: Nationalbioethics commissions have struggled to develop ethically warranted methods for conducting their deliberations. The NationalBioethicsAdvisoryCommission in its report on stem cell research adopted an approach to public deliberation indebted to Rawls in that it sought common ground consistent with shared values and beliefs at the foundation of a well-ordered democracy. In contrast, although the research cloning and stem cell research reports of the President's Council on Bioethics reveal that (...) it broached two different methods of public deliberation—balancing goods and following an overarching moral principle—it adopted neither. Thereupon its prime mover, Leon Kass, influenced particularly by the approach of Leo Strauss, sought to develop a method of public deliberation guided by tradition and practical wisdom. When this failed, the Council fell back on a method that took account of shared fundamental values of a free democracy—a method remarkably akin to that employed by the NationalBioethicsAdvisoryCommission. Respect for diverse reasonable conceptions of the good in a democratic polity requires nationalbioethics commissions to seek and incorporate that which is valuable in opposing positions. (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)
This article considers the sort of diversity in perspective appropriate for a presidential commission on bioethics, and by implication, high-level governmental commissions on ethics more generally. It takes as its point of comparison the respective reports on human cloning produced by the NationalBioethicsAdvisoryCommission, appointed by President Bill Clinton, and George W. Bush's President's Council on Bioethics, under the leadership of its original chair, Leon Kass. I argue that the Clinton (...) class='Hi'>Commission Report exemplifies forensic diversity (the type of diversity between contesting parties in a legal case), while the Kass Council Report exemplifies academic diversity (the diversity found in a medieval disputatio). Drawing upon Thomas Aquinas, I argue that the type of diversity most appropriate for such advisory bodies is deliberative diversity, which facilitates the President's process of taking counsel. After considering their respective charges, I suggest that neither the Clinton Commission nor the Kass Council possessed an adequate degree of deliberative diversity for their respective tasks. (shrink)
The number of nationalbioethics 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 NationalBioethics Council and of eventually defining its task as advising the president on matters relating to bioethics. (shrink)
The report produced by the NationalBioethicsAdvisoryCommission at the request of President Bill Clinton, titled Cloning Human Beings, provides a good example of the two-pronged approach to religion in bioethics. The report merits careful scrutiny precisely because of the deftness with which it appears to negotiate the thorny questions surrounding the role of religion in public policy. Analysis of the structure, arguments, and rhetoric of the report reveals the theoretical and practical inadequacy of (...) the currently reigning two-pronged approach to the role of religious perspectives in the field of bioethics. (shrink)
The article examines the role played by policy advice institutions in the governance of ethically controversial new and emerging science and technology in Europe. The empirical analysis, which aims to help close a gap in the literature, focuses on the evolution, role and functioning of national ethics advisory bodies (EABs) in Europe. EABs are expert bodies whose remit is to issue recommendations regarding ethical aspects of new and emerging science and technology. Negative experiences with the impacts of science (...) and technology in the past have resulted in calls for increased transparency and broader participation and pluralism in expert advice and policy decision-making. Do national EABs function as inclusive, anticipatory “hybrid forums”? Or do they resemble more “classical” expert-oriented bodies, inspired by technocratic or decisionist approaches? As part of the empirical analysis of the role and functioning of institutional ethical advisory structures in 32 European countries, an extensive analysis of EAB websites and the content of publicly available documents on such institutions has been carried out, supplemented by an online survey of representatives of the EABs. One major finding of the empirical analysis is the very uneven distribution of “hybrid forum” features of EABs across Europe. (shrink)
This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory Board, (...) and the NationalBioethicsAdvisoryCommission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)
Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. NationalBioethicsAdvisoryCommission, issued in 2001; and a current draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared (...) with statements on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too ‘aspirational’ and not sufficiently ‘pragmatic’. (shrink)
Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former NationalBioethicsAdvisoryCommission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health (...) researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)
Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US NationalBioethicsAdvisoryCommission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)
The philosophy of medicine cum bioethics has become the socially recognized source for moral and epistemic direction in health-care decision-making. Over the last three decades, this field has been accepted politically as an authorized source of guidance for policy and law. The field's political actors have included the NationalCommission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Department of Health, Education, and Welfare, the President's Commission for the Study of Ethical Problems (...) in Medicine and Biomedical and Behavioral Research , the NationalBioethicsAdvisoryCommission, and the new Council on Bioethics; these groups and agencies have set forth rules on issues ranging from the role of humans in biomedical research to the production of human embryos for research, the definition of death, and the permissibility of human cloning. The members of the field are not just scholars and teachers in an academic realm directed to both theoretical and applied issues. They are, in addition, practitioners of a conceptual and moral trade that possesses a legal and political standing. This essay critically addresses the sudden emergence of bioethics as a societally recognized source of moral guidance, a source replete with authorized moral experts. Attention is directed to moral and conceptual assumptions that have led the philosophy of medicine, and especially bioethics, to acquire a quasi-juridical/political role in guiding clinical choices, framing health-care policy, and directing court holdings. (shrink)
