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A Proposed Stem Cell Research Policy
http://www.100md.com 《干细胞学杂志》
     Department of Microbiology and Molecular Genetics, Harvard Medical School, Boston, Massachusetts, USA

    Correspondence: Louis M. Guenin, Lecturer on Ethics, Department of Microbiology and Molecular Genetics, Harvard Medical School, 200 Longwood Avenue, Boston, Massachusetts 02115, USA. Telephone: 617-484-5591; Fax: 617-738-7664; e-mail: guenin@hms.harvard.edu

    ABSTRACT

    All who pin hopes on human embryonic stem cell (hESC) research would cheer if what Jean-Jacques Rousseau called "the general will" would spring forth, recognize the moral case for this research, and remove the shackles that bind it. Instead in the U.S., the vast federally funded biomedical research engine remains on the sidelines, ruled ineligible for action except as to a modicum of cell lines originated before an arbitrary date 4 years past. The first public funds for hESC derivation, so it appears, will flow from state coffers. There has mounted a groundswell of support—from the general public, from state legislators, and within the U.S. Congress—for expanding hESC research.

    If ever there were a topic on which a public policy would constitute, in Edmund Burke’s phrase, "morality enlarged," this is one. Yet as drafters of policies that would expand hESC research have respectively invoked one or another moral rationale, they have generally not taken on board the rationale most likely to ground a consensus across competing moral views. I contribute the following so that the case for hESC research may put its best foot forward.

    At the outset, it is easy to become confused about the prohibitions and permissions that form the status quo. The situation evokes something of Yogi Berra’s puzzlement upon asking, "If people don’t want to come to the ballpark, how are you going to stop them?" Apart from the effects of a burgeoning maze of state legislation, the federal regulatory situation is a tangle. By taking pains to sort that out, we shall arrive at conclusions not widely appreciated—that a Congressional enactment, not presidential policy, is the rate-limiting step of hESC research, that such enactment prohibits the research that not only the previous but also the current administration has undertaken to fund, that neither administration’s policy achieves any moral gain for the constraints imposed, and that the federal government has already effectively interdicted procreative cloning.

    The analysis that I offer will issue in a proposed policy possessed of two desirable features. First, the policy will optimize the scope of research. Second, the policy will manifest a moral justification that can ground a consensus. The first feature will avail progress, the second stability. What I shall propose will be a succinct policy suitable for adoption by any government, federal or state, that funds hESC research. One cannot predict when such a policy will gain a preponderance of support. But articulating the proposed policy will map the logical geography. This exercise will allow us to say, at any given policymaking moment, "These are the coordinates of our destination, and this is why it is right to head there." This exercise will also avail for the short run. It will bring to the fore a moral argument by which proponents of research may broaden support for incremental expansion when, as presently, a legislative opportunity arises.

    CONFLATION AND COMPLICITY

    As against a history of steering for a spurious legal loophole and an illusory moral harbor, we shall better fulfill our hopes for social harmony and scientific progress by insisting on open and direct policymaking. As public opinion changes, there will be no dearth of commentary about what political compromises might be struck. But we should first get clear about what a morally justified policy would say.

    The principal objections to use of embryos solely as means are, first, that to every embryo there corresponds a possible person, and, second, that we should classify every embryo as an actual person for purposes of the duty not to kill. If embryo use were always wrong on either ground, it would be wrong for government to support research of which embryo use forms an induced part. But, so I have argued , there exists a set of embryos whose use and consumption in medicine is permissible and virtuous. That set consists of embryos donated to medicine under instructions forbidding intrauterine transfer. The kernel of the argument for this conclusion is as follows. A woman from whose oocyte an embryo is formed in vitro is, with the coprogenitor, the only person in the world privileged to decide whether the embryo will be transferred to a uterus. No moral view of which I know holds that a woman lies under a duty to undergo such a transfer, or that she or the coprogenitor lie under a duty to surrender for adoption an embryo formed from her oocyte. A decision to decline intrauterine transfer is a morally permissible exercise of discretion. When there occurs such a declination, the consequent lack of uterine enablement so bounds the activated oocyte’s developmental potential that it cannot mature. Hence no possible person corresponds to an embryo barred from the womb. Nor could we gain anything, for that embryo or for any other being in the universe, by classifying the embryo as an actual person for purposes of the duty not to kill; we could only bring about that the embryo will die in vain. Embryos barred from the womb and donated to medicine present us with a means by which we might relieve suffering in actual lives at no cost in potential lives. The duty of mutual aid commands us to come to the rescue of our neighbors in peril when we can do so without unreasonable cost. Whereupon it is not only virtuous but obligatory to use donated embryos in the relief of human suffering.

