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Monitoring Stem Cell Research

Chapter Two

Current Federal Law and Policy


Any overview of the state of human stem cell research under the current federal funding policy must begin with a thorough understanding of that policy. This is not as simple as it may sound. From the moment of its first announcement, on August 9, 2001, the policy has been misunderstood (and at times misrepresented) by some among both its detractors and its advocates. Its moral foundation, its political context, its practical implications, and the most basic facts regarding the policy's implementation have all been subjects of heated dispute and profound confusion. Whether one agrees with the policy or not, it is important to understand it as it was propounded, accurately and in its own terms, in the light also of the historical and political contexts in which it was put forward.

This chapter attempts to place the policy in its proper context; to articulate its moral, legal, and political underpinnings (as put forward by its authors and advocates); to offer an overview of its implementation thus far; and to begin to describe its ramifications for researchers and for medicine. By articulating the policy in its own terms, we intend neither to endorse it nor to find fault with it.
i Indeed, in the next chapter we present an overview of arguments on all sides of the question. Here we mean only to clarify, as far as we are able, the original meaning and purpose of the policy, so as to be better able to monitor its impact.


I. A brief history of the embryo research funding debate

The federal government makes significant public resources available to biomedical researchers each year-over $20 billion in fiscal year 2003 alone-in the form of research grants offered largely through the National Institutes of Health (NIH). This level of public expenditure reflects the great esteem in which Americans hold the biomedical enterprise and the value we place on the development of treatments and cures for those who are suffering. But such support is not offered indiscriminately. Researchers who accept federal funds must abide by ethically based rules and regulations governing, among other things, the use of human subjects in research. And some policymakers and citizens have always insisted that taxpayer dollars not be put toward specific sorts of research that violate the moral convictions and sensibilities of some portion of the American public. This has meant that controversies surrounding the morality of some forms of scientific research have at times given rise to disputes over federal funding policy. Among the most prominent examples has been the three-decade-long public and political debate about whether taxpayer funds should be used to support research that involves creating or destroying human embryos or making use of destroyed embryos and fetuses-practices that touch directly on the much-disputed questions of the moral status and proper treatment of nascent human life.

In the immediate aftermath of the Supreme Court's 1973 Roe v. Wade decision legalizing abortion nationwide, some Americans, including some Members of Congress, became concerned about the potential use of aborted fetuses (or embryos) in scientific research. In response to these concerns, the Department of Health, Education and Welfare (DHEW, the precursor to today's Department of Health and Human Services) initiated a moratorium on any potential DHEW sponsorship or funding of research using human fetuses or living embryos. In 1974, Congress codified the policy in law, initiating what it termed a temporary moratorium on federal funding for clinical research using "a living human fetus, before or after the induced abortion of such fetus, unless such research is done for the purpose of assuring the survival of such fetus." 1 Concurrently with that moratorium (and also addressing concerns not directly related to embryo and fetal research), Congress established a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Among its other tasks, Congress explicitly assigned the Commission responsibility for offering guidelines for human fetal and embryo research, so that standards for funding might be established and the blanket moratorium might be lifted. The statutory moratorium was lifted once the Commission issued its report in 1975. 2

In that report, the Commission called for the establishment of a national Ethics Advisory Board within DHEW to propose standards and research protocols for potential federal funding of research using human embryos and to consider particular applications for funding. In doing so, the Commission looked ahead to the possible uses of in vitro embryos, since the first successful in vitro fertilization (IVF) of human egg by human sperm had been accomplished in 1969. ii The Department adopted the recommendation in 1975, established an Ethics Advisory Board, and put in place regulations requiring that the Board provide advice about the ethical acceptability of IVF research proposals. The Board first took up the issue of research on in vitro embryos in full in the late 1970s and issued its report in 1979. 3

By that time, human IVF techniques had been developed (first in Britain) to the point of producing a live-born child (born in 1978). These techniques, and their implications for human embryo research, raised unique prospects and concerns that were distinct from some of those involved in human fetal research. As a consequence, starting in the late 1970s, funding of embryo research and funding of fetal research came to be treated as mostly distinct and separate issues. The Ethics Advisory Board concluded that research involving embryos and IVF techniques was "ethically defensible but still legitimately controverted." Provided that research did not take place on embryos beyond fourteen days of development and that all gamete donors were married couples, the Board argued, such work was "acceptable from an ethical standpoint," but the Board decided that it "should not advise the Department on the level of Federal support, if any," such work should receive. 4

This left the decision in the hands of the DHEW, which decided at that stage not to offer funding for human embryo studies. The Ethics Advisory Board's charter expired in 1980, and no renewal or replacement was put forward, creating a peculiar situation in which the regulations requiring the Ethics Advisory Board to review proposals for funding remained in effect, but the Board no longer existed to consider such requests. Funding was therefore rendered impossible in practice. Because the Ethics Advisory Board was never replaced, a de facto ban on funding remained in place through the 1980s.

In 1993, Congress enacted the NIH Revitalization Act, a provision of which rescinded the requirement that research protocols be approved by the non-existent Ethics Advisory Board. 5 This change opened the way in principle to the possibility of NIH funding for human embryo research using IVF embryos. The following year, the NIH convened a Human Embryo Research Panel to consider the issues surrounding such research and to propose guidelines for potential funding applications. The panel recommended that some areas of human embryo research be deemed eligible for federal funding within a framework of recognized ethical safeguards. It further concluded that the creation of human embryos with the explicit intention of using them only for research purposes should be supported under some circumstances. 6 President Clinton overruled the panel on the latter point, ordering that embryo creation for research not be funded, but he accepted the panel's other recommendations and permitted the NIH to consider applications for funding of research using embryos left over from IVF procedures. 7

Congress, however, did not endorse this course of action. In 1995, before any funding proposal had ever been approved by the NIH, Congress attached language to the 1996 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (the budget bill that funds DHHS and the NIH) prohibiting the use of any federal funds for research that destroys or seriously endangers human embryos, or creates them for research purposes.
This provision, known as the "Dickey Amendment" (after its original author, former Representative Jay Dickey of Arkansas), has been attached to the Health and Human Services appropriations bill each year since 1996. Everything about the subsequent debate over federal funding of embryonic stem cell research must be understood in the context of this legal restriction. The provision reads as follows:

None of the funds made available in this Act may be used for-
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204 and 46.207, and subsection 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). iii
(b) For purposes of this section, the term 'human embryo or embryos' includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. 8

This law effectively prohibits the use of federal funds to support any research that destroys human embryos or puts them at serious risk of destruction. It does not, however, prohibit the conduct of such research using private funding. Thus, it addresses itself not to what may or may not be lawfully done, but only to what may or may not be supported by taxpayer dollars. At the federal level, research that involves the destruction of embryos is neither prohibited nor supported and encouraged.

