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Fetal tissue research and the misread compromise.

The recent passage of H.R. 2507(1) by the U.S. House of Representatives represents a significant political advance in attempts to restore federal funding to research into transplanting human fetal tissue. For the first time since the unilateral administrative moratorium on federal funding for such research in 1988(2) one house of Congress has garnered the votes to pass legislation that would overturn the ban. Part 2 of the bill, Research on Transplantation of Fetal Tissue, would restore funding and provide for ethical guidelines governing the procurement and use of fetal tissue. An important factor in the current political success of Part 2 of this bill is that it has explicitly adopted the recommendations of the NIH Panel on Human Fetal Tissue Transplantation Research, published in 1989.(3) The bill establishes the conclusions of the panel's consensus report as the ethical rationale and source of ethical guidelines for the use of human fetal tissue. The report, which concludes that funding such research is "acceptable public policy, " has been widely seen as a difficult-to-reach compromise that strategically insulates elective abortion from the use of human fetal tissue. The political persuasiveness of the report's recommendations doubtless is enhanced precisely because those recommendations were responses to questions posed by an administration openly inimical to elective abortion and the use of human fetal tissue for transplant. But the authors of Part 2 have also made a very important mistake.

Part 2 of H.R. 2507 contains three provisions, not included in the original NIH panel recommendations, requiring that women who would volunteer to donate fetal tissue for transplant research certify in writing that they did not intend to have an abortion just to donate fetal tissue. These provisions pose important problems for two reasons. First, if they become law, they will signal a new direction in public policy toward abortion and toward women's privacy. Second, in requiring women who donate fetal tissue to make such certifications, the authors of the bill have misread the NIH panel recommendations that give the bill its ethical authority in a way that is both damaging and unnecessary.

Their interpretation is made possible by an inherent ambiguity in the panel report, resulting from the particular strategy the panel adopted to reach its consensus. Unless the ambiguity is carefully resolved, it may be difficult to persuade either the senators who will consider the bill this fall or future authors of similar legislation that measures such as the certificates of ethical intent in H.R. 2507 are in fact unreasonable extensions of the NIH panel's recommendations. Certifications of Ethical Intent

If the ban on the use of federal funds is overturned and research resumes under the provisions of H.R. 2507, then once a woman has signed the consent form for an elective abortion, she may be approached and asked if she wants to donate the fetal remains for transplantation research. If she agrees, H.R. 2507 would then require several things. It would require that she sign a document consenting to the donation itself. This document will contain, among other things, a statement certifying she made the decision to donate "separately and independently" from her decision to have an abortion ([sections of]498A(b) (1)). The bill would also require her to sign another, separate statement, certifying that her decision to undergo the abortion "is not made in order to provide fetal tissue" for donation ([sections of]498A(b) (2)). Finally, the bill would require that the researchers (not the physicians) keep both of these signed documents on file and that they be available for "audit" by both federal and state officials ([sections of]498A(b) (3)). The legislation makes no provision for protecting the confidentiality of these statements, nor does it offer any explanation of whose property they become, thus distinguishing these documents from other medical records. No provision is made requiring that the woman be informed of what will happen to these signed statements, much less that they will be available for audit by public officials. Perhaps because to do so would reveal the inherent difficulties in justifying such an audit, the bill does not define proper and legitimate reasons for audit, qualifications for access, or penalties for violations, nor does it identify the persons upon whom such penalties would fall.

The woman may refuse to sign these documents. In most states, she will still be allowed to have an abortion. But in Michigan, Massachusetts, Missouri, Rhode Island, and North Dakota, state law may allow the abortion provider to interpret a woman's refusal as evidence she intended to abort in order to donate, and she could be refused the abortion.(4)

Thus by the time a woman who agrees to donate fetal tissue completes the consent process, she will have signed two statements certifying that her reasons for having an abortion were acceptable to the government. These statements will subsequently be transferred out of the doctor-patient relationship into a broader public sphere where possession is held by a research community with no traditional fiduciary relationship to patients and access is granted to a variety of government officials. Implications of Certifying Ethical Intent

