Bioethics Committees and Commissions
Bioethics Committees and Commissions
BIOETHICS COMMITTEES AND COMMISSIONS
Since its inception in the 1970s, bioethics has been manifested not only in academic debate but also in committees or commissions directed toward the guidance of public discussion and policy making. In the research and clinical settings, Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), and Hospital Ethics Committees (HECs) serve the practical functions of bringing reflective expertise and modest public consensus to bear on ethical implementations of advancing scientific and technological forms of medicine and other biological research. At the state, national, and international levels, more general committees and commissions have sought to provide reflective consideration and policy guidance. These committees come in three types: term-limited, ad hoc, and permanent. The role these committees and commissions play in government and society depends on their structure and mission, the larger historical and social contexts, and trade-offs between broader, more fundamental inquiry and narrower, more policy relevant recommendations.
Bioethics Commissions in the United States
There are two broad classifications for federal bioethics commissions and committees in the United States: general and topic specific. General bioethics commissions have been appointed by Congress or the President to conduct inquiries into a diversity of issues and have both fostered wide-ranging public discussion and produced targeted policy recommendations. Topic-specific initiatives have in turn been created by different government agencies or the President to address specific technologies or aspects of scientific research. Other important elements in this context include the former Office of Technology Assessment (OTA) and other research and assessment agencies of government, state-level bioethics committees, and academic and nongovernmental bioethics centers and committees.
GENERAL FEDERAL BIOETHICS COMMISSIONS. Between 1974 and 2004, there were six general federal bioethics commissions (see Table 1 for a summary). The first public body on the national level to shape bioethics policy was the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). Created by the National Research Act of 1974 under Republican President Gerald Ford, the National Commission operated until 1978 and was administered by the Department of Health, Education and Welfare (DHEW). It contributed to the first federal regulations for the protection of human subjects of biomedical and behavioral research. The principles that served as the basis of these regulations were outlined in its 1978 Belmont Report, and the regulations became institutionalized in the form of Institutional Review Boards (IRBs). The National Commission also produced reports on research involving vulnerable subjects including prisoners, those institutionalized as mentally infirm, fetuses, and children.
One of the recommendations of the National Commission led to the creation of the Ethics Advisory Board (EAB) in 1978. During its approximately two-year existence, the EAB focused on issues involving fetuses, pregnant women, and human in vitro fertilization (IVF), but it had a broad charter that allowed it to investigate many bioethics issues. Originally intended as an ongoing standing board, the EAB was nonetheless disbanded by the Office of Science and Technology Policy in 1980 after producing four documents. Two major outcomes were the stipulation of criteria for federally-funded research in IVF and a pronouncement on human embryo research, which began a fifteen-year moratorium on such research.
One of the reasons the EAB was disbanded was because policy makers failed to distinguish its purposes from those of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission) created by Congress in 1978 under Democratic President Jimmy Carter. The President's Commission had a broad mission and the authority to initiate its own reports on emerging issues judged important by its members. It was elevated to independent presidential status (by contrast, the National Commission had operated autonomously within the DHEW). Also unlike the National Commission, the President's Commission produced fewer specific recommendations targeted at federal agencies. Instead, it produced consensus reports that articulated mainstream views. These reports are highly regarded and "many have had sustained policy influence" (United States Office of Technology Assessment 1993, p. 12). Its report on foregoing life-sustaining treatments was most influential, and it led to the development of living wills. After a three-month extension, the President's Commission expired in March 1983 under Republican President Ronald Reagan.
The Biomedical Ethics Advisory Committee (BEAC) was the fourth government-sponsored general bioethics body. In 1986, Congress established the Biomedical Ethics Board (BEB), which was composed of six Senators and six Representatives (this was modeled on the Technology Assessment Board, which oversaw the United States Office of Technology Assessment [OTA]). It took the BEB more than two years to appoint all the members of the BEAC, and in September 1988 (less than a week before it was originally scheduled to expire) the BEAC held its first meeting. Largely due to partisan politics around the abortion issue, BEAC's appropriations were frozen and it was unable to produce any reports before it officially expired in September 1989 under Republican President George H. W. Bush.