The Dickey Amendment was originally enacted before the isolation of human embryonic stem cells, first reported in 1998 by researchers at the University of Wisconsin, whose work was supported only by private funds (largely from the Geron Corporation and the University of Wisconsin Alumni Research Foundation). The discovery of these cells and their unique and potentially quite promising properties aroused great excitement both within and beyond the scientific community. It led some people to question the policy of withholding federal funds from human embryo research. Most Members of Congress, however, did not change their position, and the Dickey Amendment has been reenacted every year since. For many of its supporters, the amendment expresses their ethical conviction that nascent human life ought to be protected against exploitation and destruction for scientific research, however promising that research might be, and that at the very least such destruction should not be supported or encouraged by taxpayer dollars.

On its face, the Dickey Amendment would seem to close the question of federal funding of human embryonic stem cell research, since obtaining stem cells for such research relies upon the destruction of human embryos. But in 1999, the General Counsel of the Department of Health and Human Services argued that the wording of the law might permit an interpretation under which human embryonic stem cell research could be funded. If embryos were first destroyed by researchers supported by private funding, then subsequent research employing the derived embryonic stem cells, now propagated in tissue culture, might be considered eligible for federal funding. Although such research would presuppose and follow the prior destruction of human embryos, it would not itself involve that destruction. Thus, the Department's lawyers suggested, the legal requirement not to fund research "in which" embryos were destroyed would still technically be obeyed. 9

This has generally been taken to be a legally valid interpretation of the specific language of the statute, and indeed the subsequent policies of both the Clinton and Bush administrations have relied upon it in different ways. But some critics of the 1999 legal opinion argued that, though it might stay within the letter of the law, the proposed approach would contradict both the spirit of the law and the principle that underlies it. 10 It would use public funds to encourage and reward the destruction of human embryos by promising funding for research that immediately follows and results from that destruction-thereby offering a financial incentive to engage in such destruction in the future. By so doing, these critics argued, it would at least implicitly state, in the name of the American people, that research that destroys human embryos ought to be encouraged in the cause of medical advance. Supporters of the Clinton administration's proposed approach, however, argued that promoting such research-especially given its therapeutic potential-was indeed an appropriate government function, and that the policy proposed by DHHS was neither illegal nor improper, given the text of the statute and provided that the routine standards of research ethics (including informed consent and a prohibition on financial inducements) were met. 11

The Clinton administration adopted this course of action and drew up specific guidelines to enact it. iv But the guidelines, completed just before the end of the Clinton administration, never had a chance to be put into practice, and no funding was ever provided. Upon entering office in 2001, the Bush administration decided to take another look at the options regarding human embryonic stem cell research policy and therefore put the new regulations on hold, pending review.
In conducting its review, the Bush administration stated that it sought a way to allow some potentially valuable research to proceed while upholding the spirit (and not just the letter) of the Dickey Amendment, a spirit that the President himself has advocated. 12 The expressed hope was that the government, while continuing to withhold taxpayer support or encouragement for the destruction of human embryos, might find a way to draw some moral good from stem cell lines that had already been produced through such destruction-given that this deed, even if immoral, could not now be undone. This is the ethical-legal logic of the present stem cell funding policy: it seeks those benefits of embryonic stem cell research that might be attainable without encouraging or contributing to any future destruction of human embryos.


II. The Present Policy

The current policy on federal government funding of human embryonic stem cell research, then, must be understood in terms of the constraints of the Dickey Amendment and in terms of the logic of the moral and political aims that underlie that amendment.

At the time of the policy's announcement, a number of embryonic stem cell lines had already been derived and were in various stages of growth and characterization. The embryos from which they were derived had therefore already been destroyed and could no longer develop further. As President Bush put it, "the life and death decision had already been made." 13

The administration's policy made it possible to use taxpayer funding for research conducted on those preexisting lines, but it refused in advance to support research on any lines created after the date of the announcement. In addition, to be eligible for funding, those preexisting lines would have had to have been derived from excess embryos created solely for reproductive purposes, made available with the informed consent of the donors, and without any financial inducements to the donors-standard research-ethics conditions that had been attached to the previous administration's short-lived funding guidelines, as well as to earlier attempts to formulate rules for federal funding of human embryo research. The policy denies federal funding not only for research conducted on stem cell lines derived from embryos destroyed after August 9, 2001 (or that fail to meet the above criteria), but also (as the proposed Clinton-era policy would have) for the creation of any human embryos for research purposes and for the cloning of human embryos for any purpose. v

The moral, legal, and political grounds of this policy have been hotly contested from the moment of its announcement. Debates have continued regarding its aims, its character, its implementation, and its underlying principles, as well as the significance of federal funding in this area of research. For example, many scientists, physicians, and patient advocacy groups contend that the policy is too restrictive and thwarts the growth of a crucial area of research. On the other side, some opponents of embryo research believe the policy is too liberal and legitimates and rewards (after the fact) the destruction of nascent human life. Some ethicists argue that there is a moral imperative to remove all restrictions upon potentially life-saving research; other ethicists argue that there is a moral imperative to protect the lives of human beings in their earliest and most vulnerable stages. These and similar arguments are reviewed in the next chapter. But before one can enter into these debates, it is essential first to understand the relevant elements of the policy itself as clearly and distinctly as possible.

