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Human stem cell research: some controversies in bioethics and public policy
Blood Cells, Molecules, and Diseases 32 (2004) 100 – 105 www.elsevier.com/locate/ybcmd
Human stem cell research: some controversies in bioethics and public policy James F. Childress * Department of Religious Studies, Institute for Practical Ethics and Public Life, University of Virginia, Charlottesville, VA 22908, USA Submitted 22 September 2003 (Communicated by M. Lichtman, M.D., 15 October 2003)
Abstract In the United States, controversy has raged about ethical public policies toward some potential sources of human stem cells for research, particularly human embryos left over from in vitro fertilization (IVF) or created through somatic cell nuclear transfer. This article critically examines the ethical and policy issues, particularly as they have emerged in the reports and recommendations of two presidentially appointed advisory bodies: The National Bioethics Advisory Commission (NBAC) and the President’s Council on Bioethics (PCB). D 2003 Elsevier Inc. All rights reserved. Keywords: Bioethics; Human stem cell research; Public policy
Introduction: ethics and public policy In the United States, the ethical framework for the analysis and assessment of particular research protocols is fairly clear and stable. This framework, which is embedded in public policy, includes the principles of the Belmont Report—respect for persons, beneficence (including minimizing harm), and justice—as well as the standards and procedures that appear in the Common Rule, which applies to all research involving human participants conducted or funded by the Department of Health and Human Services and some other federal agencies and which has been extended to privately funded research at institutions with multiple assurances. This ethical framework applies to stem cell research that involves human recipients of stem cells, but an ethical and policy controversy has raged in the United States—as well as in other countries—about some sources of stem cells that might be used in such research. This controversy encompasses both ethics and policy. Many centuries ago, Aristotle rightly viewed ethics and politics as closely connected. Of course, his understanding of politics was broader than our * Department of Religious Studies, Institute for Practical Ethics and Public Life, University of Virginia, POB 400126, Cocke Hall, 101, Charlottesville, VA 22908. Fax: +1-434-924-1467. E-mail address: [email protected]. 1079-9796/$ - see front matter D 2003 Elsevier Inc. All rights reserved. doi:10.1016/j.bcmd.2003.09.023
common view of the competition of interest groups in the pursuit of power in a democracy. However, the connection between ethics and public policy (politics) remains important. In the US, the controversy about human stem cell research has been animated to a great extent by concerns related to ‘‘abortion politics’’, a label that is not inaccurate if we also recognize that the political or policy positions generally rest on assumed if not articulated moral premises, particularly about the moral status of the early embryo and what respect for the early embryo entails. The ethical issues themselves vary somewhat according to the type of public policy under discussion. At the risk of oversimplification, I would note that two major types of public policy have special relevance to human stem cell research. On one hand, public policies involve decisions about the use of governmental funds, specifically, in this case, the use of federal funds in research that involves controversial sources of stem cells, such as embryos left over following in vitro fertilization (IVF) or cloned embryos. On the other hand, public policies involve decisions about whether, apart from the use of governmental funds, to permit, regulate, or prohibit some activity such as human cloning. A judgment about one type of policy does not necessarily imply a particular judgment about the other type. For instance, it is possible to argue for a ban on governmental funding for an activity such as so-called research cloning without arguing for governmental ban on that same activity.
J.F. Childress / Blood Cells, Molecules, and Diseases 32 (2004) 100–105
In the US, debates about bioethics and public policy appear in many different contexts, such as congressional hearings. Governmental bioethics commissions, established to advise the federal government, have provided one important context for these debates. Two major governmental bioethics commissions have reported on both cloning and stem cell research and their connections since 1997: The National Bioethics Advisory Commission (NBAC), which was appointed by President Clinton and on which I served during its existence from 1996 to 2001, and the current President’s Council on Bioethics (PCB), which was appointed by President Bush in early 2002. I will focus on several ethical and policy issues in human stem cell research, particularly as these issues arise from the deliberations and reports of these two bodies.
NBAC’s report and federal funds for human stem cell research The National Bioethics Advisory Commission (NBAC), a presidentially appointed commission, first met in October 1996 with a mandate to examine the use and management of genetic information and the protection of the rights and welfare of human research subjects. However, two major scientific or technological breakthroughs soon occurred and President Clinton asked NBAC to address them. The first request followed the announcement of Dolly’s birth in 1997, when the President asked NBAC to address the ethical and legal issues associated with this technology and to report back within 90 days with recommendations. In addition to supporting the president’s prior decision to prohibit the use of federal funds for cloning humans, NBAC recommended in its report Cloning Humans (1997) [1] a federal ban, for a period of 3 –5 years, on any efforts to clone a human being and vigorous discussions during the ban about possible and desirable public policies for the long run. The report’s rationale for a federal ban focused on potential harms to children created through somatic cell nuclear transfer, but some commissioners also based their support for this recommended ban on other ethical considerations. In late 1998, following the announcement of the isolation of human embryonic stem cells and germ cells, President Clinton asked NBAC to prepare a report and recommendations regarding the provision of federal funds for human stem cell research. His letter of November 14, 1998 asked NBAC to ‘‘undertake a thorough review of the issues associated with. . . human stem cell research, balancing all ethical and medical considerations [2]’’. From then until September 1999, when the commission submitted its report to the president, NBAC examined the full range of issues associated with human stem cell research to reach the best judgment it could about the appropriate balance of ‘‘ethical and medical considerations’’ and about the appropriate ethical and policy guidelines for such research. While generating excitement, particularly because of its great medical promise, this re-
