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

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.

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)

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)

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)

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

: As the fifth national bioethics commission has concluded its work and a sixth is currently underway, it is time to step back and consider appropriate measures of success. This paper argues that standard measures of commissions' influence fail to fully assess their role as public forums. From the perspective of democratic theory, a critical dimension of this role is public engagement: the ability of a commission to address the concerns of the general public, to learn (...) how average citizens resolve moral issues in healthcare, and to monitor public opinion on the topics addressed in the commission. Such a public forum role is supported by the critical literature within bioethics, which has deemed some commissions successful, supported more generally by the history of bioethics as a reform discourse that has brought socially important values into the medical domain, and supported more generally still by the example of the great social issues commissions of the 1960s. (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 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)

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)

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)

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)

The Presidential Commission for the Study of Bioethical Issues was created by President Obama in 2009 to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in socially and ethically responsible manners. The bioethics commission is an independent and thoughtful group of experts who advises the President and, in so doing, strives to educate the nation on bioethical issues. As part of the effort to promote policies and practices (...) ensuring the ethical conduct of research, innovation, and health care delivery, the bioethics commission staff, in consultation with commission members, has used the bioethics commission reports to develop pedagogical materials for traditional and nontraditional educational settings. The goal is to use contemporary issues addressed by the bioethics commission to support teaching of bioethics ideas, principles, and theories across the major areas of study and practice. (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)

: 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)

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)

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)

Bioethicists working on national ethics commissions frequently think of themselves as advisors to the government, but distance themselves from any claims to actual authority. Governments however may find it beneficial to appear to defer to the authority of these commissions when designing laws and policies, and might appoint such commissions for exactly this reason. Where does the authority for setting laws and policies come from? This question is best answered from within a normative political philosophy. This paper explains the (...) locus of moral authority as understood within one family of normative political theories—liberal political theories—and argues that most major “liberal” commentators have understood both the source and scope of ethics commissions’ authority in a manner at odds with liberalism, rightly interpreted. The author argues that reexamining the implications of liberalism for bioethics commissions would mean changing what are considered valid criticisms of such commissions and also changing the content of national bioethics commission mandates. The author concludes that bioethicists who participate in such commissions ought to carefully examine their own views about the normative limits of governmental authority because such limits have important implications for the contribution that bioethicists can legitimately make to government commissions. (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 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)

This article focuses on two possible missions for a national bioethics commission. The first is handling differences of worldview, political orientation, and discipline. Recent work in political philosophy emphasizes regard for the dignity of difference manifested in "conversation" that seeks understanding rather than agreement. The President's Council on Bioethics gets a mixed review in this area. The second is experimenting with prophetic bioethics. "Prophetic bioethics" is a term coined by Daniel Callahan to describe an (...) alternative to compromise-seeking "regulatory bioethics." It involves a critique of modern medicine. In the contemporary context, the areas of biotechnology and access to health care cry out for prophetic attention. The Council has addressed biotechnology; unfortunately, that experience suggests that the kind of prophecy that it practices poses risks to conversation. With regard to access issues, the article proposes an effort that unites themes of human dignity, solidarity, and limits in support of reform, while highlighting, rather than papering over, differences. (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)

