Louisell, David W.

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Volume 22 Issue 2 Article 5 1976 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus David W. Louisell Follow this and additional works at: https://digitalcommons.law.villanova.edu/vlr  Part of the Constitutional Law Commons, Medical Jurisprudence Commons, and the Science and Technology Law Commons Recommended Citation David W. Louisell, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus, 22 Vill. L. Rev. 315 (1976). Available at: https://digitalcommons.law.villanova.edu/vlr/vol22/iss2/5 This Symposia is brought to you for free and open access by Villanova University Charles Widger School of Law Digital Repository. It has been accepted for inclusion in Villanova Law Review by an authorized editor of Villanova University Charles Widger School of Law Digital Repository. FETAL RESEARCHNATIONAL COMMISSION FOR THE PROTECTION OFHUMAN SUBJECTS OF BIOMEDICAL ANDBEHAVIORAL RESEARCH: RESEARCHON THE FETUSDISSENTING STATEMENT OFCOMMISSIONER DAVID W. LOUISELLtI am compelled to disagree with the Commission's Recommenda-tions (and the reasoning and definitions on which they are based)insofar as they succumb to the error of sacrificing the interests of inno-cent human life to a postulated social need. I fear this is the inevitableresult of Recommendations (5) and (6). These would permit non-therapeutic research on the fetus in anticipation of abortion and duringthe abortion procedure, and on a living infant after abortion when theinfant is considered nonviable, even though such research is precludedby recognized norms governing human research in general. Althoughthe Commission uses adroit language to minimize the appearance ofviolating standard norms, no facile verbal formula can avoid the realitythat under these Recommendations the fetus and nonviable infant willbe subjected to nontherapeutic research from which other humans areprotected.I disagree with regret, not only because of the Commission'szealous efforts but also because there is significant good in its Reportespecially its showing that much of the research in this area is thera-peutic for the individuals involved, both born and unborn, and hence ofunquestioned morality when based on prudent medical judgment. TheReport also makes clear that some research, even though nontherapeutic,is merely observational or otherwise without significant risk to thesubject, and therefore is within standard human research norms and asunexceptional morally as it is useful scientifically.But the good in much of the Report cannot blind me to its departurefrom our society's most basic moral commitment: the essential equalityof all human beings. For me the lessons of history are too poignant,and those of this century too fresh, to ignore another violation of humanintegrity and autonomy by subjecting unconsenting human beings,whether or not viable, to harmful research even for laudable scientificpurposes.Admittedly, the Supreme Court's rationale in its abortion decisionsof 1973 - Roe v. Wade and Doe v. Bolton, 310 U.S. 113, 179 -t Elizabeth Josselyn Boalt Professor of Law, University of California, Berkeley.1976-1977]1Louisell: National Commission for the Protection of Human Subjects of BiomePublished by Villanova University Charles Widger School of Law Digital Repository, 1977VILLANOVA LAW. REVIEWhas given this Commission an all but impossible task. For many seein that rationale a total negation of fetal rights, absolutely so for thefirst two trimesters and substantially so for the third. The confusionis understandable, rooted as it is in the Court's invocation of the speci-ally constructed legal fiction of "potential" human life, its acceptanceof the notion that human life must be "meaningful" in order to bedeserving of legal protection, and its resuscitation of the concept ofpartial human personhood, .which had been thought dead in Americansociety since the demise of the.Dredd Scott decision. Little wonder thatintelligent people are asking: how can one who has no right to lifeitself have the lesser right of precluding experimentation on his or herperson ?It seems to me that there are at least two compelling answers tothe notion that Roe and Doe have placed fetal experimentation, andexperimentation on noviable infants,, altogether outside the establishedprotections for human, experimentation. First, while we must abidethe Court's mandate in.a particular case on the issues actually decidedeven though the decision is wrong and in fact only an exercise of "rawjudicial power" (White, J., dissenting in Roe and Doe), this does notmean we should extend an erroneous rationale to other situations. Tothe contrary, while seeking to have the wrong corrected by the Courtitself, or by the public, the citizen should resist its extension to othercontexts. As Abraham. Lincoln, discussing the Dredd.Scott decision,put it:"(T)he candid citizen must confess that if the policy of the govern-ment upon vital questions affecting the whole people is to be irre-vocably fixed by decisions of the Supreme