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search also raises serious ethical concerns, mainly because of some potential sources of stem cells: embryos remaining after in vitro fertilization (IVF); cadaveric fetal tissue obtained from elective abortions; and embryos created for research by IVF or somatic cell nuclear transfer. NBAC’s deliberations reflected the ‘‘tension’’, felt by many, between the ethically grounded desire to realize this research’s promise of therapeutic benefits and the ethically grounded desire to treat the different sources of stem cells with appropriate respect. The commission found widespread agreement that ‘‘human embryos deserve respect as a form of human life’’, but, at the same time, disagreements ‘‘regarding both what form such respect should take and what level of protection is required at different stages of embryonic development [2]’’. At the very least this ‘‘respect’’ means that these sources should not be used unless they are necessary for research, that cadaveric fetal tissue and embryos remaining following IVF should not be bought or sold, and that alternative sources should simultaneously be explored. In addition, NBAC sought to show respect for the range of serious ethical concerns represented in various positions on stem cell research in our society. In interpreting and evaluating different policy proposals, one important distinction is between derivation of stem cells and research on developed cell lines. I will label these activities derivation and research or use. By the time of NBAC’s deliberations, two major positions on the provision of federal funds for human stem cell research had become prominent in the public arena. Position One: provide no federal funds for either derivation of or research on cell lines from embryos. This position has been held by several members of the US House of Representatives. Another position also emerged, especially as the National Institutes of Health, in seeking a way around the federal ban on funds for embryo research, drew on the distinction between derivation and research use. Position Two: provide federal funds for research on cell lines derived from embryos using private or nonfederal funds and within certain ethical guidelines. Position One opposes the use of federal funds for this controversial research to avoid encouraging the destruction of embryos and to prevent taxpayer complicity in actions some of them deem unethical. Position Two seeks to reduce both of these ethical concerns by allowing private funds to support derivation of stem cells and then to authorize federal funds for research on the derived cell lines. In proposing an alternative position, NBAC challenged the separation between derivation and research use. Position Three: provide federal funds for both the derivation of and research on cell lines derived from embryos within certain ethical guidelines. NBAC concluded that it would be acceptable for the federal government to fund research that both derives and uses stem cells from embryos remaining from fertility treatment as well as from cadaveric fetal tissue if certain guidelines and safeguards are effectively established, including an appropriate and open system of national oversight and review. Providing federal funds for derivation
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would have necessitated changing the federal ban on embryo research, and, while NBAC was preparing its report, the Clinton administration indicated that it did not find Position Three acceptable and sought, instead, to implement Position Two. NBAC’s conclusion that ‘‘it is ethically acceptable for the federal government to finance research that both derives cell lines from embryos remaining after infertility treatments and that uses those cell lines’’ reflects the judgment, based on expert testimony, that it is a mistake to suppose that derivation and use can be ‘‘neatly separated without affecting the expansion of scientific knowledge’’—instead, there is a ‘‘close connection in practical terms [2]’’. For instance, the methods for deriving stem cells may affect the properties of embryonic stem cells, and increased understanding of the nature of embryonic stem cells may come in part from the process of derivation. Several ethical concerns arise in the derivation and use of embryonic stem cells from embryos remaining after IVF, and some are similar to those that arise in the derivation and use of embryonic germ cells from cadaveric fetal tissue. NBAC proposed ways to separate, to the extent possible, donors’ decisions to dispose of their embryos from their decisions to donate them for research in order to reduce the possibility that ‘‘potential donors could be pressured or coerced into donating their embryos for stem cell research [2]’’. The commission also stressed that ‘‘potential donors should be asked to provide embryos for research only if they have decided to have those embryos discarded instead of donating them to another couple or storing them. If the decision to discard the embryos precedes the decision to donate them for research purposes, then the research determines only how the destruction occurs, not whether it occurs [2]’’. NBAC further recommended the disclosure of certain, specific information to those considering whether to donate their embryos for research. The informational components include the embryonic stem cell (ES) research ‘‘is not intended to provide medical benefit to embryo donors’’; a decision to donate or not to donate the embryos for research will not affect future care provided to the prospective donors; ‘‘the research will involve the destruction of the embryos’’; and the ‘‘embryos used in research will not be transferred to a woman’s uterus [2]’’. NBAC additionally recommended that, in federally funded research, researchers ‘‘not promise donors that ES cells derived from their embryos will be used to treat patients—subjects specified by the donors’’. Another ethical constraint needs to be in place for the derivation and use of stem cells from embryos remaining after IVF as well as for research involving cadaveric fetal tissue: ‘‘Embryos and cadaveric fetal tissue should not be bought or sold [2]’’. And NBAC called for an examination of federal statutes and regulations and state statutes to make sure that they or subsequent modifications achieve this end. NBAC’s report focused mainly on public policy decisions about the use of federal funds for embryos left over
following in vitro fertilization and for tissue from deliberately aborted fetuses. It also advised against federal funding for embryonic stem cells derived from embryos made solely for research purposes using IVF. This recommendation reflects a distinction between creating embryos through IVF to have children and creating them for research. The latter seems to treat embryos merely as means to others’ ends, perhaps in violation of appropriate respect for embryos. Yet NBAC also recognized that the deliberate creation of embryos for research could be important either for numbers of embryos or special research. However, it concluded that ‘‘either from a scientific or clinical perspective, there is no compelling reason at this time to provide federal funds for the creation of embryos for research’’. NBAC made a similar argument for not deriving or using human embryonic stem cells from embryos created through somatic cell nuclear transfer into oocytes. Both of these two negative limits come with provisos. The first proviso was temporal: ‘‘at the current time’’ or ‘‘at this time’’. The second proviso concerned need or utility. Hence, either limit could be overcome. And both negative recommendations were restricted to the provision of federal funds. In neither case did NBAC call for a federal ban on the activities themselves.