There are several important and unpleasant implications of such a law, made all the worse because, as federal law, the provisions are not confined to the vagaries of enforcement by a particular state. First, these signed declarations of ethical intent would be a new and inventive incursion on the privacy of women seeking abortion. They would be a tangible, legal expansion of the state's interest in the reasons for aborting a fetus well beyond the limits of current law. At present, the government's interest in abortion is limited to matters of fetal development, viability, aid maternal medical needs, and even then the state may examine those relatively objective matters only late in pregnancy, in the third trimester. Never before has the state been held to have an interest in establishing that the motivations of women who seek abortion meet certain moral criteria. That the law would directly affect only women who agree to the donation of tissue does not diminish the importance of the precedent it would set. A legal requirement that ethical intent be documented and audited unmistakably and powerfully legitimates the claim that the state has an interest in the morality of motives for abortion.

The certificates of ethical intent imply a new and probably unanticipated change in public policy regarding elective abortion. The challenge has been to determine whether public policy could distinguish between good and bad reasons for abortion and make law that discriminated fairly between these. Until now the very limited scrutiny allowed by Roev. Wade has been the fundamental compromise between the extremes of no restrictions whatsoever and total prohibition of abortion. H.R. 2507 would alter that by implying that there are substantive criteria for determining good and bad reasons for abortion at any time during pregnancy and establishing in law a new policy that women seeking a legal, widely disseminated medical procedure that has not been generally declared unethical, in certain instances should have their individual motives for seeking the procedure examined.

Second, accompanied by neither debate nor objection, the law would redefine the privacy standards that govern medical practice. Signed documents pertaining to private medical matters would be moved out of the fiduciary relationship between doctor and patient, not on the basis of the woman's individual consent or her health needs, or to protect her interests, but rather because the government deems it proper for those involved in requesting and using the tissue to scrutinize her motives for ethical acceptability.

Third, the law would deploy the medical profession against the patient in a new way. just prior to a surgical procedure the profession's singular concentration on the welfare of the patient should find clear expression in the comfort provided to the patient. Though it is increasingly argued that physicians appropriately serve more than one master, for example, as gatekeepers of access to scarce resources, H.R. 2507 would bring a new dimension to the concept of dual loyalty. For women who agreed to donate fetal tissue, the profession would become the instrument by which the state examined their motives and exposed private decisions to public scrutiny. More than just the confidentiality of written, private medical documents is lost in this process; it is a fundamental expression of mistrust of the patient.

Medicine is most often an encounter between strangers. The profession's intent is that the encounter offer hope of a relationship, however brief, with a community genuinely concerned for a stranger's welfare, within a larger community where such concern is too often absent. Under certain circumstances it is appropriate and routine to examine the motives of patients who seek therapy, but this examination arises from concern for the health of the patient. Thus we wonder about the person who recurrently seeks narcotics, because the behavior may signal an addiction. We carefully examine the motives of living organ donors, or of those who want surgical gender changes, because it is important to know if the patient is psychologically well-suited for drastic and risky procedures, or has expectations and needs that in fact are either unrealistic or would not be served by the operation. Generally, however, when a patient seeks an accepted therapy, her motivations are not up for ethical appraisal.

Patients arrive from many points of the social and cultural compass, with motives derived from a deep, wideranging, and often mysterious pool of needs and experiences. Suspending ethical appraisal of these motives is appropriate, often welcome, often necessary, and can be a source of the special satisfaction that medicine brings to the practitioner. The profession deliberately limits its moral role to exclude the routine evaluation of motives so that patients will not be discouraged from seeking therapy. This allows medicine to perform its particular moral function of providing care more effectively, leaving assessment, persuasion, or punishment of motives to other spheres of social interaction. Nor does the profession normally countenance providing different standards of care for patients whose ethical backgrounds are known. Criminals, prisoners of war, political or personal enemies are all meant to be treated with the same respect and care as the upstanding citizen or friend. Yet H.R. 2507 would require physicians systematically to single out women who would donate fetal tissue after an elective abortion as exceptions, estranging them from the standard of practice that applies to all others. The Ambiguity of Separation Policies

Given the implications of these provisions for women and their physicians, it is important to ask what the justification and wider purpose of this law could be. It is incidental that these provisions appear to be unrealistic and impractical: devoid of any mechanism for ferreting out liars, they are necessarily no more than symbolic gestures written into federal law. What is more important is that these legal gestures imply it is both morally legitimate and practically necessary to scrutinize the motives for abortion of women who agree to donate fetal tissue.

