During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy‐makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise (...) ethical dilemmas that traverse national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity‐building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low‐ and middle‐income countries. (shrink)

This contribution addresses some bioethical and medico-legal issues of the opinion formulated by the Italian National Bioethics Committee (CNB) in response to the dilemma between the State’s duty to protect the life and health of the prisoner entrusted to its care and the prisoner’s right to exercise his freedom of expression. The prisoner hunger strike is a form of protest frequently encountered in prison and it is a form of communication but also a language used by the (...) prisoner in order to provoke changes in the prison condition. There are no rules in the prison regulations, nor in the laws governing the legal status of prisoners, that allow the conscious will of the capable and informed subject to be opposed and forced nutrition to be carried out. However, this can in no manner make therapeutic abandonment legitimate: the medical doctor should promote every action to support the patient. In the recent opinion formulated by the CNB it was remarked how self-determination is a central concept in human rights and refers to an individual’s ability to make autonomous and free decisions about his or her life and body. (shrink)

Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a (...) descriptive study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (χ 2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. Results The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC. Conclusion In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research. (shrink)

The number of national bioethics commissions has burgeoned since the establishment of the first one in 1983. They provide an arena in which stakeholders with widely differing moral views can discuss, interact and negotiate about controversial matters. The establishment of the Brazilian committee is used as an example of how such bodies can be introduced. If such councils are to be implemented effectively and regarded as legitimate, the society as a whole should be included in the construction (...) of the proposal and represented on the council, the council should have the benefit of specialist advice when that is needed, and the council should be linked to the elected government in an official advisory capacity. The article describes long process of planning and consultation to establish Brazil's National Bioethics Council and of eventually defining its task as advising the president on matters relating to bioethics. (shrink)

The United Kingdom has many bodies that play their part in carrying out the work of national ethics committees, but its nearest equivalent of a U.S. presidential bioethics commission is the Nuffield Council on Bioethics, established in 1991. The Council is charged with examining ethical questions raised by developments in biological and medical research, publishing reports, and making representations to appropriate bodies in order to respond to or anticipate public concern. It is a nongovernment organization with no (...) defined or guaranteed channels of influence. It has no authority merely by virtue of the position it holds. Rather, it has established relational authority based on its reputation. Unlike the U.S. bioethics commission, it is not part of executive government, nor is it constituted to contribute to the legislative branch, as does the French Comité Consultatif National d'Ethique. Its nongovernmental status notwithstanding, the Nuffield Council's work affects the U.K. government and the British public, and the Council has achieved international recognition for its reports. I was the chairperson from 2012 to 2017 and draw on my experience in this piece to consider three key audiences: governments, publics, and the international community. (shrink)

As has become tradition, executive directors of United States’ presidential bioethics committees offer reflections about their experience shortly after the orderly shutdown of the commission staff. After the records are filed according to government records regulations; after all the staff members, who are hired into temporary positions that must be renewed every two years, have secured permanent employment; after preparations are made to ensure that the next commission staff (should there be one) has a budget and standard operating procedures (...) in order to begin its work in a timely manner; after the lights are turned out for the last time, the executive director makes the final climb up the stairs into the sunlight and reflects on the whirlwind. There is much about my work with the Presidential Commission for the Study of Bioethical Issues that deserves comment, but one aspect of the commission that has been especially valuable to me is its work to educate the nation on bioethical issues. This is, moreover, a contribution in which the commission staff was central, and it is one that, as an ethics educator myself, I will cherish deeply. (shrink)