Court, the instant thatthey are made, in ordinary litigation between parties in personalactions, the people 'will have ceased to be their own rulers, having,to that extent, practically resigned their government, into the handsof that eminent tribunal." (4 Basler, The Collected Works ofAbraham Lincoln, 262, 268 (1963).)Thus even if the Court had intended by its Roe 'and Doe rationale toexclude the unborn, and newly born. nonviable infants, from all legalprotection including that against harmful experimentation, I can seeno legal principle which would justify, let alone require, passive sub-mission to such a breach of our moral tradition and commitment.Secondly, the Court in Roe 'and Doe did not have before it, andpresumably did not intend to pass upon and did not in fact pass upon,the question of experimentation on the fetus or born infant. Certainlythat question was not directly involved in those cases. Granting thefullest intendment to those decisions possibly arguable, it seems to me[VOL.. 22: p. 2972Villanova Law Review, Vol. 22, Iss. 2 [1977], Art. 5https://digitalcommons.law.villanova.edu/vlr/vol22/iss2/5FETAL RESEARCHthat the woman's new-found constitutional right of privacy is fulfilledupon having the fetus aborted. If an infant survives the abortion, thereis hardly an additional right of privacy to then have him or her killedor harmed in any way, including harm by experimentation impermissibleunder standard norms. At least Roe and Doe should not be assumedto recognize such a right. And while the Court's unfortunate languagerespecting "potential" and "meaningful" life is thought by some toimply a total abandonment of in utero life for all legal purposes, at leastfor the first two trimesters, such a conclusion would so starkly confrontour social, legal, and moral traditions that I think we should notassume it. To the contrary we should assume that the language waslimited by the abortion context in which used and was not intended toeffect a departure from the limits on human experimentation universallyrecognized at least in principle.A shorthand way, developed during the Commission's delibera-tions, of stating the principle that would adhere to recognized humanexperimentation norms and that should be recommended in place ofRecommendation (5) is: No research should be permitted on a fetus-to-be-aborted that would not be permitted on one to go to term. Thisprinciple is essential if all of the unborn are to have the protection ofrecognized limits on human experimentation. Any lesser protectionviolates the automony and integrity of the fetus, and even a decisionto have an abortion cannot justify ignoring this fact. There is not onlythe practical problem of a possible change of mind by the pregnantwoman. For me, the chief vice of Recommendation (5) is that itpermits an escape hatch from human experimentation principles merelyby decision of a national ethical review body. No principled basis foran exception has been, nor in my judgment can be, formulated. Theargument that the fetus-to-be-aborted "will die anyway" proves toomuch. All of us "will die anyway." A woman's decision to have anabortion, however protected by Roe and Doe in the interests of herprivacy or freedom of her own body, does not change the nature orquality of fetal life.Recommendation (6) concerns what is now called the "nonviablefetus ex utero" but which up to now has been known by the law, and Ithink by society generally, as an infant, however premature. ThisRecommendation is unacceptable to me because, on approval of a na-tional review body, it makes certain infants up to five months gestationalage potential research material, provided the mother who has of courseconsented to the abortion, also consents to the experimentation and thefather has not objected. In my judgment all infants, however prematureor inevitable their death, are within the norms governing human experi-1976-1977]3Louisell: National Commission for the Protection of Human Subjects of BiomePublished by Villanova University Charles Widger School of Law Digital Repository, 1977VILLANOVA LAW REVIEWmentation generally. We do not subject the aged dying to unconsentedexperimentation, nor should we the youthful dying.Both Recommendations (5) and (6) have the additional vice ofgiving the researcher a vested interest in the actual effectuation of aparticular abortion, and society a vested interest in permissive abortionin general.I would, therefore, turn aside any approval, even in science's name,that would by euphemism or other verbal device, subject any unconsent-ing human being, born or unborn, to harmful research, even that in-tended to be good for society. Scientific purposes might be served bynontherapeutic research on retarded children, or brain dissection of theold who have ceased to lead "meaningful" lives, but such research isnot proposed - at least not yet. As George Bernard Shaw put it inThe Doctor's Dilemma: "No man is allowed to put his mother in thestove because he desires to know how long an adult woman will survivethe temperature of 500 degrees