The majority of national defense forces now have ethical watchdog groups--institutional ethics committees--that oversee research involving service members. Such groups monitor the special considerations and constraints under which subjects in uniform can volunteer for biological research. These committees audit particularly the ethical themes of confidentiality, equality, and justice. Themes inherent in medical research in the military include the standard Beauchamp-Childress paradigm of autonomy, beneficence, nonmaleficence, and justice, to which are added the traditional military values of loyalty, respect, courtesy, and chivalry. Contemporary thinking is that the general principle of affording service members the opportunity to volunteer for research should be maintained within the constraints of compromised training time, national security, and operational necessity. Most biological research (and its outcome) does not in practice compromise confidentiality or military security. This paper presents an audit of the functioning of one national military medical ethics committee, the Australian Defence Medical Ethics Committee, and presents a discussion of its philosophies and influence within the broader military context. The Australian Defence Medical Ethics Committee believes that most research should, as an a priori condition of approval, be intended for open publication in peer-reviewed journals.

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

PubMed Central

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

2006-01-01

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

Research Disclosure Procedures for the Kamehameha Early Education Project. Technical Report #21.

ERIC Educational Resources Information Center

Omori, Sharon; And Others

This report describes research disclosure procedures and materials developed for the Kamehameha Early Education Program (KEEP) to fulfill the informed consent principle of the ethical guidelines of the American Psychological Association. A requirement for registration of children in the program is that parents attend one of two disclosure…

Ethical and Professional Guidelines for Use of Crisis Procedures

ERIC Educational Resources Information Center

Simonsen, Brandi; Sugai, George; Freeman, Jennifer; Kern, Laura; Hampton, Jane

2014-01-01

The use of crisis procedures, such as seclusion and physical restraint, in U.S. schools has garnered a great deal of national attention, resulting in reports from professional organizations, proposed legislation, and recent recommendations from the U.S. Department of Education (U.S. DOE; 2012). In this paper, we review the recommendations from the…

[Nursing students assessment in simulated conditions : in search of meaning and ethics].

PubMed

Homerin, Marie-Pierre; Roumanet, Marie-Cécile

2014-10-01

A thought about the assessment in simulated conditions is at the origin of this research-action conducted at the Institute of Nursing Education of Chambery, France. Indeed, the differences in the assessment procedures between units that require this kind of validation and the disappointing rate of success at the examinations in simulated situations have led the trainers to raise the following question : « How can these assessments be meaningful and consistent with the goal of training (help to become autonomous and reflexive practitioners) » ?This issue was addressed with concepts such as socioconstructivism, simulation in health, assessment and ethical principles. The change of practices has been the application of the principles of ?educative? assessment according to G. Nunziatti which strongly involves the students in the assessment?s process.In order to estimate the impact of these changes of practices, an unidentified online survey was offered to all students who benefited from this kind of assessment. The results between two classes of students having had different evaluation procedures have also been compared.The objectives were, after the implementation of this new kind of evaluation, to assess the students? satisfaction, to compare the failure rate at the tests in simulated conditions and to verify the compliance with the ethical principles.This study has shown the students? satisfaction about these new forms of assessment in simulated conditions, an increased success rate in the tests and the applicability of the ethical principles with this way of proceeding. However, the principles of justice and non-maleficence are difficult to implement. Nevertheless, this critical thinking on the procedures of assessment in simulated conditions has helped to change the practices and the assessment design by the teachers.

Operational Ethics in Coalition Warfare: Whose Ethics Will Prevail? A Philosophical/Theological Conundrum

DTIC Science & Technology

2002-05-13

the identification of reason as the prime human faculty and virtue, i.e., sense of excellence and practical wisdom as the highest good. These are the...Clothes, " National Security Studies Quarterly Spring 2000, Volume VI, Issue 2, pp. 59-71. 43 Glynis Breakwell and Keith Spacie , Pressures Facing...commander to draw upon, then what is the solution to reduce the stressors highlighted by the Breakwell and Spacie study? Can there be operational

48 CFR 1403.570-2 - Procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Other Improper Business Practices 1403.570-2... response shall be coordinated with the cognizant Public Affairs Office and Ethics Officer. ...

The Role of Ethics Committees and Ethics Consultation in Allocation Decisions

PubMed Central

Strech, Daniel; Hurst, Samia; Danis, Marion

2013-01-01

Background Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. Objectives and Methods This article argues for the need for ethics consultation in rationing decisions using empirical data about the status quo and the inherent nature of bedside rationing. Subsequently, it introduces a 4-stage process for establishing and conducting ethics consultation in rationing questions with systematic reference to core elements of procedural justice. Results Qualitative and quantitative findings show a significant demand for ethics consultation expressed directly by doctors, as well as additional indirect evidence of such a need as indicated by ethically challenging circumstances of inconsistent and structurally disadvantaging rationing decisions. To address this need, we suggest 4 stages for establishing and conducting ethics consultation in rationing questions we recommend: (1) training, (2) identifying actual scarcity-related problems at clinics, (3) supporting decision-making, and (4) evaluation. Conclusion This process of ethics consultation regarding rationing decisions would facilitate the achievement of several practical goals: (i) encouragement of an awareness and understanding of ethical problems in bedside rationing, (ii) encouragement of achieving efficiency along with rationing, (iii) reinforcement of consistency in inter- and intraindvidual decision-making, (iv) encouragement of explicit reflection and justification of the prioritization criteria taken into consideration, (v) improvement in internal (in-house) and external transparency, and (vi) prevention of the misuse of the corresponding consulting structures. PMID:20706163

39 CFR 447.31 - Advisory service.

Code of Federal Regulations, 2010 CFR

2010-07-01

... by an agency designee. The Ethical Conduct Officer shall provide advice and guidance for the... Postmaster General. The Chief Operating Officer, Senior Vice Presidents, Vice Presidents, and such other... employee may obtain advice and guidance on questions of conflicts of interest from the Ethical Conduct...

17 CFR 200.16a - Inspector General.

Code of Federal Regulations, 2010 CFR

2010-04-01

...; CONDUCT AND ETHICS; AND INFORMATION AND REQUESTS Organization and Program Management General Organization... contractors and Commission employees or the Standards Of Ethical Conduct For Employees of the Executive Branch... about problems and deficiencies in the Commission's programs and operations. (c) The Inspector General...

Organ Donation After Circulatory Death: Ethical Issues and International Practices.

PubMed

Jericho, Barbara G

2018-05-21

Donation after circulatory death (DCD) is an increasingly utilized practice that can contribute to reducing the difference between the supply of organs and the demand for organs for transplantation. As the number of transplanted organs from DCD donors continues to increase, there is an essential need to address the ethical aspects of DCD in institutional DCD protocols and clinical practice. Ethical issues of respecting the end-of-life wishes of a potential donor, respecting a recipient's wishes, and addressing potential conflicts of interest are important considerations in developing policies and procedures for DCD programs. Although there may be diversity among DCD programs in Europe, Australia, Israel, China, the United States, and Canada, addressing ethical considerations in these DCD programs is essential to respect donors and recipients during the altruistic and generous act of organ donation.

Progress towards a world-wide code of conduct

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

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

1994-12-31

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

High-intensity interval exercise training before abdominal aortic aneurysm repair (HIT-AAA): protocol for a randomised controlled feasibility trial.

PubMed

Tew, Garry A; Weston, Matthew; Kothmann, Elke; Batterham, Alan M; Gray, Joanne; Kerr, Karen; Martin, Denis; Nawaz, Shah; Yates, David; Danjoux, Gerard

2014-01-10

In patients with large abdominal aortic aneurysm (AAA), open surgical or endovascular aneurysm repair procedures are often used to minimise the risk of aneurysm-related rupture and death; however, aneurysm repair itself carries a high risk. Low cardiopulmonary fitness is associated with an increased risk of early post-operative complications and death following elective AAA repair. Therefore, fitness should be enhanced before aneurysm repair. High-intensity interval exercise training (HIT) is a potent, time-efficient strategy for enhancing cardiopulmonary fitness. Here, we describe a feasibility study for a definitive trial of a pre-operative HIT intervention to improve post-operative outcomes in patients undergoing elective AAA repair. A minimum of 50 patients awaiting elective repair of a 5.5-7.0 cm infrarenal AAA will be allocated by minimisation to HIT or usual care control in a 1:1 ratio. The patients allocated to HIT will complete three hospital-based exercise sessions per week, for 4 weeks. Each session will include 2 or 4 min of high-intensity stationary cycling followed by the same duration of easy cycling or passive recovery, repeated until a total of 16 min of high-intensity exercise is accumulated. Outcomes to be assessed before randomisation and 24-48 h before aneurysm repair include cardiopulmonary fitness, maximum AAA diameter and health-related quality of life. In the post-operative period, we will record destination (ward or critical care unit), organ-specific morbidity, mortality and the durations of critical care and hospital stay. Twelve weeks after the discharge, participants will be interviewed to reassess quality of life and determine post-discharge healthcare utilisation. The costs associated with the exercise intervention and healthcare utilisation will be calculated. Ethics approval was secured through Sunderland Research Ethics Committee. The findings of the trial will be disseminated through peer-reviewed journals, and national and international presentations. Current Controlled Trials ISRCTN09433624.

How do authors of systematic reviews deal with research malpractice and misconduct in original studies? A cross-sectional analysis of systematic reviews and survey of their authors

PubMed Central

Elia, Nadia; von Elm, Erik; Chatagner, Alexandra; Pöpping, Daniel M; Tramèr, Martin R

2016-01-01

Objectives To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether they identify and report misconduct. Design Cross-sectional analysis of systematic reviews and survey of their authors. Participants 118 systematic reviews published in four journals (Ann Int Med, BMJ, JAMA, Lancet), and the Cochrane Library, in 2013. Main outcomes and measures Number (%) of reviews that applied procedures to reduce the impact of: (1) publication bias (through searching of unpublished trials), (2) selective outcome reporting (by contacting the authors of the original studies), (3) duplicate publications, (4) sponsors’ and (5) authors’ conflicts of interest, on the conclusions of the review, and (6) looked for ethical approval of the studies. Number (%) of reviewers who suspected misconduct are reported. The procedures applied were compared across journals. Results 80 (68%) reviewers confirmed their data. 59 (50%) reviews applied three or more procedures; 11 (9%) applied none. Unpublished trials were searched in 79 (66%) reviews. Authors of original studies were contacted in 73 (62%). Duplicate publications were searched in 81 (69%). 27 reviews (23%) reported sponsors of the included studies; 6 (5%) analysed their impact on the conclusions of the review. Five reviews (4%) looked at conflicts of interest of study authors; none of them analysed their impact. Three reviews (2.5%) looked at ethical approval of the studies. Seven reviews (6%) suspected misconduct; only 2 (2%) reported it explicitly. Procedures applied differed across the journals. Conclusions Only half of the systematic reviews applied three or more of the six procedures examined. Sponsors, conflicts of interest of authors and ethical approval remain overlooked. Research misconduct is sometimes identified, but rarely reported. Guidance on when, and how, to report suspected misconduct is needed. PMID:26936908

Boldt v. Boldt: A pediatric ethics perspective.

PubMed

Diekema, Douglas S

2009-01-01

On balance, the potential harms and benefits of circumcision in an older child or adolescent are sufficiently closely aligned that parents should be permitted to make decisions about circumcision on behalf of their children. To make a case for prohibition, medical harms would have to be of such likelihood and magnitude that no reasonable potential benefit (social, religious, cultural, or medical) could justify doing it to a child. However, I would suggest that the following additional principles should apply: (1) Informed permission from parents is essential. Only about half of the parents considering neonatal circumcision are given any substantive information about the procedure. That practice is not acceptable for a procedure that is not medically essential and carries some risk of harm. A fully informed consent is essential, and must include a balanced discussion of potential harms and benefits of the procedure to the child. Parents should be given accurate and impartial information and allowed to make an informed decision regarding what is in the best interest of the child. (2) Consent of both parents should be required when the procedure is not medically required. It should not be performed in the face of parental disagreement. (3) Absent a significant medical indication, circumcision should not be performed on older children and adolescents in the face of dissent or less than enthusiastic assent. (4) Circumcision should be performed competently and safely by adequately trained providers.29 This should include infection-control measures, a sterile environment for the procedure, and no mouth-penis contact. (5) Analgesia is safe and effective. Adequate analgesia and post-operative pain control must be provided. In the case of Jimmy Boldt, I would suggest that without some compelling medical reason for performing a circumcision, the procedure should not be performed in the absence of agreement between his parents. The fact that Jimmy's father had sole custody does not eliminate the mother's ethical right and obligation to look after the welfare of her son. While the mother may not have legal decision-making authority, that legal determination does not appear to be related either to a lack of interest in her son's welfare or an inability to carry out that role. Jimmy is her son, and she has an interest in seeing his welfare protected. Whether or not she has legal rights, I would be very reluctant to perform an elective procedure for cultural or religious reasons without the permission of both parents and the unambiguous assent of Jimmy himself. Neither appears to be present in the case as it presented to the courts.

