In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the research (...) involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

This book approaches the problems and circumstances confronting blacks in the context of black values, the black community, and the role of government. ^BContents:: The Black Community's Values as a Basis for Action; The Community as Agent of Change; and The Government's Role in Meeting New Challenges.

In lieu of an abstract, here is a brief excerpt of the content:Martin Heidegger and OntologyEmmanuel Levinas (bio)The prestige of Martin Heidegger 1 and the influence of his thought on German philosophy marks both a new phase and one of the high points of the phenomenological movement. Caught unawares, the traditional establishment is obliged to clarify its position on this new teaching which casts a spell over youth and which, overstepping the bounds of permissibility, is already in vogue. For once, (...) Fame has picked one who deserves it and, for that matter, one who is still living. Anyone who has studied philosophy cannot, when confronted by Heidegger’s work, fail to recognize how the originality and force of his achievements, stemming from genius, are combined with an attentive, painstaking, and close working-out of the argument—with that craftsmanship of the patient artisan in which phenomenologists take such pride. In this study, it is important for us to understand, above all, the true intentions of our author, to illuminate what he thinks really needs to be said, and to surmise what is most critical for him.To get to the heart of Heidegger’s system, it seems fitting to begin with a problem that is generally familiar. We choose the problem of knowledge, a deeper understanding of which takes us to the very threshold of Heidegger’s thought. For this problem, central to modern philosophy, is one of the main obstacles of modern philosophy that Heidegger wishes to surmount. Neo-Kantianism, which takes knowledge as the philosophical problem of the first rank, is the movement against which Heidegger rebels with all his strength. We have, thus, every chance of gaining access to his thought by the main door, so to speak. Once inside the system we will try to trace its outlines, 2 reserving, for a second part of our work, the determination of Heidegger’s place in the history of ideas, especially in the phenomenological movement, as well as of his relations with the philosopher to whom he owes so much—Edmund Husserl. 31In its most general form, the problem of the theory of knowledge has a critical significance. It consists in delineating a domain where knowledge can be certain and in determining the criteria for the legitimate scope of knowledge. But this problem, as normal and as simple as it may appear, has deeper roots. That knowledge should need a criterion at all presupposes that truth is not identical to all that is known and that the course [End Page 11] of things can fail to correspond with the course of thought. “How does knowledge correspond to being?” is a more profound formulation of the problem of knowledge.But we are not going to touch anymore on the primordial phenomenon that generates the problem. The problem of correspondence between thing and thought presupposes a free activity of thought and its isolation in relation to the object. It is precisely this presupposition which renders their harmony and even their contact problematic. “How does the subject take leave of itself to attain the object?” is what the problem of knowledge, in the last analysis, boils down to. Its true source is thus the concept of “subject” as elaborated by modern philosophy. The cogito presided over the subject’s birth. The cogito was the affirmation of the privileged nature of the subject’s immanent sphere, of its unique place in existence; hence, the cogito was the specificity of the subject’s connection to the rest of reality, the sui generis nature which opens up the passage from immanence to transcendence, the passage from ideas contained in the thinking substance to 4 their “formal existence.”The concept of the subject, understood as a substance having a specific position in the entire domain of being, presents us with difficulties of two kinds. First, how do we understand this leave-taking from the self which the thinking substance brings about and which displays an entirely original aspect? Indeed, we could say that thought, in reaching out toward objects, does not actually take leave of itself, since its objects—considered as ideas and contents of thought—are, in a certain sense, already within it. In order to make sense of this paradox, Descartes... (shrink)