There followed an extended hiatus until Democratic President Bill Clinton signed an executive order to create the National Bioethics Advisory Commission (NBAC) in 1995. Chaired by Harold T. Shapiro, the NBAC held its first meeting in 1996, and its original mission was to investigate the two priority areas of human subjects research and genetic information. After the cloning of the sheep Dolly in 1996, however, President Clinton also requested a report on cloning. This became the NBAC's first report, which recommended that federal regulation be enacted to ban research using somatic cell nuclear transfer cloning to create children. It recommended that such legislation be crafted so as not to interfere with other uses of cloning that may not be as ethically problematic. The NBAC also produced reports on research involving biological materials, stem cells, and persons with mental disorders that may impair decision-making abilities. The NBAC recommended that federal funding be used only on stem cells derived from two sources: cadaveric fetal tissue and embryos remaining after infertility treatments. The NBAC expired in 2001.
The stem cell issue sparked the creation of the President's Council on Bioethics by George W. Bush (via executive order) in 2001. In his first national address, Bush created a new policy for the federal funding of stem cell research and announced the formation of the Council under the direction of Dr. Leon R. Kass.
TOPIC-SPECIFIC INITIATIVES. Other committees and commissions have been created by the U.S. government in order to provide topic-specific guidelines and recommendations (see Table 2 for a summary). The first noteworthy example is the Recombinant DNA Advisory Committee (RAC), which was created in 1976 in accordance with the National Institutes of Health (NIH) Guidelines for Recombinant DNA Research. The RAC is a permanent committee housed in the NIH that serves a threefold function: to provide a public forum for discussion about issues involving recombinant DNA, to make recommendations to the director of NIH, and to
|SOURCE: Courtesy of Adam Briggle and Carl Mitcham.|
|National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)||1974–1978|
|Ethics Advisory Board (EAB)||1978–1980|
|President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission)||1978–1983|
|Biomedical Ethics Advisory Committee (BEAC)||1986–1989|
|National Bioethics Advisory Commission (NBAC)||1995–2001|
|President's Council on Bioethics (Council)||2001–|
review certain individual research protocols. In this last role, the RAC often works in conjunction with IRBs and IBCs.
Most other topical committees have been temporary. In March 1988, the Assistant Secretary for Health directed the NIH to appoint an ad hoc panel that became known as the Human Fetal Tissue Transplantation Research Panel. The panel met three times and issued its final report in December 1988, which approved federal funding for research involving the transplantation of human fetal tissue from induced abortions. Although not a commission, the Ethical, Legal, and Social Implications (ELSI) research program marks a landmark investment in bioethics research by the federal government. ELSI was begun in 1989 by the NIH and the Department of Energy (DOE) as a joint project to fund research on the social implications of developments associated with the Human Genome Project (HGP).
The NIH formed the Human Embryo Research Panel in January 1994. This panel classified human embryo research into three categories and drafted guidelines for the review and conduct of acceptable research. Also in 1994, President Clinton created the Advisory Committee on Human Radiation Experiments, and charged it to investigate and report on the use of human beings as subjects of federally-funded research using ionizing radiation. The committee found the government blameworthy for not having procedures in place to protect the rights of human research subjects exposed to radiation without their consent. One final example of a topical commission is the Advisory Commission on Consumer Protection and Quality in the Health Care Industry. Created by executive order in 1996, this thirty-two-member commission focused on patient protections and consumer satisfaction in the health care industry. It developed the Consumer Bill of
|Name||Duration and Agency|
|SOURCE: Courtesy of Adam Briggle and Carl Mitcham.|
|Recombinant DNA Advisory Committee (RAC)||Permanent (created in 1976); NIH|
|Human Fetal Tissue Transplantation Research Panel||March–December, 1988; NIH|
|Ethical, Legal, and Social Implications (ELSI) program||Begun in 1989, the Human Genome Project expired in 2003 (but other ELSI programs continue); NIH and DOE|
|Human Embryo Research Panel||1994; NIH|
|Advisory Committee on Human Radiation Experiments||1994–1995; created by President Bill Clinton, reported to Cabinet-level group|
|Advisory Commission on Consumer Protection and Quality in the Health Care Industry||1996–1998; created through executive order by President Bill Clinton|
Rights and Responsibilities in 1997, and issued its final report, Quality First: Better Health Care for All Americans, in 1998.