III. Moral Foundation of the Policy

In articulating its proposed funding policy in 1999 and 2000, the Clinton administration expressed a firm determination that funded research could use only those human embryos that had been left over from IVF procedures aimed at reproduction and that had been donated in accordance with the standards of informed consent and in circumstances free of financial inducements. Provided that these crucial conditions were met, the administration argued that the potential benefits of stem cell research were so great that publicly funded research should go forward. In August of 2000, reflecting on the guidelines put forward by his administration, President Clinton remarked,

Human embryo research [as approved for funding by the NIH guidelines] deals only with those embryos that were, in effect, collected for in-vitro fertilization that never will be used for that. So I think that the protections are there; the most rigorous scientific standards have been met. But if you just-just in the last couple of weeks we've had story after story after story of the potential of stem cell research to deal with these health challenges. And I think we cannot walk away from the potential to save lives and improve lives, to help people literally to get up and walk, to do all kinds of things we could never have imagined, as long as we meet rigorous ethical standards. 14

Given the promise of embryonic stem cell research, the existence of many embryos frozen in IVF clinics and unlikely ever to be transferred and brought to term, and the willingness of some IVF patients to donate such embryos for research, the Clinton administration reasoned that research using cell lines derived from these embryos could ethically be supported by federal funds. That position implies, of course, that the destruction of embryos is not inherently or necessarily unethical, or so disconcerting as to be denied any federal support. The Clinton-era NIH Embryo Research Panel put succinctly one form of this view in stating that "the preimplantation human embryo warrants serious moral consideration as a developing form of human life, but it does not have the same moral status as infants and children." 15 If there is sufficient promise or reason to support research, the claim of a human embryo to "serious moral consideration" (or, as others, including some of us, have put it, to "special respect" 16 ) could be outweighed by other moral aims or principles.

This (at least implicit) understanding of the moral status of human embryos might be seen to have put the Clinton administration at odds with the principle animating the operative law on this subject (the Dickey Amendment). But given its responsibility to carry out the laws as they are enacted, the administration sought a way to advance research within the limitations set by the statute. Its approach to the funding of embryonic stem cell research, therefore, seems to have sought an answer to this question: How can embryonic stem cell research, conducted in accordance with standards of informed consent and free donation, be maximally aided within the limits of the law? The NIH guidelines published in 2000 represent the answer the Clinton administration found: funding research on present and future embryonic stem cell lines, so long as the embryo destruction itself is done with private funds.

The Bush administration appears to have been motivated by a somewhat different question, arising from what seems to be a different view of the morality of research that destroys human embryos. President Bush put the matter this way, in discussing his newly announced policy in August of 2001:

Stem cell research is still at an early, uncertain stage, but the hope it offers is amazing: infinitely adaptable human cells to replace damaged or defective tissue and treat a wide variety of diseases. Yet the ethics of medicine are not infinitely adaptable. There is at least one bright line: We do not end some lives for the medical benefit of others. For me, this is a matter of conviction: a belief that life, including early life, is biologically human, genetically distinct and valuable. 17 vi

While expressing a desire to advance medical research, this argument describes a line that such research should not cross, and therefore past which funding should not be offered. That line, in this context, is the destruction of a human embryo for research purposes. The Bush administration thus appears to share the view that underlies both the word and spirit of the Dickey Amendment. In its approach to the stem cell issue it has sought to answer a question that differs, subtly but significantly, from that formulated by the previous administration: How can embryonic stem cell research, conducted in accordance with basic research ethics, be maximally aided within the bounds of the principle that nascent human life should not be destroyed for research?

In seeking to answer that question, the Bush administration (like the Clinton administration) had to take account of the existing situation and-as always in such instances-to mix prudential demands and opportunities with an effort at principled judgment. Given the existence of some human embryonic stem cell lines, derived from human embryos that had already been destroyed, the administration determined that it might not simply have to choose between funding research that relies on the ongoing destruction of embryos (and therefore tacitly supporting and encouraging such destruction by paying for the work that immediately follows it) and funding no human embryonic stem cell research at all. The decision regarding the funding of research on already-derived human embryonic stem cells came down to this question: Can the government support some human embryonic stem cell research without encouraging future embryo destruction?

The present funding policy is therefore not an attempt to answer the question of how the government might best advance embryonic stem cell research while conforming to the law on the subject. Rather, it is an attempt to answer the question of how the government might avoid encouraging the (presumptively) unethical act of embryo destruction and still advance the worthy cause of medical research. Whether or not one agrees with the premises defining the question, and whether or not one accepts the logic of the answer, any assessment of the policy must recognize this starting point.

From the very beginning, the policy has been described-even by many of its supporters and defenders-as occupying a kind of middle-ground position in the debate over the morality of embryo research. It has been termed a "Solomonic compromise." But while it may be a prudential compromise on the question of funding, it has been argued that the policy-as articulated by its authors-does not seem to be intended as a compromise on the question of the moral status of human embryos or the moral standing of the act of embryo destruction. In this sense, it appears to be not a political "splitting of the difference" but an effort at a principled solution. 18

To some extent, the effort reflects a traditional approach in moral philosophy to an ancient and vexing question: Can one benefit from the results of (what one believes to be) a past immoral act without becoming complicit in that act? vii The moralists' approach suggests that one may make use of such benefits if (and only if) three crucial conditions are met: (1) Non-cooperation: one does not cooperate or actively involve oneself in the commission of the act; (2) Non-abetting: one does nothing to abet or encourage the repetition of the act, for instance by providing incentives or rewards to those who would perform it in the future; and (3) Reaffirmation of the principle: in accepting the benefit, one re-enunciates and reaffirms the principle violated by the original deed in question.

As a plan for redeeming some good from embryo destruction that has already taken place, while not encouraging embryo destruction in the future, the administration's policy appears at least to seek to address each of these three conditions: (1) No federal funds have been or, by this policy, would be used in the destruction of human embryos for research. (2) By restricting research funding exclusively to embryonic stem cell lines derived before the policy went into effect, the policy deliberately refuses to offer present or future financial or other incentives to anyone who might subsequently destroy additional embryos for research; this is the moral logic behind a central feature of the policy, the cut-off date for funding eligibility (though some argue that by failing to call for an end to privately funded research the policy does not altogether avoid complicity). And (3) the President, in his speech of August 9, 2001, and since (as in the passage quoted above and elsewhere), has reaffirmed the moral principle that underlies his policy and the law on the subject: that nascent human life should not be destroyed for research, even if good might come of it. The policy as a whole draws attention to that principle by drawing a sharp line beyond which funding will not be made available.