The French medical context is characterized by institutionalization of the ethical reflection in health care facilities and an important disparity between spaces of ethical reflection. In theory, the healthcare professional may mobilise an arsenal of resources to help him in his ethical reflection. But what happens in practice? We conducted semi-structured interviews with 22 health-care professionals who did and did not have recourse to clinical ethical committees. We also implemented two focus groups with 18 professionals involved in various spaces of (...) ethical reflection in order to let them debate about a better way to organize ethical reflection in their institutional contexts. The qualitative analysis allows to us to underline the coexistence of different conceptions of ethics among health care professionals. We also observed that the participants in our study shared the experience of ethically problematic situations as roadblocks in the process of communication and decision-making. We therefore report the factors which favour or inhibit the ethical course leading to the resolution or at the very least soothing of the situation at hand. Finally, we discuss methodological issues and underline the fact that while the patient is at the heart of the professional’s ethical preoccupations, this does not imply that they are actors in decisions that concern them. (shrink)

This paper describes the establishment of a research ethics committee in a business school within a university in Ireland. Many of the procedural issues encountered by the Kemmy Business School REC with respect to its modus operandi are outlined. The difficulties faced by business school RECs arising from the need to simultaneously accommodate both academic and corporate stakeholders are discussed in the context of the ethicality of research carried out in the business domain. The experiences of the authors, both (...) of whom have served as respective chairpersons of the Kemmy Business School REC since its inception, inform the discussion. Given the dearth in the literature on research ethics in a business school context, the objective of this paper is to outline the experiences of one business school REC with respect to how it operates in order to assist other committees through the establishment phase and beyond. (shrink)

We examine the influences of social capital, source credibility, and fairness perceptions on the judgments of experienced compensation committee members who are considering a proposal to reduce management’s performance targets in the middle of a compensation cycle due to difficult circumstances. Eighty-nine U.S. public company CC members participated in a 2 × 2 experiment with social capital and source credibility each manipulated as low or high, and outcome fairness to management, process fairness to shareholders, and outcome fairness (...) to shareholders included as measured variables. While social capital and source credibility are not significant, we find that outcome fairness to the CEO and outcome fairness to shareholders are significantly related to CC members’ support for reducing performance targets during a compensation cycle. In addition, we find that more experienced CC members are less supportive of changing the performance targets. The significant interactions include one between outcome fairness to shareholders and process fairness to shareholders, which suggests that CC member support for the proposal relies on both process and outcome fairness being present. Finally, the participants’ qualitative responses reflect arguments both for and against adjusting performance targets. Overall, the results highlight the important roles of fairness and director experience in boardroom decisions and provide important insights into factors affecting CC judgments. (shrink)

The authors examine the internal and external motivating factors behind the actions of the House Committee on Ethics members by looking at the procedural efficiency of the Committee on Ethics (or lack thereof), as a natural consequence of the committee members' implicit public policy actions.