BackgroundNational Ethics Committees (NECs) offer important oversight and guidance functions and facilitate public debate on bioethical issues. In an increasingly globalized world where technological advances, multi-national research collaborations, and pandemics are creating ethical dilemmas that transcend national borders, coordination and the joining of efforts among NECs are key. The purpose of this study is to take stock of the current NEC landscape, their varying roles and missions, and the range of bioethical topics on which they deliberated since their (...) inception.MethodsData on the availability, functions, and ethical deliberations (publications) of NECs globally were gathered through a systematic search of NEC websites and through contacts known to the authors. The search was conducted in English, French, and Spanish. The data abstraction was done in Excel and included the NEC’s country, region, functions, and deliberations on bioethical issues. Deliberation topics were classified into thematic categories through an iterative process of regrouping to arrive at the main set of themes.Results124 NECs in 100 countries were identified. 44% of the NECs are in Europe and 47% are in high-income countries. Out of the 1108 retrieved publications, 40% were on bioethics in the context of research, followed by the clinic (28%) and public health issues (22%). The top five topics of these publications were: research ethics (124; 9%), genetics and genomics (62; 6%), organ transplantation (58; 5%), assisted reproductive technology (49; 4%), and end of life (36; 3%).ConclusionOur study makes an important contribution to understanding the current interests and functions of NECs and the range of their bioethics deliberations. By making the data publicly available through this publication, it allows users to conduct tailored analyses and queries based on their interests, and to seek and strengthen collaboration and exchange. It also makes the case for the fruitfulness of developing and maintaining a global repository of current and new deliberations to more effectively advance this field for the greater good of humanity, research, and public health. (shrink)

Bioethical and bio‐political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their (...) work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision‐making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific‐technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision‐making procedures – if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible. (shrink)

The establishment of Mexico's National Bioethics Commission (Comisión Nacional de Bioética), in 1992, was conceived within the context of a global movement aimed at raising awareness of the ethical implications of technological and scientific development, especially in biomedicine. In 2005, a new decree put the commission under the scope of the Secretariat of Health and granted it technical and operational autonomy, allowing it to become a regulatory agency aimed at promoting a culture of bioethics, encouraging reflection on (...) human health, and developing guidelines for health care, research, and education, through a global, secular, and democratic perspective. The commission became the leading actor in the strategy for institutionalizing bioethics in Mexico after reforms to the country's General Health Act in 2011, which required that public, social assistance, or private health care facilities establish a hospital bioethics committee to address bioethical dilemmas or issues and, when relevant, a research ethics committee to address research with human subjects. This assignment has shifted the focus of the activities and goals of the National Bioethics Commission toward establishing these committees in line with current regulations and developing mechanisms to ensure that they operate with the highest standards of ethical conduct, performance, and accountability. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:An Egg Takes Flight: The Once and Future Life of the National Bioethics Advisory Commission*Alexander Morgan Capron (bio)Attempting to describe the National Bioethics Advisory Commission (NBAC) is comparable to the surreal feat performed by the artist in a famous painting by René Magritte. The artist (Magritte himself) sits with his back to the viewer, a palette in his left hand. The brush in his right (...) hand is raised to a canvas, blank except for a bird in flight that he is in the process of painting. The artist is looking to his left at a tabletop, bare except for a single, plain egg.Having held its second formal meeting in mid-January, NBAC is certainly still embryonic, its future mysterious within its shell. Yet answers to four major questions that will determine not just what kind of bird the Commission turns out to be but the heights to which it will fly should be evident by April or May 1997. First, will the White House take the sort of interest in NBAC that is needed if it is to succeed? Second, will the Commission’s term be extended beyond October 1997—and will the decision come early enough to allow it to start soon on projects that will take more than a single year to complete? Third, will the Commission take a broad view of the issues it addresses, reexamining widely accepted assumptions and going back to basic premises, or will it respond primarily in bureaucratic terms, guided by its charter’s focus on improving the policies and practices of federal departments and agencies? Fourth, will the Commission move beyond its initially mandated topics—the rights and welfare of human research subjects and the management and use of genetic information—and become what its name promises, the nation’s advisory body on the full range of bioethical issues that arise in the organization and management of health services and research?The Origins of the Egg: NBAC’s PredecessorsThe creation of a national bioethics commission has been demanded for years, at the least since its most recent predecessor, the Biomedical Ethics [End Page 63] Advisory Committee (BEAC) finally expired in 1990. BEAC’s statutory authority lapsed after the hapless committee had spent several years itself like an in vitro embryo in a vat of liquid nitrogen. BEAC’s opponents in Congress froze its appropriation and forbad it to meet until the Biomedical Ethics Board of six senators and six representatives to which it was supposed to report resolved the chaos resulting from the Board members’ ideological differences and personal distrust; this never occurred, and the Board proved unable even to choose its chairman. 1 BEAC, which met only twice, had laid preliminary plans to study the issues raised by the new genetics, but the politics of abortion—which had greatly complicated and slowed the Board’s naming of the BEAC members—was strong enough to interfere even with the topic of genetics, on which the difference among committee members actually gave no sign of dividing on pro-life/pro-choice grounds.The disappearance of BEAC left the nation without a mechanism for “public bioethics,” and several efforts were undertaken in the early 1990s to generate a new commission that could carry on in the tradition of the two previous, successful bioethics commissions. (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research operated under a Congressional mandate in the Department of Health, Education, and Welfare from 1974 to 1978, and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which had been authorized by Congress in 1978, actually operated as an independent body with government-wide purview from January 1980 to March 1983.) The Institute of Medicine established a committee to assess the mechanisms available not only to the federal government but also to states, professional bodies, and the public for deliberating about and resolving ethical issues stemming from developments in biomedicine (Bulger, Bobby, and Fineberg 1995). In September 1992, Senators Mark O. Hatfield (R-OR), Edward M. Kennedy (D-MA), and Dennis DeConcini (D-AZ) requested that the Office of Technology Assessment (OTA) evaluate the... (shrink)