Ethics On The Fly: Toward A Drone - Specific Code Of Conduct For Law Enforcement

DTIC Science & Technology

2016-03-01

Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202- 4302, and to the Office of Management and Budget... documentary evidence of ethical frameworks for UAS currently in use by law enforcement. A comparative policy analysis is then performed to identify...Using the case study method, this thesis considered documentary evidence of ethical frameworks for UAS currently in use by law enforcement. A

Social and Leadership Factors Influencing Moral Decision Making in Canadian Military Operations: An Annotated Bibliography

DTIC Science & Technology

2011-03-01

emphasis on challenges to or failures of moral and ethical decision making. To conduct our literature review, a number of core concepts were identified...The research team identified a number of core concepts , relating specifically to the social and leadership factors that influence moral and ethical...decision making (see Table 1). Table 1: Keywords Core Concepts Related Keywords Moral *1, immoral Ethic*, unethical Decision making Decision

Field research methodology for the study of Latin American ministries of education

NASA Astrophysics Data System (ADS)

Hanson, E. Mark

1981-09-01

In Third World countries a key to the course of nation-building is the modernization of the organizational and administrative infrastructures which drive the development process. Increasing the operational capabilities, effectiveness, and efficiency of the ministry of education, and hence the quality and quantity of school outcomes, is typically a high priority item in the development plans of a nation. In order to promote the modernization of management activities in ministries, however, it is first essential to understand their existing patterns of operation. Toward this objective, the paper presents a methodological framework for a field study approach to the examination of the working of a ministry of education in Latin America. Several issues are introduced which influence the process of inquiry, such as: (1) examining the impact of historical traditions on contemporary management procedures; (2) exploring concerns for ethics and academic colonialism; (3) distinguishing between anthropological and sociological participant-observation field methods; (4) gathering and analyzing data on complex ministries; and (5) exploring the task of Third World theory building.

Ethical and Animal Welfare Considerations in Relation to Species Selection for Animal Experimentation

PubMed Central

Webster, John

2014-01-01

Simple Summary When making a choice of species for animal experimentation we must balance its suitability as a model for human medicine against the potential harms to the animals both from the procedures and the quality of their lifetime experience. The capacity to experience pain may be similar in mammals, birds and fish. The capacity to suffer from fear is governed more by sentience than cognitive ability, so it cannot be assumed that rodents or farm animals suffer less than dogs or primates. I suggest that it is unethical to base the choice of species for animal experimentation simply on the basis that it will cause less distress within society. Abstract Ethical principles governing the conduct of experiments with animals are reviewed, especially those relating to the choice of species. Legislation requires that the potential harm to animals arising from any procedure should be assessed in advance and justified in terms of its possible benefit to society. Potential harms may arise both from the procedures and the quality of the animals’ lifetime experience. The conventional approach to species selection is to use animals with the “lowest degree of neurophysiological sensitivity”. However; this concept should be applied with extreme caution in the light of new knowledge. The capacity to experience pain may be similar in mammals, birds and fish. The capacity to suffer from fear is governed more by sentience than cognitive ability, so it cannot be assumed that rodents or farm animals suffer less than dogs or primates. I suggest that it is unethical to base the choice of species for animal experimentation simply on the basis that it will cause less distress within society. A set of responsibilities is outlined for each category of moral agent. These include regulators, operators directly concerned with the conduct of scientific experiments and toxicology trials, veterinarians and animal care staff; and society at large. PMID:26479009

Theoretical Models and Operational Frameworks in Public Health Ethics

PubMed Central

Petrini, Carlo

2010-01-01

The article is divided into three sections: (i) an overview of the main ethical models in public health (theoretical foundations); (ii) a summary of several published frameworks for public health ethics (practical frameworks); and (iii) a few general remarks. Rather than maintaining the superiority of one position over the others, the main aim of the article is to summarize the basic approaches proposed thus far concerning the development of public health ethics by describing and comparing the various ideas in the literature. With this in mind, an extensive list of references is provided. PMID:20195441

Solving work-related ethical problems.

PubMed

Laukkanen, Laura; Suhonen, Riitta; Leino-Kilpi, Helena

2016-12-01

Nurse managers are responsible for solving work-related ethical problems to promote a positive ethical culture in healthcare organizations. The aim of this study was to describe the activities that nurse managers use to solve work-related ethical problems. The ultimate aim was to enhance the ethical awareness of all nurse managers. The data for this descriptive cross-sectional survey were analyzed through inductive content analysis and quantification. Participants and research context: The data were collected in 2011 using a questionnaire that included an open-ended question and background factors. Participants were nurse managers working in Finnish healthcare organizations (n = 122). Ethical considerations: Permission for the study was given by the Finnish Association of Academic Managers and Experts of Health Sciences. Nurse managers identified a variety of activities they use to solve work-related ethical problems: discussion (30%), cooperation (25%), work organization (17%), intervention (10%), personal values (9%), operational models (4%), statistics and feedback (4%), and personal examples (1%). However, these activities did not follow any common or systematic model. In the future, nurse managers need a more systematic approach to solve ethical problems. It is important to establish new kinds of ethics structures in organizations, such as a common, systematic ethical decision-making model and an ethics club for nurse manager problems, to support nurse managers in solving work-related ethical problems.

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

NASA Astrophysics Data System (ADS)

Narayanasamy, Kogilah; Shetty, M. V.

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

5 CFR 5601.101 - General.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Administrative Personnel POSTAL RATE COMMISSION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE... supplement the Standards of Ethical Conduct for Employees of the Executive Branch contained in 5 CFR part... operations of the United States Postal Service (Postal Service): (1) Includes a company or other person: (i...

5 CFR 2600.103 - Office of Government Ethics organization and functions.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) The Office of Administration and Information Management. (b) Office of the Director. The Director of... certain aspects of agency ethics programs. (f) Office of Administration and Information Management. The Office of Administration and Information Management provides support to all OGE operating programs...

5 CFR 2600.103 - Office of Government Ethics organization and functions.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) The Office of Administration and Information Management. (b) Office of the Director. The Director of... certain aspects of agency ethics programs. (f) Office of Administration and Information Management. The Office of Administration and Information Management provides support to all OGE operating programs...

5 CFR 2600.103 - Office of Government Ethics organization and functions.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) The Office of Administration and Information Management. (b) Office of the Director. The Director of... certain aspects of agency ethics programs. (f) Office of Administration and Information Management. The Office of Administration and Information Management provides support to all OGE operating programs...

5 CFR 2600.103 - Office of Government Ethics organization and functions.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) The Office of Administration and Information Management. (b) Office of the Director. The Director of... certain aspects of agency ethics programs. (f) Office of Administration and Information Management. The Office of Administration and Information Management provides support to all OGE operating programs...

Comparison of cross culture engineering ethics training using the simulator for engineering ethics education.

PubMed

Chung, Christopher

2015-04-01

This paper describes the use and analysis of the Simulator for Engineering Ethics Education (SEEE) to perform cross culture engineering ethics training and analysis. Details describing the first generation and second generation development of the SEEE are published in Chung and Alfred, Science and Engineering Ethics, vol. 15, 2009 and Alfred and Chung, Science and Engineering Ethics, vol. 18, 2012. In this effort, a group of far eastern educated students operated the simulator in the instructional, training, scenario, and evaluation modes. The pre and post treatment performance of these students were compared to U.S. Educated students. Analysis of the performance indicated that the far eastern educated student increased their level of knowledge 23.7 percent while U.S. educated students increased their level of knowledge by 39.3 percent.

The capacity for ethical decisions: the relationship between working memory and ethical decision making.

PubMed

Martin, April; Bagdasarov, Zhanna; Connelly, Shane

2015-04-01

Although various models of ethical decision making (EDM) have implicitly called upon constructs governed by working memory capacity (WMC), a study examining this relationship specifically has not been conducted. Using a sense making framework of EDM, we examined the relationship between WMC and various sensemaking processes contributing to EDM. Participants completed an online assessment comprised of a demographic survey, intelligence test, various EDM measures, and the Automated Operation Span task to determine WMC. Results indicated that WMC accounted for unique variance above and beyond ethics education, exposure to ethical issues, and intelligence in several sensemaking processes. Additionally, a marginally significant effect of WMC was also found with reference to EDM. Individual differences in WMC appear likely to play an important role in the ethical decision-making process, and future researchers may wish to consider their potential influences.

Mifepristone in Italy: the case of a drug trapped between ethics and clinical practice.

PubMed

Banfi, Roberto; Pavone, Eleonora; Cerri, Rita; Menichetti, Monica

2007-08-01

In Italy mifepristone is not yet marketed. Gynaecologists in our hospital asked to use this medication as a less traumatic method for voluntary abortions. We followed the standard procedure defined by the Italian Health Ministry (IMH) for purchasing drugs from abroad but encountered several unexpected barriers. Starting from this case, this paper is aimed at identifying these barriers which we found to be not only professional, but also ethical, religious and moral.

Palliative sedation: ethical perspectives from Latin America in comparison with European recommendations.

PubMed

Manzini, Jorge L

2011-09-01

Palliative sedation is a standard procedure used in palliative care especially for patients at the very end of their lives, who are enduring otherwise intractable suffering. It consists of the administration of sedatives and, when necessary, other drugs, usually by infusion, either subcutaneously or intravenously, at the necessary rate to achieve the patient's relief, by means of reducing the consciousness of the patient. If this administration is not discontinued, the usual outcome is the patient's death. So, the most frequent criticisms regarding the procedure are those that consider it as a form of euthanasia. The intention of the review is analyzing the status questionis in Europe and Latin America. Current thinking and research about this issue refers especially to the terminology, the boundaries between palliative sedation and slow euthanasia, especially in pediatric settings, the lacking of precise definition for concepts such as refractory symptoms and unbearable suffering, and the place for existential suffering in this context; the ethical positioning of Latin-American normative and authors is similar to that of Europe. It does not seem that solution to the conflicting points will come from better guidelines or more experts' meetings. Instead, efforts should be directed to reinforce moral, professional integrity, within the framework of an ethics of virtue, as inherent to palliative care. Such ethics can effectively be taught and infused, and then required to all healthcare professionals.

The bioethics of separating conjoined twins in plastic surgery.

PubMed

Lee, Michelle; Gosain, Arun K; Becker, Devra

2011-10-01

The incidence of craniopagus twins approximates four to six per 10 million births. Although rare, surgical separation of conjoined twins poses significant technical and ethical challenges. The present report uses the case of craniopagus twins AD and TD to examine the bioethical issues faced by a multidisciplinary medical team in planning the separation of craniopagus twins. AD and TD are craniopagus twins conjoined at the head. TD's head is conjoined to the back of AD's head. Neurologically, AD has the dominant cerebral circulation. TD has two normal kidneys, whereas AD has none. AD depends on TD's renal function and, on separation, will require either a kidney transplant or lifelong dialysis. This case report reviews one approach to analyzing and solving complex ethical dilemmas in pediatric plastic surgery. The principles reviewed are (1) autonomy and informed consent, focusing especially on the role of children in the informed consent process; (2) beneficence and nonmaleficence, two intricately intertwined principles because separation could potentially cause irreversible harm to one twin while improving the quality of life for the other (as separation is not a life-saving procedure, is it ethical to perform a procedure with unknown surgical risk to improve children's quality of life?); and (3) justice (is it fair to allocate excessive medical resources for the twins' separation?). The present report explores the ethics behind such decisions with respect to the separation of conjoined twins.

Ethics of primate use

NASA Astrophysics Data System (ADS)

Prescott, M. J.

2010-11-01

This article provides an overview of the ethical issues raised by the use of non-human primates (NHPs) in research involving scientific procedures which may cause pain, suffering, distress or lasting harm. It is not an exhaustive review of the literature and views on this subject, and it does not present any conclusions about the moral acceptability or otherwise of NHP research. Rather the aim has been to identify the ethical issues involved and to provide guidance on how these might be addressed, in particular by carefully examining the scientific rationale for NHP use, implementing fully the 3Rs principle of Russell and Burch (1959) and applying a robust "harm-benefit assessment" to research proposals involving NHPs.

Organ donation after cardiac death: legal and ethical justifications for antemortem interventions.

PubMed

Richards, Bernadette; Rogers, Wendy A

2007-08-06

Organ donation after cardiac death increases organ availability, but raises several legal and ethical issues, including consent. Medical interventions for people who are unconscious usually require guardian consent and must meet patients' best-interests standards. Antemortem procedures can improve the success of organ transplant after cardiac death, but do not serve the patient's medical interests, and it is contentious whether consent for antemortem interventions is legal under current Australian guardianship legislation. We argue that consent decisions should take patients' wishes as well as their medical interests into account. Antemortem interventions are ethically and legally justified if the interventions are not harmful and the person concerned wished to be an organ donor.

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2011 CFR

2011-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2012 CFR

2012-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure...

