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.

Details goverment, private, and international response to the policy recommendations of the National Bioethics Advisory Commission.

The National Bioethics Advisory Commission, of which I was a member, was established by a 1995 executive order that identified its “first priority” as “the protection of the rights and welfare of human research subjects.” Not surprisingly, then, most of NBAC's work focused on research involving human subjects or participants. A second priority concerned “issues in the management and use of genetics information, including but not limited to, human gene patenting.” NBAC's charter (in contrast to the (...) executive order) listed this charge as “part B” of the “first priority.” Nonetheless, NBAC never fully developed it. In addition to responding to requests and recommendations from the National Science and Technology Council, NBAC could accept suggestions from Congress and the public for bioethical issues it should consider, and it could also identify other issues to consider and set priorities among them. From its first meeting on October 4, 1996, until its charter expired on October 3, 2001, NBAC produced six reports, with 120 recommendations. In this essay, I make a few observations about principles and moral reasoning in NBAC's deliberations and about NBAC's attention to religious beliefs in the context of two bioethical controversies, provide a rough evaluation of NBAC's impact, and consider three possible models for future public bioethics directed at federal public policy. (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: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)

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)

: National bioethics commissions have struggled to develop ethically warranted methods for conducting their deliberations. The National Bioethics Advisory Commission 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 National Bioethics Advisory Commission. Respect for diverse reasonable conceptions of the good in a democratic polity requires national bioethics commissions to seek and incorporate that which is valuable in opposing positions. (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)

ABSTRACTSome people might argue that there are already too many different documents, guidelines, and regulations in bioethics. Some overlap with one another, some are advisory and lack legal force, others are legally binding in countries, and still others are directed at narrow topics within bioethics, such as HIV/AIDS and human genetics. As the latest document to enter the fray, the UNESCO Declaration has the widest scope of any previous document. It embraces not only research involving human beings, (...) but addresses broader concerns in medicine and healthcare. The UNESCO draft declaration has some minor weaknesses, but on the whole, the strengths outweigh the weaknesses. One weakness is that some items in the draft are stated in a way that is too restrictive, thereby appearing to rule out legitimate activities. A strength of the Declaration is that it is relatively brief, yet at the same time contains sufficient detail to make it something more than a rehearsal of mere pieties. As the most recent of the numerous bioethics and human rights documents, the UNESCO draft draws on many of the earlier documents and also includes some of the most recent thinking about ethical norms and obligations. Perhaps its greatest strength lies not in details of the principles or their implementation, but rather in its stature as an international declaration issued by a United Nations organization. (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 National Bioethics Advisory Commission, 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)

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)

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)

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)