The article examines reasons and features of the Italian bioethics movement in itself and in relationship to that in the U.S.A. Research, consultation, teaching are the most requested professional activities. Ethics committees are now established in several places and at different level: national (National Italian Committee for Bioethics), regional (Italy has about twenty regions with some political power), and institutional (research centers, university, main hospitals).

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they play compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent (...) of ethics committees report that they play a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Veterans Affairs National Center for Clinical EthicsJames L. Bernat (bio)The veterans health administration is the largest health care system in the United States and, indeed, is larger that the health care system of many foreign countries. In February 1991 the Department of Veterans Affairs (V.A.) in Washington, D.C. awarded a contract to the clinical ethics group at the Veterans Affairs Medical Center in White River Junction, Vermont (...) to establish the V.A. National Center for Clinical Ethics. In this article I describe the organizational context, mission, operation, and future direction of the Center, which William A. Nelson, Ph.D., and I co-direct.The Veterans Health AdministrationThe Department of Veterans Affairs operates 171 hospitals providing services ranging from primary, secondary, and tertiary medical care to psychiatric hospitals, rehabilitation centers, and nursing homes. The V.A. also provides outpatient services at all hospitals and at dozens of free-standing outpatent clinics. V.A. medical centers employ over 14,000 physicians and serve approximately 4.5 million veteran patients (Hollingsworth and Bondy 1990; Mirvis 1990).The V.A. serves an important educational function, providing training sites for medical students, postgraduate physicians, and trainees in other health-related fields. Approximately 78 percent of V.A. medical centers are affiliated with medical schools. Over one-third of all American medical students and over 40 percent of interns and residents spend a portion of their training in V.A. medical centers. More than 100,000 students in all health-related fields train in V.A. facilities annually (Hollingsworth and Bondy 1990).Research is another mission of the V.A. Many academic physicians and scientists derive their research and salary funding from V.A contracts and awards. The V.A. Research Career Development Program provides the means for many medical school faculty members to achieve successful careers as scientists and clinical investigators. Although research accounts for only slightly more than 1 percent of the V.A. medical budget, two V.A. researchers have been awarded the Nobel Prize (Hollingsworth and Bondy 1990). [End Page 385]In comparison to other medical care settings, the average V.A. patient is likely to be older, poorer, male, less well-educated, more chronically ill, and more expensive to care for. Many patients first patronize the V.A. system after they have been bankrupted by the costs of a major illness. Unlike young, healthy patients ideally favored by health maintenance organizations, these patients immediately require large expenditures for hospitalizations, medications, and other treatments. Additional burdens have been placed on V.A. facilities by a record of chronic federal underfunding over the past decade, despite expanded patient censuses at every facility.Bioethical issues arise in V.A. facilities with great frequency for several reasons. Older and poorer patients are often sicker, have fewer home-support resources, and have completed fewer advance directives for health care. Chronic operational underfunding requires explicit health care rationing systemwide. Academic physicians within the V.A. system have multiple professional duties that have the potential for conflict. Although their primary duty is to their patients, they also must serve the federal government and their medical school academic supervisors. The practice of medical care rationing pits the physician's professional duty to his patient against his duty to the system (Mirvis 1990).The V.A. has responded to these bioethical demands with several initiatives. Hospital ethics advisory committees have been developed in nearly every V.A. medical center. The V.A. National Bioethics Committee has been empaneled to encourage uniform policies across the V.A. system concerning bioethical issues. Most recently, funds were provided for the V.A. National Center for Clinical Ethics.Functions of the National Center for Clinical Ethics (NCCE)The NCCE has a fourfold mission: 1) to enhance the quality of clinical ethics programs at all 171 V.A. medical centers nationwide; 2) to staff the V.A. National Bioethics Committee; 3) to assist administrators and planners in the V.A. Central Office on policy development concerning bioethical issues; and 4) to study, organize, and coordinate clinical, educational, and research bioethics programs throughout the system.Enhancing the quality of clinical ethics programs at V.A. medical centers is largely an... (shrink)