40 CFR 26.1706 - Criteria and procedure for decisions to protect public health by relying on otherwise...

Code of Federal Regulations, 2010 CFR

2010-07-01

... protect public health by relying on otherwise unacceptable research. 26.1706 Section 26.1706 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Ethical Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions § 26.1706 Criteria and procedure...

Contribution of the ethics committee of the French Intensive Care Society to describing a scenario for implementing organ donation after Maastricht type III cardiocirculatory death in France

PubMed Central

2012-01-01

French law allows organ donation after death due to cardiocirculatory arrest. In the Maastricht classification, type III non-heart-beating donors are those who experience cardiocirculatory arrest after the withdrawal of life-sustaining treatments. French authorities in charge of regulating organ donation (Agence de la Biomédecine, ABM) are considering organ collection from Maastricht type III donors. We describe a scenario for Maastricht type III organ donation that fully complies with the ethical norms governing care to dying patients. That organ donation may occur after death should have no impact on the care given to the patient and family. The dead-donor rule must be followed scrupulously: the organ retrieval procedure must neither cause nor hasten death. The decision to withdraw life-sustaining treatments, withdrawal modalities, and care provided to the patient and family must adhere strictly to the requirements set forth in patient-rights legislation (the 2005 Léonetti law in France) and should not be influenced in any way by the possibility of organ donation. A major ethical issue regarding the family is how best to transition from discussing treatment-withdrawal decisions to discussing possible organ retrieval for donation should the patient die rapidly after treatment withdrawal. Close cooperation between the healthcare team and the organ retrieval team is crucial to minimize the distress of family members during this transition. Modalities for implementing Maastricht type III organ donation are discussed here, including the best location for withdrawing life-sustaining treatments (operating room or intensive care unit). PMID:22747673

Ethical issues regarding caring for dermatology patients in the U.S. Department of Veterans Affairs Health Care System.

PubMed

Reich, Reuben; Stevens, Emily; Dellavalle, Robert P

2012-01-01

The U.S. Department of Veterans Affairs (VA) operates the largest integrated health care system within the United States. VA budgets continue to escalate in an environment of heightened financial prudence and accountability. Despite having received many awards in areas from patient satisfaction and safety to product innovations, like any health care system, the VA is not immune to ethical conflict that requires exploration and evaluation. Several VA dermatologists, including section chiefs, were interviewed, and their responses to ethical complexities encountered or anticipated were analyzed in fictional case scenarios. Five morally concerning issues were highlighted. These include (1) providing care in a teaching setting with limited resources to a patient population with few other health care alternatives; (2) stereotyping patients, altogether an uncommon act, is possibly easier to do in the VA and has the potential to negatively affect patient care; (3) service-related disability claim cases often include medical opinion and findings documented in the medical record when judgments are made, thus the VA physician can have a significant effect on the outcome of these claims; (4) whether the VA provides a setting for apathetic physicians to thrive or instead allows for a more meaningful work experience and then how to manage the subpar performer; (5) except for the treatment of HIV lipodystrophy with injectables, primary cosmetic procedures are prohibited at the VA and can lead to difficulties for the VA dermatologist attempting to comply in a era where dermatology is being more closely associated with cosmesis. Published by Elsevier Inc.

When Ethics Constrains Clinical Research: Trial Design of Control Arms in “Greater Than Minimal Risk” Pediatric Trials

PubMed Central

de Melo-Martín, Inmaculada; Sondhi, Dolan

2011-01-01

Abstract For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations. PMID:21446781

Are paediatric operations evidence based? A prospective analysis of general surgery practice in a teaching paediatric hospital.

PubMed

Zani-Ruttenstock, Elke; Zani, Augusto; Bullman, Emma; Lapidus-Krol, Eveline; Pierro, Agostino

2015-01-01

Paediatric surgical practice should be based upon solid scientific evidence. A study in 1998 (Baraldini et al., Pediatr Surg Int) indicated that only a quarter of paediatric operations were supported by the then gold standard of evidence based medicine (EBM) which was defined by randomized controlled trials (RCTs). The aim of the current study was to re-evaluate paediatric surgical practice 16 years after the previous study in a larger cohort of patients. A prospective observational study was performed in a tertiary level teaching hospital for children. The study was approved by the local research ethics board. All diagnostic and therapeutic procedures requiring a general anaesthetic carried out over a 4-week period (24 Feb 2014-22 Mar 2014) under the general surgery service or involving a general paediatric surgeon were included in the study. Pubmed and EMBASE were used to search in the literature for the highest level of evidence supporting the recorded procedures. Evidence was classified according to the Oxford Centre for Evidence Based Medicine (OCEBM) 2009 system as well as according to the classification used by Baraldini et al. Results was compared using Χ (2) test. P < 0.05 was considered statistically significant. During the study period, 126 operations (36 different types) were performed on 118 patients. According to the OCEBM classification, 62 procedures (49 %) were supported by systematic reviews of multiple homogeneous RCTs (level 1a), 13 (10 %) by individual RCTs (level 1b), 5 (4 %) by systematic reviews of cohort studies (level 2a), 11 (9 %) by individual cohort studies, 1 (1 %) by systematic review of case-control studies (level 3a), 14 (11 %) by case-control studies (level 3b), 9 (7 %) by case series (type 4) and 11 procedures (9 %) were based on expert opinion or deemed self-evident interventions (type 5). High level of evidence (OCEBM level 1a or 1b or level I according to Baraldini et al. PSI 1998) supported 75 (60 %) operations in the current study compared to 18 (26 %) in the study of 1998 (P < 0.0001). The present study shows that nowadays a remarkable number of paediatric surgical procedures are supported by high level of evidence. Despite this improvement in evidence-based paediatric surgical practice, more than a third of the procedures still lack sufficient evidence-based literature support. More RCTs are warranted to support and direct paediatric surgery practice according to the principals of EBM.

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

PubMed

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

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

The Navy’s Moral Compass: Commanding Officers and Personal Misconduct

DTIC Science & Technology

2016-07-01

commanding officer corps and our service, to take positive action to develop each officer’s moral compass and establish an ethical standard. Step One...high moral ground in their discretionary judgments. Furthermore, the Army Operating Concept of 2010 includes three pages of ethical and behavioral...Journal of Business Ethics 12, no. 6 (1993), p. 265. 24. U.S. Navy Dept., U.S. Navy Regulations (Washington, D.C.: 1990), sec. 802, para. 1. 25

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

Institutional Ethical Review and Ethnographic Research Involving Injection Drug Users: A Case Study

PubMed Central

Small, Will; Maher, Lisa; Kerr, Thomas

2014-01-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators’ responses to the committee’s concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. PMID:24581074

Strategic Leadership Development: An Operation Domain Application

DTIC Science & Technology

1997-03-01

effectiveness. Notes 1 Quoted in Stephen R. Covey The 7 Habits of Highly Effective People : Restoring the Character Ethic (New York: Simon and Schuster...Press, Inc., 1993. Covey, Stephen R. The 7 Habits of Highly Effective People : Restoring the Character Ethic. New York, Simon and Schuster 1989

24 CFR 320.3 - Eligible issuers of securities.

Code of Federal Regulations, 2014 CFR

2014-04-01

... policies of the issuer permit any discrimination based on race, religion, color, national origin, age, or...) Ethics and standards. A mortgage lender shall qualify as an eligible issuer only so long as it conducts its business operations in accordance with accepted mortgage banking practices, ethics, and standards...

24 CFR 320.3 - Eligible issuers of securities.

Code of Federal Regulations, 2012 CFR

2012-04-01

... policies of the issuer permit any discrimination based on race, religion, color, national origin, age, or...) Ethics and standards. A mortgage lender shall qualify as an eligible issuer only so long as it conducts its business operations in accordance with accepted mortgage banking practices, ethics, and standards...

24 CFR 320.3 - Eligible issuers of securities.

Code of Federal Regulations, 2013 CFR

2013-04-01

... policies of the issuer permit any discrimination based on race, religion, color, national origin, age, or...) Ethics and standards. A mortgage lender shall qualify as an eligible issuer only so long as it conducts its business operations in accordance with accepted mortgage banking practices, ethics, and standards...

Therapeutic cloning: from consequences to contradiction.

PubMed

Coors, Marilyn

2002-06-01

The British Parliament legalized therapeutic cloning in December 2000 despite opposition from the European Union. The watershed event in Parliament's move was the active and unprecedented government support for the generation and destruction of human embryonic life merely as a means of medical advancement. This article contends that the utilitarian analysis of this procedure is necessary to identify the real world risks of therapeutic cloning but insufficient to identify the breach of defensible ethical limits that this procedure represents. A value-oriented approach to Kantian ethics demonstrates that the utilitarian endorsement of therapeutic cloning entails a contradiction of the necessity of human vulnerability and a faulty valuation of the human embryo. The concern is that a narrow utilitarian focus ultimately commodifies human embryonic life and preferences outcomes as the sole determinant of moral value.

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

What is it to practise good medical ethics? A Muslim's perspective.

PubMed

Serour, G I

2015-01-01

Good medical ethics should aim at ensuring that all human beings enjoy the highest attainable standard of health. With the development of medical technology and health services, it became necessary to expand the four basic principles of medical ethics and link them to human rights. Despite the claim of the universality of those ethical principles, their perception and application in healthcare services are inevitably influenced by the religious background of the societies in which those services are provided. This paper highlights the methodology and principles employed by Muslim jurists in deriving rulings in the field of medical ethics, and it explains how ethical principles are interpreted through the lens of Islamic theory. The author explains how, as a Muslim obstetrician-gynaecologist with a special interest in medical ethics, including international consideration of reproductive ethics issues, he attempts to 'practise good medical ethics' by applying internationally accepted ethical principles in various healthcare contexts, in ways that are consistent with Islamic principles, and he identifies the evidence supporting his approach. He argues that healthcare providers have a right to respect for their conscientious convictions regarding both undertaking and not undertaking the delivery of lawful procedures. However, he also argues that withholding evidence-based medical services based on the conscientious objection of the healthcare provider is unethical as patients have the right to be referred to services providing such treatment. 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.

Multimedia Information eXchange for I-NET, Inc. at the Kennedy Space Center: A continuing study of the application of worldwideweb technology

NASA Technical Reports Server (NTRS)

Metcalf, David

1995-01-01

Multimedia Information eXchange (MIX) is a multimedia information system that accommodates multiple data types and provides consistency across platforms. Information from all over the world can be accessed quickly and efficiently with the Internet-based system. I-NET's MIX uses the World Wide Web and Mosaic graphical user interface. Mosaic is available on all platforms used at I-NET's Kennedy Space Center (KSC) facilities. Key information system design concepts and benefits are reviewed. The MIX system also defines specific configuration and helper application parameters to ensure consistent operations across the entire organization. Guidelines and procedures for other areas of importance in information systems design are also addressed. Areas include: code of ethics, content, copyright, security, system administration, and support.

Organ procurement after euthanasia: Belgian experience.

PubMed

Ysebaert, D; Van Beeumen, G; De Greef, K; Squifflet, J P; Detry, O; De Roover, A; Delbouille, M-H; Van Donink, W; Roeyen, G; Chapelle, T; Bosmans, J-L; Van Raemdonck, D; Faymonville, M E; Laureys, S; Lamy, M; Cras, P

2009-03-01

Euthanasia was legalized in Belgium in 2002 for adults under strict conditions. The patient must be in a medically futile condition and of constant and unbearable physical or mental suffering that cannot be alleviated, resulting from a serious and incurable disorder caused by illness or accident. Between 2005 and 2007, 4 patients (3 in Antwerp and 1 in Liège) expressed their will for organ donation after their request for euthanasia was granted. Patients were aged 43 to 50 years and had a debilitating neurologic disease, either after severe cerebrovascular accident or primary progressive multiple sclerosis. Ethical boards requested complete written scenario with informed consent of donor and relatives, clear separation between euthanasia and organ procurement procedure, and all procedures to be performed by senior staff members and nursing staff on a voluntary basis. The euthanasia procedure was performed by three independent physicians in the operating room. After clinical diagnosis of cardiac death, organ procurement was performed by femoral vessel cannulation or quick laparotomy. In 2 patients, the liver, both kidneys, and pancreatic islets (one case) were procured and transplanted; in the other 2 patients, there was additional lung procurement and transplantation. Transplant centers were informed of the nature of the case and the elements of organ procurement. There was primary function of all organs. The involved physicians and transplant teams had the well-discussed opinion that this strong request for organ donation after euthanasia could not be waived. A clear separation between the euthanasia request, the euthanasia procedure, and the organ procurement procedure is necessary.