The authors of H.R. 2507 probably did not intend to set new precedents for public policy on abortion, or to create further incursions on the privacy of patients. They were most likely only trying to improve the political viability of the bill by providing means above and beyond those of the NIH panel report for reassuring the public that the use of fetal tissue would not lead women to abort for the purposes of donation and that fetal tissue from such abortions would not be used in research. Yet the justification for the certification provisions arises from an important ambiguity in the panel report that was central to the strategy of compromise the panel chose.

The panel's approach to consensus reflected the difficult circumstances in which it was convened. Given an unusually narrow focus compared with other commissions, it was asked to respond to a short list of questions concerning the relevance of abortion to the use of tissue, shortly after the draft executive order banning all such research was leaked. The questions concerned only the relevance of elective abortion, to the exclusion of other issues important to the transplantation of fetal tissue. So dominant was the issue of abortion that members of the panel were chosen with an eye specifically to their personal beliefs regarding it.(5) The panel had an unusually short period of time to do its job-it was originally intended to accomplish its task in one three-day meeting, a process extended by two meetings. It was given its task by an administration opposing free access to elective abortion, at a time when abortion was becoming a dangerous single issue for politicians and irreconcilably polarized in public debate. And it was to arrive at recommendations that would somehow accommodate the views of opponents of abortion, advocates of the use of fetal tissue (which included an increasingly vocal constituency of those with illnesses potentially curable by fetal tissue), and advocates of freedom of choice and privacy in abortion.

The subsuming question put to the panel was whether elective abortion was morally relevant to the use of human fetal tissue. In its approach to this question, and to the questions that followed from this, the panel pursued its consensus by a three-step strategy of compromise. First, it elected not to discuss, debate, or even describe the varying views on abortion that are held in this country. In part, the panelists believed that it was not their charge to "settle the issue of abortion, or to weigh the worthiness of competing principled perspectives on abortion itself" (p. 1). Doubtless it seemed necessary to avoid a protracted and possibly irreconcilable debate, given time constraints. The result is that the report did not address or answer directly the question of what "moral relevance" means, or why abortion is normally relevant to the use of human fetal issue.(6)

In place of such a discussion, the panel simply acknowledged, without going any further, that elective abortion was morally relevant because it was a very contentious issue. Then, acknowledging that a minority of panel members held both abortion and the use of human fetal time to be immoral, the majority proposed two possible positions to which individuals in the majority could subscribe: either (1) elective abortion is moral and the use of fetal tissue is moral; or (2) abortion is immoral but its immorality can be "separated" from the use of human fetal tissue by appropriate policy. Either of these two positions would allow members of the majority to declare that the use of human fetal tissue was acceptable public policy" (pp. 1-2). The report did not disclose how many members of the panel held which view, and thus the panel avoided any overt endorsement of a particular view on the morality of abortion, while still allowing for a consensus on the acceptability of using human fetal tissue.

The second step the panel took was to make recommendations aimed at preventing the encouragement of abortion while acknowledging simultaneously that there was no empirical evidence to support the need for such a policy (p. 3). The central empirical claim of the report is that women might deliberately have abortions just to donate fetal tissue in response to "general altruism" (for the good of society as a whole), "specific altruism" (to aid a personal acquaintance), or in response to financial incentives,(7) even though the panel stated it "regarded it as highly unlikely that a woman would be encouraged to make this decision [to abort] because of the knowledge that the fetal remains might be used in research." The report acknowledged that there is no evidence, despite over thirty years of highly productive and lucrative use of human fetal tissue m research and therapy, that women voluntarily increase the number of abortions they have to donate fetal tissue, or that any mechanism for enticing them to do so has arisen. The report further stated that women are unlikely to abort for this purpose in the future. Nonetheless, the panel felt the possibility of such behavior was sufficient grounds for making policies to prevent women from doing so, in part as a means to "allay the moral controversy in our society about abortion" and reduce "the vulnerability of some pregnant women to exploitation and coercion."(8)