Background In Italy, clinical ethics is not well institutionalized. On February 7, 2023, the Italian Ministry of Health published four long-awaited decrees regarding the reorganization of ethics committees. Aim: The aim of this article is twofold: firstly, we aim to briefly summarize the development of clinical ethics in Italy from a legislative point of view; secondly, we aim to examine how Italian regions are implementing the part of the new decrees on the organization of ethics committees that concerns clinical ethics. (...) Methods: As for the first aim, we conducted a critical interpretive review (CIR). The search was restricted to the opinions offered by the Italian National Bioethics Committee (CNB) and to the major Italian legislative decrees on the topic. Regarding the second aim, we conducted an online search through Regional Official Bulletins of each Italian region. Results: Our analysis showed that despite the recommendations from the CNB to differentiate Research Ethics Committees (RECs) and Clinical Ethics Committees (CECs), over the years legislative attention has mainly focused on RECs and pharmacological matters. The new decrees allow regions to be flexible in organizing their activities. However, it emerged that only four regions (Veneto, Friuli-Venezia Giulia, Puglia, Emilia-Romagna) have split the roles, while all the other regions have entrusted both roles to a single committee. Conclusion: The risk for Italy is to take a step backward in the development of clinical ethics. Possible solutions could be either making Local Ethics Committees (CELs) mandatory or institutionalizing Ethics Consultation services (ECSs). (shrink)

Today local, national and international ethics committees have become an effective means of social regulation in many European countries. Science itself is an important precondition for the development of bioethical knowledge and ethics expertise. Cultural, social, historical and religious preconditions can facilitate different forms and methods of ethics expertise in each country. Ukrainian ethics expertise has some methodological problems connected with its socio-cultural, historical, science and philosophy development particularities. In this context, clarification of some common legitimacies or methodological approaches (...) to ethics committee (EC) phenomena such as globalization, scientization and the prioritization of an ethics paradigm are very important. On the other hand, elaborate study and critical analysis of international experience by Ukraine and other Eastern European countries will provide the integration of their local and national ethics expertises into a world bioethics ethos. (shrink)

Compared to institutional and area-based ethics committees, little is known about the structure and activities performed by ethics committees at national medical organizations and societies. This five year follow-up study aimed to determine (1) the creation and function of ethics committees at medical organizations in Japan, and (2) their general strategies to deal with ethical problems. The study sample included the member societies of the Japanese Association of Medical Sciences (n=92 in 1998, n=96 in 2003). Instruments consisted of two (...) sections: (1) the structure, function and activities of ethics committees, and (2) the strategies for dealing with ethical problems. Response rates were 84.4% in 1998 and 64.4% in 2003. Findings showed a significant increase of ethics committees at medical organizations between 1998 (25.6%) and 2003 (50.0%). Members were mostly male, medical doctors in clinical or basic medicine, and members of the organization. The major functions of ethics committees were ethical reviews of research protocols, policy making and ethical reviews of manuscripts submitted for journal publication. Among organizations that did not have an ethics committee, a significant decrease was found in organizations that replied that they had never experienced an ethical problem which needed further investigation (p<0.01). Findings suggested an overall rise in awareness of the importance of ethical issues and also highlighted an increase in recognition of responsibility regarding ethical problems. (shrink)