Putting Public Health Ethics into Practice: A Systematic Framework

PubMed Central

Marckmann, Georg; Schmidt, Harald; Sofaer, Neema; Strech, Daniel

2015-01-01

It is widely acknowledged that public health practice raises ethical issues that require a different approach than traditional biomedical ethics. Several frameworks for public health ethics (PHE) have been proposed; however, none of them provides a practice-oriented combination of the two necessary components: (1) a set of normative criteria based on an explicit ethical justification and (2) a structured methodological approach for applying the resulting normative criteria to concrete public health (PH) issues. Building on prior work in the field and integrating valuable elements of other approaches to PHE, we present a systematic ethical framework that shall guide professionals in planning, conducting, and evaluating PH interventions. Based on a coherentist model of ethical justification, the proposed framework contains (1) an explicit normative foundation with five substantive criteria and seven procedural conditions to guarantee a fair decision process, and (2) a six-step methodological approach for applying the criteria and conditions to the practice of PH and health policy. The framework explicitly ties together ethical analysis and empirical evidence, thus striving for evidence-based PHE. It can provide normative guidance to those who analyze the ethical implications of PH practice including academic ethicists, health policy makers, health technology assessment bodies, and PH professionals. It will enable those who implement a PH intervention and those affected by it (i.e., the target population) to critically assess whether and how the required ethical considerations have been taken into account. Thereby, the framework can contribute to assuring the quality of ethical analysis in PH. Whether the presented framework will be able to achieve its goals has to be determined by evaluating its practical application. PMID:25705615

Management of ethical issues related to care of seriously ill dialysis patients in free-standing facilities.

PubMed

Song, Mi-Kyung; Hanson, Laura C; Gilet, Constance A; Jo, Minjeong; Reed, Teresa J; Hladik, Gerald A

2014-09-01

There are few data on the frequency and current management of clinical ethical issues related to care of seriously ill dialysis patients in free-standing dialysis facilities. To examine the extent of clinical ethical challenges experienced by care providers in free-standing facilities and their perceptions about how those issues are managed. A total of 183 care providers recruited from 15 facilities in North Carolina completed a survey regarding the occurrence and management of ethical issues in the past year. Care plan meetings were observed at four of the facilities for three consecutive months. Also, current policies and procedures at each of the facilities were reviewed. The two most frequently experienced challenges involved dialyzing frail patients with multiple comorbidities and caring for disruptive/difficult patients. The most common ways of managing ethical issues were discussions in care plan meetings (n = 47) or discussions with the clinic manager (n = 47). Although policies were in place to guide management of some of the challenges, respondents were often not aware of those policies. Also, although participants reported that ethical issues related to dialyzing undocumented immigrants were fairly common, no facility had a policy for managing this challenge. Participants suggested that all staff obtain training in clinical ethics and communication skills, facilities develop ethics teams, and there be clear policies to guide management of ethical challenges. The scope of ethical challenges was extensive, how these challenges were managed varied widely, and there were limited resources for assistance. Multifaceted efforts, encompassing endeavors at the individual, facility, organization, and national levels, are needed to support staff in improving the management of ethical challenges in dialysis facilities. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

[Establishing and operating a human biobank. Ethical aspects].

PubMed

Jahns, Roland

2016-03-01

Particularly in the past decade which has been marked by efforts to foster individualized/personalized medicine the need for well-characterized high-quality collections of human biological material has significantly increased. When establishing and operating a human biobank the interests and the "freedom" of biomedical research must always be weighed against the interests and rights of patients and/or donors; in this process ethical aspects should be considered systematically. In addition, the importance of quality control and quality assurance has largely increased in human biobanking, both from a scientific and even more from an ethical point of view, because donated biological materials are potentially stored for decades and (on request) might serve for currently not foreseeable biomedical research purposes. In addition, the compatibility of national human biobanks with international biobank networks becomes increasingly important.

The investigation of life-threatening child abuse and Munchausen syndrome by proxy.

PubMed Central

Evans, D

1995-01-01

The use of covert video surveillance in the investigation of suspected life-threatening child abuse and Munchausen syndrome by proxy raises important ethical questions. That the recently reported provision of this facility in North Staffordshire was not presented to a Local Research Ethics Committee (LREC) for approval as a research exercise raises important questions about the ethical review of research and practice. The case made for avoiding such review is first set out and then examined. The three main premisses which form the basis of the view that LREC approval is not required are identified and tested in turn. The conclusion is that there is an undeniable element of research involved in the procedure and that the welfare of all those subjected to the surveillance would be best protected by the submission of the protocol to an independent committee for ethical assessment. PMID:7776355

[Care between ethics, work and political].

PubMed

Svandra, Philippe

2015-09-01

Down to the roots, the ethics of care have stood up a "different voice". Building on Carol Gilligan's works, the concept was developed widely in opposition with the rational and universalist aspect of Kant's moral philosophy. However, it also appears that this vision of care runs counter sets the three other main dominant moral theories, ie, utilitarism, John Rawls' procedural ethics and the Aristotelian virtue ethics. We may assert that the care theory presents itself as a contextualized moral theory aiming at taking into account others' vulnerability, in a practical way. Hence, the general term of "care" may encompass the notions of "help", "support" and "healing process", which, in France, for have often been opposed for varied reasons--historical, economical, psychological, professional etc... Switching from a moral position to a professional and practical activity, the concept of care has now undeniably taken on now a social and political dimension.

Imaginative ethics--bringing ethical praxis into sharper relief.

PubMed

Hansson, Mats G

2002-01-01

The empirical basis for this article is three years of experience with ethical rounds at Uppsala University Hospital. Three standard approaches of ethical reasoning are examined as potential explanations of what actually occurs during the ethical rounds. For reasons given, these are not found to be satisfying explanations. An approach called "imaginative ethics", is suggested as a more satisfactory account of this kind of ethical reasoning. The participants in the ethical rounds seem to draw on a kind of moral competence based on personal life experience and professional competence and experience. By listening to other perspectives and other experiences related to one particular patient story, the participants imagine alternative horizons of moral experience and explore a multitude of values related to clinical practice that might be at stake. In his systematic treatment of aesthetics in the Critique of Judgement, Kant made use of an operation of thought that, if applied to ethics, will enable us to be more sensitive to the particulars of each moral situation. Based on this reading of Kant, an account of imaginative ethics is developed in order to bring the ethical praxis of doctors and nurses into sharper relief. The Hebraic and the Hellenic traditions of imagination are used in order to illuminate some of the experiences of ethical rounds. In conclusion, it is argued that imaginative ethics and principle-based ethics should be seen as complementary in order to endow a moral discourse with ethical authority. Kantian ethics will do the job if it is remembered that Kant suggested only a modest, negative role of principle-based deliberation.

Using newly deceased patients in teaching clinical skills: its ethical and educational challenges.

PubMed

Saber, Mahboobeh; Enjoo, Seyed Ali; Mahboudi, Ali; Tabei, Seyed Ziaadin

2018-04-01

The newly deceased patients have long been used in medical schools to teach clinical skills without any challenges as it helps to train skilled doctors. Nowadays, the use of moulages and simulators are common in teaching clinical skills since these tools provide the opportunity for frequent practice without any pain and injury. There are specific procedures which still require the use of cadavers. However, the increased significance of patient rights has generally challenged the practicality of using the deceased bodies for this purpose. This study was designed with the aim of determining to what extent clinical skill training is dependent on the recently deceased patients. This was a cross-sectional mixed-method triangulation design conducted in two phases. In the first phase, a researcher-made questionnaire was used to collect quantitative data of the medical students and residents. The data were used to assess the frequency of experience. In the second stage, semi-structured interviews were conducted with faculty members and fellows in order to evaluate the educational impact of this type of procedure and the influential factors. The quantitative data were analyzed using statistical software, and the qualitative codes were extracted following a content analysis. Finally, a comparative analysis was performed. Twenty five residents (26%) and seven medical students (14%) had the experience of performing procedures on the recently deceased patients for training purposes. About half of the residents and 33% of the medical students had observed their colleagues practicing procedures on cadavers. In the qualitative phase, the main categories included professional ethics, law and educational requirements. A relatively low number of medical students and residents had experienced procedures on the newly deceased patients. In this regard, ethical, religious and legal concerns might have played a part despite the desire to learn. It would be effective to direct these educational experiences toward procedures that cannot be mastered through moulages and simulators, and to lay the legal and executive ground so that performing these procedures under the supervision of professors, and with a level of documentation would have no legal challenges.

It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

PubMed

Ravinetto, Raffaella; Tinto, Halidou; Diro, Ermias; Okebe, Joseph; Mahendradhata, Yodi; Rijal, Suman; Gotuzzo, Eduardo; Lutumba, Pascal; Nahum, Alain; De Nys, Katelijne; Casteels, Minne; Boelaert, Marleen

2016-01-01

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global', 'context centred' and 'patient centred'.

The new military medical ethics: legacies of the Gulf Wars and the War on Terror.

PubMed

Miles, Steven H

2013-03-01

United States military medical ethics evolved during its involvement in two recent wars, Gulf War I (1990-1991) and the War on Terror (2001-). Norms of conduct for military clinicians with regard to the treatment of prisoners of war and the administration of non-therapeutic bioactive agents to soldiers were set aside because of the sense of being in a 'new kind of war'. Concurrently, the use of radioactive metal in weaponry and the ability to measure the health consequences of trade embargos on vulnerable civilians occasioned new concerns about the health effects of war on soldiers, their offspring, and civilians living on battlefields. Civilian medical societies and medical ethicists fitfully engaged the evolving nature of the medical ethics issues and policy changes during these wars. Medical codes of professionalism have not been substantively updated and procedures for accountability for new kinds of abuses of medical ethics are not established. Looking to the future, medicine and medical ethics have not articulated a vision for an ongoing military-civilian dialogue to ensure that standards of medical ethics do not evolve simply in accord with military exigency. © 2011 Blackwell Publishing Ltd.

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.

Revisiting the Biomedicalization of Aging: Clinical Trends and Ethical Challenges

PubMed Central

Kaufman, Sharon R.; Shim, Janet K.; Russ, Ann J.

2008-01-01

Developments in the realms of medical innovation and geriatric clinical intervention impact our understanding of the nature of late life, the possibilities for health in advanced age, medical decision making, and family responsibility in ways that could not have been predicted 15 years ago. This essay begins to map new forms of biomedicalization in the U.S. and to underscore their emergence in a new ethical field. We suggest that a new kind of ethical knowledge is emerging through “routine” clinical care, and we offer examples from the following interventions: cardiac procedures, kidney dialysis, and kidney transplant. This new ethical knowledge is characterized by the difficulty of saying “no” to life-extending interventions, regardless of age. We explore the intensification of the biomedicalization of old age through a discussion of three features of the new ethical field: (a) the ways in which routine medical care overshadows choice; (b) the transformation of the technological imperative to a moral imperative; and (c) the coupling of hope with the normalization and routinization of life-extending interventions. We argue that societal expectations about longevity and standard medical care come together today in a shifting ethics of normalcy, with unexplored sociocultural ramifications. PMID:15611209

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.

Ethics in computer software design and development

Treesearch

Alan J. Thomson; Daniel L. Schmoldt

2001-01-01

Over the past 20 years, computer software has become integral and commonplace for operational and management tasks throughout agricultural and natural resource disciplines. During this software infusion, however, little thought has been afforded human impacts, both good and bad. This paper examines current ethical issues of software system design and development in...

Effects of situational conditions on students' views of business ethics.

PubMed

Matsui, Tamao; Kakuyama, Takashi; Tsuzuki, Yukie

2003-12-01

This study investigated undergraduates' responses regarding selected ethical issues facing managers and employees of today's businesses. The focus of the study lies in the influences of two situational variables (organizational roles and prospects) on students' response pattern. Japanese students (306 men and 81 women, M = 20.1 yr., SD = 2.2) imagined that they were managers or operative employees of a middle-sized manufacturing company and that their company had high or low prospects. The response pattern tended to be more ethical for "managers," whereas the response pattern tended to be less ethical for "employees" in a "low prospect" than in a "high prospect" company.

Stem Cell Trials for Cardiovascular Medicine: Ethical Rationale

PubMed Central

Teraa, Martin; Hesam, Husna; van Delden, Johannes J.M.; Verhaar, Marianne C.; Bredenoord, Annelien L.

2014-01-01

Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to maneuver between the Skylla of hyper accelerated translation without rigorously conducted RCTs and the Charybdis of the missed opportunity of valuable knowledge. PMID:24164351

The development and psychometric validation of the Ethical Awareness Scale.