STATE LEVEL AND NONGOVERNMENTAL COMMISSIONS. Many state legislatures and executive branches must incorporate bioethics into their public policy making. Given this growing need, several states have created committees and commissions, most of which have been devoted to a single issue. Access to health care has been the single largest issue addressed by state-level committees. Some states, however, have created commissions designed to consider a broad range of issues. Two examples of state-level commissions are the New Jersey State Commission on Legal and Ethical Problems in the Delivery of Health Care, created in 1985 as a permanent legislative committee, and the New York State Task Force on Life and the Law, also created in 1985, with a broad mandate to make recommendations for policies involving medical technologies.
In addition to academic bioethics centers, several nongovernmental organizations in the United States have created bioethics centers or committees. For example, the American Medical Association, the nation's largest professional association of physicians, houses the Institute for Ethics, which studies ethical issues related to health care and biomedical research. Many churches and religious groups have also established bioethics committees. Two examples are the American Bioethics Advisory Commission, founded by the American Life League, and the Center for Bioethics and Human Dignity, founded by several Christian bioethicists.
International Bioethics Commissions
Before the term bioethics was used, the Nuremberg War Crimes Tribunal in 1945 made the treatment of human subjects in scientific research a major issue. Subsequent work by the World Medical Association led to the Declaration of Helsinki in 1964, which outlined ethical principles for medical research involving human subjects.
The first explicitly-named bioethics group on the international level was the Steering Committee for Bioethics (CDBI), which is a multidisciplinary ad hoc group created by the Council of Europe in 1983 (although it underwent name changes in 1985 and 1993). CDBI adopted the first international treaty on bioethics in 1996. The Commission of the European Union has also established bioethics committees, including the Working Group on Human Embryos Research; the Working Group on Ethical, Social, and Legal Aspects of Human Genome Analysis; and the Working Party on Ethical and Legal Issues Raised by New Reproductive Technology (also known as the Glover Commission), which produced the Glover Report in 1989.
On an even broader international level, the United Nations Educational, Scientific, and Cultural Organization (UNESCO) division of Ethics of Science and Technology created two bioethics advisory bodies in 1993 under the umbrella term of Bioethics Program: the International Bioethics Committee (IBC) and the Inter-governmental Bioethics Committee (IGBC). A major outcome of this program was the adoption of the Universal Declaration on the Human Genome and Human Rights by the General Conference, the only international instrument in the field of bioethics, endorsed by the United Nations General Assembly in 1998.
Bioethics Commissions Outside the United States
Susan Poland (1998) compiled a comprehensive list of bioethics committees and commissions around the world (see also Martinez 2003). Although dominated by the United States, Canada, and Europe, there have been commissions in the Philippines, Mexico, Japan, Turkey, Russia, Israel, and elsewhere. What is most striking about this list is the diversity in structure, function, duration, context, and other variables. For example, although many commissions are temporary, there are some permanent and semi-permanent bodies. Canada and Australia have established permanent law reform commissions to make recommendations to parliament (Kasimba and Singer 1989, Williams 1989).
An example of a permanent committee more strictly focused on bioethics is the French National Consultative Committee on Ethics in the Biological and Medical Sciences (CCNE). Created in 1983, this agency is the first broad bioethics commission on a national level in France with the power not only to review research protocols but also to advise the government on appropriate legislative action (Isambert 1989). Another example of a permanent advisory body is the Human Genetics Commission in the United Kingdom, which is a non-statutory, independent advisory committee established in 1999. Its role is to advise Ministers on the appropriate response to developments in human genetics. Yet another example is the Standing Committee on Ethics in Experimentation established by the Medical Research Council of Canada (a grant-funding institution for health science research) in 1984. This committee aids in the development of federal policy as well. In 2004, Israel began formalizing plans for a National Council of Bioethics, which will serve as a governmental statutory authority, allowing it to monitor existing bioethics committees and giving it rather unusual legislative power for a bioethics panel.
Other bioethics commissions are special instantiations of a broader model of commission-based inquiry used by governments to investigate problems that face decision makers. Several European parliaments utilize the model of Enquete commissions, which are temporary bodies established to provide policy advice on vast range of issues. Many Enquetes have focused on bioethical issues; for example, the German commission studying "Law and Ethics of Modern Medicine" (2000; reinstated in 2003). Moreover, as in the United States, not all bioethics commissions are established by governments. For example, in Canada nongovernmental organizations such as the Canadian Medical Association and certain churches have formed bioethics committees.