In lieu of an abstract, here is a brief excerpt of the content:Bioethics Commissions: Town Meetings with a “Blue, Blue Ribbon”Susan Cartier Poland (bio)Town meetings are characteristic of New England. In theory, a quorum of registered voters in a small municipality meets annually to decide local public policy. In fact, special interests and the town bureaucracy control the meeting.Like a town meeting, a commission (or committee or council) comes into being, whether on an ad hoc or permanent basis, (...) to direct a government function. Bioethics commissions specialize in one area: the intersection of public policy with developments, either real or anticipated, in the basic and applied sciences.That specialization of commissions carries over into the selection of the members. More often than not commission members are appointed on the basis of expertise in a specific area. Although some commissions are still made up entirely of one kind of expert, usually medical, the majority of these government bodies seek breadth between the fields of law, religion, ethics, and science (including medicine and the social sciences).In the words of Mrs. Rigenbach, the law clerk to Chief Judge Carl B. Rubin of the United States District Court for the Southern District of Ohio, selection of persons “knowledgeable in the field” constitutes a “blue, blue ribbon” jury. In contrast, a “blue ribbon” jury is composed of those persons having “the greatest amount of formal education” (In re Richardson-Merrill, Inc. (Bendectin litigation), 624 Federal Supplement 1212 at 1217 (1985)). The problem with persons knowledgeable in the field is that their minds may have already been made up. For a jury, this is a disaster; for a bioethics commission, this directs and shapes the research, investigation, and discussion, or, in short, it makes for more efficient decision making.For this Scope Note, the definition of commission begins with the Bioethicsline description of its index term “advisory committees” as committees or commissions set up to advise government bodies on public policy. Furthermore, a commission [End Page 91] (or committee) receives government funding and support in exchange for its expertise in research, investigation, reporting, and recommendations.Six functions served by bioethics commissions have been clearly and succinctly described by LeRoy Walters (Commissions and Bioethics. Journal of Medicine and Philosophy 14 (4): 363–68, August 1989). The functions are: (1) to legitimize action; (2) to delay action or resolution; (3) to identify duplication; (4) to be representative; (5) to do research and find facts; and (6) to provide education and support (pp. 364–65). Since 1989, however, another government function has moved to the forefront. Instead of remaining within the legislative arena, government commissions serve the judiciary as well, in cases involving complex and technical questions. The now defunct Law Reform Commission of Canada recognized this use when it included in its annual reports a section on its “Influence on Law Reform through Judicial Decisions.”In mid-1997, the United States Supreme Court in its consolidated cases on assisted suicide used extensively the writings from a state commission, the New York State Task Force on Life and the Law, to support its rationale. Not only did the Court make use of the Task Force’s work, but in so doing the Court extended the efforts of the commission beyond its jurisdiction of New York into another jurisdiction on the opposite coast, Washington state. Furthermore, although the commission was chartered by one state, through the federal court system, its influence became national.Outside the U.S., the United Nations recently adopted its first bioethics text on the ethics of genetic research, and Canada is reworking its human research guidelines into a single set of guidelines that will apply to research in both the natural sciences and the social sciences.This Scope Note attempts to compile for the researcher and the reference librarian those commissions, existing and defunct, that have addressed bioethics issues. Only one other such attempt is known to the author, an Office of Technology Assessment [OTA] Background Paper, Biomedical Ethics in U.S. Public Policy (1993). Due to space limitations, not all publications could be listed; the selections included represent the range of topics from a particular group or the more frequently cited sources. Future updates of this compilation are planned, so please notify the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Another Bioethics Commission?Renie Schapiro (bio)Ever Since the Ill-Fated Biomedical Ethics Advisory Committee (BEAC) ended almost before it began a few years ago, bioethicists and the members of Congress who take an interest in them have wondered whether a governmental commission is still a feasible way to address bioethics issues.The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (...) in the 1970s, and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in the early 1980s, have generally received high marks for their work. But since the expiration of the President's Commission in 1983, no federal body has been able to sustain the momentum.Tempers around the abortion issue couldn't be tamed enough even to elect a board chairman for the BEAC, or for the body to begin studying the issues. From its inception, abortion politics threatened to dog its work.Both the National Commission and the President's Commission studied issues touching on the abortion question. The President's Commission reported on genetic screening. The National Commission looked at fetal research. Both were able to produce respected reports that largely steered clear of the abortion acrimony.But that was then. The question facing policy makers inside the Beltway is how we can learn from the past experiences to make some new body work now. The question extends far beyond the abortion issue, of course.When certain people in Washington start asking questions, the answer usually comes by way of a study. Sometimes, as in this case, more than one study.In the March 1992 issue, this Journal reported on an Institute of Medicine study on ethics commissions. That study is still underway. It is scheduled to be completed in January 1994.More recently, the Office of Technology Assessment (OTA), an arm of Congress, also took on the issue. The OTA project is intended to be a quicker, more confined study. It began last fall and a final report is expected later this month.The primary force behind the OTA study is Senator Mark Hatfield. In a September 8, 1992 letter, co-signed by Senators Edward Kennedy and Dennis DeConcini, he asked OTA to prepare a background report to assist Congress in [End Page 77] "determining what is the best approach to explaining policy problems with biomedical and ethical dimensions."The letter noted: "As the 21st Century approaches, Congress will face policy dilemmas for which an informed decision can only be made through understanding not just the legal or economic dimensions of the questions, but the ethical considerations as well."Hatfield's interest in bioethics issues over the past few years has centered largely on biotechnology, and particularly patent rights. He had planned to introduce legislation to put a moratorium on patenting of genetically altered organisms, which according to Hatfield staffer Douglas Pahl caused a "firestorm" in the biotechnology community.As a result, Kennedy and DeConcini said they would hold hearings on the issue if Hatfield would withdraw the amendment. The three agreed to request a short-term OTA report on possible governmental structures for dealing with bioethics issues and a longer report looking at patenting issues.In their letter, the three senators asked OTA to prepare a history of bioethics in public policy. Referring specifically to the past commissions, they asked, "What lessons can we learn from each of these—or similar—entities? What worked, or did not work, and why?" The request also asked OTA to examine international institutions.In response to the request, OTA held a workshop entitled "Biomedical Ethics in U.S. Public Policy" on December 4, 1992. It brought together 15 people who had participated in commissions—from local to international—as well as observers of these bodies and health professionals who used their products.1According to project director Robyn Nishimi, the workshop was meant to be a free-wheeling discussion. Although there was no total consensus, the focus of the discussion tended to be on how to make a commission function effectively, rather than on whether there should be one. That workshop will be part of a report of about 40-60 pages OTA hopes to... (shrink)