PubMed

Milliken, Aimee; Ludlow, Larry; DeSanto-Madeya, Susan; Grace, Pamela

2018-04-19

To develop and psychometrically assess the Ethical Awareness Scale using Rasch measurement principles and a Rasch item response theory model. Critical care nurses must be equipped to provide good (ethical) patient care. This requires ethical awareness, which involves recognizing the ethical implications of all nursing actions. Ethical awareness is imperative in successfully addressing patient needs. Evidence suggests that the ethical import of everyday issues may often go unnoticed by nurses in practice. Assessing nurses' ethical awareness is a necessary first step in preparing nurses to identify and manage ethical issues in the highly dynamic critical care environment. A cross-sectional design was used in two phases of instrument development. Using Rasch principles, an item bank representing nursing actions was developed (33 items). Content validity testing was performed. Eighteen items were selected for face validity testing. Two rounds of operational testing were performed with critical care nurses in Boston between February-April 2017. A Rasch analysis suggests sufficient item invariance across samples and sufficient construct validity. The analysis further demonstrates a progression of items uniformly along a hierarchical continuum; items that match respondent ability levels; response categories that are sufficiently used; and adequate internal consistency. Mean ethical awareness scores were in the low/moderate range. The results suggest the Ethical Awareness Scale is a psychometrically sound, reliable and valid measure of ethical awareness in critical care nurses. © 2018 John Wiley & Sons Ltd.

Female genital mutilation: when a cultural practice generates clinical and ethical dilemmas.

PubMed

Gibeau, A M

1998-01-01

Female genital mutilation (FGM) is of growing concern to health care providers in the United States and Canada as more women from countries where the procedure is practiced emigrate to North America. An introduction to the demographics of FGM, including prevalence rates, is a necessary antecedent for understanding the cultural rationales for this widespread practice. Considering the health consequences of this practice promotes questions about legal and ethical aspects of care as North Americans approach FGM from their own individual cultural frameworks.

[Pneumothorax following dry needling treatment: legal and ethical aspects].

PubMed

Ronconi, Gianpaolo; De Giorgio, Fabio; Ricci, Eleonora; Maggi, Loredana; Spagnolo, Antonio G; Ferrara, Paola Emilia

2016-01-01

Trigger point "dry needling" is a technique used to treat myofascial pain. It involves using filiform needles which are inserted into muscles to give local pain relief. Few cases of serious adverse events following this treatment have been reported in the literature. In this paper we describe the case of a professional swimmer who developed pneumothorax after dry needling treatment and discuss the medicolegal and ethical aspects related to competencies and responsibilities of medical doctors and physiotherapists performing the procedure.

29 CFR 1404.4 - Roster and status of members.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... Arbitrators shall conform to the ethical standards and procedures set forth in the Code of Professional... arbitrators or factfinders which include consideration of such factors as background and experience...

[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.

Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee.

PubMed

Tersmette, Derek Gideon; Engberts, Dirk Peter

2017-01-01

The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.

Prevalence and content of written ethics policies on euthanasia in Catholic healthcare institutions in Belgium (Flanders).

PubMed

Gastmans, Chris; Lemiengre, Joke; van der Wal, Gerrit; Schotsmans, Paul; Dierckx de Casterlé, Bernadette

2006-04-01

Euthanasia is performed worldwide, regardless of the existence of laws governing it. Belgium became the second country in the world to enact a law on euthanasia in 2002. Healthcare institutions bear responsibility for guaranteeing the quality of care for patients at the end of life, and for ensuring support for caregivers involved. Therefore, institutional ethics policies on end-of-life decision-making, especially on euthanasia, may be useful. A cross-sectional mail survey of general directors of Catholic hospitals and nursing homes in Belgium was used to describe the prevalence and content of written ethics policies for competent terminally ill, incompetent terminally ill, and non-terminally ill patients. Of the 298 targeted institutions, 81% of hospitals and 62% of nursing homes returned complete questionnaires. Of these, 79% of hospitals and 30% of nursing homes had a written ethics policy on euthanasia. Of hospitals 83% and of nursing homes 85% permitted euthanasia for competent terminally ill patients only in exceptional cases in accordance with legal due care criteria and provisions outlined by the palliative filter procedure. Euthanasia for incompetent terminally ill patients was prohibited by 27% of the hospitals and by 60% of the nursing homes. For non-terminally ill patients, these figures were 43 and 64%, respectively. Catholic healthcare institutions in Belgium (Flanders) made great efforts to develop written ethics policies on euthanasia. Only a small group of institutions completely prohibited euthanasia. Most of the institutions considered euthanasia to be an option if all possible alternatives (e.g., palliative filter procedure, which contains more rigorous criteria than those in the Belgian Euthanasia Act), have been thoroughly investigated.

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

PubMed

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

2015-01-01

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

The organizational costs of ethical conflicts.

PubMed

Nelson, William A; Weeks, William B; Campfield, Justin M

2008-01-01

Ethical conflicts are a common phenomenon in today's healthcare settings. As healthcare executives focus on balancing quality care and cost containment, recognizing the costs associated with ethical conflicts is only logical. In this article, we present five case vignettes to identify several general cost categories related to ethical conflicts, including operational costs, legal costs, and marketing and public relations costs. In each of these cost categories, the associated direct, indirect, and long-term costs of the ethical conflict are explored as well. Our analysis suggests that organizations have, in addition to philosophical reasons, financial incentives to focus on decreasing the occurrence of ethical conflicts. The cost categories affected by ethical conflicts are not insignificant. Such conflicts can affect staff morale and lower the organization's overall culture and profit margin. Therefore, organizations should develop mechanisms and strategies for decreasing and possibly preventing ethical conflicts. The strategies suggested in this article seek to shift the organization's focus when dealing with conflicts, from just reacting to moving upstream-that is, understanding the root causes of ethical conflicts and employing approaches designed to reduce their occurrence and associated costs. Such an effort has the potential to enhance the organization's overall culture and ultimately lead to organizational success.

Ethical aspects of registry-based research in the Nordic countries

PubMed Central

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

2015-01-01

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

Continuous Evaluation in Ethics Education: A Case Study.

PubMed

McIntosh, Tristan; Higgs, Cory; Mumford, Michael; Connelly, Shane; DuBois, James

2018-04-01

A great need for systematic evaluation of ethics training programs exists. Those tasked with developing an ethics training program may be quick to dismiss the value of training evaluation in continuous process improvement. In the present effort, we use a case study approach to delineate how to leverage formative and summative evaluation measures to create a high-quality ethics education program. With regard to formative evaluation, information bearing on trainee reactions, qualitative data from the comments of trainees, in addition to empirical findings, can ensure that the training program operates smoothly. Regarding summative evaluation, measures examining trainee cognition, behavior, and organization-level results provide information about how much trainees have changed as a result of taking the ethics training. The implications of effective training program evaluation are discussed.

Collections of human biological samples for scientific purposes. Why do current regulation need to be clarified and how?

PubMed

Deplanque, Dominique; Birraux, Guillaume; Bertoye, Pierre-Henri; Postaire, Eric

2009-01-01

The collection of human biological samples is of major importance for future research in France and Europe. In recent years, new regulatory procedures have been designed to monitor these activities; but they are somewhat complex and some clarifications are needed. The law needs also to be amended. The definition of biobanking activities should be clarified, and regulatory procedures, including consultation of the Ethics Committee, declarations to the Ministry of Research and the protection of personal data, should be simplified. It is also of great importance to correctly define the modalities in which Biobanks are granted their authorisations. The role of Ethics Committees regarding the evaluation of information and the consent procedures should also be clarified, particularly when samples from children are used, or when the samples are used for genetic analyses. As well as scientific and public health aspects, the storage of human biological samples may also have important economic consequences. It is hence crucial to adapt the procedure for submitting patents, particularly when several public or private partners are working together. The possible changes to both French and European laws planned in the next months would be an ideal time to introduce these changes.

The history of head transplantation: a review.

PubMed

Lamba, Nayan; Holsgrove, Daniel; Broekman, Marike L

2016-12-01

Since the turn of the last century, the prospect of head transplantation has captured the imagination of scientists and the general public. Recently, head transplant has regained attention in popular media, as neurosurgeons have proposed performing this procedure in 2017. Given the potential impact of such a procedure, we were interested in learning the history of the technical hurdles that need to be overcome, and determine if it is even technically possible to perform such a procedure on humans today. We conducted a historical review of available literature on the technical challenges and developments of head transplantation. The many social, psychological, ethical, religious, cultural, and legal questions of head transplantation were beyond the scope of this review. Our historical review identified the following important technical considerations related to performing a head transplant: maintenance of blood flow to an isolated brain via vessel anastomosis; availability of immunosuppressive agents; spinal anastomosis and fusion following cord transfection; pain control in the recipient. Several animal studies have demonstrated success in maintaining recipient cerebral perfusion and achieving immunosuppression. However, there is currently sparse evidence in favor of successful spinal anastomosis and fusion after transection. While recent publications by an Italian group offer novel approaches to this challenge, research on this topic has been sparse and hinges on procedures performed in animal models in the 1970s. How transferrable these older methods are to the human nervous system is unclear and warrants further exploration. Our review identified several important considerations related to performing a viable head transplantation. Besides the technical challenges that remain, there are important ethical issues to consider, such as exploitation of vulnerable patients and informed consent. Thus, besides the remaining technical challenges, these ethical issues will also need to be addressed before moving these studies to the clinic.

Past, Present, and Future of Minimally Invasive Abdominal Surgery

PubMed Central

Antoniou, George A.; Antoniou, Athanasios I.; Granderath, Frank-Alexander

2015-01-01

Laparoscopic surgery has generated a revolution in operative medicine during the past few decades. Although strongly criticized during its early years, minimization of surgical trauma and the benefits of minimization to the patient have been brought to our attention through the efforts and vision of a few pioneers in the recent history of medicine. The German gynecologist Kurt Semm (1927–2003) transformed the use of laparoscopy for diagnostic purposes into a modern therapeutic surgical concept, having performed the first laparoscopic appendectomy, inspiring Erich Mühe and many other surgeons around the world to perform a wide spectrum of procedures by minimally invasive means. Laparoscopic cholecystectomy soon became the gold standard, and various laparoscopic procedures are now preferred over open approaches, in the light of emerging evidence that demonstrates less operative stress, reduced pain, and shorter convalescence. Natural orifice transluminal endoscopic surgery (NOTES) and single-incision laparoscopic surgery (SILS) may be considered further steps toward minimization of surgical trauma, although these methods have not yet been standardized. Laparoscopic surgery with the use of a robotic platform constitutes a promising field of investigation. New technologies are to be considered under the prism of the history of surgery; they seem to be a step toward further minimization of surgical trauma, but not definite therapeutic modalities. Patient safety and medical ethics must be the cornerstone of future investigation and implementation of new techniques. PMID:26508823

[Critical appraisal of organ procurement under Maastricht 3 condition].

PubMed

Puybasset, L; Bazin, J-E; Beloucif, S; Bizouarn, P; Crozier, S; Devalois, B; Eon, B; Fieux, F; Gisquet, E; Guibet-Lafaye, C; Kentish, N; Lienhart, A; Nicolas-Robin, A; Otero Lopez, M; Pelluchon, C; Roussin, F; Beydon, L

2012-05-01

The ethics committee of the French Society of Anesthesia and Intensive Care (Sfar) has been requested by the French Biomedical Agency to consider the issue of organ donation in patients after a decision of withdrawing life supporting therapies has been taken. This category of organ donation is performed in the USA, Canada, United Kingdom, the Netherlands and Belgium. The three former countries have published recommendations, which formalize procedures and operations. The Sfar ethics committee has considered this issue and envisioned the different aspects of the whole process. Consequently, it sounds a note of caution regarding the applicability of this type of organ procurement in unselected patient following a decision to withdraw life supporting therapies. According to the French regulation concerning organ procurement in brain dead patients, the committee stresses the need to restrict this specific way of procurement to severely brain injured patients, once confirmatory investigations predicting a catastrophic prognosis have been performed. It suggests that the nature of the confirmatory investigation required should be formalized by the French Biomedical Agency on behalf of the French parliamentarians. This should help preserving population trust regarding organ procurement and provide a framework to medical decision. This text has been endorsed by the Sfar. Copyright © 2012. Published by Elsevier SAS.

Thank you for your lovely card: ethical considerations in responding to bereaved parents invited in error to participate in childhood cancer survivorship research.

PubMed

Wakefield, Claire E; McLoone, Jordana K; Donovan, Leigh A; Cohn, Richard J

2015-02-01

Research exploring the needs of families of childhood cancer survivors is critical to improving the experiences of future families faced by this disease. However, there are numerous challenges in conducting research with this unique population, including a relatively high mortality rate. In recognition that research with cancer survivors is a relational activity, this article presents a series of cases of parents bereaved by childhood cancer who unintentionally received invitations to participate in survivorship research. We explore six ethical considerations, and compare our experiences with that described previously. Our considerations include the sharing of confidential information with external parties to confirm past patients' vital status and appropriate researcher responses to bereaved parents. The management of researchers' emotional safety when working with illness populations and the fact that study invitations can elicit grief responses in non-bereaved families are discussed. To conclude, we argue for the benefits of inviting bereaved parents whose children died after treatment completion in survivorship research. Such parents' early survivorship experiences will otherwise be systemically neglected. We argue that discussing complex cases can assist researchers to protect participants' and researchers' emotional well-being. We hope to contribute to the dearth of discussion about research operating procedures to address these issues.

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.

Microsurgical Resection of a Solitary Spinal Epidural Cavernous Angioma: 3-Dimensional Operative Video.