In lieu of an abstract, here is a brief excerpt of the content:Ethics Committees in HospitalsPat Milmoe McCarrick (bio)(Literature about hospital ethics committees has grown enormously since Scope Note 3 first appeared. This update provides new information about resources and documents now available while continuing to include important earlier sources.)Hospital ethics committees increasingly have taken hold in the United States since 1983, when the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research encouraged their (...) creation in its report, Deciding to Forego Life-Sustaining Treatment (III, 1983, p. 5).The President's Commission report (pp. 160-64) suggested the following roles for ethics committees: 1) review of treatment decisions made on behalf of incompetent, terminally ill patients; 2) review of medical decisions having ethical implications with the option, in cases of disagreement, to refer cases to a court with proper jurisdiction; 3) provision of social, psychological, spiritual, or other counseling for patients, family members, physicians, or other hospital staff; 4) establishing guidelines regarding treatment or other medical decisions; and 5) sponsoring or conducting educational programs to inform all concerned, including the public, about ethical problems in medicine.No exact count of these committees is available. According to estimates cited by Donald F. Phillips, managing editor of Hospital Ethics, about two-thirds to three-fourths of hospitals with more than 200 beds have ethics committees, as do about one-third of hospitals under 200 beds. He thinks that about half of the 6,000 hospitals in the United States now have working ethics committees.Several journal articles and a court decision in the late 1970s influenced their formation. A 1975 journal article by pediatrician Karen Teel (VII A) urged the use of hospital ethics committees to provide for dialogue in individual care situations as an appropriate sharing of responsibility. Another early article suggested that beyond parents and treating physicians, a "disinterested," mixed lay and medical committee could consider cases about defective newborns to improve the ethical decisionmaking process (VII A, Robertson and Fost, 1976). Three 1977 discussions in the Hastings Center Report highlighted this new concept (VII A, Levine; Shannon; Veatch).Produced at the National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, Washington, DC 20057. It is supported by funds provided under grant number LM04492 from the National Library of Medicine, National Institutes of Health. Literature available through June 1992 is represented in this Scope Note. [End Page 285]The court decision was the March 31, 1976 ruling by the New Jersey Supreme Court in the Karen Quinlan case. The parents of a young woman in a persistent vegetative state had requested that she be taken off a respirator. The court designated a "prognosis" role for the hospital ethics committee and stipulated that the committee must concur that the patient will never return to a "cognitive, sapient state" before the life-support system can be withdrawn (In the Matter of Karen Quinlan, 70 N.J. 10, 355 A.2d 647, cert. denied sub nom. Garger v. New Jersey, 429 U.S. 922 (1976)). Shortly after the Quinlan decision, Massachusetts General Hospital's Clinical Care Committee created an ad hoc subcommittee (a psychiatrist, a legal counsel, an ICU nurse, an oncologist/internist, a surgeon, and a lay person who had recovered from serious cancer disease) which looked at 15 cases. Based on the subcommittee's success, establishment of a permanent committee to review treatment of the terminally ill was recommended by the critical care committee (VII A, Clinical Care Committee 1976).In its 1984 Baby Doe rules, the federal government recommended establishment of infant care review committees, which promoted the growth of hospital ethics committees (VII C, Povar 1991). In July 1987 Maryland became the first state to require by law that hospitals establish patient care advisory committees to offer advice about choices available in the care of life-threatening illnesses; this requirement was extended to nursing homes in 1990 [codified as amended at Md. Health-Gen. Code Ann. Sections 19-370 to -374 (1990)] (VII C, Hollinger 1991).Recently the role for these committees has been noted in the Accreditation Manual for Hospitals, 1992 Supplement (p. 10, Patient Rights, Section RI. 1.1.6.1) of the Joint Commission... (shrink)

Background Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Main text Aided by two frameworks for legitimate priority setting, we discuss how CECs can (...) contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC’s deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. Conclusions On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions. (shrink)

This study examines the impact of the Chief Executive Officer ’s interlocking, created through serving on other companies’ audit committees and/or boards, on corporate social responsibility performance of the focal company and that of its linked companies. We find that CEO interlocking positively affects CSR performance of both the focal company and its linked companies. Further analysis shows that interlocks created by the CEO enhance CSR performance and in turn the financial performance of both the focal company and its (...) linked companies. Our findings are robust to a battery of analyses, including Heckman’s selection bias correction, propensity score matching, alternative measures of CSR performance, and CEO interlocks. These findings are important to regulators, company management teams, and other stakeholders with an interest in how the social ties of CEOs influence companies’ CSR performance and in the CSR–financial performance nexus. (shrink)

Compilation of the most important documents and speeches by Pierre de Coubertin on Olympism and the Olympic Games.

The study reported in this paper explored the ethical requirements of social research participants, an area where there is still little empirical research, by interviewing people who had participated in one of five recent social research studies. The findings endorse the conceptualization of informed consent as a process rather than a one-off event. Four different dynamics of decision-making were followed by participants in terms of the timing of decisions to participate and the information on which they were based. (...) Multiple information events were important, as was verbal as well as written information. Study participants reacted unfavourably to the idea of written consent. Although prior information was relevant to participant experience of the interview, what emerged more strongly as relevant was the behaviour of interviewers and the interviewing strategy used. The authors suggest that naturalistic, authentic approaches to information-giving are necessary, and that in scrutinizing them research ethics committees need to look not only at written information but also at verbal information giving, and how interviewer information-giving is supported by training and supervision. They suggest that committees also need to concern themselves more broadly with who will carry out interviews and the training, mentoring and monitoring in place to shape their conduct of interviews. In considering research instruments, research ethics committees need to consider not only whether interviewers will capture accurate and appropriate data but also whether they are likely to lead to a satisfactory interaction for participants. Given the impossibility of anticipating each individual participants information needs and their reaction to the interviewing strategy, the authors suggest that interviewers and participants need to be encouraged to negotiate the conduct of interviews jointly, and discuss how such negotiating roles might be supported. (shrink)

Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article, we share the experience of on-site monitoring of clinical trials by the Ethics Committee of a tertiary care, academic and research centre in India. We found a large number of (...) shortcomings in the areas of informed consent, adverse events, insurance and reimbursement, which would not have been detected by off-site document review. Interestingly, many shortcomings were also not detected by on-site monitoring arranged by clinical trial sponsors. We therefore conclude that on-site monitoring of ongoing clinical trials is a highly important activity for Indian Ethics Committees. (shrink)

ABSTRACT Objective: To describe how local research ethics committees (LRECs) consider and apply research ethics in the evaluation of biomedical research proposals. Design: A qualitative study was conducted using purposeful sampling, focus groups and a grounded theory approach to generate data and to analyse the work of the LRECs. Setting and participants: 11 LRECs of the Mexican Institute of Social Security (IMSS). Results: LRECs considered ethics to be implicit in all types of research, but that ethics reviews were only (...) necessary for projects that included the direct participation of human beings. The LRECs appeared to understand the importance of consent, as in the completion of a consent form, but did not emphasise the importance of the process of acquiring ‘informed’ consent. The committees considered their main roles or functions to be: (a) to improve the methodological quality of research and to verify – if applicable – the ethical aspects; (b) to encourage personnel to undergo research training; (c) to follow‐up research to oversee the adherence to norms and compliance with a specified research timetable. Conclusions: This study provides a valuable insight into how these LRECs understand the ethical review process. The emphasis of the committees was on rules, regulations, improving research methodology and research training, rather than a focus on efforts to protect the rights and well being of research subjects. The results encourage further normative and descriptive lines of investigation concerning education and the development of LRECs. (shrink)

This study examines whether the gender of the directors on fully independent audit committees affects the ability of the committees in constraining earnings management and thus their effectiveness in overseeing the financial reporting process. Using a sample of 525 firm-year observations over the period 2003 to 2005, we are unable to identify an association between the proportion of female directors on audit committees and the extent of earnings management.

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 :168–175, 2001). Institutions such as Institutional Review Boards and Ethics Committees (...) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. 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. 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. (shrink)

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public and bioethicists in Ethics Committees in Japan. (...) Keywords: ethics committees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (shrink)

After the approval of a code of ethics, the creation of a permanent board‐level ethics committee is the next step in the institutionalization of business ethics. This study explores how the board's structure and demographic characteristics explain the decision to form an ethics committee. The analysis is based on the constituents of the Standard and Poor's Europe 350 index. Consistent with our hypotheses, we find that ethics committees are more likely to be found in firms with a lower (...) presence of executive directors and of directors holding MBA degrees. However, we also observe that boards chaired by executive directors seem to favor the creation of an ethics committee. Additionally, as we had anticipated, firms with stronger agency conflicts seem to be more willing to create committees. The analysis conducted with segmented samples reveals that the model has greater explanatory power when applied to firms from common‐law and French civil‐law countries than when applied to firms from the German–Scandinavian civil‐law area. Finally, our results indicate that a firm's country of origin is a more influential factor in explaining the decision to create an ethics committee than the industry to which it belongs or even the magnitude of its agency conflicts. (shrink)