ABSTRACT This article presents an overview of the Portuguese transposition of the European Directive on Good Clinical Practice (2001/20/e) concerning scientific and academic debates on bioethics and clinical investigation. Since the Directive was transposed into Portuguese law by its National Assembly, the bureaucracy of clinical trials has been ever more complex. Despite demands for swift application processes by the Pharmaceutical industry, supported by the European Parliament, the Directive's transcription to the national law has not always delivered the (...) expected outcome. However, this has led to an increased number of applications for clinical trials in Portuguese hospitals. In this article I revise bioethical publications and decree‐laws enabling an informed appraisal of the anxieties and prospects for the implementation of the clinical trials Directive in Portugal. This article also places the European Directive in the field of sociology of bioethics, arguing that Portuguese bioethical institutions differ from those of the US, and also from Northern European counterparts. The main divergence is that those people in Portugal who claim expertise in ‘legal’ bioethics do not dominate either the bureaucratic structure of research or ethics committees for health. Even experts in the applied ethics field now claim that ‘professional bioethicists do not exist’. The recent creation of a national Ethics Committee for Clinical Investigation (CEIC) in line with the European Directive on Good Clinical Practice (GCP) will not change the present imbalance between different professional jurisdictions in the national bioethical debate in Portugal. (shrink)

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)

The Universal Declaration on Bioethics and Human Rights adopted by the United Nations Educational, Scientific, and Cultural Organisation on 19 October 2005 is an important step in the search for global minimum standards in biomedical research and clinical practice. As a member of UNESCO International Bioethics Committee, I participated in the drafting of this document. Drawing on this experience, the principal features of the Declaration are outlined, before responding to two general charges that have been levelled at (...) UNESCO’s bioethical activities and at this particular document, are outlined. One criticism is to the effect that UNESCO is exceeding its mandate by drafting such bioethical instruments—in particular, the charge is that it is trespassing on a topic that lies in the responsibility of the World Health Organization. The second criticism is that UNESCO’s reliance on international human rights norms is inappropriate. (shrink)

Western society today is less unified by a set of core values than ever before. Undoubtedly, the concept of moral consensus is a difficult one in a liberal, democratic and pluralistic society. But it is imperative to avoid a rigid majoritarianism where sensitive personal values are at stake, as in bioethics. Bioethics has become an influential part of public and professional discussions of health care. It has helped frame issues of moral values and medicine as part of a (...) more general effort to find consensus about some of the most perplexing questions of our time. But why is it thought that a moral consensus is important or that it deserves respect? How does moral consensus acquire legitimacy in a society that includes diverse value systems? How is moral consensus possible and how do small groups help create or distort consensus processes? Written by a medical school professor trained in philosophy, this timely work tackles these questions from philosophical, historical, and social scientific standpoints. It begins by describing the traditional ambivalence about consensus in Western culture as well as the uncertain relationship in modernity between consensus and expertise. After outlining the current bioethical consensus, the book gives philosophical and political analyses of the idea of consensus, then assesses the role of consensus in national ethics commissions and in the ethics committee movement. Moreno constructs an original, naturalistic philosophy of moral consensus, referred to as "bioethical naturalism", and then applies sociology and social psychology to actual consensus processes. The book concludes with an account of bioethics as a consensus-oriented social reform movement. This insightful volume will be essential reading for bioethicists, philosophers, physicians, members of ethics committees, and all those concerned with ethical and social issues in health care. (shrink)

Ethics advisory groups, in various forms, have existed for at least 50 years in the United States and other countries. In science and biomedicine, four principal types of committees can be distinguished: policy-making and/or advisory committees, health professional association committees, health care ethics committees, and research ethics committees. Overall, these bodies have been of use to governments, policy makers, health care professionals, and the public in considering ‘what is ethical’ and ‘what is unethical’ in areas such as research involving humans (...) or animals or environmental questions such as whether to use genetically modified crops. This paper concentrates on a particular and... (shrink)