    The foregoing argument uses no premise peculiar to any particular religious or moral view. It does not, for instance, assert that before day 40, a conceptus lacks a soul (as in Thomistic Catholicism) or is "mere water" (as in Judaism). The duty of mutual aid, the absence of a duty of intrauterine embryo transfer—these are common to all leading moral and religious views. The foregoing argument occupies a place in an overlapping consensus, albeit a place not yet widely recognized.

    On the basis of this argument, I propose the following rule of public policy applicable in any polity:

    The government shall support biomedical research using human embryos that, before or after formation, have been donated to medicine under donor instructions forbidding intrauterine transfer.

    The donor action referenced here is more than informed consent. In respect of donor action, voluntary informed consent without inducement (save for expense reimbursement) is necessary but is not, as assumed in recent proposals , sufficient. Embryo use is justified when there occurs a morally permissible exercise of discretion, by a woman and coprogenitor from whose cells the embryo has been or will be formed, to refuse intrauterine transfer and give the embryo to medicine. Such donors do not merely acquiesce, they choose. This accords with common sense. We do not say that Sue acquired a bicycle on her birthday because her parents provided informed consent that it be transferred to Sue. We say that they gave it to Sue.

    In our national debate, discussants have overlooked the justificatory importance of donor decisions. For their part, policymakers have become preoccupied with producing the longest possible lists of "strict ethical standards." Most of the entries on the lists either reiterate requirements that are already law (e.g., informed consent) or set forth procedures that most proponents of hESC research immediately find congenial. But for presumptive opponents, and those on the fence, the issue is not how, but whether. A convincing argument that research meets "ethical standards" must confront the main bone of contention, which remains embryo sacrifice. Therefore it behooves proponents to emphasize the event that justifies embryo sacrifice, a donor decision against intrauterine transfer conveyed by instructions to the donee. In recent legislation, neither this decision nor these instructions are mentioned.

    To excuse that oversight, it might be said that a parental decision against intrauterine transfer is inferable if we assume that parents know that some rule applicable to investigators prohibits intrauterine transfer. Instead of hoping for an inference, we can be explicit. The above proposed rule authorizes the use of a donated embryo if and only if the donor has decided and instructed against intrauterine transfer. This rule wears its justification on its sleeve. In public debate, this will show to its advantage. We need ancillary norms too, but the proposed rule is primary.

    The proposed rule authorizes not only stem cell but other humanitarian research. This includes studies by fertility clinicians who, challenged to produce one healthy baby without producing multiple births, seek to study embryogenesis. The rule does not allow procreative cloning. I have else where related a story that has been neglected by legislators welcoming an opportunity to vote. Since 1998, the Food and Drug Administration (FDA) has effectively interdicted procreative cloning, this because the practice would be manifestly unsafe. I have also related in detail, against anticipated objections, that the FDA possesses the authority to do what it has accomplished, and that the agency solidified its exercise of authority by a regulation effective January 21, 2004 . In consequence of FDA vigilance, there has not occurred a single reported attempt at procreative cloning in the U.S. On pain of criminal penalties for any attempt, the likely incidence is nil. As for procreative cloning when safe, we have heard speculations about the lives of clones, speculations betraying a heavy dose of genetic determinism. We have not reached a consensus that there obtains a compelling nonsafety ground for government intervention curtailing reproductive privacy. That will be a topic for another decade. For the indefinite future, the need for legislative action is a figment of legislative imagination. Legislation against cloning is at best redundant, at worst a platform for banning nuclear transfer in research.