Zachary Schrag would like to put the burden of proof for continuation of research ethics review in the Social Sciences on those who advocate for research ethics committees (RECs), and asks that we take the concerns that he raises seriously. I separate his concerns into a principled issue and a number of pragmatic issues. The principled issue concerns the justification for having research ethics committees; the pragmatic issues concern questions such as the effectiveness of review and the expertise of (...) the committee members. I argue that RECs can be justified by their role in improving ethical practice and in reducing wrongs done to research participants. I propose a model of review for doing this, which I think would also address the pragmatic issues raised. I then offer an account of where the UK ethics review system is now and suggest three steps which could improve social science ethics review in the UK and move it in a perhaps more desirable direction. (shrink)

How the diversity of membership of research ethics committees is arrived at has, to date, largely been fairly arbitrary. However, a tool to help determine one's moral preference is now available and it is introduced here as, arguably, having the potential to assist with ensuring a more meaningful diversity amongst an ethics committee's membership. The tool is seen to be easily applied – but, it is argued, may be conceived on at least two false premises. Firstly, despite different theories (...) of ethics, none can be proved to give the ‘right’ answer other than in its own terms. Secondly, if there is an ethical hierarchy, as the model suggests, then ethical diversity must become redundant for the possibility of achieving ethical excellence. (shrink)

Originally published in 1961. Michael Polanyi was a polymath who influenced economics and the sciences as well as philosophy. His wide-ranging research in physical science is as well-known as his work on freedom and knowledge and his arguments against positivism and reductionism. This collection of essays written for him touches on all aspects of his influence but rotates around his published lectures Personal Knowledge: Towards a Post-Critical Philosophy. The contributors address four areas – The Scientist as Knower, Historical Perspectives, The (...) Knowledge of Society and the Knowledge of Living Things. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels (...) of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

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

This clinical ethics case examines whether to continue prescribing Adderall, an unlicensed drug in the UK, to a 30-year-old American patient with uncertain diagnosis who claims benefit from the medication. The ethics committee analyzed key tensions: balancing the patient's preference and reported benefits against diagnostic uncertainty and medical best practices, weighing short-term functioning against long-term risks of an addictive medication, and considering resource allocation implications of prescribing an unlicensed drug. While acknowledging the patient's positive response to Adderall, the (...) class='Hi'>committee recommended trying UK-approved medications first while working to establish a clearer diagnosis and building a stronger doctor-patient relationship, rather than simply continuing to prescribe based on patient preference alone. (shrink)

With disagreement, doubts, or ambiguous grounds in end–of-life decisions, doctors are advised to involve a clinical ethics committee. However, little has been published on doctors’ experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors’ experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian (...) physicians who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients’ relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs’ discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs’ discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians. (shrink)

sirFollowing Dr Barber's letter1 relating to the mechanism for approval of Local Research Ethics Committees , I have also had concerns over the intense pressure for a fast turn around for local approval. Projects may have been six months or more in the Multicentre Research Ethics Committe process and then arrive on my desk with multiple telephone calls requiring ….

In this article we highlight the main points of the development of bioethics and ethics committees in France. We argue that the French cultural context of medicine and its current political transformations favor new models of hospital ethics committee and we provide an example of such a model developed at Paris's Institut Curie, the oldest French cancer treatment and research centre.

In Turkey, there was no legal regulation of research on human beings until 1993. In that year “the amendment relating to drug researches” was issued. The main objectives of the regulation are to establish a central ethics committee and local ethics committees, and to provide administrative control.There are no compulsory clinical ethics lectures in the medical curriculum, so it is also proposed that research ethics committees play a central educational role by helping physicians to be aware of moral problems (...) and by contributing to the training of research teams. (shrink)