Some bioethics commissions have exerted their influence on the future work of other commissions around the world. The Warnock Commission in the United Kingdom (chaired by philosopher Dame Mary Warnock) is one example. This fifteen-member committee met from 1982 to 1984 in order to examine the social, ethical, and legal implications of developments in assisted reproduction. Its report, The Warnock Report on Human Fertilization and Embryology (1984), is a landmark in the field because of its treatment of moral issues and its forthright explanation of the difficulties in seeking moral consensus. This distinguished it from previous reports (such as Peel  and Black ). Furthermore, the report was concise, readable, and showed respect for dissenting views (Campbell 1989). Both the process and product of this commission have influenced the work of other bioethics committees.
Historical and cultural contexts are crucial elements in determining the parameters for both the style and content of bioethics commissions. For example, in Japan there is a long tradition of paternalistic and authoritative relationships between medical professionals and patients and their families. Although there is a deep respect for elders in Japanese culture, there is also an ingrained research-oriented mentality that treats patients more as medical cases than persons (Kimura 1989). The culture is rapidly changing in Japan, but these traditions shape the challenges faced by bioethics commissions, because democratic deliberation and the "rights based" approach to medical ethics are both relatively new. In Germany, the Nazi legacy has left a "culture of remembrance" that vows to never again relive the horrors of state-sponsored eugenics and applied biology (Brown 2004). The protection of the sanctity of persons is written directly into its constitution, and Germany has a history of strict bioethics policies. Germany's unique history has impacted the way it structures inquiries into matters of bioethics. For the most part, German bioethics commissions have been conservative, control-oriented, paternalistic, and skeptical of scientific and technological developments (Sass 1989). The creation of the National Ethics Council by Chancellor Gerhard Schröder in 2001, however, signified a break in this dominant culture as once-taboo topics were made available for more serious discussion.
In contrast to the United States, many bioethics commissions in other nations have more limited public access policies. However, like the United States, most of these commissions include members who are not health care professionals or scientists.
Bioethics commissions and committees have been created to serve a variety of purposes, including helping heterogeneous societies articulate common values and foster consensus about biomedical advances; serving as a crucial interface for science and politics; providing specific policy recommendations, technical advice, and even serving the judiciary; reviewing the implementation of existing laws; educating the general public about complex ethical issues arising from the rapid development of science and technology; serving as a forum for public participation in policy making; undertaking research; legitimizing action; and delaying action (see United States Office of Technology Assessment 1993; Walters 1989). Although they can be powerful due to their prestige and access to resources, no specific committee or commission can be all-encompassing. Trade-offs among the above functions are inevitable, perhaps the most important being between a wide-ranging, fundamental inquiry and a more topical, focused investigation geared toward the needs of decision makers. The wider commissions are more adept at educating the public and guiding long-term debates about basic ethical principles, whereas the narrower commissions tend to be more immediately policy relevant.
Maximizing the value of bioethics commissions requires utilizing relationships with bioethics centers, government, and society. A multitude of bioethics centers, professions, and organizations provides a widespread, pluralistic approach to bioethics debates, which promotes diversity of perspectives and propinquity to patients and researchers. Federal bioethics commissions can command the resources necessary to address nationwide issues, foster broad discussions, and articulate conflicting views, but can also be inflexible or captured by political interests. Understanding when to create permanent versus term-limited or ad hoc bodies is also an element influencing the utility of commissions and committees (see United States Office of Technology Assessment 1993).
Another important variable is membership composition, including the roles of different forms of expertise and public input. Membership is usually the most politically charged element of committees. Two examples are the U.S. President's Council on Bioethics and Israel's National Council of Bioethics, which have both been accused of being biased and captured by narrow political interests. In the former case, Chairman Leon Kass is seen as overly pessimistic about technology, while in the latter case Chairman Michel Ravel is seen as overly permissive of scientific research and its applications. Those who criticize these councils claim that common interest goals are not being served. This highlights the need to craft wise membership selection mechanisms in order to lend credibility to the commission.