The Bush administration’s policy on federal funds Following months of controversy, President Bush on August 9, 2001, in a nationally televised speech, announced his policy regarding the use of federal funds for embryonic stem cell research. His position further specifies Position Three. It provides federal funds only for research on cell lines derived from leftover embryos where the derivation occurred, using private or nonfederal funds, before the time of his announcement. Position Four: provide federal funds for research on cell lines derived from embryos before 9:00 PM, EDT, August 9, 2001, with private or nonfederal funds, and within certain ethical guidelines. These ethical guidelines include the informed consent of donors of embryos created solely for reproductive purposes in the absence of financial inducements. The goal for the fourth policy, as expressed by the Bush administration, is to maintain ‘‘a fundamental moral line’’ in exploring the promise and potential of stem cell research. That ‘‘fundamental moral line’’ is not to ‘‘sanction or encourage’’ the destruction of human embryos with the potential for life. Whether one agrees with this goal or not, it has already been pursued in the context of federally funded transplantation research using tissue from deliberately aborted fetuses, where the long-standing concern has been not to ‘‘sanction or encourage’’ abortions that would not otherwise have occurred (and this has now been extended, without much public attention, to research on germ cells derived from deliberately aborted fetuses). In my judgment, the arguments that support Position Four can also support Position Three. What is critically
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important is establishing effective ethical safeguards. Ethical safeguards in the use of embryos left over following in vitro fertilization should ensure, to the greatest extent possible, the couple’s voluntary and informed decision to destroy their embryos—rather than use them or donate them to another couple—and their voluntary and informed decision to donate them for research. As already noted, the research would then determine how the destruction occurs, not whether it will occur. As matters stand in most jurisdictions, couples may determine how to dispose of their embryos. Of course, further effective safeguards would be needed to avoid fertility clinics’ deliberate creation of ‘‘excess’’ embryos. Why is the third policy important? Mainly because of the need for more and better cell lines than the very restrictive fourth policy has allowed. At a senate hearing on ‘‘Stem Cell Research’’, conducted by the U.S. Senate Committee on Health, Education, Labor and Pensions and chaired by Senator Edward M. Kennedy, on September 5, 2001, I presented my own views, along with some themes from NBAC’s report. This hearing, held just a month after President Bush had announced his policy on the use of federal funds, focused to a great extent on Health and Human Services Secretary Tommy Thompson’s claims about the numbers of cell lines that would be available for federally funded researchers. Senators raised serious concerns about those claims. It is now clear that their concerns were warranted, for, in fact, the number of stem cell lines available for research with federal funds is only a fraction of what the Bush administration indicated in 2001. Just over 10 cell lines appear to be both usable and accessible [3], and scientists, as well as members of the public and patient groups, lament the lost opportunities. Indeed, our collective moral duty to alleviate human suffering and reduce premature deaths provides a strong reason to provide federal funds for this research, within moral limits.
President’s Council on Bioethics (PCB) In announcing his administration’s policy on the use of federal funds in stem cell research (Position Four above), President Bush promised ‘‘I will also name a president’s council to monitor stem cell research, to recommend appropriate guidelines and regulations and to consider all of the medical and ethical ramifications of biomedical innovation. This council will consist of leading scientists, doctors, ethicists, lawyers, theologians and others and will be chaired by Dr. Leon Kass, a leading biomedical ethicist from the University of Chicago. This council will keep us apprised of new developments and give our nation a forum to continue to discuss and evaluate these important issues. As we go forward, I hope we will always be guided by both intellect and heart, by both our capabilities and our conscience’’. However, by the end of September 2001, when NBAC’s charter expired, the Bush administration had not established
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a successor body, because 9/11 understandably and rightly redirected its attention. Finally, on November 28, 2001, at least partly in response to Advanced Cell Technology’s announcement that it had cloned embryos, President Bush issued an Executive Order to establish the new council. On January 16, 2002, the White House announced the membership of the new President’s Council on Bioethics (PCB), which then held its first meeting the next 2 days. According to Kass, the idea was to have a council on bioethics, not a council of bioethicists. In July 2002, the PCB issued its first report Human Cloning and Human Dignity [4]. That the PCB selected this topic for attention was not surprising, in view of the lack of a federal ban on reproductive cloning (what the PCB calls ‘‘cloning-to-produce-children’’) and the vigorous, often rancorous, debate about research cloning (what the PCB calls ‘‘cloning-for-biomedical research’’). Indeed, it would have been surprising for the PCB to start with some other topic. After all, when President Bush met with the PCB at its first meeting, he said: ‘‘Let me say two other things and then I will listen. One, you need to monitor the stem cell issue. That was the charge I gave on national TV that day [August 9, 2001]. . . And the other thing is that I have spoken clearly on cloning. I just don’t think its right. On the other hand, there is going to be a lot of nuance and subtlety to the issue, I presume. And I think this is very important for you all to help the nation understand what this means’’. The PCB report takes a very different approach than NBAC (for a fuller picture of PCB’s activities, see its excellent website http://www.bioethics.gov). The PCB report seeks a ‘‘richer and deeper understanding of what human cloning entails, how we should think about it, and what we should do about it [4]’’. And it does so by considering ‘‘broad human goods’’ that cloning may serve or threaten. This teleological approach examines the ‘‘meaning’’ of human cloning to produce children and for biomedical research in reference to such ‘‘broad human goods’’ as procreation and relief of suffering. The PCB intended its report to ‘‘inform’’ public policy through its thorough, deep, and broad examination of human cloning in its larger contexts. It is difficult, even impossible, to move from a moral assessment of particular actions or activities to public policy, at least in a direct route. In addition, there are ethical questions about how to address public policy in a radically pluralistic society. From my standpoint, the PCB report fails adequately to develop the moral dimensions of formulating public policy in a liberal, pluralistic society marked by presumptions in favor of reproductive and scientific freedom and by a variety of human goods and conceptions of human flourishing. It is preferable, I believe, to recognize a societal presumption in favor of reproductive and scientific freedom and then to ask when this presumption—and it is only a presumption—can be justifiably rebutted. Hence, this approach would focus on the ethics of public policy. The PCB would reject such an approach—and NBAC’s approach—as too procedural be-