PubMed

Ceccato, Guilherme H W; Henning, Lucélio; Prado, Julyana L; Rassi, Marcio S; Borba, Luis A B

2018-05-21

Solitary spinal epidural cavernous angiomas are rare vascular malformations. Surgical excision is the treatment of choice, as these lesions tend to grow or bleed at some point. In this 3-dimensional, narrated video, we present the case of a 61-year-old male who presented with progressive pain in the right paravertebral region secondary to an epidural cavernous angioma located at the T6/T7 level. Under intraoperative neurophysiological monitoring, a laminectomy between T5 and T7 was performed. A reddish, well delimited, and highly vascularized epidural mass was identified and dissected from the adjacent dura and nerve root, and an en bloc total resection was achieved. The patient was discharged neurologically intact on postoperative day 4, presenting a remarkable improvement of his pain at 2-month follow-up. Total excision of these lesions is possible in most of cases, remaining the standard treatment, with minimum complications. All procedures were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All data related to patient identification were removed from this surgical video and manuscript, with no need of a written informed consent.

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.

Ethics of placebo-controlled clinical trials in multiple sclerosis: a reassessment.

PubMed

Polman, C H; Reingold, S C; Barkhof, F; Calabresi, P A; Clanet, M; Cohen, J A; Cutter, G R; Freedman, M S; Kappos, L; Lublin, F D; McFarland, H F; Metz, L M; Miller, A E; Montalban, X; O'Connor, P W; Panitch, H; Richert, J R; Petkau, J; Schwid, S R; Sormani, M P; Thompson, A J; Weinshenker, B G; Wolinsky, J S

2008-03-25

The increasing number of established effective therapies for relapsing multiple sclerosis (MS) and emerging consensus for early treatment raise practical concerns and ethical dilemmas for placebo-controlled clinical trials in this disease. An international group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to reconsider prior recommendations regarding the ethics of placebo-controlled trials in MS. The group concluded that placebo-controlled trials can still be done ethically, with restrictions. For patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons (e.g., economics). Suggestions are provided to protect subject autonomy and improve informed consent procedures. Recommendations are tighter than previously suggested for placebo-controlled trials in "resource-restricted" environments where established therapies may not be available. Guidance is also provided on the ethics of alternative trial designs and the balance between study subject burden and risk, scientific rationale and interpretability of trial outcomes.

A Framework for Ethical Decision Making in the Rehabilitation of Patients with Anosognosia.

PubMed

Egbert, Anna Rita

2017-01-01

Currently, the number of patients diagnosed with impaired self-awareness of their own deficits after brain injury-anosognosia-is increasing. One reason is a growing understanding of this multifaceted phenomenon. Another is the development and accessibility of alternative measurements that allow more detailed diagnoses. Anosognosia can adversely affect successful rehabilitation, as often patients lack confidence in the need for treatment. Planning such treatment can become a complex process full of ethical dilemmas. To date, there is no systematic way to deal with different aspects of anosognosia rehabilitation planning. This is the first article to present a framework for ethical decision making in establishing rehabilitation plans that are focused on increasing patients' self-awareness of their own deficits after brain injury. It concentrates especially on addressing the ethical dilemmas that may arise, and describes stepwise procedures that can be applied to distinct theoretical approaches, as well as diagnostic and rehabilitation methods. To show the flexibility of the use of this framework, alternative approaches are discussed. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

Bioethics and the demise of the concept of human dignity: has medicine killed ethics?

PubMed

Kirchhoffer, David G

2011-01-01

The rise of "dignity talk" has led to the concept of human dignity being criticized in recent years. Some critics argue that human dignity must either be something we have or something we acquire. Others argue that there is no such thing as human dignity and people really mean something else when they appeal to it. Both "dignity talk" and the criticisms arise from a problematic conception of medical ethics as a legalistic, procedural techne. A retrieval of hermeneutical ethics, by contrast, offers a way to overcome both the legalism of contemporary ethics and the abuses and criticisms of the concept of human dignity. Such an ethics affirms both the inherent dignity of a human being as a multi-dimensional, meaning-seeking, historically-situated, relational individual, who desires to live a good life, and the realized sense of his/her own dignity toward which s/he works. As such, human dignity cannot be reduced to one feature of the human, and instead functions as both a descriptive category that avoids moralism, and as a normative category that allows relativity whilst avoiding relativism.

The bioethics of enhancing human performance for spaceflight

PubMed Central

Gibson, T M

2006-01-01

There are many ways of enhancing human performance. For military aviation in general, and for spaceflight in particular, the most important tools are selection, training, equipment, pharmacology, and surgery. In the future, genetic manipulation may be feasible. For each of these tools, the specific modalities available range from the ethically acceptable to the ethically unacceptable. Even when someone consents to a particular procedure to enhance performance, the action may be ethically unacceptable to society as a whole and the burden of risk for the individual may be too great. In addition, there are several characteristics that define the quality and the acceptability of the consent. Each method of enhancing performance will be examined in the context of the principles of medical ethics in a western society: autonomy, non‐maleficence, beneficence, and justice. The aim is to draw the attention of aeromedical practitioners to the complexities of ethical dilemmas such as this particular one in order to help them to develop a morally justifiable code of practice that balances society's needs against individual ambitions and corporate goals. PMID:16507654

Implementing accountability for reasonableness--the case of pharmaceutical reimbursement in Sweden.

PubMed

Jansson, Sandra

2007-04-01

This paper aims to describe the priority-setting procedure for new original pharmaceuticals practiced by the Swedish Pharmaceutical Benefits Board (LFN), to analyse the outcome of the procedure in terms of decisions and the relative importance of ethical principles, and to examine the reactions of stakeholders. All the 'principally important' decisions made by the LFN during its first 33 months of operation were analysed. The study is theoretically anchored in the theory of fair and legitimate priority-setting procedures by Daniels and Sabin, and is based on public documents, media articles, and semi-structured interviews. Only nine cases resulted in a rejection of a subsidy by the LFN and 15 in a limited or conditional subsidy. Total rejections rather than limitations gave rise to actions by stakeholders. Primarily, the principle of cost-effectiveness was used when limiting/conditioning or totally rejecting a subsidy. This study suggests that implementing a priority-setting process that fulfils the conditions of accountability for reasonableness can result in a priority-setting process which is generally perceived as fair and legitimate by the major stakeholders and may increase social learning in terms of accepting the necessity of priority setting in health care. The principle of cost-effectiveness increased in importance when the demand for openness and transparency increased.

Ethical Dilemmas for Oocyte Donations: Slippery Slope for Conflicts of Interest.

PubMed

Tulay, Pinar

2016-01-01

Oocyte donations have increased with improvements in oocyte cryopreservation procedures in recent years. Women with medical conditions that require chemotherapy or radiotherapy have begun to opt for oocyte cryo¬preservation prior to their treatment or to enroll in an oocyte donation program. Alternatively, some women apply for "third-party" oocyte donation programs for nonmedical reasons such as delayed childbearing. Although society seems to accept oocyte donations for medical reasons, it appears that there are still some moral issues surrounding nonmedical oocyte donations. In this review, the ethical aspects of oocyte donations and donors' perspectives are discussed. With developing technologies, the genetic screening of donors has expanded to include diseases. This review explores the ethical issues involved in genetic screening of gamete donors.

Ethics and law in research with human biological samples: a new approach.

PubMed

Petrini, Carlo

2014-01-01

During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.

Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

PubMed Central

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

Introduction According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal’s instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author’s instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions Only every second psychiatry journal adheres to the ICMJE’s recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE’s recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research. PMID:24901366

Survey of animal welfare, animal behavior, and animal ethics courses in the curricula of AVMA Council on Education-accredited veterinary colleges and schools.

PubMed

Shivley, Chelsey B; Garry, Franklyn B; Kogan, Lori R; Grandin, Temple

2016-05-15

OBJECTIVE To explore the extent to which veterinary colleges and schools accredited by the AVMA Council on Education (COE) have incorporated specific courses related to animal welfare, behavior, and ethics. DESIGN Survey and curriculum review. SAMPLE All 49 AVMA COE-accredited veterinary colleges and schools (institutions). PROCEDURES The study consisted of 2 parts. In part 1, a survey regarding animal welfare, behavior, and ethics was emailed to the associate dean of academic affairs at all 49 AVMA COE-accredited institutions. In part 2, the curricula for the 30 AVMA COE-accredited institutions in the United States were reviewed for courses on animal behavior, ethics, and welfare. RESULTS Seventeen of 49 (35%) institutions responded to the survey of part 1, of which 10 offered a formal animal welfare course, 9 offered a formal animal behavior course, 8 offered a formal animal ethics course, and 5 offered a combined animal welfare, behavior, and ethics course. The frequency with which courses on animal welfare, behavior, and ethics were offered differed between international and US institutions. Review of the curricula for the 30 AVMA COE-accredited US institutions revealed that 6 offered a formal course on animal welfare, 22 offered a formal course on animal behavior, and 18 offered a formal course on animal ethics. CONCLUSIONS AND CLINICAL RELEVANCE Results suggested that AVMA COE-accredited institutions need to provide more formal education on animal welfare, behavior, and ethics so veterinarians can be advocates for animals and assist with behavioral challenges.

Crucial contextual attributes of nursing leadership towards a care ethics.

PubMed

Gustafsson, Lena-Karin; Stenberg, Maja

2017-06-01

It is of importance to understand and communicate caring ethics as a ground for qualitative caring environments. Research is needed on nursing attributes that are visible in nursing leadership since it may give bases for reflections related to the patterns of specific contexts. The aim of this study was to illuminate the meaning of crucial attributes in nursing leadership toward an ethical care of patients in psychiatric in-patient settings. The design of the study was descriptive and qualitative with a phenomenological hermeneutical approach. Participants and research context: The study comprised focus group interviews with nurses working in indoor psychiatric care who participated after giving informed consent. Ethical considerations: Since the topic and informants are not labeled as sensitive and subject to ethical approval, it is not covered by the ethics committee's aim and purpose according to Swedish law. However, careful procedures have been followed according to ethics expressed in the Declaration of Helsinki. When identifying the thematic structures, analysis resulted in three major themes: To supply, including the following aspects: to supply evidence, to supply common space, and to supply good structures; To support, including the following aspects: to be a role model, to show appreciation and care, and to harbor; To shield, including the following aspects: to advocate, to emit non-tolerance of unethical behavior, and to reprove. Leadership is challenging for nurses and plays an important role in ethical qualitative care. These findings should not be understood as a description about nurse manager's role, which probably has different attributes and more focus on an organizational level. Making the understanding about crucial attributes explicit, the nurse may receive confirmation and recognition of crucial attributes for ethical care in order to move toward an ethical care.

Unexpected Complications of Novel Deep Brain Stimulation Treatments: Ethical Issues and Clinical Recommendations

PubMed Central

Cheeran, Binith; Pugh, Jonathan; Pycroft, Laurie; Boccard, Sandra; Prangnell, Simon; Green, Alexander L.; FitzGerald, James; Savulescu, Julian; Aziz, Tipu

2017-01-01

Background Innovative neurosurgical treatments present a number of known risks, the natures and probabilities of which can be adequately communicated to patients via the standard procedures governing obtaining informed consent. However, due to their novelty, these treatments also come with unknown risks, which require an augmented approach to obtaining informed consent. Objective This paper aims to discuss and provide concrete procedural guidance on the ethical issues raised by serious unexpected complications of novel deep brain stimulation treatments. Approach We illustrate our analysis using a case study of the unexpected development of recurrent stereotyped events in patients following the use of deep brain stimulation (DBS) to treat severe chronic pain. Examining these unexpected complications in light of medical ethical principles, we argue that serious complications of novel DBS treatments do not necessarily make it unethical to offer the intervention to eligible patients. However, the difficulty the clinician faces in determining whether the intervention is in the patient's best interests generates reasons to take extra steps to promote the autonomous decision making of these patients. Conclusion and recommendations We conclude with clinical recommendations, including details of an augmented consent process for novel DBS treatment. PMID:28557242

17 CFR 200.14 - Office of Administrative Law Judges.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND REQUESTS Organization and Program Management General Organization § 200.14 Office of Administrative Law Judges. (a) Under the Administrative Procedure Act (5 U.S.C...

Selected Readings in Genetic Engineering

ERIC Educational Resources Information Center

Mertens, Thomas R.; Robinson, Sandra K.

1973-01-01

Describes different sources of readings for understanding issues and concepts of genetic engineering. Broad categories of reading materials are: concerns about genetic engineering; its background; procedures; and social, ethical and legal issues. References are listed. (PS)

17 CFR 200.83 - Confidential treatment procedures under the Freedom of Information Act.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SECURITIES AND EXCHANGE COMMISSION ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND REQUESTS Information... a personnel, medical or similar file relating to a Commission member or employee which would...

Research ethical committees in Scotland.