: National bioethics commissions have been critiqued for a variety of structural, procedural, and political aspects of their work. A more recent critique published by Dzur and Levin uses political philosophy to constructively critique the work of national bioethics commissions as public deliberative forums. However, this public forum critique of bioethics commissions ignores empirical research in political science and normative claims that suggest that advisory commissions can and should have diverse of functions beyond that (...) of being public forums. The present paper argues that the public forum critique too narrowly considers the roles that bioethics commissions can play in public bioethics and ignores the moral obligation of commissions to fulfill their mandates. Evaluations of commissions must consider that these institutions can serve in capacities other than those of a public deliberative forum and use additional measures to evaluate the multiple roles and successes of bioethics commissions in public policy. (shrink)

There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub‐Committee on Medical Research Ethics in 1999. The Co‐operation Group for Laboratory Animal Sciences was established in 2001. Only the Board on Gene (...) Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub‐Committee on Medical Research Ethics acts as a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power to their opinions and statements. The commissions work in close collaboration with each other, having regular meetings. They arrange seminars and conferences, and share information with each other. The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi‐professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years. (shrink)

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)

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)

The report produced by the National Bioethics Advisory Commission 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)

In the forty‐year history of U.S. bioethics commissions, these government‐sanctioned forums have often demonstrated their power to address pressing problems and to enable policy change. For example, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established in 1974, left a legacy of reports that were translated into regulations and had an enormous practical impact. And the 1982 report Splicing Life, by the President's Commission for the Study of Ethical Problems in (...) Medicine and Biomedical and Behavioral Research, became the basis for the National Institutes of Health's Recombinant DNA Advisory Committee as well as for the Food and Drug Administration's developing “Points to Consider” when contemplating the introduction of recombinant DNA into human beings. Some efforts of bioethics commissions, however, are not tightly connected to policy change or to outcomes directly linked to a specific report. While direct policy impact is indeed a useful metric for government bioethics commissions, it is not their only legitimate utility. For instance, bioethics commissions can also be incubators for deliberation on a hot topic, giving policy‐makers time to think through options while the political heat has some time to dissipate. Or a bioethics commission may stake out a position that enables a politician to take action while not necessarily following its recommendations. (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)

In lieu of an abstract, here is a brief excerpt of the content:President’s Council on BioethicsEdmund D. Pellegrino (bio) and F. Daniel Davis (bio)Approximately two weeks before what was to have been its final meeting, the White House dissolved the President’s Council on Bioethics by terminating the appointments of its 18 members. The letters of dismissal, dated 10 June 2009, informed the members that their service on the Council would end with the close of business the next day.The Council’s (...) term was set to expire on 30 September 2009. After President Obama’s election in November and during the transition, we were advised to proceed on the assumption that the Council would be permitted to cease on that date. Reasons for the abrupt move to disband the Council are unknown. We have accepted the fact that we Council members served at the pleasure of the President and that he simply exercised his rightful prerogative. No explanation is therefore required.Some observers have speculated that the action was retaliatory. They related to the fact that several members of the Council disagreed with the President’s stem cell policy in a signed statement published in the Hastings Center’s Bioethics Forum. Others have speculated that the move was pre-emptive. At its final meeting, scheduled for 25–26 June, the Council was set to sign-off on two of its final publications. One was a comprehensive report on the ethics of organ transplantation, and the other a white paper entitled Health Care and the Common Good. The aim was immediately to release the latter as a contribution to the intensifying debate about health care reform. Health Care and the Common Good could well have aided rather than impeded the President’s drive to better control health care costs and achieve universal coverage. The Council report attempted to ground both goals in the ethical framework of, as the title indicates, the common good of all Americans.In his letter terminating the members’ appointments, Assistant to the President for Presidential Personnel Don Gips said that the President “recognizes the values of having a commission of experts in bioethical issues to provide objective and non-ideological bioethics advice to his administration.” Gips went on to say that the President is “currently rethinking the purposes and goals of such a bioethics commission, and is carefully considering a revitalized mission and mandate.” And, [End Page 309] responding to media enquiries, White House press officer Reid Cherlin explained that the President’s Council was terminated because it was a “philosophically leaning advisory group” and, according to a New York Times account by Nicholas Wade, “because it favored discussion over developing a shared consensus.” As for the ultimate outcome of the President’s “rethinking,” Cherlin indicated that President Obama will appoint a new commission with the mandate of offering “practical policy options” in bioethics.In the light of our experiences with the Council, we leave it with hopes that certain questions of national importance will be addressed. In light of the nature of federal advisory commissions, what is or are the proper roles of a national bioethics commission? If the aim is to provide advice and counsel to the President or, perhaps to the U. S. Congress, is that advice best rendered as a group consensus or as an in-depth exploration of the inevitably conflicting ethical perspectives on a given issue? How should such a commission be constituted—with what sorts of individuals? And what is the nature of the expertise that they individually and collectively bring to the commission’s functions? If the commission is to promote public debate and discussion, how exactly should it go about that task? And how is the efficacy of a commission to be assessed? Such questions inevitably lead us deep into contested territory, as the experience of this Council has shown: into the intersections of politics, religion, and science and into the relations between practice and theory—between policy and what some seem to deride as “philosophy.” Indeed, policy without an underlying philosophy is an edifice without a foundation; philosophy without policy is a foundation without an edifice.At the last meeting of the Council in March 2009, we launched a discussion of these questions with the... (shrink)

