The Legitimization of Fetal Tissue Transplantation Research Under Roe v. Wade

• Publication year: 2022
• Citation: Vol. 34

34 Creighton L. Rev. 895. THE LEGITIMIZATION OF FETAL TISSUE TRANSPLANTATION RESEARCH UNDER ROE v. WADE

Creighton Law Review

Vol. 34

JOSE L. GONZALEZ, M.D., ESQ.(fn+)

I. INTRODUCTION

Live, in-utero fetal research illustrates one of society's acceptable uses of human fetal tissue for therapeutic purposes.(fn1) Through inutero fetal research, the application of novel surgical techniques and procedures has allowed physicians to correct various prenatal fetal disorders once thought inevitably debilitating and potentially fatal.(fn2) By way of a benefits-to-risks balancing analysis, society has been willing to support the practice of live fetus research in-utero so long as it is for the welfare of the affected fetus.(fn3) Similarly, under implicit government consent, research on tissue from spontaneously aborted, dead fetuses in the 1950s was instrumental in the development of the polio and rubella vaccines.(fn4) Fetal tissue research can be categorized as research with fetal tissues to develop therapy (e.g., the development of the polio and rubella vaccines) and as transplantation research that uses fetal tissue as therapy. It is this latter use of fetal tissues for research purposes that is the focus of this paper.

Although willing to sanction consensual-by-proxy, therapeutic inutero intrusions into incompetent live fetuses, society has, in general, refused to extend its approval for similar, potentially therapeutic transplantation research procedures utilizing fetal tissues from elective abortions. Transplantation research using fetal tissue has the potential to cure or greatly improve the quality of life for thousands of patients suffering from a wide variety of presently incurable and potentially debilitating conditions.(fn5) Early transplantation studies withhuman fetal tissue have shown promising results in alleviating the symptoms of both Parkinson's disease(fn6) and insulin-deficient Diabetes Mellitus.(fn7) Another less studied area of potential benefit from transplanted fetal tissue research includes the various inherited immune deficiencies such as DiGeorge's Syndrome.(fn8)

Society has already decided that, despite the cause of death, the consensual use of human cadavers for organ transplantation, research and medical school dissection is not inherently disrespectful or unethical. Although the use of new fetal tissue transplantation research techniques and procedures may well be unethical if applied prior to adequate investigation through regulated research, the actual transplantation of tissue from dead human fetuses, by itself, should be no more problematic nor objectionable to public policy than dissecting cadavers or transplanting their organs.

Unfortunately, however, the recognized relationship between the transplantation of fetal tissue and elective abortions as the source for such tissue has repeatedly pre-empted society's, and subsequently Congress', acceptability of these potentially therapeutic medical research procedures. The perceived and feared magnitude of this association has effectively clouded any meaningful or productive debate on the per se benefits and risks of fetal tissue transplantation research.(fn9) In fact, the arguments against fetal tissue transplantation for any purpose, whether therapeutic, educational or research, have so far been limited to only an extended subset discussion on the highly volatile moral issues surrounding abortion rights.(fn10) As a result, the con-troversy over the morality and therefrom, the legality of fetal tissue transplantation research, has become politically tainted with a pervasive equivocation as to which ethical principles are relevant in determining the legitimacy of this unique treatment intervention. An earnest and focused debate on the ethical, legal and medical issues that arise in the arena of fetal tissue transplantation research thus poses both a challenge and an opportunity.

The fetus' potential for life has become a determinative issue whenever the ethical approach to transplantation research with dead fetuses is considered, even though the pregnancy's prerequisite termination makes it clear that such potential will never be fulfilled. Nonetheless, this morally based deterrent erroneously presumes that the option for fetal transplantation research will substantially influence a woman's prerequisite decision to abort. When contrasted with the similarly compelling ethical and legal interests encompassing the pregnant woman's decisional autonomy to abort, the physician's right to perform the research and the seriously ill third person's concerns in obtaining treatment for their otherwise incurable illnesses, a restrictive, abortion-centered viewpoint will undoubtedly culminate in serious collisional controversies.(fn11)

This article contends that ethical and legal, abortion-influenced concerns are unpersuasive and should not bar research with fetal tissue transplanted from aborted dead fetuses as possible therapy for individuals with serious, life-threatening illnesses. Through appropriate government regulations, a woman's decision to abort can be effectively separated from the subsequent process of consensual fetal donation and transplantation. Consequently, acknowledging that the Supreme Court has adjudged the woman's decision to abort to be constitutionally protected,(fn12) the lingering ethical queries encircling fetal tissue transplantation should not be whether abortion itself is morally acceptable, but rather, whether such research is justifiable because of its overwhelming curative potential. The only remaining question will then be not whether fetal transplantation research should be done and regulated, but how.

II. GOVERNMENT REGULATION

A. THE FEDERAL STATUTE AND LEGISLATIVE HISTORY

Even though fetal tissue transplantation had been ongoing in the private sector for many years, the legal controversy surrounding its regulation did not publicly first surface until October 1987, when the then director of the National Institutes of Health ("N.I.H."), James Wyngaarden, requested official approval from the Department of Health and Human Services ("HHS") to fund the use of fetal brain tissue in a research protocol that had already been sanctioned by the N.I.H.'s own review board.(fn13) The dread of arousing public controversy led the Assistant Secretary for HHS, Robert Windom, to deny the N.I.H. Director's request and, citing ethical concerns, issue instead a temporary moratorium on federal funding for fetal research involving tissue from induced, non-spontaneous abortions.(fn14) Windom further instructed the N.I.H. to convene an outside advisory committee of experts, known as the Human Fetal Tissue Transplantation Research Panel ("the Panel"), to study and report on the ethical, legal and scientific issues associated with fetal tissue transplantation research.(fn15) The Panel was principally charged with addressing ten questions concerning the alleged connection between elective abortions and the use of human fetal tissue in research.(fn16)

The Panel's completed report recommended not only the acceptance of the report and its recommendations, but also the lifting of the moratorium on federal funding of human fetal tissue transplantation research and the development of additional guidelines, as appropriate, to implement the advisory committee's conclusions.(fn17) Disregarding the Panel's contrary conclusions that the use of human fetal tissue for transplantation research was acceptable public policy, Windom chose to continue the moratorium indefinitely on the unconfirmed grounds that this type of research would increase the incidence of electively induced abortions. Windom's administrative declaration entirely ignored the Panel's recommendations that effective safeguards could be erected to ensure that abortions solely for research purposes would not occur.(fn18) In reality, however, even before this stirring public interchange within the Executive branch transpired, funding for fetal tissue research had already been clearly limited by Congress since 1974 through a series of provisions amended to the Public Health Services Act of 1944.(fn19)

The 1974 amendments to the 1944 Public Health Services Act statutorily established a National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research ("the Council").(fn20) Subsequent to the Council's recommendations, Congress embarked on a multi-session odyssey of investigational hearings, planning committee meetings and unsuccessfully proposed bills that after a prolonged and complex legislative process eventually culminated in the passing of the Health Research Extension Act of 1985 ("1985 Act").(fn21) Provisions within the 1985 Act outlined the limitations under which research on any non-viable, aborted fetuses, as well as on ex-utero living fetuses, for whom viability had not been ascertained could be conducted and federally funded.(fn22) Specifically, section 498(a) of the 1985 Act restricted fetal research and experimentation only to those projects which could enhance, without imposing added risks, the health quality of the involved fetus and whose purpose was to advance important biomedical knowledge not obtainable by other means.(fn23) Concurrent with these provisions, the 1985 Act also abolished the Secretary of HHS's independent authority to grant a waiver or modification of the above-listed statutory...