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cause it starts with the presumption in favor of freedom, rather than the human goods at stake. However, the PCB does recognize two ‘‘balancing principles’’ regarding public policy. One of these reverses the presumption in favor of freedom, in light of the PCB’s ethical analysis: ‘‘Because of the gravity of the issues at stake, whoever bears the power of decision needs to be persuaded that we should now proceed with human cloning, in either or both of its forms [4]’’. The second principle holds that ‘‘we should interfere [with human cloning] only if the harms are deemed serious, important to the common good, and likely to occur [4]’’. If developed, these principles could provide a closer connection between morality and public policy and between morality and prudence than the report now does. Although the PCB members unanimously called for a federal prohibition of cloning-to-produce-children, important divisions erupted about cloning-for-biomedical research. In the final tally, a 10-member majority called for a 4-year federal moratorium on cloning-for-biomedical research. Even though seven of those 10 members actually favored a ban, they compromised with the three members who endorsed a moratorium to constitute a majority. In short, the spirit of the academic seminar that Kass hoped the PCB could maintain evaporated in its effort to develop public policy recommendations, backed by a majority. Seven members of the PCB supported a second policy option that, while also calling for a federal ban on cloningto-produce-children, recommended proceeding with regulated research on cloned embryos. The proposed regulations included a legal requirement not to develop cloned embryos beyond 14 days and not to implant them in any uterus; establishment of governmental oversight body; a ban on commerce in living cloned human embryos; respect for highest standards for research involving human subjects, especially in the procurement of eggs; prior scientific review of proposed uses; and continued research into other sources of stem cells and tissues. There was no consensus among the members in the minority about the rationale for this position, particularly regarding the moral status of the embryo. Some affirmed an intermediate moral status, that is, a status between mere human cells and human person, but insisted that respect for an entity with intermediate moral status is not incompatible with using it in destructive research. Others resisted the notion of special (even if intermediate) moral status for the early embryo and construed the moral issues as essentially the same as the ones that arise in treating any other human cells. Critically important are informed consent by donors of eggs and somatic cells, quality of research, and scientific integrity [4]. It is remarkable that the PCB ended up with so much disagreement. After all, its members were handpicked, the chair’s views are well known to be generally in line with the Bush administration’s views on this topic, and it was established with a specific mandate to address human embryonic stem cell research. However, the PCB report displayed not only split recommendations but also, within each
of the main positions, several subpositions. In some ways this report is indicative of our societal confusion or persistent uncertainty. And it is not surprising that the White House responded to the PCB report by saying that the President would not change his position, which, ‘‘based on principle’’, holds that it is morally wrong to attempt to clone a human being whether for reproductive or research purposes. The first PCB report suffered the same fate as NBAC’s earlier reports on Cloning Humans and Human Stem Cell Research: their recommendations were not adopted as public policy. Philosopher Daniel Callahan and others have drawn a distinction between regulatory and prophetic bioethics. Clearly, governmental bodies, established to address public bioethics, are more likely to be regulatory in nature, that is, aimed at formulating desirable and feasible public policies. Even though the PCB aimed as much (or more so) to influence public culture, as public policy, it was still not as prophetic as many observers desired, particularly when the policies recommended by the majority resulted from what critics deemed a morally ambiguous compromise.
Diverse religious perspectives Views about appropriate respect for the embryo hinge on convictions about the embryo’s moral status, as already noted, and those convictions often reflect religious perspectives. There are diverse religious views on human embryonic stem cell research, both across traditions and within traditions. On May 7, 1999, NBAC convened a meeting at Georgetown University to hear presentations on religious perspectives relating to human stem cell research. Altogether, 11 scholars in Roman Catholic, Jewish, Eastern Orthodox, Islamic, and Protestant traditions presented formal testimony that day, and two others made statements in the public comment period. Their statements, as well as later statements of other traditions (e.g., the Mormon tradition), reveal significantly different perspectives on the ethics of research on unimplanted human embryos [5,6]. Even when similarly opposed to abortion, different religious positions may reach divergent moral conclusions about human embryonic stem cell research. Their different conclusions follow, in part, from different premises about the moral status of the early embryo existing outside a woman’s womb. Although Roman Catholicism officially opposes human embryonic stem cell research, some Roman Catholic moral theologians endorse it. A number of Jewish thinkers hold that the extracorporeal embryo, in the petri dish or cryopreserved, does not have standing in Jewish law and that it is justifiable to go forward with embryonic stem cell research. Protestants represent a wide range of views, as could be expected in view of the more than two hundred denominations in the US that are identified as Protestant. Some Muslim thinkers also accept embryonic stem cell research [5,6]. In brief, no consensus exists among religious traditions— or secular moral traditions—about the moral status of the
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extracorporeal embryo. This diversity sets the context for an ethical assessment of public policy toward human embryonic stem cell research. An ethical public policy in our pluralistic society has to respect diverse fundamental beliefs. And yet it must not be held hostage to any single view of embryonic life.
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Acknowledgments This paper is based on a presentation at a Focused Workshop on ‘‘Stem Cell Plasticity’’ held in Providence, RI, April 8 – 11, 2003, sponsored by The Leukemia and Lymphoma Society, Roger Williams Medical Center, and the University of Nevada, Reno.
Conclusions Stem cell research has great promise for helping to alleviate human disease and suffering. But it is multifaceted, in part because of the different possible sources of stem cell research. And some of those sources are particularly controversial. This paper has offered an analysis and assessment of some of opposing ethical positions about potential sources, especially as developed in the context of two major national bioethics bodies, NBAC and PCB, neither of which could resolve the societal controversy because of the fundamental values at stake. Yet each attempted to enrich the societal conversation about the profound ethical issues regarding potentially beneficial research on human stem cells. Because of the controversy and competing ethical values, as well as the evolving science, it is premature to bring closure by ruling out any particular approaches to or sources of stem cells or by enshrining one approach or source as the best.
References [1] National Bioethics Advisory Commission, Cloning Human Beings, National Bioethics Advisory Commission, Rockville, MD, 1997 June. [2] National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, vol. I. National Bioethics Advisory Commission, Rockville, MD, 2000 June. [3] E. Zerhouni, Testimony before Labor, HHS, Education Subcommittee, Senate Appropriations Committee, U.S. Senate, May 22, 2003, Federal Document Clearing House Congressional Testimony, May 22, 2003. [4] The President’s Council on Bioethics, Human Cloning and Human Dignity, Public Affairs Press, New York, 2002. [5] National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, vol. 2. National Bioethics Advisory Commission, Rockville, MD, 2000 June. [6] National Bioethics Advisory Commission, Summary of Presentations on Religious Perspectives Relating to Research Involving Human Stem Cells, May 7, 1999, Ethical Issues in Human Stem Cell Research, vol. 1. National Bioethics Advisory Commission, Rockville, MD, 2000 June, pp. 99 – 104.