In lieu of an abstract, here is a brief excerpt of the content:In the Belly of the Whale:Some Thoughts on Preserving the Integrity of the New Bioethics CommissionF. Daniel Davis (bio)10 July 2010. Washington, D.C. President Obama's Presidential Commission for the Study of Bioethical Issues has just concluded its inaugural meeting, designed as a primer—the first of three that it plans to hold—on synthetic biology. As a topic for deliberation by a national bioethics commission, "synbio" (...) is ideal. A cloud of equipoise hangs over the practical implications of recent developments in this, the latest phase in the evolution of biotechnology—a seemingly genuine uncertainty about the need for additional mechanisms of oversight to mitigate potential risks to biosafety or biosecurity. Despite these concerns, its advocates and practitioners enthusiastically champion the prospect of eventual, perhaps significant benefits to be gained with progress in "synbio," including, for example, enhanced processes for the mass production of vaccines and biofuels. And yet like the advent of recombinant DNA technologies in the mid-1970s, synthetic biology has generated not only hope for benefits and concern for risks, but also questions variously described as "deep," "profound," "fundamental," and "philosophical": Is the capacity to synthesize novel, living entities yet another technological invitation to hubris on the part of humankind? Will that capacity alter the relationship between humankind and nature? How should we think about the moral status of living entities created de novo in the laboratory? Should we even care? How will wide-scale applications of synthetic biology tip the scales of social justice? And finally, the democratization of synthetic biology, the growth of DIY-BIO (do-it-yourself-biology) communities beyond the usual scientific arenas of academia and industry, has infused old questions about scientific freedom and responsibility with new complexities—all in the midst of an American public that is reportedly unaware and uneducated about this new chapter in the often triumphant, unsettling history of biotechnology.Thus, the topic of synthetic biology presents the new commission with several possibilities. It could very well make a substantial contribution to public policies responsive to both the current capabilities and the possible trajectories of [End Page 291] these emergent biotechnologies. The very fact that the President explicitly asked the Commission to take up the topic and report back to him (in six months) means that that potential is especially promising. It could, as well, delve into the "deeper" philosophical questions that "synbio" raises with the aim of bringing both depth and breadth to the tasks of critically analyzing and reflecting upon what currently is known and what, with regard to the future, can only be glimpsed of this amalgam of the life sciences, engineering, and other disciplines. The Commission could also set its sights on diminishing the apparent deficit in public understanding of these biotechnologies. And finally, with this topic as well as any others it takes up, the Commission, along with the administration that established it, could make an effort to reinvigorate public bioethics in the United States. At the very least, in the sobering light of experience with the President's Council on Bioethics, certain actions or behaviors could be avoided in the interests of preserving the integrity—the moral and political legitimacy—of the new commission. Although each of these possibilities warrants further explanation, my focus here is the final one.The Belly of the WhaleIn several decades, some future historian of public bioethics in the U.S. will be able to look back on the bioethics commissions established to date and offer an insightful, comprehensive—maybe even magisterial—account of their beginnings and endings, their deliberations and the political forces that shaped them, and perhaps most important, their ultimate value as public bodies. Lacking the strategic perch of historical distance, and fresh from the trenches, I can only offer a few somewhat informed but partial observations and arguments about public bioethics in the context of contemporary American politics, acknowledging at the outset that my thoughts are open to, and needful of, critical amendment or supplement by others.In the U.S., bioethics commissions are political creatures, established through the authority of the Congress or the President for the purpose of providing counsel to the legislative and/or executive... (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)

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)

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)

The term “globalization” was popularized by Marshall McLuhan in War and Peace in the Global Village. In the book, McLuhan described how the global media shaped current events surrounding the Vietnam War [1] and also predicted how modern information and communication technologies would accelerate world progress through trade and knowledge development. Globalization now refers to a broad range of issues regarding the movement of goods and services through trade liberalization, and the movement of people through migration. Much has also been (...) written on the global effects of environmental degradation, population growth, and economic disparities. In addition, the pace of scientific development has accelerated, with both negative and positive implications for global health. Concerns for national health transcend borders, with a need for shared human security and an enhanced role for international cooperation and development [2]. These issues have significant bioethical implications, and thus a renewed academic focus on the ethical dimensions of public health is needed. Future developments in science and health policy also require a firm grounding in bioethical principles. These core principles include beneficence; nonmaleficence ; respect for persons and human dignity ; and attention to equity and social justice. According to the World Health Organization [3], global ethical approaches should monitor and update ethical norms for research, as necessary; anticipate ethical implications of advances in science and technology for health; apply internationally accepted codes of ethics; ensure that agreed standards guide future work on the human genome; and ensure that quality in health systems and services is assessed and promoted. (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)

The National Medical Commission of India introduced the Competency Based Curriculum in Medical Education for undergraduate medical students in 2019 with a new module named Attitude, Ethics and Communication (AETCOM) across the country. There was a consensus for teaching medical ethics in an integrated way, suggesting dedicated hours in each phase of undergraduate training. The AETCOM module was prepared and circulated as a guide to acquire necessary competency in attitudinal, ethical and communication domains. This study was aimed to (...) explore the perceptions of students and medical teachers and identify the challenges in teaching and learning process of the newly implemented AETCOM module. It was a mixed method designed study with structured questionnaires for students and teachers at various medical schools in India. Based on the quantitative data, in-depth interviews with medical teachers were undertaken. Challenges were perceived by both students and teachers. The students had a mixed perception, facing difficulties in passive learning with scarce resource materials. Challenges identified by teachers were a lack of knowledge and skills required for teaching bioethics, the logistics of managing large numbers of students in the stipulated time frame, interdisciplinary integration—both horizontal and vertical, and assessment program in terms competency-based education. The study draws the attention of all stakeholders for a revision and efforts for further improvement in the teaching and assessment process, and setting a standard model in medical education in India. (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)

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and (...) interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (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)

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)