The third step was to make policies to ensure the separation between elective abortion and the use of human fetal tissue. The panel proposed several substantive recommendations aimed at achieving this separation: women may not be told (except in the most general terms if they specifically ask) about the possibility of donating fetal tissue until after they sign a consent for abortion, to avoid influencing their decision to abort if they are having doubts at that late stage (pp. 2-5); women may not designate a recipient for the tissue (p. 8); and women may not be paid for donation (pp. 9-10). In each case, the explicit reason given was to prevent "encouraging" abortion. Along with recommendations to preclude clinics' profiting from fetal tissue procurement and to prevent women and clinics from altering the timing and method of abortion, these are the guidelines the panel recommended to achieve the separation so important to the moral acceptability of the use of human fetal tissue.

This is the central problem. It is certainly true that the reader, particularly the legislator, cannot tell from the language of the NIH report what the panel believed about the morality of abortion, nor what it was claiming in principle about the moral problem of the connection between elective abortion and the use of human fetal tissue. The reader is aware only that the panel desires to prevent the use of human fetal tissue from "encouraging" abortion. But in the absence of any discussion that defines the moral framework and gives voice to the diversity of views, in the presence of policy recommendations felt to be so necessary that lack of any empirical evidence does not count against them, and given guidelines for separation that focus strongly on reducing the influences on the motives for abortion of women who would donate fetal tissue, a reader could not be criticized for drawing certain relatively clear conclusions. One could very reasonably believe that the panel functionally defined what it believed to be the central moral problem in the use of human fetal tissue: that women might be encouraged to have abortions when they otherwise would not, and that preventing women from being influenced in this direction is what it means to achieve the necessary "separation" of abortion from use of fetal tissue.

But this is an unnecessary and unfortunate interpretation. The approach to compromise that depends on the absence of philosophical discussion and empirical evidence is the source of a fundamental ambiguity, which cannot be resolved from reading the panel's report. The report in fact yields at least two interpretations.

The first is the one the House tacitly adopted, as reflected in the bill's provisions of certification. The other interpretation, more conservative and at the same time more constructive, is simply to recognize that, indeed, the panel said nothing at all about the moral status of abortion, or of motives for aborting fetal tissue, and that the silence was deliberate. Having agreed not to discuss either the principles or the evidence to avoid a protracted and possibly irreconcilable debate, the panel offered guidelines that still appear intuitively obvious and innocuous. Some may find the unsupported presumption that women would abort to donate for any of the proposed reasons to be objectionable, but the recommendations may still be seen as an acceptable compromise. In part, this is because some of the separation policies of the NIH panel can be justified independently of concerns for women's motives to abort. Payment for donation of tissues or organs in any situation is regarded as ethically very suspect and is currently forbidden.(9) Designating recipients is likewise generally held to be undesirable, for reasons of justice and fairness. Though the panel does not make this clear, one could agree upon policy guidelines identical to some of those it suggested with no reference at all to women's motives for abortion, and be glad the guidelines also appear to satisfy criteria of separation for those who require it.

But the authors of H.R. 2507 have developed laws that reflect the other, overexplicit reading of the NIH panel report. They begin with the panel's recommendations directed anonymously at all women who might donate fetal tissue, and decide that it is both legitimate and necessary to identify and discourage those particular individuals who would abort to donate. They have distilled this interpretation of the NIH panel's separation policies to its essence: since it is the motivations of women that threaten to offend, have them promise they did not offend. The Lessons of H.R. 2507

This extension of the separation guidelines of the NIH panel recommendations by the authors of H.R. 2507 is harmful to both the interests of women and the goal of encouraging research into fetal tissue transplantation. For supporters of fetal tissue research, the passage of a bill with these provisions may easily prove a pyrrhic victory, as many abortion providers will simply refuse to become involved in such a process and will not convey the request for donation. Researchers, who by law will be held responsible for keeping the statements available for audit, will likewise not wish to become involved in the acquisition and audit of private records that are rightly not their domain. The first public breach of confidentiality that results from the transfer of these documents or their audit by public officials (and such a breach will certainly occur) will sharply reduce the number of women who will even consider donation.