Of course, since these terms from the parlance of moral philosophy were not those explicitly employed by the policy's authors, they can go only so far in helping us to understand the policy's foundation. As in any public policy decision, prudence is here mixed with principle, in the hope that the two might reinforce (rather than undermine) each other, and a variety of moral aims are brought together. The desire to afford some aid to a potentially promising field of research moderates what might otherwise have been an at least symbolically stauncher stance against embryo destruction: no public funding whatsoever, even for work on stem cell lines obtained from embryos destroyed in the past. Moreover, the desire to show regard for established principles and standards of ethical research leads to an insistence that, to be approved, stem cell lines must have been drawn from embryos produced for reproduction and obtained with consent and without financial inducements. In these ways, the policy gives some due to competing moral and prudential demands. But the policy's central feature-the announcement date separating eligible from ineligible stem cell lines-holds firm to the principle that public funds should not be used to encourage or support the destruction of embryos in the future .

It is perhaps worth pointing out that one's attitude regarding the best federal funding policy is not simply determined by one's view regarding the moral standing of human embryos, and that even persons who hold the same view of the moral standing of human embryos may not all agree on the best policy. For example, support for the current policy does not necessarily require a belief that human embryos are persons with full moral standing; and conversely, those who believe that human embryos are persons do not necessarily support the policy. One might believe, for instance, that an embryo is a mystery, not clearly "one of us" but unambiguously a life-in-process, and thus conclude that we should err on the side of restraint (non-destruction) when moral certainty is impossible. Or, one might believe that embryos are not simply persons but are nonetheless either worthy of protection from harm or at least worthy of more respect than ordinary human tissues or animals, and that it would be wrong to begin a massive public project of embryo research that offends the deeply-held beliefs of many citizens. Meanwhile, an individual who believes that human embryos have the same moral standing as children or adults may be deeply unsatisfied with the present policy, since merely denying federal encouragement for future embryo destruction while taking no action to prevent privately-funded stem cell research that destroys embryos may be an insufficient response to the ongoing destruction of nascent human life.

For some of its supporters, the policy goes as far as it seems possible to go within the bounds of the spirit and aims of the law-that the government should not encourage or support the destruction of nascent human life for research. Yet at the same time, it goes farther than the federal government has gone before in the direction of actually funding research involving human embryos, since no public funds had ever before been spent on such research. To go further-say, by funding research on the currently ineligible lines derived after August 9, 2001-would not extend the logic of the policy or of the law, but rather contradict them both: it would be a difference not of degree but of principle. By implying that research using embryos destroyed in the future might one day be supported with public funding, such a policy shift would at least implicitly encourage the very act (embryo destruction) that the current policy aims not to encourage. Of course, such a change might well be in order, but the case for it must address itself to the moral argument and its principles, and not only to the state of research and its progress or promise.

Rather than focus on this principled aspect of the policy, the public debate has tended to concentrate on the precise balance of benefits and harms resulting from the combination of the administration's policy and the state of the relevant science. It has focused on whether there are "enough" cell lines or on whether the science is advancing as quickly as it could. And it has proceeded as though the administration's aim was simply to maximize progress in embryonic stem cell research without transgressing the limits of the letter of the law.

Had the decision been based on that aim alone, then claims or evidence of slowed progress alone might, in themselves, constitute an effective argument against it on its own terms (on the ground that the law technically permits federal funding of research on cells derived from embryos whose destruction was underwritten by private funding). But if one accepts the premise that the decision was grounded also in a discernible (albeit highly controversial) moral aim, one cannot show that the policy is wrong merely by pointing to the potential benefits of stem cell research or the potential harm to science caused by restrictions in federal funding. The present policy aims to support stem cell research while insisting that federal funds not be used to support or encourage the future destruction of human embryos. To argue with that policy on its own terms, therefore, one would need to argue with its view of the significance of that aim. Concretely, this means arguing with its ethical position regarding the destruction of nascent human life and with its ethical-political position regarding the significance of government funding of a contested activity.

This latter point-regarding the meaning of government funding-is much neglected in the current debates and deserves further clarification. That will require delving into the important distinction between government permission (that is, an absence of prohibitions) of an activity and government support for an activity. This ethical-political distinction lies at the heart of the stem cell debate.


IV. The significance of Federal Funding

The national debate over human embryonic stem cell research often raises the most fundamental questions about the moral status of human embryos and the legitimacy of research that destroys such embryos. Yet, looking over this debate, it is easy to forget that the question at issue is not whether research using embryos should be allowed, but rather whether it should be financed with the federal taxpayer's dollars.

The difference between prohibiting embryo research and refraining from funding it has often been blurred by both sides to the debate. Ignored in the battles over embryo research itself, the ethical-political question regarding funding is rarely taken up in full.

That question arises because modern governments do more than legislate and enforce prohibitions and limits. In the age of the welfare state, the government, besides being an enforcer of laws and a keeper of order, is also a major provider of resources. Political questions today, therefore, reach beyond what ought and ought not be allowed. They include questions of what ought and ought not be encouraged, supported, and made possible by taxpayer funding. The decision to fund an activity is more than an offer of resources. It is also a declaration of official national support and endorsement, a positive assertion that the activity in question is deemed by the nation as a whole, through its government, to be good and worthy. When something is done with public funding, it is done, so to speak, in the name of the country, with its blessing and encouragement.

To offer such encouragement and support is therefore no small matter. The federal government is not required to provide such material support, even for activities protected by the Constitution, let alone for those permitted but not guaranteed. 19 The affording of most federal funding is entirely optional, and the choice to make such an offer is therefore laden with moral and political meaning, well beyond its material importance. In the age of government funding, the political system is sometimes called upon to decide not only the lowest standards of conduct, but also the highest standards of legitimacy and importance. When the nation decides an activity is worth its public money, it declares that the activity is valued, desired, and favored.

The United States has long held the scientific enterprise in such high regard. Since the middle of the twentieth century, the federal government, with the strong support of the American people, has funded scientific research to the tune of many hundreds of billions of dollars. The American taxpayer is by far the greatest benefactor of science in the world, and the American public greatly values the contributions of science to human knowledge, human health, and human happiness. And we Americans have overwhelmingly been boosters of medical science and medical progress, deeming them worthy of support for moral as well as material reasons.