Human stem cell research: some controversies in bioethics and public policy James F. Childress * Department of Religious Studies, Institute for Practical Ethics and Public Life, University of Virginia, Charlottesville, VA 22908, USA Submitted 22 September 2003 (Communicated by M. Lichtman, M.D., 15 October 2003)
Abstract In the United States, controversy has raged about ethical public policies toward some potential sources of human stem cells for research, particularly human embryos left over from in vitro fertilization (IVF) or created through somatic cell nuclear transfer. This article critically examines the ethical and policy issues, particularly as they have emerged in the reports and recommendations of two presidentially appointed advisory bodies: The National Bioethics Advisory Commission (NBAC) and the President’s Council on Bioethics (PCB). D 2003 Elsevier Inc. All rights reserved. Keywords: Bioethics; Human stem cell research; Public policy
Introduction: ethics and public policy In the United States, the ethical framework for the analysis and assessment of particular research protocols is fairly clear and stable. This framework, which is embedded in public policy, includes the principles of the Belmont Report—respect for persons, beneficence (including minimizing harm), and justice—as well as the standards and procedures that appear in the Common Rule, which applies to all research involving human participants conducted or funded by the Department of Health and Human Services and some other federal agencies and which has been extended to privately funded research at institutions with multiple assurances. This ethical framework applies to stem cell research that involves human recipients of stem cells, but an ethical and policy controversy has raged in the United States—as well as in other countries—about some sources of stem cells that might be used in such research. This controversy encompasses both ethics and policy. Many centuries ago, Aristotle rightly viewed ethics and politics as closely connected. Of course, his understanding of politics was broader than our * Department of Religious Studies, Institute for Practical Ethics and Public Life, University of Virginia, POB 400126, Cocke Hall, 101, Charlottesville, VA 22908. Fax: +1-434-924-1467. E-mail address: [email protected]. 1079-9796/$ - see front matter D 2003 Elsevier Inc. All rights reserved. doi:10.1016/j.bcmd.2003.09.023
common view of the competition of interest groups in the pursuit of power in a democracy. However, the connection between ethics and public policy (politics) remains important. In the US, the controversy about human stem cell research has been animated to a great extent by concerns related to ‘‘abortion politics’’, a label that is not inaccurate if we also recognize that the political or policy positions generally rest on assumed if not articulated moral premises, particularly about the moral status of the early embryo and what respect for the early embryo entails. The ethical issues themselves vary somewhat according to the type of public policy under discussion. At the risk of oversimplification, I would note that two major types of public policy have special relevance to human stem cell research. On one hand, public policies involve decisions about the use of governmental funds, specifically, in this case, the use of federal funds in research that involves controversial sources of stem cells, such as embryos left over following in vitro fertilization (IVF) or cloned embryos. On the other hand, public policies involve decisions about whether, apart from the use of governmental funds, to permit, regulate, or prohibit some activity such as human cloning. A judgment about one type of policy does not necessarily imply a particular judgment about the other type. For instance, it is possible to argue for a ban on governmental funding for an activity such as so-called research cloning without arguing for governmental ban on that same activity.
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In the US, debates about bioethics and public policy appear in many different contexts, such as congressional hearings. Governmental bioethics commissions, established to advise the federal government, have provided one important context for these debates. Two major governmental bioethics commissions have reported on both cloning and stem cell research and their connections since 1997: The National Bioethics Advisory Commission (NBAC), which was appointed by President Clinton and on which I served during its existence from 1996 to 2001, and the current President’s Council on Bioethics (PCB), which was appointed by President Bush in early 2002. I will focus on several ethical and policy issues in human stem cell research, particularly as these issues arise from the deliberations and reports of these two bodies.
NBAC’s report and federal funds for human stem cell research The National Bioethics Advisory Commission (NBAC), a presidentially appointed commission, first met in October 1996 with a mandate to examine the use and management of genetic information and the protection of the rights and welfare of human research subjects. However, two major scientific or technological breakthroughs soon occurred and President Clinton asked NBAC to address them. The first request followed the announcement of Dolly’s birth in 1997, when the President asked NBAC to address the ethical and legal issues associated with this technology and to report back within 90 days with recommendations. In addition to supporting the president’s prior decision to prohibit the use of federal funds for cloning humans, NBAC recommended in its report Cloning Humans (1997) [1] a federal ban, for a period of 3 –5 years, on any efforts to clone a human being and vigorous discussions during the ban about possible and desirable public policies for the long run. The report’s rationale for a federal ban focused on potential harms to children created through somatic cell nuclear transfer, but some commissioners also based their support for this recommended ban on other ethical considerations. In late 1998, following the announcement of the isolation of human embryonic stem cells and germ cells, President Clinton asked NBAC to prepare a report and recommendations regarding the provision of federal funds for human stem cell research. His letter of November 14, 1998 asked NBAC to ‘‘undertake a thorough review of the issues associated with. . . human stem cell research, balancing all ethical and medical considerations [2]’’. From then until September 1999, when the commission submitted its report to the president, NBAC examined the full range of issues associated with human stem cell research to reach the best judgment it could about the appropriate balance of ‘‘ethical and medical considerations’’ and about the appropriate ethical and policy guidelines for such research. While generating excitement, particularly because of its great medical promise, this re-