ABSTRACT Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics (...) Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision‐making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. (shrink)

At every moment, somewhere in the world, a group of men and women are sitting around a table deliberating about an ethical issue posed by medicine and research, whether as a research ethics committee; a hospital or clinical ethics committee; a stem‐cell review committee; a gene transfer research committee; a biobank ethics committee; an ethics advisory committee for a medical or nursing association or nongovernmental organization; a state, provincial, national, or intergovernmental bioethics (...) committee; or an ad hoc panel examining a particular development or case. However, the last national committee in the United States, the Presidential Commission for the Study of Bioethical Issues, held its final meeting at the end of August 2016 and closed its doors. Should we regret its departure? I believe that the United States would benefit from having another national bioethics advisory body, but I do not think that the commission should simply have continued under a new president in the same form. Instead, looking at the experience of that commission and its six predecessors—who they were, how they worked, the functions they served, and the problems they experienced—we can derive some useful ideas for anyone planning to build the next commission. (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)

The purpose of this article is to provide a short overview of the condition of clinical ethics committees (CECs) and other forms of the so-called "ethics support" infrastructure. This includes but is not limited to CECs because some countries also have ethics consultation services that function independently from the CECs. It seems that properly structured CECs and other types of ethics support have a potential to act as facilitators of ethically sensitive healthcare decision-making. This goal can be achieved if the (...) ethics support infrastructure becomes an integral part of the healthcare institution where the majority of ethical dilemmas and the need for ethical debate arise. At the same time, CECs can become a useful tool for implementing bioethical standards developed at both national and international levels, including those established by the Council of Europe instruments. This is the main reason why the issue of developing clinical ethics support services might be very important for the Steering Committee on Bioethics (CDBI) of the Council of Europe. More specifically, the question is what special role ethics support services can play in the context of the follow up to the Council of Europe Symposium in the decision-making process regarding medical treatment in end-of-life situations (Strasbourg, 30 November-1 December). Very often, cases to be considered by the CECs and ethics consultants deal with the difficult end-of-life treatment choices. (shrink)

Much has been written about the role of hospital ethics committees. Ethics committees may have begun in Seattle in the early 1960s, but they were reified in. New Jersey by the Quinlan Court in the 1970s and thrived in the national bioethics movement of the 1980s.In this flurry of ethics activity, several new forms of ethics committees have evolved. New forms of ethics committees include patient care-oriented ethics committees. Many ethicists are familiar with mission-oriented ethics committees. Such committees (...) have taken on new roles, and Include PROs, IPCs, and HREAPs. In general, these committees are regulatory in nature and may often rely on rules and regulations to assess patient cases, research protocols, and health professional practices. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of two (...) workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials. (shrink)

Abstract Gender and Ethics Committees: Where’s the Different Voice? -/- Prominent international and national ethics commissions such as the UNESCO Bioethics Commission rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under-representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women’s bodies, and when such committees claim to derive ‘universal’ standards. Are women missing from many ethics committees because of relatively straightforward, (...) if discriminatory, demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ‘anti-female’? It has been argued, for example, that there is a ‘different voice’ in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ‘masculine paradigm’ in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women’s representation on ethics committees in Eastern and Western Europe, a critical analysis of the supposed ‘masculinism’ of the principlist approach, and a case example in which a ‘different voice’ did indeed make a difference. (shrink)

Presidential commissions come and go by design, and it is reasonable to wonder about the impact of their recommendations. I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments (from 1994 to 1995) and as senior consultant to the National Bioethics Advisory Commission (from 1999 to 2000) for its report on multinational research. I continue to reflect on and look for the impact of both these (...) commissions.ACHRE's charter included the review of experiments with ionizing radiation sponsored or conducted by the United States government since the 1940s. The committee was also charged with investigating specific intentional releases of radiation into the environment. ACHRE had a somewhat unique difficulty built into its work: the need to make retrospective ethical judgments. With the National Bioethics Advisory Commission, my main role as senior consultant consisted of writing chapters of the report on multinational research for the commissioners’ approval. A more important concern for me as a hired consultant was how to maintain intellectual and moral integrity. Unlike when writing scholarly papers, where I can express my own views, when I was drafting text for a presidential commission, the commissioners’ views took precedence over my own when we disagreed. I wondered, how much could I comply with the commissioners’ positions without compromising my own integrity? (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 289-292.