But this enthusiasm for medical science is not without its limits. As already noted, we attach restrictions to federally funded research, for instance to protect human subjects. In fact at times we even use funding to place restrictions on research that might otherwise not be constrained. Indeed, federal funding sometimes serves as a means by which private research can be subjected to critical standards, since institutions that receive federal funds are often inclined (and given strong administrative incentives) to abide by the prescribed ethical standards throughout all of their activities, not only those directly receiving public dollars. Some supporters of funding therefore argue that extending public money to research is the most effective means of making certain that nearly all researchers, public and private, adhere to basic standards of ethics and safety. Public funding also requires researchers to make their work available to the public and for critical review by their peers, and it may encourage some degree of responsibility not necessarily encouraged by commercial endeavors. viii

In addition to conditions attached to government funding of research, law sometimes erects specific limits on certain practices that might be medically beneficial. For example, we put limits on some practices that might offer life-saving benefits, such as the buying and selling of organs for transplantation, currently prohibited under the National Organ Transplant Act. Also, as in the present case, many Americans and their congressional representatives have moral reasons for opposing certain lines of research or clinical practice, for example those that involve the exploitation and destruction of human fetuses and embryos.

The two sides of the embryo research debate tend to differ sharply on the fundamental moral significance of the activity in question. One side believes that what is involved is morally abhorrent in the extreme, while the other believes embryo research is noble or even morally obligatory and worthy of praise and support. It would be very difficult for the government to find a middle ground between these two positions, since the two sides differ not only on what should or should not be done, but also on the moral premises from which the activity should be approached.

To this point, the federal government has pursued a policy whereby it does not explicitly prohibit embryo research but also does not officially condone it, encourage it, or support it with public funds (though state governments have often taken more active roles in both directions, as detailed in Appendix E). This approach, again, combines prudential demands with moral concerns. It has allowed the political system to avoid banning embryo research against the wishes of those who believe it serves an important purpose, while not compelling those citizens who oppose it to fund it with their tax money. This approach is also based, at least in part, on the conviction that debates over the federal budget are not the place to take up the anguished question of the moral status of human embryos.

But the position is not only a compromise between those who would have the government bless and those who would have the government curse this activity. It is also a statement of a certain principle: namely, that public sanction makes a serious difference and ought not to be conferred lightly. While embryo destruction may be something that some Americans support and engage in, it is not something that America as a nation has officially supported or engaged in. ix

Of course, if the funding issue were merely a proxy for the larger dispute over the moral status of human embryos, then the present arrangement might appeal only to those who would protect human embryos, and it would succeed only as long as they were able to enact it. The argument might end there, with a vote-count on the question of the moral status or standing of human embryos. But some proponents of the present law suggest that the particulars and contours of the embryo research debate offer an additional rationale for that arrangement. Here again, it is important to remember that the issue in question is public funding, not permissibility. Opponents of embryo research have in most cases acquiesced (likely owing to various prudential and moral factors) in narrowing the debate at the federal level to the question of funding. They do not argue for a wholesale prohibition of embryo research by national legislation, even though many of them see such work as an abomination and even a form of homicide. In return, proponents of the Dickey Amendment argue that it would be appropriate for supporters of research to agree to do without federal funding in this particular field.

On the other hand, it might reasonably be argued that part of living under majority rule is living with the consequences of sometimes being in the minority. Were the Congress to overturn the current policy of withholding public funds from the destruction of embryos, opponents of funding for embryo research would not be alone in being compelled to pay for activities they abhor. We all see our government do things, in our name, with which we disagree. Some of these might even involve life and death questions of principle, for instance in waging wars that some citizens deeply oppose. The existence of strong moral opposition to some policy is not in itself a decisive argument against proceeding with that policy.

These concerns give the question of funding its own crucial ethical significance, even apart from the more fundamental question of the legitimacy and propriety of the act being funded. This matter of funding broadly understood, together with the moral and prudential aims apparently motivating the administration's policy, as well as the legal context created by the Dickey Amendment, are the essential prerequisites for thinking about the underlying logic of the current policy. The combination of these elements gives form not only to the specific rules set forth in the administration's funding policy, but also to the implementation of that policy, to which subject we now turn.


V. Implementation of the Present Policy

The complex and critical task of implementing the funding policy falls largely to the National Institutes of Health, which administers most federal funding of biomedical research. As noted, the administration's policy attempts to advance stem cell research within the bounds already laid out regarding further destruction of human embryos. Thus, while the funding criteria of the policy set the bounds, the NIH, in its ongoing work, is expected to advance the goal of maximally effective funding and support within those bounds.

To this end, the NIH has worked to "jump-start" this field of research through a series of coordinated activities. 20 To plan and oversee these activities, the NIH has established a Stem Cell Task Force charged with determining the best uses for public funds in the field and with putting in place the resources required to make effective use of those funds.

The most basic material resources in question are the human embryonic stem cell lines themselves. In August 2001, President Bush announced that "more than sixty genetically diverse stem cell lines" (or stem cell preparations) already existed, and so would be eligible for funding under his policy. 21 The NIH now believes the actual number to be somewhat higher, so that seventy-eight lines (or preparations) are known to be eligible for funding. x The lines are held by universities, companies, and other entities throughout the world. According to the National Institutes of Health's latest report (September 2003), the following organizations have developed stem cell derivations eligible for federal funding (that is, derived prior to August 9, 2001, under the approved conditions):

Name Number of Derivations

BresaGen, Inc. , Athens, Georgia

4

CyThera, Inc. , San Diego, California

9

ES Cell International , Melbourne, Australia

6

Geron Corporation , Menlo Park, California

7

Göteborg University , Göteborg, Sweden

19

Karolinska Institute , Stockholm, Sweden

6

Maria Biotech Co. Ltd . - Maria Infertility Hospital Medical Institute, Seoul, Korea

3

MizMedi Hospital - Seoul National University, Seoul, Korea

1

National Centre for Biological Sciences/ Tata Institute of Fundamental Research , Bangalore, India