Other analysts have suggested that the particular strategy the NIH panel adopted to avoid a discussion of abortion and the principles that would morally connect it to the use of fetal tissue may pose potentially broader difficulties for the usefulness of their report. It has been suggested that this strategy failed to give voice to the rich diversity of views concerning the issues that underlie the use of such tissue, and did not consider the need to reevaluate traditional views in the light of the new challenges posed by such use. To help establish a broader ethical consensus for policy makers in the long nm, an advisory panel should not only reach consensus but also make explicit its reasons.(10)

However, as the certification provisions of H.R. 2507 demonstrate, the silence of the NIH panel may have its own power to persuade. These provisions are the first legislative fruits of the panel's policy-making process. Any federal law that would require written declarations of ethical intent on the part of women donating aborted fetal tissue, and that would transfer these declarations to the public sphere, is peculiar enough to merit significant concern. It is remarkable that these provisions have gone largely unnoticed. This is the second year legislation that includes these provisions has been proposed, without public comment. Recently a letter from the American Association of Medical Colleges (AAMC) went out over the signatures of representatives of more than thirty medical and health organizations urging passage of this bill, with no mention of these provisions or their implications. That federal legislation mandating such measures could generate so little discussion, and could pass out of committee without comment by legislators generally sympathetic to health care issues and the concept of privacy in the choice for abortion, suggests that many others besides the authors of H.R. 2507 have to some degree been persuaded that the motives of women who might abort to donate is a central moral difficulty in the use of human fetal tissue. They have lost sight of the potential implications for developing policy based on this unargued presumption.

Thus two suggestions seem appropriate. First and most obvious, these provisions should be deleted from the bill as it makes its way through the Senate, while leaving intact the legislation to restore funding to fetal tissue research. The lesson for the Senate, and for authors of future legislation designed to improve upon the separation policies of the NIH panel, is that they should not read more into the panel's recommendations than is warranted. Many may find the policy recommendations objectionable for lack of supporting argument or evidence, and for what they imply about women's motives for abortion. While in their current form at least some of these recommendations are a reasonable if uneasy compromise, to extend the perceived logic of the NIH panel's recommendations beyond what they have recommended, particularly in laws aimed at women's motives for aborting, substitutes error for ambiguity.

Second, as H.R. 2507 demonstrates, an important presumption has passed more or less silently from the milieu of ethical discussion into the realm of public policy. The contention that women would systematically and in significant numbers undertake elective abortion primarily to donate fetal tissue, either in response to market demands for such tissue or out of a sense of altruism, is a claim requiring, if not proof, at least a display of an argument. Scholars and also perhaps members of the panel ought to explain why policy makers and the public should give credence to this contention, and to the claim that abortion for the express purpose of donating human fetal tissue is a central ethical problem in using that tissue. In so doing, the presumption that policy must target the motives of women who agree to donate fetal tissue would get the explicit debate it richly deserves, and policy makers would be further alerted that this presumption is not yet, and may never be, a sound basis for law.

This work has been supported m part by grants from the General Services Foundation and the Minnesota Medical Foundation. References

1. National Institutes of Health Revitalization Amendments of 1991.

2. The order may well have been illegal. See R. P. Charrow, "Fetal Tissue Transplantation Ban: Illegal Political Solution to a Moral Problem, " Journal of NIH Research 3 April 1991): 20-24.

3. Report of the Human Fetal Tissue Transplantation Research Pane& vol. I Bethesda, Md.: Department of Health and Human Services, National Institutes of Health, December 1988).

4. Mass. Ann. Laws ch. 112 [sections of]12J (a) (III) (Law. Co-op. 1985); Mich. Comp. laws Ann. [sections of]333.2689 (West 1980); N.D. Cent. Code [sections of]14-02.2-02(2) (1981); R-I. Gen. Laws [sections of 1154-1 (e) (Supp. 1986).