In lieu of an abstract, here is a brief excerpt of the content:Landmark Legal Cases in BioethicsSusan Cartier Poland (bio)Only a few decades old, the interdisciplinary field of bioethics has developed surrounded by centuries of legal tradition and moral philosophy. Bioethics and the law have weaved back and forth over time influencing each field. Sometimes ethics leads the debate on problematical issues; for example, the Recombinant DNA Advisory Committee at the National Institutes of Health established regulations (...) prior to initiating human gene therapy. At other times, law takes over; Roe v. Wade, for example, has polarized and closed public discussion on abortion. Most frequently, however, scientific developments initiate discussion in both fields, as when the announcement of the birth of Dolly—the first cloned mammal—sparked President Clinton to ask the National Bioethics Advisory Commission for a report on cloning.A back-and-forth pattern also exists within the law itself, this time between legislator and judge. Legislators enact statutes, which apply universally to regulate conduct in society. Judges, on the other hand, interpret statutes and apply them to particular cases to resolve disputes between parties. Case law, as judge-made law is called, that grows in the absence of legislation becomes the common law. Legislatures can change the course of common law development by enacting more law, usually as amendments, but sometimes as repeals. A judge who sees the facts of a case or the law differently may also change the common law. And so the counterpoint between legislator and judge goes.A legal case becomes a landmark in bioethics because of its historical or precedential value to the field. Historical cases reflect judicial reasoning or rationalization that lays the conceptual foundation for a bioethical principle. Perhaps the best known example of this is the focus on the right to self-determination in Schloendorff that led to the development of informed consent. The principle of autonomy in bioethics derives its legal impetus from this line of cases.A case that acquires landmark status because of its precedential value does so for one of two reasons based on legal precedents. First, the case may be one of “first impression.” In the legal sense, that means that the particular case with its [End Page 191] facts or issues is the first one that a particular court has confronted within that court’s jurisdiction or area of decision-making authority. To be a landmark in bioethics, however, the ordinary sense of “first impression” applies. The first time that a particular bioethical topic has appeared in court for legal resolution makes a case one of “first impression” for bioethics. The case of Baby M on surrogacy contracts illustrates this.The second way in which a case can achieve landmark status based on precedents involves legal precedent and the jurisdictional basis of the court system. Under the common law system, a preceding case that involves the same or similar facts or issues as a current case must be followed by lower—i.e., less authoritative—courts in the same jurisdiction. That judicial rule of decision making is called stare decisis. It creates an institution of continuity, yet allows for change due to differences in judicial interpretation of facts and issues, which is called distinguishing the case.All courts under United States jurisdiction must follow the U.S. Supreme Court. By its sheer power of authority, the Court issues opinions that, if they concern bioethical topics, make cases landmarks in bioethics. For example, Roe v. Wade made abortion legal and set off the debate between maternal and fetal rights. Casey later refined, or to some redefined with a discussion of stare decisis, the bioethical underpinnings of Roe by framing the debate as one between maternal rights and state interests.In law, precedents concern only appellate cases. Trial courts, like that in McFall v. Shimp, handle questions of both fact and law. Appellate courts, like that in Brotherton, hear appeals from the lower trial courts and address legal issues only. Trial judges apply the law to facts, and appellate judges reason about the trial judge’s legal interpretation.Appellate court decisions are the ones most frequently published, either in print or electronically online, for citation. Consequently they are the easiest to locate and retrieve. “Reporters” as... (shrink)

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade (...) moral disagreement, conflict, and ‘outsiders’ are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well‐known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper. (shrink)

