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LEGAL ASPECTS OF FETAL TISSUE TRANSPLANTATION
Tim Ligget and Gen Nelson
Rationale: Fetal tissue transplantation is a new technology which could revolutionize the treatment of diabetes, Parkinson's disease and Alzheimer's disease. The controversies surrounding this technique involve ethical, legal and social and religious issues. Since this technology will inevitably affect all of our lives, it is imperative to introduce students to the concepts involved, and assist them in making responsible, carefully considered decisions about this procedure. Intended Audience: High School Biology students (9-12 grades) Objectives: In this unit, students will:
Materials: Case Study, Role Playing Scripts, Background Information, Selected Bibliography (provided in this unit). Optional: Additional reference material which students can use for further research. Procedure:
Evaluation: Student's arguments made during the role play may be evaluated based on their rational merit. Individual student's position papers may also be evaluated. Emphasis should be placed on the reasoning skills and decision making process used by the student rather than on the opinion itself. APPENDICES:
BACKGROUND INFORMATION In the past decade, research has opened the doors to fetal tissue transplantation, a procedure which could potentially provide therapy for victims of diabetes, Parkinson's disease and Alzheimer's disease. As in many areas of biotechnology, the development of this technique has outpaced the development of ethical policy. A national conference was held in Cleveland, Ohio in December, 1986, to examine the ethical and political ramifications of fetal tissue research. In March, 1988, the federal government (Department of Health and Human Services) imposed a moratorium on the use of fetal tissue in research. This effectively stopped all research on this subject in federally funded laboratories. Dr. James Wyngaarden, Director of the National Institutes of Health, appointed an advisory committee to consider the ethical issues involved. This committee was composed of 21 people, representing ethicists, lawyers, biomedical researchers, clinical physicians, public policy experts and religious leaders. Their report, published in December, 1988, expressed consensus in support of fetal tissue research but included dissenting opinions. Despite this support from the NIH committee, the government extended the moratorium indefinitely in 1990. This created a situation in which most states permit fetal tissue transplantation but the federal government denies funding for research in this area. In July, 1991, the United States House of Representatives voted to overturn the ban on federal funding, but this bill was not passed. A second effort in 1992 was passed by both the House and Senate, but President Bush is expected to veto this legislation, and it is not known if the bill has sufficient support for Congress to override the veto. The only current pieces of legislation that address this issue are the Uniform Anatomical Gift Act and the Organ Transplant Act. According to these laws, an organ donor (and presumably a pregnant woman) may NOT be paid for the tissue donated, the doctor determining death (performing the abortion) may NOT perform the transplant, and in the case of organ transplants from children, written consent of either parent must be obtained. The Uniform Anatomical Gift Act specifically permits the use of fetal tissue for transplantation, but eight states (Arizona, Arkansas, Illinois, Indiana, Louisiana, New Mexico, Ohio and Oklahoma) have enacted statutes that prohibit research with aborted fetuses. Missouri has enacted a law that prohibits the use of fetal tissue for transplantation if the physician knows that the woman requested the abortion to obtain fetal tissue for transplantation into herself or another. This statute does not apply to transplants using fetal tissue that was obtained from abortions performed for other (e.g. family planning) reasons, and it is noteworthy because it is the only existing statute that addresses the motivation for the abortion. The constitutional validity of this statute is still in question. The Oklahoma, Ohio, Louisiana, Indiana and Illinois laws prohibit experimenting upon the fetus, but a project involving transplantation of fetal cells into the brain of a person with Parkinson's disease would be an experiment on the recipient of the transplant (not the fetus) and therefore would not be illegal. The Arizona, New Mexico and Arkansas statutes are less stringent and prohibit transplantation in those states, but do not specifically prohibit the procurement of fetal tissue for experimental or transplant uses in other states. Again, the constitutionality of these statutes is still under scrutiny. A proposed amendment to the California Health and Safety Code introduced by Senator Torres included the following provisions: a woman may choose to donate the tissue after having an abortion, but she may not receive payment, valuables or services of any kind in return for donating this tissue, and she may not designate the recipient of the tissue. This bill also dictates that the physician performing the abortion may not be involved in distributing, studying or transplanting the tissue. To summarize, the proposed California amendment generally supported fetal tissue transplantation, but the bill was withdrawn after opposition from pro-life groups. Before discussing fetal tissue transplantation, it is necessary to define precisely the terms involved and distinguish the transplantation issue from other surrounding controversies. This case study focuses strictly on the therapeutic use of fetal tissue transplantation, and does NOT include other aspects of research on fetal tissue. Experiments have shown that transplants using tissue from spontaneous abortions are not as successful as transplants using tissue from induced abortions. With this in mind, the case study has been developed based on the assumption that transplantation will require tissue procured from induced abortions, and that tissue from spontaneous abortions will not be adequate. Finally, in order to focus on the legal issues surrounding fetal tissue transplantation, it is necessary to separate this procedure completely from abortion per se. Allowing the two subjects to overlap only clouds the issue, and for this reason we assume that, regardless of personal opinions, abortion is currently legal in the United States. Accepting a woman's right to terminate a pregnancy provides us with a starting point for a discussion of the fate of the fetal tissue following the abortion. The questions surrounding fetal tissue transplantation are numerous and varied. Both ethical and legal issues deserve consideration. The central questions will be framed in a general context here and more specific, probing questions will be provided in the context of the role play which follows. We do not attempt to provide answers to any of these questions; our aim is simply to put the issues on the table and stimulate rational discussion.