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search also raises serious ethical concerns, mainly because of some potential sources of stem cells: embryos remaining after in vitro fertilization (IVF); cadaveric fetal tissue obtained from elective abortions; and embryos created for research by IVF or somatic cell nuclear transfer. NBAC’s deliberations reflected the ‘‘tension’’, felt by many, between the ethically grounded desire to realize this research’s promise of therapeutic benefits and the ethically grounded desire to treat the different sources of stem cells with appropriate respect. The commission found widespread agreement that ‘‘human embryos deserve respect as a form of human life’’, but, at the same time, disagreements ‘‘regarding both what form such respect should take and what level of protection is required at different stages of embryonic development [2]’’. At the very least this ‘‘respect’’ means that these sources should not be used unless they are necessary for research, that cadaveric fetal tissue and embryos remaining following IVF should not be bought or sold, and that alternative sources should simultaneously be explored. In addition, NBAC sought to show respect for the range of serious ethical concerns represented in various positions on stem cell research in our society. In interpreting and evaluating different policy proposals, one important distinction is between derivation of stem cells and research on developed cell lines. I will label these activities derivation and research or use. By the time of NBAC’s deliberations, two major positions on the provision of federal funds for human stem cell research had become prominent in the public arena. Position One: provide no federal funds for either derivation of or research on cell lines from embryos. This position has been held by several members of the US House of Representatives. Another position also emerged, especially as the National Institutes of Health, in seeking a way around the federal ban on funds for embryo research, drew on the distinction between derivation and research use. Position Two: provide federal funds for research on cell lines derived from embryos using private or nonfederal funds and within certain ethical guidelines. Position One opposes the use of federal funds for this controversial research to avoid encouraging the destruction of embryos and to prevent taxpayer complicity in actions some of them deem unethical. Position Two seeks to reduce both of these ethical concerns by allowing private funds to support derivation of stem cells and then to authorize federal funds for research on the derived cell lines. In proposing an alternative position, NBAC challenged the separation between derivation and research use. Position Three: provide federal funds for both the derivation of and research on cell lines derived from embryos within certain ethical guidelines. NBAC concluded that it would be acceptable for the federal government to fund research that both derives and uses stem cells from embryos remaining from fertility treatment as well as from cadaveric fetal tissue if certain guidelines and safeguards are effectively established, including an appropriate and open system of national oversight and review. Providing federal funds for derivation
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would have necessitated changing the federal ban on embryo research, and, while NBAC was preparing its report, the Clinton administration indicated that it did not find Position Three acceptable and sought, instead, to implement Position Two. NBAC’s conclusion that ‘‘it is ethically acceptable for the federal government to finance research that both derives cell lines from embryos remaining after infertility treatments and that uses those cell lines’’ reflects the judgment, based on expert testimony, that it is a mistake to suppose that derivation and use can be ‘‘neatly separated without affecting the expansion of scientific knowledge’’—instead, there is a ‘‘close connection in practical terms [2]’’. For instance, the methods for deriving stem cells may affect the properties of embryonic stem cells, and increased understanding of the nature of embryonic stem cells may come in part from the process of derivation. Several ethical concerns arise in the derivation and use of embryonic stem cells from embryos remaining after IVF, and some are similar to those that arise in the derivation and use of embryonic germ cells from cadaveric fetal tissue. NBAC proposed ways to separate, to the extent possible, donors’ decisions to dispose of their embryos from their decisions to donate them for research in order to reduce the possibility that ‘‘potential donors could be pressured or coerced into donating their embryos for stem cell research [2]’’. The commission also stressed that ‘‘potential donors should be asked to provide embryos for research only if they have decided to have those embryos discarded instead of donating them to another couple or storing them. If the decision to discard the embryos precedes the decision to donate them for research purposes, then the research determines only how the destruction occurs, not whether it occurs [2]’’. NBAC further recommended the disclosure of certain, specific information to those considering whether to donate their embryos for research. The informational components include the embryonic stem cell (ES) research ‘‘is not intended to provide medical benefit to embryo donors’’; a decision to donate or not to donate the embryos for research will not affect future care provided to the prospective donors; ‘‘the research will involve the destruction of the embryos’’; and the ‘‘embryos used in research will not be transferred to a woman’s uterus [2]’’. NBAC additionally recommended that, in federally funded research, researchers ‘‘not promise donors that ES cells derived from their embryos will be used to treat patients—subjects specified by the donors’’. Another ethical constraint needs to be in place for the derivation and use of stem cells from embryos remaining after IVF as well as for research involving cadaveric fetal tissue: ‘‘Embryos and cadaveric fetal tissue should not be bought or sold [2]’’. And NBAC called for an examination of federal statutes and regulations and state statutes to make sure that they or subsequent modifications achieve this end. NBAC’s report focused mainly on public policy decisions about the use of federal funds for embryos left over
following in vitro fertilization and for tissue from deliberately aborted fetuses. It also advised against federal funding for embryonic stem cells derived from embryos made solely for research purposes using IVF. This recommendation reflects a distinction between creating embryos through IVF to have children and creating them for research. The latter seems to treat embryos merely as means to others’ ends, perhaps in violation of appropriate respect for embryos. Yet NBAC also recognized that the deliberate creation of embryos for research could be important either for numbers of embryos or special research. However, it concluded that ‘‘either from a scientific or clinical perspective, there is no compelling reason at this time to provide federal funds for the creation of embryos for research’’. NBAC made a similar argument for not deriving or using human embryonic stem cells from embryos created through somatic cell nuclear transfer into oocytes. Both of these two negative limits come with provisos. The first proviso was temporal: ‘‘at the current time’’ or ‘‘at this time’’. The second proviso concerned need or utility. Hence, either limit could be overcome. And both negative recommendations were restricted to the provision of federal funds. In neither case did NBAC call for a federal ban on the activities themselves.