    What does require legislative attention is DA. For Congress without self-contradiction to authorize NIH-funded use of hESCs, it must override, let lapse, or repeal DA. The proposed Stem Cell Research Enhancement Act of 2005, popularly known as "the Castle-DeGette bill," would override DA. Its provisions would govern "notwithstanding any other provision of law" . But it would override DA only to the extent of authorizing use of other-derived lines from surplus embryos (Fig. 1). In hitching itself to the use-derivation distinction originated by NIH, this legislation produces an effect presumably not intended by its sponsors, namely, it reinforces the belief that to derive stem cells from donated embryos is wrong. Consider then discussants who start from that belief. These discussants find reason to oppose the legislation inasmuch as a government that induces embryo destruction is complicit in the destruction. Although some people might be taken in by the illusion of a responsibility firewall between embryo destruction and the government, that illusion has not yet influenced enough people to boost support for the legislation to a veto-proof majority in the U.S. Congress. And for the long run, we cannot construct a stable consensus on an illusion. The opportunity remains to populate a broader and stable consensus. To those who hesitate to approve embryo use, we may offer an earlier mentioned twofold argument. First, no possible persons correspond to donated embryos barred from the womb. Second, no one can gain anything for such embryos, or for any other beings, by declining research. Research on hESCs is moral not because derivation and use are distinguishable, but because both are permissible in consequence of permissible donor decisions. This reasoning—not recitals of biological facts about embryos—meets head on any posit of actual or corresponding potential persons. It furnishes a cogent case for the Castle-DeGette bill and for other incremental steps toward the proposed rule.

    Figure 1. Authorizing publicly supported research involving human embryos. Abbreviations: DA, Dickey Amendment; hESC, human embryonic stem cell.

    To any legislator prepared to support use of other-derived hESCs, three further reasons may be given for overriding DA to the extent of the proposed rule. First, a legislator will want to get in step with the voters. Consider that a voter either approves of sacrificing donated embryos, or does not. A voter who approves of donated embryo sacrifice will assume that funded investigators sacrifice embryos. That voter has no reason to distinguish between self- and other-derived lines. That distinction, like that between deriving and using lines, is not heard in moral discourse. Nor does it appear in such state policies as California proposition 71. The distinction is wholly a bureaucratic invention, one that may be sent by the board with the DA prohibition that prompted it. DA itself, a mere appropriations rider, is unknown to most of the public. Meanwhile for a voter who disapproves of any embryo sacrifice, there is no solace in prohibiting only the use of self-derived hESC lines. To that voter, it will be apparent—either immediately, or as soon as the voter discovers that the imagined firewall is illusory—that inducing others to derive hESC lines brings in its train complicity in embryo destruction. Second, leaving in place a ban on embryo destruction while authorizing use of embryonic derivatives will hamper research. The third reason pertains to DA’s ban on creating embryos. As scientists use surplus embryos to derive cell lines, create embryos by nonprocreative cloning, and use clones to study reprogramming, to model diseases, and to perform autologous transplantation, the moral justification does not vary with the procedure. The argument given above for the proposed rule justifies all medical use of donated embryos, whether surplus embryos or embryos formed in research, on one and the same ground—donor exercise of discretion to decline intrauterine transfer . Nowhere does intent to initiate a pregnancy play a role in that argument. Hence the use of surplus embryos does not rest on morally higher ground than the creation of embryos in research.

    On the foregoing grounds it may be said that each of DA’s prohibitions frustrates fulfillment of our collective moral responsibilities as above conceived. This constitutes a compelling reason to retire both prohibitions. So long as they remain, it may be pertinent to adduce one institutional observation. The National Science Foundation and Department of Energy are funding sources to which DA has never applied.

    Under the proposed rule, not only will the publicly supported and the morally permissible coincide, the rule itself will manifest this. The rule defines eligible research by conditions that confer moral permissibility. As the rule optimizes the scope of research, it displays its justification. This avails for purposes of presenting the rule to our fellow citizens who do not yet approve of the humanitarian use of embryos barred from the womb. The more conspicuous we make our moral logic, the stronger the moral consensus that we may foster.

    REFERENCES

    Pub. L. 108–199, 510(a), 118 Stat. 3, 277 (2004), and verbatim predecessors since 1996.

    65 Fed. Reg. 51976 (August 25, 2000).

    Memorandum of General Counsel, Department of Health and Human Services, to Director, National Institutes of Health, January 15, 1999.

    66 Fed. Reg. 57107 (November 14, 2001).

    H.R. 4812, H.R. 4531, 108th Cong., 2d Sess. (2004).

    H.R. 10 (Rep. Castle et al.) and S. 471 (Sen. Specter et al.), 109th Cong., 1st Sess. (2005).

    Daley GQ. Missed opportunities in embryonic stem cell research. N Engl J Med 2004;351:627–628.

    Guenin LM. Wishful thinking will not obviate embryo use. Stem Cell Reviews (in press).

    Guenin LM. Morals and primordials. Science 2001;292:1659–1660.

    Guenin LM. The set of embryo subjects. Nature Biotech 2003;21:482–483.

    Guenin LM. Stem cells, cloning, and regulation. Mayo Clinic Proc 2005;80:241–250.(Louis M. Guenin)