These and many other questions are currently under debate at all levels, from individuals to government policy. As previously stated, the federal moratorium freezes funding for research on fetal tissue transplantation, and this has effectively halted work on the development of this technique in laboratories that rely on federal funding. The direction which fetal tissue transplantation will take in the future is unknown. The presence or absence of federal funding for such research is certainly a vital consideration, and yet it seems likely that political considerations will continue to slow down the decision making process. Without a clear mandate from the federal government, states will be left to develop policy on their own, resulting in a wide variety of legislation which may or may not be constitutionally valid. It is imperative, then, to bring this issue to the minds of individuals, so that each citizen can consider the ethical implications for him/herself and develop a rational, defensible opinion on this potentially revolutionary form of therapy.
CASE STUDY Popeye and Olive Sailorman are a happily married couple with two children. Both enjoy a comfortable life style and a stable home life. Olive's elderly father is diagnosed as having Parkinson's disease. His symptoms are mild but his family is told by his physician that he will become more and more disabled with time. Close to the time that she learns about her father, Olive reads an article in the local newspaper about a research project being run at a local university. A team of researchers, led by Dr. Brutus, have applied to the federal and state governments for permission to do a study with Parkinson's victims. She visits with Dr. Brutus to learn more about the disease. During the course of their discussions, she finds out that Parkinson's can be reversed by implanting fetal brain cells in the brain of the patient. A month later Olive learns that she has become pregnant. As her father's condition begins to deteriorate, she and Popeye consider some therapeutic options for him. Recalling her discussions with Dr. Brutus, Olive and Popeye begin to discuss the option of using the fetal tissue to donate the cells to cure her father. Questions:
ROLE PLAYING SCRIPTS 1. Clergy This group is comprised of religious experts from several denominations. They are of the undivided opinion that fetal tissue transplantation is unacceptable due to the fact that an abortion is necessary to obtain the tissue. They object in the strongest terms to the possibility of the Sailormans use of the tissue. 2. American Civil Liberties Union Lawyer The ACLU is very active in protecting the civil rights of people. They are interested in this case due to its legal ramifications and the precedents that could be set. They are concerned with the rights of the Sailormans', the fetus and Olive's father. With this in mind, members of this group should determine whose rights are of paramount importance in this situation and develop their position based on that determination. 3. Review Board From The University Where Dr. Brutus Works The review board is interested in the possible role of the university as a pioneering research center. The experimentation is not often done and this would place the university on the cutting edge of this type of work. 4. Lawyers For The Sailormans The lawyers are at the meeting to voice the views of the Sailormans. The Sailormans have told their lawyers that they are very anxious to proceed with the abortion and transplantation even though there is a chance that the treatment might fail. 5. Dr. Brutus And Colleagues These doctors are experts in the use of the fetal tissue. Dr. Brutus has studied the procedure for several years, and practiced in Europe to refine his skills. This group feels confident that a fetal tissue transplant will improve Olive's father's condition. 6. American Association Of Retired Persons The AARP represents the interests of the elderly. They are here to advocate for all the elderly Americans who might receive some benefits from fetal tissue transplantation. Directions: Each group must develop a position on all the questions listed below the case study. For each question, the group should write down their response and support their opinion with AT LEAST THREE SPECIFIC reasons.
TEACHER PREPARATION NOTES
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