PubMed Central

Thompson, I E; French, K; Melia, K M; Boyd, K M; Templeton, A A; Potter, B

1981-01-01

A questionnaire was sent to 41 ethical committees in Scotland requesting information about their constitution and supervision of clinical research. Thirty-four (83%) replies were received. Committees varied in size from one to 73 members, most of whom were medical. Ten had no nurse members and only three had lay members without direct NHS connections. Sixteen saw their role as advisory rather than supervisory. Thirteen had not met in the past year whereas two had held 10 or more meetings. Limited use (12) was made of standard protocols, and only six had formal procedures for monitoring research in progress. Only seven of 370 proposals were rejected outright. Risk/benefit dilemmas and difficulties relating to informed consent were the commonest problems encountered. The committees provide only limited safeguards for patients and research workers, and more effective, standardised procedures are indicated. PMID:6781629

Spinning the wheels: a CAPS survey of ethical issues in pediatric surgery.

PubMed

Bagwell, C E; Goodwin, S R

1992-11-01

To evaluate decision-making factors of pediatric surgeons when faced with ethical dilemmas in a clinical setting, questionnaires were mailed to members of the Canadian Association of Paediatric Surgeons. The surgeons were asked to respond to scenarios regarding ethical dilemmas in the treatment of children. Fifty-one responses (57%) were computer analyzed based on chosen responses to the clinical dilemma and demographic factors such as age, sex, marital status, country of citizenship, religion, and "religiousness," a determination of religious conviction as viewed by the respondent. In addition, ethical convictions were sought regarding abortion, fetal research, AIDS, HIV testing, denial of medical care due to religious beliefs (Jehovah's Witness), and limitations in health care access for indigents. In general, respondents found it difficult to separate ethical guidelines for determining aggressive treatment--absolute value of life; best interests of the child; parental authority; and ability of the child to engage in social, intellectual, or emotional attachments (quality of life)--in the face of actual patient care issues. In fact, results of this survey indicate that the operating surgeon applies his/her medical knowledge and surgical "experience" to each individual case, incorporating his or her own ethical beliefs (in a respondent's words: "In the operating room, the surgeon must satisfy his own conscience in making decisions") while cognizant of legal guidelines for "standard care" ("Decisions would be based on personal experience, and what the local society believes to be right").(ABSTRACT TRUNCATED AT 250 WORDS)

The Promise and Perils of Business Ethics.

ERIC Educational Resources Information Center

Huber, C. E.

The 640 member schools of the Association of American Colleges were surveyed in 1978 to determine interest in curriculum on business ethics. It was also attempted to determine how many schools provided their students with a general education program that included basic courses in the nature and operation of American business. The purpose was to…

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

PubMed Central

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

2014-01-01

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

Transplantation ethics from the Islamic point of view.

PubMed

Golmakani, Mohammad Mehdi; Niknam, Mohammad Hussein; Hedayat, Kamyar M

2005-04-01

Organ transplantation has been transformed from an experimental procedure at Western academic centers to an increasingly common procedure in private and public hospitals throughout the world. Attendant with advancements in organ harvesting, preservation, and transplantation come moral issues. Islam is a holistic religion that takes into account social affairs of man as well as spiritual ones. Islam has a long history of ethics literature including the subgenre of medical ethics. Historical considerations are discussed as to why Muslim thinkers were late to consider contemporary medical issues such as organ donation. Islam respects life and values the needs of the living over the dead, thus allowing organ donation to be considered in certain circumstances. The sources of Islamic law are discussed in brief in order for non-Muslims to appreciate how the parameters of organ transplantation are derived. The Islamic viewpoint, both Shiite and Sunni, is examined in relation to organ donation and its various sources. The advantages and disadvantages of brain dead and cadaveric donation is reviewed with technical and ethical considerations. The Islamic concept of brain death, informed and proxy consent are also discussed. We discuss the concept of rewarded donation as a way to alleviate the current shortage of organs available for transplantation and consider secular and religious support for such a program. Suggestions are made for greater discussion and exchange of ideas between secular and religious thinkers in the Islamic world and between the Islamic world and secular Western countries.

Ethics education in research involving human beings in undergraduate medicine curriculum in Brazil.

PubMed

Novaes, Maria Rita Garbi; Guilhem, Dirce; Barragan, Elena; Mennin, Stewart

2013-12-01

The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1--ethics in research (26); 2--ethical procedures and advanced technology (46); 3--ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. © 2012 John Wiley & Sons Ltd.

A robotic shower system : Acceptance and ethical issues.

PubMed

Klein, Barbara; Schlömer, Inga

2018-01-01

Being able to maintain personal hygiene plays a crucial role for independent living in old age or when suffering from disabilities. Within the European project ICT Supported Bath Robots (I‑SUPPORT) an intelligent robotic shower system is being developed, which enables patients to shower independently at home or in institutionalized settings. The aim of this contribution is the identification of ethical issues in the development of a robotic shower system utilizing the model for the ethical evaluation of socio-technical arrangements (MEESTAR). In I‑SUPPORT a variety of concepts and methods are implemented in order to achieve technology acceptance such as user-centered requirements analysis, usability-tests and analysis of sociocultural and ethical aspects. This article reports the analysis of focus groups with 14 older adults and 9 professional caregivers utilizing MEESTAR as a heuristic approach for analyzing sociotechnical arrangements and identifying ethical problems. The MEESTAR procedure was adapted to the research question and client groups and implemented as a discursive method. This gave an insight into the meaning and background of ethical aspects and also a deeper insight into nursing processes as well as the requirements which the system should fulfil. Shortcomings are that the ethical dimensions are not everyday language and the time restrictions. In the next step a standardized assessment instrument will be developed and piloted.

The "Commitment Model" for Clinical Ethics Consultations: Society's Involvement in the Solution of Individual Cases.

PubMed

Fournier, Véronique; Spranzi, Marta; Foureur, Nicolas; Brunet, Laurence

2015-01-01

Several approaches to clinical ethics consultation (CEC) exist in medical practice and are widely discussed in the clinical ethics literature; different models of CECs are classified according to their methods, goals, and consultant's attitude. Although the "facilitation" model has been endorsed by the American Society for Bioethics and Humanities (ASBH) and is described in an influential manual, alternative approaches, such as advocacy, moral expertise, mediation, and engagement are practiced and defended in the clinical ethics field. Our Clinical Ethics Center in Paris was founded in 2002 in the wake of the Patients' Rights Act, and to date it is the largest center that provides consultation services in France. In this article we shall describe and defend our own approach to clinical ethics consultation, which we call the "Commitment Model," in comparison with other existing models. Indeed commitment implies, among other meanings, continuity through time, a series of coherent actions, and the realization of important social goals. By drawing on a recent consultation case, we shall describe the main steps of our consultation procedure: interviews with major stakeholders, including patients and proxies; case conferences; and follow up. We shall show why we have chosen the term "commitment" to represent our approach at three different but interrelated levels: commitment towards patients, within the case conference group, and towards society as a whole. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Institutional ethical review and ethnographic research involving injection drug users: a case study.

PubMed

Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

The ethics of neonatal research: An ethicist's and a parents' perspective.

PubMed

Janvier, Annie; Farlow, Barbara

2015-12-01

The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development of a moral judgment measure for veterinary education.

PubMed

Verrinder, Joy M; Phillips, Clive J C

2014-01-01

Veterinarians increasingly face animal ethics issues, conflicts, and dilemmas, both in practice and in policy, such as the tension between clients' and animals' interests. Little has been done to measure the capacity of veterinarians to make ethical judgments to prevent and address these issues or to identify the effectiveness of strategies to build this capacity. The objectives of this study were, first, to develop a test to identify the capacity of veterinarians to make ethical decisions in relation to animal ethics issues and, second, to assess students' perceptions of the usefulness of three methods for the development of ethical decision making. The Veterinary Defining Issues Test (VetDIT) was piloted with 88 first-year veterinary students at an Australian university. The veterinary students were at a variety of reasoning stages in their use of the Personal Interest (PI), Maintaining Norms (MN), and Universal Principles (UP) reasoning methods in relation to both human ethics and animal ethics issues and operated at a higher level of reasoning for animal than human ethics. Thirty-eight students assessed three methods for developing ethical decision-making skills and identified these as being helpful in clarifying their positions, clarifying others' positions, increasing awareness of the complexity of making ethical decisions, using ethical frameworks and principles, and improving moral reasoning skills, with two methods identified as most helpful. These methods and the VetDIT have the potential to be used as tools for development and assessment of moral judgment in veterinary education to address animal ethics issues.

Transplanting the Body: Preliminary Ethical Considerations.

PubMed

Miller, Lantz Fleming

2017-11-01

A dissociated area of medical research warrants bioethical consideration: a proposed transplantation of a donor's entire body, except head, to a patient with a fatal degenerative disease. The seeming improbability of such an operation can only underscore the need for thorough bioethical assessment: Not assessing a case of such potential ethical import, by showing neglect instead of facing the issue, can only compound the ethical predicament, perhaps eroding public trust in ethical medicine. This article discusses the historical background of full-body transplantation, documents the seriousness of its current pursuit, and builds an argument for why prima facie this type of transplant is bioethically distinct. Certainly, this examination can only be preliminary, indicating what should be a wide and vigorous discussion among practitioners and ethicists. It concludes with practical suggestions for how the medical and bioethics community may proceed with ethical assessment.

Ethics and/or Aesthetics? Reflections on Cosmetic Surgery for Adolescents.

PubMed

Vergallo, Gianluca Montanari; Marinelli, Enrico; Napoletano, Simona; Di Luca, Natale Mario; Zaami, Simona

2018-01-01

Cosmetic surgery entails various ethical issues, even more so in cases involving adolescent patients. Cosmetic surgeons need to take into account how modern societies consider physical appearance an essential component of everyday life, as well as the vulnerability of youths and adolescents. For that reason, it is imperative to thoroughly assess the psychological and emotional states, in addition to the motivations, of minor patients. That goal can be achieved through the use of the DAS-59, (the Derriford Appearance Scale)1 , an effective and dependable tool devised to evaluate the psychological difficulties and distress experienced by people living with problems of appearance. Prior to undergoing cosmetic surgery procedures, adolescents should be required to go through adequate counseling, over multiple sessions and extended to their family members as well, on account of the complex issues inherent in evaluating the risk-benefit ratio and a prospective patient's decision-making capability. A concerted effort on the part of surgeons, psychiatrists or psychologists is key in determining the real motivations behind a minor's decision to opt for cosmetic surgery in the first place. Possible psychiatric conditions may in fact prevent a minor from making a free, informed decision. From an ethical standpoint, cosmetic surgery procedures should be geared to serve the best interest of the minor patient, who may experience distress over his or her body image, from a health and psychological balance perspective and improve his or her social, affective and working life. Besides, cosmetic surgery should not be overly invasive compared to its potential benefits. Those procedures aimed at achieving ″ideal beauty″ are not desirable and ought to be banned. By virtue of such criteria, the authors have set out to evaluate the ethical admissibility of some aesthetic treatments. Thus, doctors should not consent to any request coming from their patients, but rather, intervene only in presence of an objective physical flaw or deformity, e.g. protruding ears, which have a potential to negatively affect social life and interactions.

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

How do authors of systematic reviews deal with research malpractice and misconduct in original studies? A cross-sectional analysis of systematic reviews and survey of their authors.

PubMed

Elia, Nadia; von Elm, Erik; Chatagner, Alexandra; Pöpping, Daniel M; Tramèr, Martin R

2016-03-02

To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether they identify and report misconduct. Cross-sectional analysis of systematic reviews and survey of their authors. 118 systematic reviews published in four journals (Ann Int Med, BMJ, JAMA, Lancet), and the Cochrane Library, in 2013. Number (%) of reviews that applied procedures to reduce the impact of: (1) publication bias (through searching of unpublished trials), (2) selective outcome reporting (by contacting the authors of the original studies), (3) duplicate publications, (4) sponsors' and (5) authors' conflicts of interest, on the conclusions of the review, and (6) looked for ethical approval of the studies. Number (%) of reviewers who suspected misconduct are reported. The procedures applied were compared across journals. 80 (68%) reviewers confirmed their data. 59 (50%) reviews applied three or more procedures; 11 (9%) applied none. Unpublished trials were searched in 79 (66%) reviews. Authors of original studies were contacted in 73 (62%). Duplicate publications were searched in 81 (69%). 27 reviews (23%) reported sponsors of the included studies; 6 (5%) analysed their impact on the conclusions of the review. Five reviews (4%) looked at conflicts of interest of study authors; none of them analysed their impact. Three reviews (2.5%) looked at ethical approval of the studies. Seven reviews (6%) suspected misconduct; only 2 (2%) reported it explicitly. Procedures applied differed across the journals. Only half of the systematic reviews applied three or more of the six procedures examined. Sponsors, conflicts of interest of authors and ethical approval remain overlooked. Research misconduct is sometimes identified, but rarely reported. Guidance on when, and how, to report suspected misconduct is needed. 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/

Comparison of the classic TVT and TVT-Secur.