3

Pochon CHA University , Seoul, Korea

2

Reliance Life Sciences , Mumbai, India

7

Technion University , Haifa, Israel

4

University of California , San Francisco, California

2

Wisconsin Alumni Research Foundation , Madison, Wisconsin

5

Although all of these lines (or preparations) are deemed eligible for funding according to the criteria of the administration's policy, not all are presently available for use by researchers (nor is it clear that all of them will ever be available for widespread use). Indeed, a point critical to understanding the current situation is that as of the autumn of 2003 only twelve lines are available for use, 22 while most of the other lines are not yet adequately characterized or developed (some exist only as frozen stocks) and so have at least not yet become available. xi The process of establishing a human embryonic stem cell line, turning the originally extracted cells into stable cultured populations suitable for distribution to researchers, involves an often lengthy process of growth, characterization, quality control and assurance, development, and distribution. In addition, the process of making lines available to federally funded researchers involves negotiating a contractual agreement (a "materials transfer agreement") with the companies or institutions owning the cell lines, establishing guidelines for payment, intellectual property rights over resulting techniques or treatments, and other essential legal assurances between the provider and the recipient.

The entire process-scientific and legal-has tended to take at least a year for each cell line. Thus, determining which of the 78 eligible lines are in sufficiently good condition, characterizing and developing those lines, and establishing the arrangements necessary to make them available has been a demanding task. By September of 2003, slightly over two years after the enactment of the funding policy, twelve of the eligible lines had become available to federally funded researchers. xi The NIH has made available "infrastructure award" funds (totaling just over $6 million to date) to a number of the institutions that possess eligible cell-lines, to enable them to more quickly and effectively develop more lines to distribution quality. As a result, while the number of available lines (only one in the summer of 2002 but risen to twelve in the autumn of 2003) xi is expected to continue to grow with time, it is unclear how many of the 78 lines will finally prove accessible and useful. According to the NIH, as of the autumn of 2003, the owners of the available lines have distributed over 300 shipments of lines to researchers. No information is presently available on the number of individual researchers or institutions that have received lines. 23

Successful implementation of the current funding policy depends not only on the availability of eligible lines, but also on adequate allocation of financial resources to develop and make use of those lines and to advance the field in general. The funding policy, though it limits the targets of funding to the eligible lines, does not directly delimit or restrict the amount of money and other resources that the NIH may invest in human embryonic stem cell research. The amount invested, a decision left to NIH and the Congressional appropriations process, is largely a function of the number of qualified applicants for funding and of the NIH's own priorities and funding decisions. Of course, if more lines were eligible for funding, it is quite possible that more funding would be allocated, but the amount that can be allocated to work on existing lines is not limited by the funding criteria. In fiscal year 2002, the NIH devoted approximately $10.7 million to human embryonic stem cell research. Based upon a September 2003 estimate, it will have spent approximately $17 million in fiscal year 2003. It is expected that further increases will follow as the field and the number of grant applications grow.

As of November 2003, NIH funds have been allocated to support the following new and continuing awards for human embryonic stem cell research: nine infrastructure awards to assist stem cell providers to expand, test, and perform quality assurance, and improve distribution of cell lines that comply with the administration's funding criteria (aimed at making more of the eligible lines available); 28 investigator-initiated awards for specific projects; 88 administrative supplements (awarded to scientists already receiving funds for work on other sorts of stem cells, either non-embryonic or non-human, to enable them to begin to work with eligible human embryonic stem cell lines); two pilot and feasibility awards; three awards to support exploratory human embryonic stem cell centers; one institutional development award; four post-doctoral training fellowships; one career enhancement award; and six awards to fund stem cell training (including short-term courses) to provide hands-on training to enable researchers to learn the skills and techniques of culturing human embryonic stem cells.

The latter task, of training new researchers, the NIH regards as one of its principal challenges in advancing the field, and, along with available lines and available financial resources, as a key measure of how the field is progressing. As NIH Director Elias A. Zerhouni put it in his presentation before this Council,

I don't think the limiting factor is the cell lines. I really don't. I really think the limiting factor is human capital and trained human capital that can quickly evaluate a wide range of research avenues in stem cells. 24

The NIH has therefore devoted funding to the training of investigators and the cultivation of career development pathways, including short-term courses in stem cell culture techniques and (long-term) career enhancement awards in the field. Some critics have contended, however, that the two issues (funding restrictions and the scarcity of personnel) are likely connected, and that limits on the cell lines eligible for funding and the surrounding political controversy cause some potential researchers to stay away from the field, contributing to a shortage of investigators. 25

These federal resources, then, have been directed toward the advancement of human embryonic stem cell research within the bounds of the determination to refrain from supporting or funding new destruction of human embryos. Scientists may receive federal funding-at any level determined appropriate by the NIH-for any sort of meritorious research, using as many of the approved lines as they are eventually able to use. They can, of course, also receive federal funding for using or deriving new animal embryonic stem cell lines, to assess the potential of these cells for treatment of animal models of human disease (though of course animal models provide only limited information because they are not in many cases exactly extrapolatable to the specific situations that hold in human disease and development, and so cannot replace human cell sources).

Researchers can, in addition, use federal funds for work involving human embryonic germ cells, obtained from aborted fetuses. They can carry out research projects using embryonic germ cell lines already derived, following review and approval of specific institutional assurances, informed consent documents, scientific protocol abstracts, and Institutional Review Board approvals by the NIH's Human Pluripotent Stem Cell Review Group (HPSCRG). They can also receive federal funds for the derivation and study of new embryonic germ cell lines following the same HPSCRG review and approval process. In addition, of course, they can develop animal embryonic germ cell lines to assess the potential of these cells through animal models.

Also, researchers can receive federal funds for work conducted on human adult (non-embryonic) stem cells. There are no restrictions regarding what American scientists can do with regard to adult stem cells using taxpayer funds, other than those requiring them to honor the usual human subject protections and clinical research requirements (if they are to be transplanted into human patients). The NIH has devoted substantial resources to the study of human adult stem cells, allocating over $170 million to the field in fiscal year 2002, and approximately $181.5 million in fiscal year 2003 (approximately ten times the amount devoted to human embryonic stem cell work).