Fahrenheit, no matter how important orinteresting that particular addition to the store of human knowledgemay be." Is it the mere youth of the fetus that is thought to foreclosethe full protection of established human experimentation norms? Suchreasoning would imply that a child is less deserving of protection thanan adult. But reason, our tradition, and the U.N. Declaration of HumanRights all speak to the contrary, emphasizing the need of special pro-tection for the young.Even if I were to approach my task as a Commissioner from autilitarian viewpoint only, I would have to say that on the record hereI am not convinced that an adequate showing has been made of thenecessity for nontherapeutic fetal experimentation in the scientific orsocial interest. The Commission's reliance is on the Battelle Report andits reliance is misplaced. The relevant Congressional mandate was toconduct an investigation and study of the alternative means for achiev-ing the purposes of fetal research (P.L. 93-348, July 12, 1974, Sec.202 (b) ; National Research Act).As Commissioner Robert E. Cooke, M.D., who is sophisticated inresearch procedures, pointed out in his Critique of the Battelle Report:"The only true objective approach beyond question, since scientistsmake [the analysis of the necessity for nontherapeutic fetal research],is to collect information and analyze past research accomplishmentswith the intention of disproving, not proving the hypothesis that re-search utilizing the living human fetus nonbeneficially is necessary."The Battelle Report seems to me not in accord with the Congressionalintention in that it proceeds from -a viewpoint opposite to that quoted,and is really an effort to prove the indispensability of nontherapeutic318' [VOL. 22 : p. 2974Villanova Law Review, Vol. 22, Iss. 2 [1977], Art. 5https://digitalcommons.law.villanova.edu/vlr/vol22/iss2/5FETAL RESEARCHresearch. In any event, if that is its purpose, it fails to achieve it, formost of what it claims to have been necessary could be justified astherapeutic research or at least as noninvasive of the fetus (e.g., prob-ably amniocentesis). In view of the haste with which this statement mustbe prepared if it is to accompany the Commission's Report, rather thanenlarge upon these views now I refer both to the Cooke Critique andthe Battelle Report itself both of which I am informed will be a part ofor appended to the Commission's Report.An emotional plea was made at the Commission's hearings not toacknowledge limitations on experimentation that would inhibit thecourt-granted permissive abortion. However, until its last meeting, Ithink the Commission for the most part admirably resisted the tempta-tion to distort its purpose by pro-abortion advocacy. But at the lastmeeting, without prior preparation or discussion, it adopted Recom-mendation (12) promotive of research on abortion techniques. ThisI feel is not germane to our task, is imprudent and certainly was notadequately considered.Finally, I do not think that the Commission should urge liftingthe moratorium on fetal research as stated in Recommendation (16).To the extent that duration of the moratorium is controlled by Section213 of the National Research Act, the subject is beyond our controland we ought not assume authority that is not ours. This is matter notfor us and not, ultimately, for any administrative official, but for Con-gress. If the American people as a democratic society really intend towithdraw from the fetus and nonviable infant the protection of theestablished principles governing human experimentation, that action Ifeel should come from the Congress of the United States, in the absenceof a practical way to have a national vote. Assuming that any repre-sentative voice is adequate to bespeak so basic and drastic a change inthe public philosophy of the United States, it could only be the voiceof Congress. Of course there is no reason why the Secretary of DHEWcannot immediately make clear that no researcher need stand in fearof therapeutic research.As noted at the outset, the Commission's work has achieved somegood results in reducing the possibilities of manifest abuses and therebyaccording a measure of protection to humans at risk by reason of re-search. That it has not been more successful is in my judgment not dueso much to the Commission's failings as to the harsh and pervasivereality that American society is itself at risk - the risk of losing itsdedication "to the proposition that all men are created equal." We mayhave to learn once again that when the bell tolls for the lost rights ofany human being, even the politically weakest, it tolls for all.1976-1977]5Louisell: National Commission for the Protection of Human Subjects of BiomePublished by Villanova University Charles Widger School of Law Digital Repository, 1977

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus

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National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research on the Fetus

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