In Italy, during the first wave of the Covid-19 pandemic, the Italian Society of Resuscitators and Pain Therapists (SIAARTI) and the Italian National Bioethics Committee (CNB) published ethical guidance on the allocation of scarce intensive care resources. In this paper, we outline and compare these documents in detail, highlighting differences and similarities. In particular, we argue that major differences exist with respect to the principles and values underpinning the documents and the normative allocation criteria proposed. Conversely, similarities (...) can be traced with respect to a functional rather than substantial endorsement of the age criterion, the importance of transparency, and the consideration over healthcare professionals’ responsibility regarding allocative decisions. In conclusion, we argue that Italy has lacked a comprehensive and publicly-accountable policy articulating principles and operational criteria geared to strengthen the “ethical preparedness” of the country in dealing with current and possible future public health emergencies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 (...) The subject was the future of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

Flesh of My Flesh is a collection of articles by today's most respected scientists, philosophers, bioethicists, theologians, and law professors about whether we should allow human cloning. It includes historical pieces to provide background for the current debate. Religious, philosophical, and legal points of view are all represented.

Leading biologists and physicians in France have been considering bioethical problems for several decades. In 1983 an important new forum for bioethical discussion in France was created, with the establishment of the Comité Consultatif National d'Ethique pour les Sciences de la Vie et de la Santé. This committee has produced numerous important opinions and reports on such topics as research involving human subjects, fetal tissue research, and the new reproductive technologies. At the local level the discussion of bioethical (...) questions is carried on by ethics committees, which are charged with the responsibility of reviewing research protocols. Keywords: commissions, ethics committees, codes of ethics, physicians, human experimentation, reproductive technologies CiteULike Connotea Del.icio.us What's this? (shrink)

Given the costs of litigation high-profile court cases about withdrawing life-sustaining medical treatment for seriously ill children in England & Wales tend to be followed by discussion about how to avoid similar cases in future. Whilst two proposals, mediation and replacing the best interests standard with a harm threshold, have received broad attention, a proposal to replace the court by a specialist review committee has not been further investigated. This article analyses the effects of a putative replacement of the (...) courts by a specialist review committee using the process enacted by the futility clauses in the Texas Advance Directives Act (TADA) as a model. Under TADA life-sustaining treatment may legally be withdrawn when a review committee deems it futile and no alternative healthcare provider can be identified. The investigation finds that installing a national review committee with the power to decide whether life-sustaining treatment is futile would have reduced the number of court cases about withdrawal thereof in England & Wales to a handful over the last 3 decades. In addition to shorter procedures and costs savings, a national review committee modelled after TADA would have advantages for both clinicians and parents. Advantages for clinicians are more limited exposure to delivery of clinical care that may cause moral distress and less exposure to adverse press and social media content. Advantages for parents are that the process would establish them as ethical decision makers and offer the possibility of a transfer of the care of the child provided an alternative healthcare provider can be found. As such decisions taken by a specialist review committee may be more acceptable for parents than those of the courts. (shrink)

Cloning was the issue that put the National Bioethics Advisory Commission on the map, but the first clue that NBAC would address cloning was a terse fax from the White House to each of us who served on the Commission. The fax noted that with the birth of the sheep named Dolly, mammalian cloning was now a reality, and it tasked NBAC with providing advice on the ethics of human cloning and how the nation should respond to it. (...) We were given ninety days to report our findings. That's a very tight deadline for a report written by a committee, but we met it, and along the way, I learned important lessons. My goal in this essay is to share what I learned at the ramparts of what I will call, with apologies to George Lucas, the Cloning Wars and through NBAC's work on five additional reports. (shrink)

Bioethics literature on national security issues is surprisingly sparse and the implications of neuroscience for national security are of increasing public and scholarly interest. This article elaborates one important source of evidence that can be found in reports by US government advisory committees over the past few years. It demonstrates that the growing interest in neuroscience on the part of national security agencies can be discerned in part by reviewing recent reports from the US National (...) Academies. The relationship between national security concerns and neuroscience is complex. Primary questions are discussed in the anthropomorphic terms of concerns and goals, and there is no inference to any particular sort of deliberations within these systems that leads ineluctably to a certain science policy agenda. This article also assesses the cultural underpinnings of neuroscience and ethical implications of evolving neurotechnologic capacity. (shrink)