Finally, researchers remain free to pursue work (including the derivation of new lines of embryonic stem cells) in the private sector, without government funding. Indeed, as discussed above, embryonic stem cells were first isolated and developed in the private sector, or in university laboratories using private sector funds, and no work in the field was publicly funded at all until 2001. Under present law, work supported by private funds can proceed without restriction. Under rules promulgated in the spring of 2002, such work does not need to be conducted in a separate laboratory, but a clear separation of the funds used to support this work from any federally funded work of the laboratory is required. Of course, because of the highly interlocking and complex nature of the various aspects of operating a laboratory, such separation can still prove extremely difficult to manage. It is not clear precisely how much privately funded work using human embryonic stem cells has been undertaken in the past few years, but some general figures are available. The most recent and thorough survey available, based on figures from 2002, 26 suggests that approximately 10 companies in the United States were actively engaged in embryonic stem cell work, employing several hundred researchers and, cumulatively over the past several years, spending over $70 million in the field, which is well over twice what the NIH has so far spent. 27 Those involved in privately-funded research in the field, however, generally do not see private funding as a substitute for federal funds, but would much prefer that the field had the opportunity to benefit from both. They also argue that restrictions on federal funds, and the controversy surrounding the subject, act to dissuade potential investors from entering the field, and thereby have a "chilling effect" on private as well as publicly funded research. 28

Moreover, just as federal policy can affect privately conducted research, so too a number of states have enacted policies affecting stem cell research, ranging from all-out prohibitions of such research to official statements of support and positive encouragement. xii The status of such research, and the conditions to which it is subject, can vary dramatically from state to state, independent of federal funding policy.


VI. Conclusion

The administration's policy on the funding of embryonic stem cell research rests on several moral and ethical-legal principles, set upon the reality of existing law:

1. The law: The Dickey Amendment, which the President is required to enforce.

2. The principle underlying the law: The conviction, voiced by the administration, a majority of the Congress, and some portion of the public, that federal taxpayer dollars should not be used to encourage the exploitation or destruction of nascent human life, even if scientific and medical benefits might come from such acts.

3. The principle underlying the desire to offer funding: That efforts to heal the sick and the injured are of great national importance and should be vigorously supported, provided that they respect important moral boundaries.

4. The significance of federal funding: That federal funding constitutes a meaningful positive statement of national approval and encouragement, which should be awarded only with care, particularly in cases where the activity in question arouses significant public moral opposition.

The significance of the policy is best understood in light of these key elements. Its soundness is most reasonably measured against them and against the policy's implementation by the National Institutes of Health.
Though the prudential and principled considerations raised in this chapter governed the formulation of the policy, or at least defined its articulation by its advocates and authors, these are not the only terms by which federal funding policy might be conceived or measured. In the next chapter we present an overview of the ethical and policy debates that have raged for the past two years around both the wisdom of the present policy and the fundamental issues at stake in human embryonic stem cell research.

_________________

Footnotes

i. Some Members of the Council oppose the current policy, some Members support it. Yet the descriptive account that we offer here aspires to be seen as accurate and fair, regardless of where one personally stands on the issue. Nearly all Members of this Council recognize, as we said in our report Human Cloning and Human Dignity , that "all parties to this debate have something vital to defend, something vital not only to themselves but also to their opponents in the debate, and indeed to all human beings. No human being and no human society can afford to be callous to the needs of suffering humanity, cavalier regarding the treatment of nascent human life, or indifferent to the social effects of adopting in these matters one course of action rather than another." ( Human Cloning and Human Dignity , p. 121.) Thus, whatever we think of the current funding policy, we recognize that this is a genuine ethical dilemma and that reasonable people of good will may come to different conclusions about where the best ethical or policy position lies. We therefore also believe that not only results but also reasons matter, and that it behooves us to understand the principled or prudential reasons for the current policy (as well as for any alternative policy that might be offered to replace it).

ii. In its discussion of "fetal" research, the commission defined the fetus as the product of conception from the time of implantation onward, which therefore included what we generally think of (and define in this report) as embryos in utero. Its separate consideration of embryo research was therefore directed at in vitro embryos.

iii. These legal citations refer to the federal regulations and federal statute relating to research on living human fetuses.

iv. These regulations, as published in the Federal Register, are provided in Appendix D.

v. The official NIH statement of this policy is provided in Appendix C.

vi. Using similar language, but speaking even more unambiguously, President Bush reiterated his ethical view of the destruction of human embryos for medical research in a speech on human cloning legislation, saying, "I believe all human cloning is wrong, and both forms of cloning ought to be banned, for the following reasons. First, anything other than a total ban on human cloning would be unethical. Research cloning would contradict the most fundamental principle of medical ethics, that no human life should be exploited or extinguished for the benefit of another. Yet a law permitting research cloning, while forbidding the birth of a cloned child, would require the destruction of nascent human life." ("Remarks by the President on Human Cloning Legislation," as made available by the White House Press Office, April 10, 2002.)

vii. Readers should note that in reporting on this approach, as applicable to President Bush's stem cell decision, the Council is not itself declaring its own views on whether the past act of embryo destruction was "immoral." (Some of us think it was, some of us think it wasn't.) We are rather describing what we understand to be the moral logic of the decision as put forward.

viii. Indeed, some even argue that the terms and conditions set for federal funding of research could be defined in such a way as not only to subject private research to general standards but also to help influence the eventual distribution of the products of that research to all those in need, or to serve other goods deemed publicly worthy.

ix. The repeated reenactment of the Dickey Amendment by the Congress may be taken as evidence of some support for this assertion.

x. These numbers took almost everyone by surprise. Prior to the President's announcement, the best estimates of the number of human embryonic stem cell lines then existing worldwide ranged between 10 and 20. But eligibility is not the same thing as availability, as we will discuss.

xi. By the time of final publication of this document, in January 2004, the number of available lines had risen to 15. This number is likely to rise further, and readers are advised to keep abreast of the current number and availability of embryonic stem cell lines eligible for funding at the NIH Stem Cell Registry website, stemcells.nih.gov.

xii. State policies regarding embryo research are detailed in Appendix E.

_________________

Endnotes

1. National Research Act, Pub. L. No. 93-348, § 213, 88 Stat. 342 (passed by the 93rd Congress as H.R. 7724, July 12, 1974).