The philosophy of medicine cum bioethics has become the socially recognized source for moral and epistemic direction in health-care decision-making. Over the last three decades, this field has been accepted politically as an authorized source of guidance for policy and law. The field's political actors have included the NationalCommission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Department of Health, Education, and Welfare, the President's Commission for the Study of Ethical Problems (...) in Medicine and Biomedical and Behavioral Research, the NationalBioethicsAdvisoryCommission, and the new Council on Bioethics; these groups and agencies have set forth rules on issues ranging from the role of humans in biomedical research to the production of human embryos for research, the definition of death, and the permissibility of human cloning. The members of the field are not just scholars and teachers in an academic realm directed to both theoretical and applied issues. They are, in addition, practitioners of a conceptual and moral trade that possesses a legal and political standing. This essay critically addresses the sudden emergence of bioethics as a societally recognized source of moral guidance, a source replete with authorized moral experts. Attention is directed to moral and conceptual assumptions that have led the philosophy of medicine, and especially bioethics, to acquire a quasi-juridical/political role in guiding clinical choices, framing health-care policy, and directing court holdings. (shrink)
: Pluripotent human stem cell research may offer new treatments for hundreds of diseases, but opponents of this research argue that such therapy comes attached to a Faustian bargain: cures at the cost of the destruction of many frozen embryos. The NationalBioethicsAdvisoryCommission (NBAC), government officials, and many scholars of bioethics, including, in these pages, John Robertson, have not offered an adequate response to ethical objections to stem cell research. Instead of examining the (...) ethical issues involved in sacrificing human embryos for the goal of curing fatal and disabling diseases, they seek to either dismiss the moral concerns of those with objections or to find an "accommodation" with those opposed to stem cell research. An ethical argument can be made that it is justifiable to modify or destroy certain human embryos in the pursuit of cures for dread and lethal diseases. Until this argument is made, the case for stem cell research will rest on political foundations rather than on the ethical foundations that the funding of stem cell research requires. (shrink)
ABSTRACTThis article considers the sort of diversity in perspective appropriate for a presidential commission on bioethics, and by implication, high‐level governmental commissions on ethics more generally. It takes as its point of comparison the respective reports on human cloning produced by the NationalBioethicsAdvisoryCommission, appointed by President Bill Clinton, and George W. Bush's President's Council on Bioethics, under the leadership of its original chair, Leon Kass. I argue that the Clinton (...) class='Hi'>Commission Report exemplifies forensic diversity, while the Kass Council Report exemplifies academic diversity. Drawing upon Thomas Aquinas, I argue that the type of diversity most appropriate for such advisory bodies is deliberative diversity, which facilitates the President's process of taking counsel. After considering their respective charges, I suggest that neither the Clinton Commission nor the Kass Council possessed an adequate degree of deliberative diversity for their respective tasks. (shrink)
In February 1997, following the announcement that the Roslin Institute in Scotland had successfully cloned a sheep by means of cell-nuclear transfer, US President Clinton requested the NationalBioethicsAdvisoryCommission to review legal and ethical issues of cloning and to recommend federal actions to prevent abuse. In the meantime he directed the heads of executive departments and agencies not to allocate federal funds for ‘cloning human beings’. The Commission consulted with members of relevant academic (...) disciplines and other professions, representatives of interest groups and members of the general public, and received written submissions. Unsurprisingly, given the prospect of human cloning and the sensational announcement in January 1998 by the American physicist-cum-embryologist Richard Seed that he would aim to clone himself, public debate in the US has been fairly voluble. (shrink)
Genetic counselors are on the front lines of the genetic revolution, presented with tests of varying predictive values and reliability, unfair testing distribution mechanisms, tests for conditions where no treatment exists, and companies that oversell the usefulness of their tests to physicians and nurses. Many scholars, both genetic testing task forces as well as the newly formed NationalBioethicsAdvisoryCommission, have all noted that genetic counseling programs and services are critical for adequate genetic testing. At (...) the same time, in our own work at the University of Pennsylvania we have encountered many requests for new materials for training genetic counselors in ethics and providing ethics resources for genetic counseling. One of us has noted elsewhere that it is crucial that resources from the Human Genome Project, the Centers for Disease Control, and other public agencies be devoted to providing better resources for genetic counselors facing difficult ethical issues. Although the American Board of Genetic Counseling requires that training programs include some formal coursework in ethics, many wonder whether enough is being done to prepare genetic counselors for an ever-tougher job, and in particular there has been much concern expressed about whether is an outmoded ideal that hampers this profession as it attempts to grow and identify the value of its practice. On the basis of many comments to us by genetic counselors and on the basis of our review of the current literature, we hypothesized that accredited genetic counseling training programs are poised at the turn of the century to begin planning a new approach toteaching the philosophy of genetic counseling, one that integrates philosophical, theoretical, and ethical training throughout thecurriculum in genetic counseling. (shrink)
: The appearance of a sheep named Dolly, the first clone of an adult mammal, dramatically affected the agenda, pace of work, and visibility of the NationalBioethicsAdvisoryCommission. The Commission's approach to its task and some of the issues it considered in responding to President Clinton's request for review and recommendations within 90 days are described.
: Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and NationalBioethicsAdvisoryCommission. This paper proposes a Federal Life (...) Sciences Policy Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States. (shrink)
Multiple groups, including the NationalBioethicsAdvisoryCommission, the American Society of Clinical Oncology, the National Coalition of Comprehensive Cancer Centers, Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group.
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.
Este artículo considera el problema de justicia en la investigación biomédica en países en desarrollo. En particular se hace foco en la discusión de si el requisito de poner a disposición toda intervención probada efectiva puede ser considerado como una obligación post investigación de los patrocinadores hacia la comunidad anfitriona. Primero, se discuten las concepciones de la Comisión Nacional de Asesoramiento sobre Bioética (NBAC) de los Estados Unidos y de las guías éticas internacionales sobre la obligación post investigación hacia la (...) comunidad. Luego, se examinan las interpretaciones del modelo de disponibilidad razonable y el modelo de beneficios justos sobre la condición de acceso a los beneficios post investigación. Por último, presento y critico el argumento del carácter contraproducente de la obligación post investigación que afirma que la obligación post investigación limita el desarrollo de la investigación y empeora la situación de las poblaciones de los países en desarrollo. [ABSTRACT] This article refers to the problem of justice in biomedical research in developing countries and in particular it focus in the discussion of whether the requirement of making available any effective intervention could be consider a post-trial obligation of the sponsor towards the host community. First, the NationalAdvisoryBioethicsCommission’s (NBAC) conception and the international guidelines’ conception of post-trial obligations towards the community are discussed. Second, the interpretation of reasonable availability model and the fair benefits model of the condition of access to post trial benefits are examined. Finally, I present and criticize the moral counterproductive argument which affirms that post trial obligations towards the community prevent new drug research and make population in developing countries worse off. (shrink)
The aim of this paper is to compare two reports on human cloning, one by the US President’s Council on Bioethics and one by the Italian Comitato Nazionale per la Bioetica. I shall focus on those arguments against human cloning, in both reports, which are articulated in terms of (a) the development of human identity, (b) the meaning of human reproduction, and (c) the nature of family relationships. My general conclusion will be that the arguments against human cloning put (...) forth by both reports are not sound, because they are grounded on the dubious assumption that there is a “natural way” of thinking about identity, reproduction, and family relationships. (shrink)
United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped (...) IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original NationalCommission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)
The field of bioethics aims to ensure that modern scientific and technological advancements have been primarily developed for the benefits of humankind. This field is deeply rooted in the traditions of Western moral philosophy and socio-political theory. With respect to the view that the practice of bioethics in certain community should incorporate religious and cultural elements, this paper attempts to expound bioethical tradition of the Malay-Muslim community in Malaysia, with shedding light on the mechanism used by the (...) class='Hi'>National Fatwa Council to evaluate whether an application of biological sciences is ethical or not. By using the application of the genetically modified food as a case study, this study has found that the council had reviewed the basic guidelines in the main references of shari'ah in order to make decision on the permissibility of the application. The fatwa is made after having consultation with the experts in science field. The council has taken all factors into consideration and given priority to the general aim of shari'ah which to serve the interests of mankind and to save them from harm. (shrink)
This paper is about human rights and policing in Bangladesh, with special focus on the role of National Human Rights Commission. The protection and promotion of human rights in Bangladesh has become difficult as the law enforcement agencies, particularly the police and the Rapid Action Battalion, are involved in human rights violations. An overall culture of impunity for human rights violations exists in Bangladesh. The National Human Rights Commission appears to have failed to break the culture (...) of impunity in Bangladeshi politics. This paper explains the reasons why the National Human Rights Commission in Bangladesh largely fails to make the political system in particular law enforcement agencies accountable. (shrink)
The first NationalBioethics Conference in India was held from 25 to 27 November 2005 at the YMCA and Rail Nikunj, in Mumbai, India, under the aegis of the Indian Journal of Medical Ethics. Twenty institutions from all over the country participated in organising the conference, including All India Institute of Medical Sciences from Delhi, King Edward Memorial Hospital, Forum for Medical Ethics Society and Jaslok Hospital from Mumbai, National AIDS Research Institute from Pune, Institute of Legal (...) Medicine from Chennai, and Christian Medical College from Vellore among others. More than 400 delegates from all over the world attended the conference. It was interesting to see that the participants were from different areas of healthcare delivery, …. (shrink)
In 2005 the new Governor of Puerto Rico appointed a panel of experts to evaluate the healthcare system of Puerto Rico and make recommendations. Among other things, the panel recommended the creation of an advisory board on bioethics for the commonwealth of Puerto Rico.