This article aims at raising awareness about the intersection of populism and bioethics. It argues that illiberal forms of populism may have negative consequences on the evolution of bioethics as a discipline and on its practical objectives. It identifies at least seven potential negative effects: (1) The rise of populist leaders fosters “epistemological populism,” devaluing the expert and scientific perspectives on which bioethics is usually based, potentially steering policies away from evidence-based foundations. (2) The impact of “moral (...) populism” is evident in legislative prioritization of the “morality of common people,” often solicited through popular consultations on issues like abortion, drug legalization, or LGBT issues. (3) Populist distrust in autonomous governmental agencies and advisory bodies, including national bioethics commissions, can compromise expert advice, challenging both their authority and decisions. (4) Populists may erode transparency by undermining institutions responsible for it, hindering access to vital information for bioethical research. (5) “Medical populism” creates adversarial dynamics, prompting politicians to make simplistic healthcare policy decisions based on political rather than informed criteria, adversely affecting vulnerable populations. (6) Radical-right populist parties’ “welfare chauvinism” may shape healthcare policies, impacting service access and resource allocation, disproportionately affecting vulnerable groups such as migrants, but indirectly affecting the rest of the population. (7) Nationalist sentiments associated with populism may obstruct international collaborations, posing challenges for global bioethics that seeks to address ethical concerns beyond national borders. In summary, these dynamics raise significant bioethical concerns encompassing evidence-based decision-making, transparency, healthcare equity, and global collaboration. How bioethicists may respond to these challenges is discussed. (shrink)

Multiple groups, including the National Bioethics Advisory Commission, 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.

Comparative assessments of national bioethics commissions in the United States commonly look at the differences among these groups over their forty‐year history. A particular focus has been differences in the membership, mission, methods, and reports of the President's Council on Bioethics, which was active from 2001 until 2009, compared to those of its predecessors and the recent Presidential Commission for the Study of Bioethical Issues, active from 2009 until 2016. The differences are real, but disproportionate attention (...) to them can obscure the substantial similarities in commissions’ structure and function throughout the history of expert bioethics advice to government. As the Trump administration considers what role, if any, a bioethics commission will play in its work, it would be well served to consider how choices regarding the design of such a group and the topics it examines can best facilitate the unique contributions it can make to the government and to the country. (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)

Instead of another federal advisory panel to identify ethical principles governing human subjects research, it is time we had a national board with authority to regulate and review such research.

In this essay, I offer some reflections on how the topics were identified and approached by the Presidential Commission for the Study of Bioethical Issues, on which I had the honor to serve, in the hope that the reflections may be useful to future national bioethics commissions. In the executive order that established the bioethics commission, President Obama explicitly recognized the ethical imperative to responsibly pursue science, innovation, and advances in biomedical research and health care, (...) and the importance of national attention to these issues. The bioethics commission prioritized practicable, actionable, targeted recommendations. Like most earlier U.S. national bioethics commissions, President Obama's commission did not undertake projects on significant and troublesome issues related to health and health care that were not associated with new science or technology. Issues such as health care access, health care delivery, opioid addiction, end‐of‐life care, and physician‐aid‐in‐dying are topical and ethically complex areas of significance to bioethics, and they are also being discussed and debated by the public, the media, and policy‐makers. In my view, there are good reasons to select and prioritize projects as well as a justification for confining commission efforts to issues related to novel science and emerging technologies, when there is only one national‐level bioethics commission that has been established by the Office of the President. (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 National Bioethics Advisory Commission, 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)

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 National Bioethics Advisory Commission 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 National Bioethics Advisory Commission 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 National Commission 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 National Bioethics Advisory Commission, 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)

ABSTRACT Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, (...) involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in‐depth interviews and 78 responses to open‐ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research. (shrink)