2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research on the Fetus: Report and Recommendations (Washington, D.C.) 1975. Reprinted at 40 Fed. Reg. 33,526 (1975).

3. "HEW Support of Human In Vitro Fertilization and Embryo Transfer: Report of the Ethics Advisory Board," 44 Fed. Reg. 35,033 (June 18, 1979) at 35,055-35,058.

4. Ibid.

5. National Institutes of Health Revitalization Act of 1993, Pub. L. No. 103-43, § 121(c), 107 Stat. 122 (1993), repealing 45 C.F.R. § 46.204(d).

6. National Institutes of Health, Report of the Human Embryo Research Panel , Bethesda, MD: NIH (1994).

7. "Statement by the President," as made available by the White House Press Office, December 2, 1994.

8. The text of the Dickey Amendment can be found in each year's Labor/HHS Appropriations Bill. The original version, introduced by Representative Jay Dickey, is in § 128 of Balanced Budget Downpayment Act, I, Pub. L. No. 104-99, 110 Stat. 26 (1996). For subsequent fiscal years, the rider is found in Title V, General Provisions, of the Labor, HHS and Education Appropriations Acts in the following public laws: FY 1997, Pub. L. No. 104-208; FY 1998, Pub. L. No. 105-78; FY 1999, Pub. L. No. 105-277; FY 2000, Pub. L. No. 106-113; FY 2001, Pub. L. No. 106-554; and FY 2002, Pub. L. No. 107-116. The most current version (identical in substance to the rest) is in Consolidated Appropriations Resolution, 2003, Pub. L. No. 108-7, 117 Stat. 11 (2003).

9. "Rendering legal opinion regarding federal funding for research involving human pluripotent stem cells," Memo from Harriet S. Rabb, General Counsel of the Department of Health and Human Services to Harold Varmus, Director of the National Institutes of Health, January 15, 1999. (Available through the National Archives.)

10. This case was made, for instance, in a letter authored by Rep. Jay Dickey and signed by seventy other Members of Congress to DHHS Secretary Donna Shalala, February 11, 1999.

11. DHHS Secretary Shalala argued this point in a letter responding to the Congressional letter of opposition (see note 10, above), February 23, 1999.

12. President Bush has made a number of statements articulating the position that nascent human life (including at the early embryonic stage) is deserving of protection and ought not be violated. See especially: "Stem Cell Science and the Preservation of Life," The New York Times, August 12, 2001, p. D13; "Remarks by the President on Human Cloning Legislation," as made available by the White House Press Office, April 10, 2002; "Remarks by the President at the Dedication of the Pope John Paul II Cultural Center," as made available by the White House Press Office, March 22, 2001; and "President Speaks at 30th Annual March for Life on the Mall," as made available by the White House Press Office, January 22, 2003.

13. "Remarks by the President on Stem Cell Research," as made available by the White House Press Office, August 9, 2001.

14. "Remarks by the President upon Departure for New Jersey," as made available by the White House Press Office, August 23, 2000.

15. National Institutes of Health, Report of the Human Embryo Research Panel , Bethesda, MD: NIH, 1994.

16. See, for instance, the "Moral Case for Cloning-for-Biomedical-Research" presented by some Members of the Council in the Council's July 2002 report Human Cloning and Human Dignity : An Ethical Inquiry, chapter 6.

17. Bush, G.W., "Stem Cell Science and the Preservation of Life," The New York Times , August 12, 2001, p. D13.

18. See, for instance, Council discussion at its September 3, 2003, meeting. A transcript of that session is available on the Council's website at www.bioethics.gov

19. This question has been addressed by the Supreme Court on a number of occasions, in which the Court found that even activities protected as rights under the Constitution are not thereby inherently worthy of financial support from the federal government. See, for instance, Maher v. Roe 432 U.S. 464 (1977); Harris v. McRae 448 U.S. 297 (1980); and Rust v. Sullivan 500 U.S. 173 (1991). Also see Berkowitz, P. "The Meaning of Federal Funding," a paper commissioned by the Council and included in Appendix F of this report.

20. The information provided in this section relies primarily on a presentation delivered before the Council by NIH Director Elias Zerhouni on September 4, 2003, and on data otherwise made available by the National Institutes of Health. The full transcript of Director Zerhouni's presentation may be found on the Council's website at www.bioethics.gov.

21. "Remarks by the President on Stem Cell Research," as made available by the White House Press Office, August 9, 2001.

22. As of the autumn of 2003, the following providers have eligible lines available for distribution: BresaGen (2 available lines), ES Cell International, Australia (5 available lines), MizMedi Hospital, South Korea (1 available line), Technion University, Israel (2 available lines), University of California at San Francisco (1 available line), Wisconsin Alumni Research Foundation (1 available line). A complete list of available and eligible lines, updated as more lines become available, can be found at the NIH Stem Cell Registry website at stemcells.nih.gov.

23. This information has been made available to the Council by the National Institutes of Health.

24. Quoted from a presentation before the Council by NIH Director Elias Zerhouni, September 4, 2003. The full transcript of Director Zerhouni's presentation may be found on the Council's website at www.bioethics.gov.

25. See, for instance, the presentation of Thomas Okarma, President and CEO of Geron Corporation, before the Council on September 4, 2003. The full transcript of Okarma's presentation may be found on the Council's website at www.bioethics.gov.

26. Lysaght, M.J., and Hazlehurst, A.L., "Private Sector Development of Stem Cell Technology and Therapeutic Cloning," Tissue Engineering 9(3): 555-561 (2003).

27. The dollar amount spent specifically on embryonic stem cell research in the private sector is not apparent from Lysaght and Hazlehurst's survey. The $70 million figure is drawn from a presentation before the Council by Thomas Okarma, President and CEO of Geron Corporation, the oldest and largest of the private companies involved in embryonic stem cell research. Okarma told the Council, speaking only of Geron, "We have spent over $70 million on this technology, most of it since 1999 after the cells were derived. That's a number against which the NIH disbursements pale by both absolute and relative terms." The full transcript of Okarma's presentation may be found on the Council's website at www.bioethics.gov.

28. Ibid., and see also (for instance) Mitchell, S., "U.S. stem cell policy deters investors," The Washington Times , November 2, 2002 (original source: UPI).

 


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