As the only nation in the western world without a national health insurance program, the United States faces ongoing issues of access and fairness in health care coverage. The Clinton administration tried and failed to address the problem of universal coverage. Since then we have focused on the narrower, but nonetheless real, issues of fairness and equity in the benefits package provided in insurance plans. The LORAN Commission spent two years trying to devise agreed-upon principles to govern such (...) issues. The lesson learned was the same as that of the Ethics Force study: there was no possibility of getting agreement, let alone consensus, among the participants on how to decide what should be a covered benefit. There were, however, two generally agreed upon principles that emerged regarding health care: “Every individual should be treated alike,” and “When it comes to health, cost cannot be a consideration.” That formula translated into providing everyone with everything. The only certain outcome from such a policy would be fiscal insolvency and ultimately bankruptcy. (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)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 175-188 [Access article in PDF] Scope Note 38 Bioethics Resources on the Web * Once described as an "enormous used book store with volumes stacked on shelves and tables and overflowing onto the floor" (Pool, Robert. 1994. Turning an Info-Glut into a Library. Science 266 (7 October): 20-22, p. 20), Internet resources now receive numerous levels of organization, from basic directory (...) listings to elaborate "links" (cross-references to other Internet documents) that flash and glow in the dark. In many ways, the Internet functions as a direct extension of the traditional library. Following linked references across various sites is an electronic version of browsing library stacks, and the serendipitous discoveries made while "surfing the Net" recall the wonders of physically going "book-to-book." Although many of the Internet's best aspects augment library strengths by eliminating physical distance from sources, Net resources pose unique problems for researchers. It is not always clear who is responsible for the content of Web documents, when the document was produced, or how often (if ever) it is updated. Internet resource tools, then, must enable researchers to identify appropriate resources and to evaluate what they find when they get there. Web Research as Taking "Snapshots" Given the Internet's visual nature and fluid content, the process of conducting research on the Web has been likened to taking an informal picture of information on a specific date at a particular time. This metaphor also conveys the "zoom-in" aspect of searching through Web pages by going from general to specific categories. In the first section of this Scope Note, National Reference Center for Bioethics Literature (NRCBL) staff present a snapshot of bioethics resources taken during the spring months of 2000. Entries are divided into the categories of directories, electronic journals, full-text documents, news/current awareness, and teaching resources. In the two subsequent sections, this series of categories is repeated for entries on a specific topic within bioethics-genetics-and again for general search and evaluation tools. Where a Web site may contain pages applicable [End Page 175] to more than one category, multiple entries are made for that site with appropriate information for each category.Much as telecommunication advances have strengthened the relationship of patients and providers as partners, the dynamic nature of the Internet acknowledges that the researcher functions as a librarian whenever accessing the Web. It is our hope that BIOETHICSLINE and the other NRCBL databases not only will enable researchers to search the Web more efficiently, but also will help them to evaluate what they find when they get there. Bioethicsline on the Web: An International Plan in Progress Once only available through libraries, the U.S. National Library of Medicine (NLM), the funding agency for the ongoing development of the BIOETHICS LINE® database from the Kennedy Institute, has provided free Web access to that database of 63,000 citations since September 1998 through Internet Grateful Med. Plans are now underway to eliminate such specialty databases and incorporate all citations into PubMed (for journal articles) or LOCATORplus (for book-like materials and chapters in books). Both of these databases are likewise available at no cost on the Web. In the transition to PubMed and LOCATORplus some features of BIOETHICSLINE that presently are available may be lost. Researchers are encouraged to contact the National Reference Center for Bioethics Literature with search requests or for search strategy assistance with either the current or the future system ([email protected]).The inclusion of bioethics citations in PubMed and LOCATORplus will have several advantages. First, unique keywords from the Bioethics Thesaurus will be considered for inclusion in Medical Subject Headings (MeSH), the indexing vocabulary for PubMed and LOCATORplus, thereby enhancing retrieval of relevant clinical literature by offering more precise terminology covering ethical issues. Second, it will be easier to identify foreign-language materials, which are not currently included in the scope of BIOETHICSLINE. Third, the updating schedule will become more frequent. On the other hand, there may be some loss of searching precision because certain specialized features... (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)

Researchers, scientists, and physicians in Uganda have become increasingly aware of the need to develop a systematic approach to reviewing bio-medical research conducted in their country. Much of this awareness and their concern stems from Uganda's high seroprevalence of human immunodeficiency virus and the consequent large influx of research monies and HIV researchers from developed countries, including the United States and Great Britain.We report on the proceedings of a five-day symposium on bioethical principles governing clinical trials, which convened in Jinja, (...) Uganda in September 1994. The thirteen male and female workshop participants included representatives from the Uganda Ministry of Health, Makerere University, the Uganda AIDS Commission, Uganda's National Council of Science and Technology, and the National Chemotherapeutic Laboratory. These representatives included ethicists, physicians, researchers, and pharmacists, all of whom have conducted research themselves. Initial workshop sessions focused on the history of human experimentation and the development of protections for human participants in medical research, both in the United States and internationally. (shrink)