This study aims to characterise Human Research Ethics Committee (HREC) members’ perceptions on five main themes associated with ethics reviews, namely, the nature of research, ethical/moral issues, assent, participants’ risk and HREC prerogatives issues. Three hundred and sixteen HREC members from over 200 HRECs throughout Australia responded to an online questionnaire survey. The results show that in general, HREC members’ beliefs are reasoned and align with sound principles of ethical reviews. There seems to be a disposition for living up (...) to ethical/moral values, avoiding the issue of consent waivers and respecting participants’ welfare, as well as a sense of ambiguity about HREC prerogatives. Problematic areas were a tendency towards over-valuing quantitative research methods for their perceived validity and a neutral view on issuing consent waivers to participants with intellectual disability and, finally, the belief that research that limits disclosure, plans deception or actively conceals is morally unjustifiable. Implications for professional development and policy-making are discussed. (shrink)

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

Committee decision making is examined in this study focusing on the role assigned to the committee members. In particular, we are concerned about the comparison between committee performance under specialization and non-specialization of the decision makers. Specialization (in the context of project or public policy selection) means that the decision of each committee member is based on a narrow area, which typically results in the acquirement and use of relatively high expertise in that area. When the (...) committee members’ expertise is already determined, specialization only means that the decision of each committee member is based solely on his/her relatively high expertise area. This form of specialization is potentially inferior relative to non-specialization under which the decision of each committee member is based on different areas, not just his/her relatively high expertise area. Given that the expertise of the committee members is already determined but unknown, our analysis focuses on non-specializing individuals whose decision is based on a decision rule that does not require information on the decision-making skills. Under these realistic assumptions, non-specialization is shown to be preferable over specialization, depending on the aggregation rule applied by the committee. The significance of our approach is not limited to the specific results that we obtain. Rather, it should be viewed as a first step toward a deeper examination of the role of individual decision makers in enhancing the performance of collective decision making. (shrink)

In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee before it can be allowed to take place. However, as the demand for such tissue has rapidly increased in recent years, and biobanks have been created to meet these needs, committees have had to deal with a growing number of such demands. Detailed instructions for evaluating every kind of tissue request are scarce. Committees charged with evaluating research protocols therefore (...) sometimes face uncertainty in their decision-making. We examine how a pool of Swiss REC members deal with a number of cases involving human tissue, in order to determine the standards they adhere to, and their understanding and implementation of existing laws and guidelines. There is considerable divergence in the approaches and decisions of Swiss REC members regarding human tissue sample requests, particularly concerning the issue of informed consent. Despite recent trends towards less strict consent requirements for biosample research, many of our respondents continue to employ demanding standards for researchers. The question of informed consent, and the circumstances in which it is required, continues to result in differences of opinion. While room for local and cultural interpretation is essential to the workings of an REC, misunderstanding of existing guidelines, or an absence of regulation in sensitive areas, will only lead to suboptimal functioning of the REC itself. Our data suggests that there is uncertainty and disagreement on the question of consent for human tissue sample, which existing laws and guidelines may not fully clarify. Methods to address these uncertainties should be implemented in order to ensure efficient and harmonious review of research protocols. (shrink)

A previous research ethics article by the authors provided evidence to support the claim that the New Zealand Ethics Committee (NZEC) was a powerless ethics committee. Ethics review applicants were not formally obliged to seek ethics review, and any committee recommendations were given on a ‘take it or leave it’ basis. One year later, the capacity of applications has doubled, and NZEC finds its core assumptions challenged as funders and government agencies now compel contracted researchers to make (...) use of this free service. Moreover, NZEC has expanded into research areas inhabited by market researchers, long shy of ethics review. Review requirements and remit expansion challenges some, but not all, aspects of NZEC’s assumption of powerlessness as NZEC remains committed to research ethics, not research governance, and it adheres to the principles of the New Brunswick Declaration to respect applicants the same way it expects applicants to respect participants. This annual survey of applicants makes NZEC accountable to its applicants, providing evidence once more that NZEC’s expeditious and cordial review of applications is considered different from traditional ethics review. (shrink)

As hospital ethics committees become more common in American hospitals, their degree of success should be measured. Just as new technological procedures are evaluated, institutional innovations should also be evaluated. Currently, little is known about the success of HECs, and some authors have wondered whether these committees serve any useful purpose at all. This article reviews the descriptive results of a 1990 study on HEC success as they pertain to the question of how to measure committee success.