The Bush administration’s policy on federal funds Following months of controversy, President Bush on August 9, 2001, in a nationally televised speech, announced his policy regarding the use of federal funds for embryonic stem cell research. His position further specifies Position Three. It provides federal funds only for research on cell lines derived from leftover embryos where the derivation occurred, using private or nonfederal funds, before the time of his announcement. Position Four: provide federal funds for research on cell lines derived from embryos before 9:00 PM, EDT, August 9, 2001, with private or nonfederal funds, and within certain ethical guidelines. These ethical guidelines include the informed consent of donors of embryos created solely for reproductive purposes in the absence of financial inducements. The goal for the fourth policy, as expressed by the Bush administration, is to maintain ‘‘a fundamental moral line’’ in exploring the promise and potential of stem cell research. That ‘‘fundamental moral line’’ is not to ‘‘sanction or encourage’’ the destruction of human embryos with the potential for life. Whether one agrees with this goal or not, it has already been pursued in the context of federally funded transplantation research using tissue from deliberately aborted fetuses, where the long-standing concern has been not to ‘‘sanction or encourage’’ abortions that would not otherwise have occurred (and this has now been extended, without much public attention, to research on germ cells derived from deliberately aborted fetuses). In my judgment, the arguments that support Position Four can also support Position Three. What is critically
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important is establishing effective ethical safeguards. Ethical safeguards in the use of embryos left over following in vitro fertilization should ensure, to the greatest extent possible, the couple’s voluntary and informed decision to destroy their embryos—rather than use them or donate them to another couple—and their voluntary and informed decision to donate them for research. As already noted, the research would then determine how the destruction occurs, not whether it will occur. As matters stand in most jurisdictions, couples may determine how to dispose of their embryos. Of course, further effective safeguards would be needed to avoid fertility clinics’ deliberate creation of ‘‘excess’’ embryos. Why is the third policy important? Mainly because of the need for more and better cell lines than the very restrictive fourth policy has allowed. At a senate hearing on ‘‘Stem Cell Research’’, conducted by the U.S. Senate Committee on Health, Education, Labor and Pensions and chaired by Senator Edward M. Kennedy, on September 5, 2001, I presented my own views, along with some themes from NBAC’s report. This hearing, held just a month after President Bush had announced his policy on the use of federal funds, focused to a great extent on Health and Human Services Secretary Tommy Thompson’s claims about the numbers of cell lines that would be available for federally funded researchers. Senators raised serious concerns about those claims. It is now clear that their concerns were warranted, for, in fact, the number of stem cell lines available for research with federal funds is only a fraction of what the Bush administration indicated in 2001. Just over 10 cell lines appear to be both usable and accessible [3], and scientists, as well as members of the public and patient groups, lament the lost opportunities. Indeed, our collective moral duty to alleviate human suffering and reduce premature deaths provides a strong reason to provide federal funds for this research, within moral limits.
President’s Council on Bioethics (PCB) In announcing his administration’s policy on the use of federal funds in stem cell research (Position Four above), President Bush promised ‘‘I will also name a president’s council to monitor stem cell research, to recommend appropriate guidelines and regulations and to consider all of the medical and ethical ramifications of biomedical innovation. This council will consist of leading scientists, doctors, ethicists, lawyers, theologians and others and will be chaired by Dr. Leon Kass, a leading biomedical ethicist from the University of Chicago. This council will keep us apprised of new developments and give our nation a forum to continue to discuss and evaluate these important issues. As we go forward, I hope we will always be guided by both intellect and heart, by both our capabilities and our conscience’’. However, by the end of September 2001, when NBAC’s charter expired, the Bush administration had not established
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a successor body, because 9/11 understandably and rightly redirected its attention. Finally, on November 28, 2001, at least partly in response to Advanced Cell Technology’s announcement that it had cloned embryos, President Bush issued an Executive Order to establish the new council. On January 16, 2002, the White House announced the membership of the new President’s Council on Bioethics (PCB), which then held its first meeting the next 2 days. According to Kass, the idea was to have a council on bioethics, not a council of bioethicists. In July 2002, the PCB issued its first report Human Cloning and Human Dignity [4]. That the PCB selected this topic for attention was not surprising, in view of the lack of a federal ban on reproductive cloning (what the PCB calls ‘‘cloning-to-produce-children’’) and the vigorous, often rancorous, debate about research cloning (what the PCB calls ‘‘cloning-for-biomedical research’’). Indeed, it would have been surprising for the PCB to start with some other topic. After all, when President Bush met with the PCB at its first meeting, he said: ‘‘Let me say two other things and then I will listen. One, you need to monitor the stem cell issue. That was the charge I gave on national TV that day [August 9, 2001]. . . And the other thing is that I have spoken clearly on cloning. I just don’t think its right. On the other hand, there is going to be a lot of nuance and subtlety to the issue, I presume. And I think this is very important for you all to help the nation understand what this means’’. The PCB report takes a very different approach than NBAC (for a fuller picture of PCB’s activities, see its excellent website http://www.bioethics.gov). The PCB report seeks a ‘‘richer and deeper understanding of what human cloning entails, how we should think about it, and what we should do about it [4]’’. And it does so by considering ‘‘broad human goods’’ that cloning may serve or threaten. This teleological approach examines the ‘‘meaning’’ of human cloning to produce children and for biomedical research in reference to such ‘‘broad human goods’’ as procreation and relief of suffering. The PCB intended its report to ‘‘inform’’ public policy through its thorough, deep, and broad examination of human cloning in its larger contexts. It is difficult, even impossible, to move from a moral assessment of particular actions or activities to public policy, at least in a direct route. In addition, there are ethical questions about how to address public policy in a radically pluralistic society. From my standpoint, the PCB report fails adequately to develop the moral dimensions of formulating public policy in a liberal, pluralistic society marked by presumptions in favor of reproductive and scientific freedom and by a variety of human goods and conceptions of human flourishing. It is preferable, I believe, to recognize a societal presumption in favor of reproductive and scientific freedom and then to ask when this presumption—and it is only a presumption—can be justifiably rebutted. Hence, this approach would focus on the ethics of public policy. The PCB would reject such an approach—and NBAC’s approach—as too procedural be-