PubMed

Abduljabbar, H S O; Al-Shamrany, H M A; Al-Basri, S F; Abduljabar, H H; Tawati, D A; Owidhah, S P

2013-01-01

Tension-free vaginal tape (TVT) is a well-established surgical procedure for the treatment of female stress urinary incontinence (SUI) and TVT-Secur was designed to reduce the undesired complications and to minimize the operative procedure as much as possible. To present the authors' experience in using the classic TVT and TVT-Secur and to evaluate and compare complications and short- and long-term results. A retrospective study and analysis of 230 patients presented with SUI at King Abdulaziz University Hospital (KAUH) and United Doctor Hospital (UDH) from March 1, 2007 until July 3, 2010. Classical TVT and TVT-Secur with or without associated operation were performed. All patients were controlled at six months and complications, as well as objective results, have been reported. The study was approved by ethical committee of KAUH. All patients with SUI admitted to KAUH and UDH for sub-urethral tape were analyzed (230 patients); 149 had classical TVT and 81 had TVT-Secur. Their age ranged from 30 years to 73 years with a mean of 49.8 years and std of 9.4. Their parity ranged from two to 15 with a mean of 6.2 and std of 2.4. One hundred eighty patients had SUI and 50 patients had mixed incontinence. The type of anesthesia used was general anesthesia in 69.6% (160) of cases and regional anesthesia in form of epidural or spine in 30.4% (70) of cases. Operative complications revealed a bladder perforation in 3.5% (eight) of cases and 2.2% had bleeding of more than 200 ml, and 53 patients which contribute to 23% had retention and required a catheter for 48 hours or more. After three months, it was observed that erosion of the mesh occurred in three cases. Fourteen cases (7%) continue to have SUI failure rate. The classical TVT and TVT-Secur were found to be very effective, easy, and safe procedures and with excellent results.

[Ethics in clinical practice and in health care].

PubMed

Pintor, S; Mennuni, G; Fontana, M; Nocchi, S; Giarrusso, P; Serio, A; Fraioli, A

2015-01-01

The clinical ethics is the identification, analysis and solution of moral problems that can arise during the care of a patient. Given that when dealing with ethical issues in health care some risks will be encountered (talking about ethics in general, or as a problem overlapped with others in this area, or by delegation to legislative determinations) in the text certain important aspects of the topic are examined. First of all ethics as human quality of the relationship between people for the common good, especially in health services where there are serious problems like the life and the health. It is also necessary a "humanizing relationship" between those who work in these services in order to achieve quality and efficiency in this business. It is important a proper training of health professionals, especially doctors, so that they can identify the real needs and means of intervention. It is also important that scientific research must respect fundamental ethical assumptions. In conclusion, ethics in health care is not a simple matter of "cookbook" rules, but involves the responsibility and consciousness of individual operators.

Effective health care corporate compliance.

PubMed

Saum, T B; Byassee, J

2000-01-01

The pace and intensity of oversight and investigation of health care organizations has greatly increased at all levels. Well run organizations with ethical management committed to following all laws and regulations are still at risk for compliance violations and punitive penalties. Under the Federal Sentencing Guidelines, organizations with an "effective" corporate compliance program may receive reduced penalties. The seven components of an effective program as defined in the guidelines are: (1) Standards and procedures; (2) oversight responsibilities; (3) employee training; (4) monitoring and auditing; (5) reporting systems; (6) enforcement and discipline; and (7) response and prevention. Lack of a compliance program needlessly exposes the organization to an avoidable risk of damage from non-compliance--whether intentional or not. Moreover, an effective program can contribute to the efficient operation of the organization and be a key piece of its corporate culture.

Endovascular blood flow measurement system

NASA Astrophysics Data System (ADS)

Khe, A. K.; Cherevko, A. A.; Chupakhin, A. P.; Krivoshapkin, A. L.; Orlov, K. Yu

2016-06-01

In this paper an endovascular measurement system used for intraoperative cerebral blood flow monitoring is described. The system is based on a Volcano ComboMap Pressure and Flow System extended with analogue-to-digital converter and PC laptop. A series of measurements performed in patients with cerebrovascular pathologies allows us to introduce “velocity-pressure” and “flow rate-energy flow rate” diagrams as important characteristics of the blood flow. The measurement system presented here can be used as an additional instrument in neurosurgery for assessment and monitoring of the operation procedure. Clinical data obtained with the system are used for construction of mathematical models and patient-specific simulations. The monitoring of the blood flow parameters during endovascular interventions was approved by the Ethics Committee at the Meshalkin Novosibirsk Research Institute of Circulation Pathology and included in certain surgical protocols for pre-, intra- and postoperative examinations.

Neuroscience, ethics, and national security: the state of the art.

PubMed

Tennison, Michael N; Moreno, Jonathan D

2012-01-01

National security organizations in the United States, including the armed services and the intelligence community, have developed a close relationship with the scientific establishment. The latest technology often fuels warfighting and counter-intelligence capacities, providing the tactical advantages thought necessary to maintain geopolitical dominance and national security. Neuroscience has emerged as a prominent focus within this milieu, annually receiving hundreds of millions of Department of Defense dollars. Its role in national security operations raises ethical issues that need to be addressed to ensure the pragmatic synthesis of ethical accountability and national security.

Psychotropics without borders: ethics and legal implications of internet-based access to psychiatric medications.

PubMed

Klein, Carolina A

2011-01-01

Medical practitioners are revisiting many of the ethics and the legal implications surrounding the clinical frameworks within which we operate. In today's world, distinguishing between virtual and physical reality continues to be increasingly difficult. The physician may be found grappling with the decision of whether to continue to treat a patient who may be obtaining psychotropic medications through the Internet. This article approaches some of the clinical and legal implications and the ethics regarding the availability of prescription psychotropics over the Internet.

A Phase II Trial on the Effect of Low Dose versus High Dose Vitamin D Supplementation on Bone Mass in Adults with Neurofibromatosis 1 (NF1)

DTIC Science & Technology

2016-10-01

USAMRMC ORP HRPO. Ethics board approval from UBC has been approved by HRPO, and U of Cincinnati is under review. The University of Hamburg is working...UBC ethics committee approval was established, and USAMRMC ORP HRPO approval was provided October 20, 2015. Additional continuing review approval in...operations, and once translated to German will be submitted to its ethics committee. The CRFs have been translated into German and will be submitted

[Cost-conscious medical decisions. Normative guidance within the conflicting demands of ethics and economics].

PubMed

Marckmann, G; In der Schmitten, J

2014-05-01

Under the current conditions in the health care system, physicians inevitably have to take responsibility for the cost dimension of their decisions on the level of single cases. This article, therefore, discusses the question how physicians can integrate cost considerations into their clinical decisions at the microlevel in a medically rational and ethically justified way. We propose a four-step model for "ethical cost-consciousness": (1) forego ineffective interventions as required by good evidence-based medicine, (2) respect individual patient preferences, (3) minimize the diagnostic and therapeutic effort to achieve a certain treatment goal, and (4) forego expensive interventions that have only a small or unlikely (net) benefit for the patient. Steps 1-3 are ethically justified by the principles of beneficence, nonmaleficence, and respect for autonomy, step 4 by the principles of justice. For decisions on step 4, explicit cost-conscious guidelines should be developed locally or regionally. Following the four-step model can contribute to ethically defensible, cost-conscious decision-making at the microlevel. In addition, physicians' rationing decisions should meet basic standards of procedural fairness. Regular cost-case discussions and clinical ethics consultation should be available as decision support. Implementing step 4, however, requires first of all a clear political legitimation with the corresponding legal framework.

Ethical and Sociocultural Aspects of Sexual Function and Dysfunction in Both Sexes.

PubMed

Atallah, Sandrine; Johnson-Agbakwu, Crista; Rosenbaum, Talli; Abdo, Carmita; Byers, E Sandra; Graham, Cynthia; Nobre, Pedro; Wylie, Kevan; Brotto, Lori

2016-04-01

This study aimed to highlight the salient sociocultural factors contributing to sexual health and dysfunction and to offer recommendations for culturally sensitive clinical management and research as well for an ethically sound sexual health care, counseling and medical decision-making. There are limited data on the impact of sociocultural factors on male and female sexual function as well as on ethical principles to follow when clinical care falls outside of traditional realms of medically indicated interventions. This study reviewed the current literature on sociocultural and ethical considerations with regard to male and female sexual dysfunction as well as cultural and cosmetic female and male genital modification procedures. It is recommended that clinicians evaluate their patients and their partners in the context of culture and assess distressing sexual symptoms regardless of whether they are a recognized dysfunction. Both clinicians and researchers should develop culturally sensitive assessment skills and instruments. There are a number of practices with complex ethical issues (eg, female genital cutting, female and male cosmetic genital surgery). Future International Committee of Sexual Medicine meetings should seek to develop guidelines and associated recommendations for a separate, broader chapter on ethics. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Ethical issues and dentists' practices with children with intellectual disability: A qualitative inquiry into a local French health network.

PubMed

Camoin, Ariane; Dany, Lionel; Tardieu, Corinne; Ruquet, Michel; Le Coz, Pierre

2018-01-29

The provision of dental care for children with intellectual disability raises many ethical questions. The aim of this qualitative study was to explore approaches to dental treatment in an anxious child with intellectual disability and the ethical dilemmas that ensue. Semi-structured interviews were conducted between February and May 2012. A clinical scenario was used to establish a starting point for a discussion of the clinical approach and lead to an ethical reflection. Four topics were discussed: first contact with the patient, information, attitude towards the patient and outcome from the practitioner's viewpoint. The coding procedure used thematic content analysis. Most practitioners fetched the patient from the waiting room personally, greeted them, gave them special attention, and either began the consultation at once, or used distraction to relax the patient. Verbal language and tell-show-do were most often used to provide information. Anxiety and pain were evaluated using parental assessment and standardized scales. A reassuring attitude was adopted. An ethical dilemma arose if the patient refused care or had to be restrained. Practitioners reported sacrificing ethical values (patient autonomy, beneficence and non-maleficence) when making a clinical decision. Copyright © 2018 Elsevier Inc. All rights reserved.

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

PubMed Central

Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

2017-01-01

Introduction A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). Methods and analysis The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethics and dissemination Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. Trial registration number ISCRTN88609453; Pre-results. PMID:28928192

Contribution of the ethics committee of the French society of intensive care medicine to a scenario for the implementation of organ donation after Maastricht III-type cardiac death in France.

PubMed

Graftieaux, J-P; Bollaert, P-E; Haddad, L; Kentish-Barnes, N; Nitenberg, G; Robert, R; Villers, D; Dreyfuss, D

2014-02-01

French law allows organ donation after death due to cardiocirculatory arrest. In the Maastricht classification, type III non-heart-beating donors are those who experience cardiocirculatory arrest after the withdrawal of life-sustaining treatments. French authorities in charge of regulating organ donation (Agence de la Biomédecine, ABM) are considering organ collection from Maastricht type III donors. We describe a scenario for Maastricht type III organ donation that fully complies with the ethical norms governing care to dying patients. That organ donation may occur after death should have no impact on the care given to the patient and family. The dead-donor rule must be followed scrupulously: the organ retrieval procedure must neither cause nor hasten death. The decision to withdraw life-sustaining treatments, withdrawal modalities, and care provided to the patient and family must adhere strictly to the requirements set forth in patient-rights legislation (the 2005 Léonetti law in France) and should not be influenced in any way by the possibility of organ donation. A major ethical issue regarding the family is how best to transition from discussing treatment-withdrawal decisions to discussing possible organ retrieval for donation should the patient die rapidly after treatment withdrawal. Close cooperation between the healthcare team and the organ retrieval team is crucial to minimize the distress of family members during this transition. Modalities for implementing Maastricht type III organ donation are discussed here, including the best location for withdrawing life-sustaining treatments (operating room or intensive care unit). Copyright © 2014. Published by Elsevier SAS.

Legal and ethical aspects of organ donation after euthanasia in Belgium and the Netherlands.

PubMed

Bollen, Jan; Ten Hoopen, Rankie; Ysebaert, Dirk; van Mook, Walther; van Heurn, Ernst

2016-08-01

Organ donation after euthanasia has been performed more than 40 times in Belgium and the Netherlands together. Preliminary results of procedures that have been performed until now demonstrate that this leads to good medical results in the recipient of the organs. Several legal aspects could be changed to further facilitate the combination of organ donation and euthanasia. On the ethical side, several controversies remain, giving rise to an ongoing, but necessary and useful debate. Further experiences will clarify whether both procedures should be strictly separated and whether the dead donor rule should be strictly applied. Opinions still differ on whether the patient's physician should address the possibility of organ donation after euthanasia, which laws should be adapted and which preparatory acts should be performed. These and other procedural issues potentially conflict with the patient's request for organ donation or the circumstances in which euthanasia (without subsequent organ donation) traditionally occurs. 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/