Committee protocols typically involve a deliberation stage in which members try to influence and convince other regarding the “right” decision. Beyond information exchange, such deliberations also aim to affect the preferences and the votes of other members. Using a model of social influence, we demonstrate how deliberation procedures affect the voting outcome and how different protocols of consultation by committees’ chairs may affect their decisions. We then analyze the ability of a “designer” to control the deliberation protocol and (...) to manipulate the deliberation procedure to increase the probability that the outcome he favors will be selected. (shrink)

Currently, research ethics committees in the UK meet behind closed doors—their workings and most of the content of their decisions are unavailable to the general public. There is a significant tension between this current practice and a broader societal presumption of openness. As a form of public institution, the REC system exists to oversee research from the perspective of society generally.An important part of this tension turns on the kind of justification that might be offered for the REC system. In (...) this paper I adapt Daniels and Sabin’s accountability for reasonableness model for just resource allocation to the research ethics context to provide some structural legitimacy and to enable progress on the question of openness. After considering the consequences of adopting this model for open REC meetings, I then examine some reasons that might be offered against open meetings. These arguments do not overwhelm the core intuitions behind the presumption of openness but they do, I suggest, give us reason to retreat from fully public meetings. I conclude that there should be important adjustments to the system towards public accountability and that there are grounds for stopping short of fully public meetings. (shrink)

Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.

The conference committee is one of the most important joint committees in het American Congress, appointed to reconcile differences between bills adopted in the two houses of Congress in different forms.Each house is authorized to call for a conference. Usually, only the most important bills are submitted to a conference committee, and minor bills wilt be adopted by concessions of one of the houses.Each house commits his conferees, and can give them instructions on how to vote. These instructions (...) however are not imperative. The number of conferees in each delegation is not necessarily equal, but each delegation votes as a unit and in the way determined by the majority in the delegation. The committee only is allowed to examine the matters in disagreement and cannot add any new provisions to the bills.When an agreement is reached a conference report is written and signed by the majority of the conferees in each delegation, after which it is sent back to the houses for approval.The bill as modified by the conference committee can be adopted or rejected, in which case a second conference can be asked for. No amendments are allowed. The conference committee, sometimes called the «Third House of Congress» not only has become a very powerful institution but also a necessary one. It is responsible for about one third of the legislation including the most important bills.lts necessity is confirmed by its two century-existence, and the fact that it has been copied in other federal states such as the Federal Republic of Germany and Switzerland. (shrink)

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

BackgroundThe COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for (...) a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.MethodsWe conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.ResultsFive main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.ConclusionsNumerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues. (shrink)

ABSTRACT There is growing concern about the reuse and exportation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing (...) country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re‐use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels. (shrink)

According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees. The purpose of this study was to evaluate how the above guidelines are implemented in real practice. There were 111 hospitals selected out of 176 Polish clinical hospitals and hospitals accredited by Center of Monitoring Quality in Health System. The study was conducted by the survey method. There were 56 hospitals that responded to the survey. The number of HECs members fluctuated (...) between 3 and 16 members, where usually 5 members were part of the board committee. The composition of the HECs for professions other than physicians was diverse and non-standardized. Only 55 % of HECs had a professional set of standards. 98 % of HECs had specific tasks. 62 % of HECs were asked for their expertise, and 55 % prepared <6.88 % of the opinions were related to interpersonal relations between hospital personnel, patients and their families with emphasis on the interactions between superiors and their inferiors or hospital staff and patients and their families. Only 12 % of the opinions were reported by the respondents as related to ethical dilemmas. In conclusion, few Polish hospitals have HECs, and the structure, services and workload are not always adequate. To ensure a reliable operation of HECs requires the development of relevant legislation, standard operating procedures and well trained members. (shrink)