An alternative path to institutionalizing bioethics is what Eric Juengst (1996) calls the "un-commission" model, best represented by the original design of the ELSI program, which adapted NIH mechanisms to create extramural grant support for research, education, and public participation projects on the social implications of genome research. The main critique of this program is that it could not affect policy, but Juengst argues that even national commissions are severely constrained in their ability to communicate policy recommendations effectively. He suggests that the "un-commission" model is better capable of providing adequate social-impact assessments to serve as a sound contextual base for policy making. This model of complementary research and public deliberation attached to scientific research funding provides another option for identifying and developing responses to emerging bioethics issues. The charge still stands, however, that such a model fails to immediately impact policy, and only adds "basic ethics research" to the basic science research, neither of which can truly aid decision makers or the public. Perhaps the best method is to provide distinct forums for both policy-relevant inquiry and basic ethical and social impacts research.
Commissions and committees gather interdisciplinary panels of experts to ponder questions that arise at the interface of science, technology, and society. However, most of these questions cannot be answered by specialists. In fact, delegating this decision-making responsibility to experts may undermine the public participation necessary to uphold strong democratic practices in the face of rapid changes. In this light, then, the proper role of bioethics commissions may be to clarify values and educate the public in order to ensure the "very possibility of a democratic future in the biotechnical age that is now upon us" (McClay 2004, p. 18). What bioethics commissions should provide are not final answers, but rather a clearer understanding of the questions and the consequences different answers may pose.
Brody, Baruch A. (1989). "The President's Commission: The Need to be More Philosophical." Journal of Medicine and Philosophy 14(4): 369–384. Argues that greater philosophical clarity on terms such as "life" and "death" would have led to more coherent policies.
Brown, Eric. (2004). "The Dilemmas of German Bioethics." The New Atlantis 5(Spring): 37–53. Provides a historical overview of bioethics in Germany and assesses recent and potential future developments.
Campbell, Alastair B. (1989). "Committees and Commissions in the United Kingdom." Journal of Medicine and Philosophy 14(4): 385–402.
Isambert, Francois-Andre. (1989). "Ethics Committees in France." Journal of Medicine and Philosophy 14(4): 445–456.
Juengst, Eric T. (1996). "Self-critical Federal Science? The Ethics Experiment within the U.S. Human Genome Project." Social Philosophy and Policy 13(2): 63–95. Evaluates the ELSI experiment as a model for addressing policy issues raised by innovations in science. Illustrates the tensions inherent in the dual missions of providing policy advice and undertaking inquiry and the difficulty for any bioethics commission (or "un-commission") model in communicating policy recommendations.
Kasimba, Pascal, and Peter Singer. (1989). "Australian Commissions and Committees on Issues in Bioethics." Journal of Medicine and Philosophy 14(4): 403–424. Examines contributions of government commissions to ethical issues raised by medical and biological sciences.
Kimura Rihito. (1989). "Ethics Committees for 'High Tech' Innovations in Japan." Journal of Medicine and Philosophy 14(4): 457–464.
Martinez, Julio Luis, ed. (2003). Comites De Bioetica [Bioethics committees]. Madrid: Universidad Pontificia. A Spanish publication that provides an overview and evaluations of bioethics committees.
McClay, Wilfred M. (2004). "Science and Self-Government." The New Atlantis 4(Winter): 17–22. Gives a positive assessment of a report issued by the President's Council on Bioethics.
Poland, Susan Cartier. (1998). "Bioethics Commissions: Town Meetings with a 'Blue, Blue Ribbon."' Kennedy Institute of Ethics Journal 8(1): 91–109. Available as a monograph from National Reference Center for Bioethics Literature, Kennedy Institute, Georgetown University, Washington, DC. A comprehensive listing of bioethics commissions around the world.
Sass, Hans-Martin. (1989). "Blue-Ribbon Commissions and Political Ethics in the Federal Republic of Germany." Journal of Medicine and Philosophy 14(4): 465–472.
United States Office of Technology Assessment (OTA). (1993). Biomedical Ethics in U.S. Public Policy. Reviews the history of four Federal bioethics initiatives: the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Ethics Advisory Board, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, and the Biomedical Ethics Advisory Committee.
Walters, LeRoy. (1989). "Commissions and Bioethics." Journal of Medicine and Philosophy 14(4): 363–368. The lead paper in a special issue of the journal devoted to bioethics commissions.
Williams, John R. (1989). "Commissions and Biomedical Ethics: the Canadian Experience." Journal of Medicine and Philosophy 14(4): 425–444.
The President's Council on Bioethics. Available from http://www.bioethics.gov/. Provides a list of past U.S. commissions and committees with several links to reports.