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cause it starts with the presumption in favor of freedom, rather than the human goods at stake. However, the PCB does recognize two ‘‘balancing principles’’ regarding public policy. One of these reverses the presumption in favor of freedom, in light of the PCB’s ethical analysis: ‘‘Because of the gravity of the issues at stake, whoever bears the power of decision needs to be persuaded that we should now proceed with human cloning, in either or both of its forms [4]’’. The second principle holds that ‘‘we should interfere [with human cloning] only if the harms are deemed serious, important to the common good, and likely to occur [4]’’. If developed, these principles could provide a closer connection between morality and public policy and between morality and prudence than the report now does. Although the PCB members unanimously called for a federal prohibition of cloning-to-produce-children, important divisions erupted about cloning-for-biomedical research. In the final tally, a 10-member majority called for a 4-year federal moratorium on cloning-for-biomedical research. Even though seven of those 10 members actually favored a ban, they compromised with the three members who endorsed a moratorium to constitute a majority. In short, the spirit of the academic seminar that Kass hoped the PCB could maintain evaporated in its effort to develop public policy recommendations, backed by a majority. Seven members of the PCB supported a second policy option that, while also calling for a federal ban on cloningto-produce-children, recommended proceeding with regulated research on cloned embryos. The proposed regulations included a legal requirement not to develop cloned embryos beyond 14 days and not to implant them in any uterus; establishment of governmental oversight body; a ban on commerce in living cloned human embryos; respect for highest standards for research involving human subjects, especially in the procurement of eggs; prior scientific review of proposed uses; and continued research into other sources of stem cells and tissues. There was no consensus among the members in the minority about the rationale for this position, particularly regarding the moral status of the embryo. Some affirmed an intermediate moral status, that is, a status between mere human cells and human person, but insisted that respect for an entity with intermediate moral status is not incompatible with using it in destructive research. Others resisted the notion of special (even if intermediate) moral status for the early embryo and construed the moral issues as essentially the same as the ones that arise in treating any other human cells. Critically important are informed consent by donors of eggs and somatic cells, quality of research, and scientific integrity [4]. It is remarkable that the PCB ended up with so much disagreement. After all, its members were handpicked, the chair’s views are well known to be generally in line with the Bush administration’s views on this topic, and it was established with a specific mandate to address human embryonic stem cell research. However, the PCB report displayed not only split recommendations but also, within each
of the main positions, several subpositions. In some ways this report is indicative of our societal confusion or persistent uncertainty. And it is not surprising that the White House responded to the PCB report by saying that the President would not change his position, which, ‘‘based on principle’’, holds that it is morally wrong to attempt to clone a human being whether for reproductive or research purposes. The first PCB report suffered the same fate as NBAC’s earlier reports on Cloning Humans and Human Stem Cell Research: their recommendations were not adopted as public policy. Philosopher Daniel Callahan and others have drawn a distinction between regulatory and prophetic bioethics. Clearly, governmental bodies, established to address public bioethics, are more likely to be regulatory in nature, that is, aimed at formulating desirable and feasible public policies. Even though the PCB aimed as much (or more so) to influence public culture, as public policy, it was still not as prophetic as many observers desired, particularly when the policies recommended by the majority resulted from what critics deemed a morally ambiguous compromise.
Diverse religious perspectives Views about appropriate respect for the embryo hinge on convictions about the embryo’s moral status, as already noted, and those convictions often reflect religious perspectives. There are diverse religious views on human embryonic stem cell research, both across traditions and within traditions. On May 7, 1999, NBAC convened a meeting at Georgetown University to hear presentations on religious perspectives relating to human stem cell research. Altogether, 11 scholars in Roman Catholic, Jewish, Eastern Orthodox, Islamic, and Protestant traditions presented formal testimony that day, and two others made statements in the public comment period. Their statements, as well as later statements of other traditions (e.g., the Mormon tradition), reveal significantly different perspectives on the ethics of research on unimplanted human embryos [5,6]. Even when similarly opposed to abortion, different religious positions may reach divergent moral conclusions about human embryonic stem cell research. Their different conclusions follow, in part, from different premises about the moral status of the early embryo existing outside a woman’s womb. Although Roman Catholicism officially opposes human embryonic stem cell research, some Roman Catholic moral theologians endorse it. A number of Jewish thinkers hold that the extracorporeal embryo, in the petri dish or cryopreserved, does not have standing in Jewish law and that it is justifiable to go forward with embryonic stem cell research. Protestants represent a wide range of views, as could be expected in view of the more than two hundred denominations in the US that are identified as Protestant. Some Muslim thinkers also accept embryonic stem cell research [5,6]. In brief, no consensus exists among religious traditions— or secular moral traditions—about the moral status of the
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extracorporeal embryo. This diversity sets the context for an ethical assessment of public policy toward human embryonic stem cell research. An ethical public policy in our pluralistic society has to respect diverse fundamental beliefs. And yet it must not be held hostage to any single view of embryonic life.
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Acknowledgments This paper is based on a presentation at a Focused Workshop on ‘‘Stem Cell Plasticity’’ held in Providence, RI, April 8 – 11, 2003, sponsored by The Leukemia and Lymphoma Society, Roger Williams Medical Center, and the University of Nevada, Reno.
Conclusions Stem cell research has great promise for helping to alleviate human disease and suffering. But it is multifaceted, in part because of the different possible sources of stem cell research. And some of those sources are particularly controversial. This paper has offered an analysis and assessment of some of opposing ethical positions about potential sources, especially as developed in the context of two major national bioethics bodies, NBAC and PCB, neither of which could resolve the societal controversy because of the fundamental values at stake. Yet each attempted to enrich the societal conversation about the profound ethical issues regarding potentially beneficial research on human stem cells. Because of the controversy and competing ethical values, as well as the evolving science, it is premature to bring closure by ruling out any particular approaches to or sources of stem cells or by enshrining one approach or source as the best.
References [1] National Bioethics Advisory Commission, Cloning Human Beings, National Bioethics Advisory Commission, Rockville, MD, 1997 June. [2] National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, vol. I. National Bioethics Advisory Commission, Rockville, MD, 2000 June. [3] E. Zerhouni, Testimony before Labor, HHS, Education Subcommittee, Senate Appropriations Committee, U.S. Senate, May 22, 2003, Federal Document Clearing House Congressional Testimony, May 22, 2003. [4] The President’s Council on Bioethics, Human Cloning and Human Dignity, Public Affairs Press, New York, 2002. [5] National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, vol. 2. National Bioethics Advisory Commission, Rockville, MD, 2000 June. [6] National Bioethics Advisory Commission, Summary of Presentations on Religious Perspectives Relating to Research Involving Human Stem Cells, May 7, 1999, Ethical Issues in Human Stem Cell Research, vol. 1. National Bioethics Advisory Commission, Rockville, MD, 2000 June, pp. 99 – 104.