5. James F Childress, Deliberations of the Human Fetal Tissue Transplantation Research Panel," in Biomedical Politics, ed. K E. Hanna (Washington, D.C.: Institute of Medicine; National Academy Press), 1991; Stephen E. Toulmin, 'The National Commission on Human Experimentation: Procedures and Outcomes," in Scientific Controversies: Case Studies in the Resolution and Closure of disputes in Science and Technology, ed. Tristram Engelhardt and Arthur Caplan (New York: Cambridge University Press, 1987); Dorothy E. Vawter et al., The Use of Human Fetal Tissue: Scientific, Ethical, and Policy Concerns (Minneapolis: University of Minnesota Center for Biomedical Ethics, January 1990).

6. P. A. King, Commentary on Childress, "Deliberations of the Human Fetal Tissue Transplantation Research Panel," in Biomedical Politics.

7. We have taken this classification of reasons for aborting to donate from Childress, "Deliberations," which clarifies the presentation of the panel's report.

8. Childress, "Deliberations, " p. 221.

9. Arthur Caplan, C. T. Van Buren, N. L. Tilney, "Rich Man, Poor Man, Beggar Man, Thief: All Should Be Organ and Tissue Donors Not Sellers," forthcoming.

10. King, Commentary on Childress, pp. 251-52. Warren Kearney is with the Center for Biomedical Ethids, University of Minnesota, Minneapolis, Minn. Dorothy E. Vauter is a research associate of the Center for Biomedical Ethics. Karen G. Gervais is with the Center for Biomedical Ethics and teaches philosophy at St. Olaf College. The bill to restore federal funding for human fetal tissue research has been passed by the House and awaits Senate approval. But it requires women who are willing to donate fetal tissue to certify that they did not have an abortion with the intent to donate. it further requires researchers to keep the certifications on file and available for government audit. Both requirements spell trouble. Never before has the state been held to have an interest in establishing that the motivations of women who seek abortion meet certain moral criteria ... Accompanied by neither debate nor objection, the law would redefine the privacy standards that govern medical practice. That federal legislation mandating such measures could generate so little discussion, and could pass out of committee without comment by legislators generally sympathetic to health care issues and the concept of privacy in the choice for abortion, suggests that many others besides the authors of H.R. 2507 have to some degree been persuaded that the motives of women who might abort to donate is a central moral difficulty in the use of human fetal tissue.

H.R. 2507

Research on Fetal Tissue


In general--In research carried out under subsection (a), human fetal tissue may be used only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that * the woman donates the fetal tissue for use in research ... * the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; * the woman has not been informed of the identity of any such individuals; and * in the case of tissue provided pursuant to an induced abortion, the decision to make the donation is made separately and independently of the decision to undergo the abortion.

Additional statement-... human fetal tissue obtained pursuant to an induced abortion may be used only if* in addition to and separate from the statement made pursuant to paragraph (1), the woman involved makes a statement, made in writing and signed by the woman, declaring that the decision of the woman to undergo the abortion is not made in order to provide fetal tissue for research purposes; and * the made before the abortion is performed.

Availability of statements for audit-... human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved provides assurances satisfactory to the Secretary that, with respect to any statement required ... to be made regarding the tissue to be used in the research, the statement is available for audit by the Secretary and other appropriate federal and state officials.

Informed consent of researcher and donee-In research carried out under subsection (a), human fetal tissue may be used only if* the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual* aware that the tissue is human fetal tissue and that the tissue may have been obtained pursuant to an induced abortion; * has provided such information to other individuals with responsibilities regarding the research; and * will provide such information to an individual before obtaining the consent of the individual to be a recipient of a transplantation of the tissue; and * the individual with such principal responsibility provides assurances satisfactory to the Secretary that the statement required ... is available for audit by the Secretary and other appropriate federal and state officials. Nullification of Moratorium

In general-Except as provided in subsection (c), no official of the executive branch may impose a policy that the Department of Health and Human Services is prohibited from conducting or supporting any research on the transplantation of human fetal tissue for therapeutic purposes. Such research shall be carried out in accordance with section 498A of the Public Health Service Act (as added by section 111 of this Act), without regard to any such policy that; may have been in effect prior to the date of the enactment of this Act.
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Title Annotation:includes excerpts from H.R. 2507; ethical aspects of the bill to restore federal funding to human fetal tissue research
Author:Kearney, Warren; Vawter, Dorothy E.; Gervais, Karen G.
Publication:The Hastings Center Report
Date:Sep 1, 1991
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