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Legal Aspects of Tissue Transplantation

By Genevieve Nelson



ABSTRACT

This lesson uses a role play format to discuss the bioethical issues involved with fetal tissue transplantation. Students first view two videotapes: Nova "The Case of the Frozen Addict" and a 60 Minutes segment entitled "Life, Death and Politics." The Nova videotape introduces a case in which fetal tissue transplantation was used to treat Parkinson's-like symptoms caused by synthetic heroin. The 60 minutes segment is about a Baptist minister and his wife who use fetal tissue transplantation to treat their child, who has Hurler's Syndrome. In the role play, students take the positions of various people and organizations and discuss the views of these groups on this procedure.

This unit was developed in collaboration with Tim Liggett, Haverford School, Haverford, PA and published in the Woodrow Wilson Institute 1992 Biology Module. Since then, the Clinton administration has lifted the ban on fetal tissue research. As a result, this type of transplantation is likely to become more prevalent in the future.


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 grade)

OBJECTIVES

In this unit, students will:
  1. investigate the current legal status of fetal tissue transplantation, including current legislation and court cases,

  2. engage in a role play discussion of a specific case study,

  3. explore the ethical controversies surrounding this procedure,

  4. formulate and defend an opinion about appropriate use of this technology.

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

  1. Students read Background Information and Case Study provided. Alternatively, this material could be presented by the teacher in a lecture format.

  2. Teams of students are assigned or choose roles.

  3. Students research their role and develop a group position on the appropriate use of fetal tissue transplantation. The depth of this research is dictated by the time available.

  4. Students engage in role play discussion focused on the Case Study. Teacher or another student should serve as moderator and facilitator. The moderator is responsible for keeping the discussion on track and under control.

  5. Following the role play, teacher "debriefs" students in an informal discussion of the issues brought up by the Case Study.

  6. Each student writes a paper in which they explain their personal opinion on the case study questions and support this opinion with specific reasons.

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

  • Legal Aspects of Fetal Tissue Transplantation Background Information Sheet
  • Case Study: Fetal Tissue Transplantation Module
  • Role Playing Scripts
  • Selected Bibliography
  • Teacher Preparation Notes

  • 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 out paced 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 (eg. 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 precisely define 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 completely separate this procedure 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.

    1. Since abortion is legal, does the woman's motivation for the abortion matter? Is it possible to distinguish between tissue from abortions that were performed for family planning reasons as opposed to tissue from abortions that were performed for the purpose of obtaining tissue for a transplant? Does it matter if the fetus was conceived so that tissue could be obtained? Is it possible or practical to develop policy and laws based on motivation? Can motivation be adequately and accurately assessed?

    2. Can a pregnant woman designate the recipient of tissue from her abortion? This ties into the question of motivation- if, for example, a family member has diabetes, can the woman indicate that the tissue from her abortion should be used to treat this family member?

    3. Can a woman be paid to donate tissue from an abortion? Would this create a "market" for fetal tissue? Would the possibility of payment induce women, who would otherwise carry the pregnancy to term, to abort?

    4. Must a woman make the decision to abort before she is informed of the possible uses of the fetal tissue? Would the possibility of some good (in the form of a therapeutic transplant) coming from the abortion reduce the guilt/grief felt by a woman contemplating abortion?

    5. Can the doctor performing the abortion be involved in the distribution, research and transplantation of the fetal tissue? If this separation is not mandated, would doctors have an incentive to counsel women to abort so the tissue could be used for transplantation?

    6. Would bans on fetal tissue transplantation be constitutional? Since abortion is legal, is there a rational basis for a ban on fetal tissue transplantation? Would a ban on transplantation interfere with a woman's right to abort? Would the fact that tissue could not be used for some good purpose place an undue burden on the woman's right to choose abortion? Would such a ban interfere with with recipient's right to obtain health care?

    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 with 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 the 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 fathers condition begins to deteriorate, she and Popeye consider some therapeutic options for her father. 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:

  • If Popeye and Olive decide to abort the fetus, should they be allowed to donate the fetal tissue for transplantation?

  • Should Popeye and Olive be allowed to designate Olive's father as recipient of the fetal tissue?

  • Should Dr. Brutus be allowed to pay Olive for donating the tissue?

  • Should Olive be allowed to have the abortion if her primary reason for wanting it is to provide a source of tissue for transplantation into her father?
  • ROLE PLAYING SCRIPTS

    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.

    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.

    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.

    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.

    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.

    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.

    STUDENT 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

    1. The case study, questions and role play provided are suggested scenarios. Feel free to write a different case study or develop additional questions or roles.

    2. This activity should take approximately one class period to introduce, another period or evening to allow the students to develop their positions, a third period to run the role play, and a fourth period to "debrief" and discuss the issues raised by the role play. The scripts are meant to be suggestions for the various positions. You are welcome to adapt the roles to your own circumstances.

    3. Students should be divided into groups of four or five. Each group is given an index card which describes their position. The information on these cards should not be shared between groups. Students should appoint one member of the group as the spokesperson, and another member as the recorder to write down the group's position and supporting reasons for each question. The discussion should be run in a town meeting format. The teacher should serve as moderator and facilitator for this discussion.

    4. The teacher is not the center of this lesson. Students should develop their own opinions and direct the discussion in ways that seem appropriate to them. Unless directly asked, teachers should not volunteer their personal opinions.

    5. After the group discussion, students should write (in class or as a homework assignment) a paper in which they explain their OWN opinion on the case study questions and support their opinion with specific reasons. The teacher may decide whether or not to grade these papers. If papers are graded, they must be graded on the reasoning and decision making skills demonstrated, NOT on the specific opinion expressed. If papers are not graded, teachers should make careful and detailed comments to provide students with feedback on their reasoning.

    6. "Debriefing" after the case study is essential. This discussion should encourage students to
  • think critically about their own opinion,
  • listen carefully to the opinions of others, and
  • realize that there is no single right answer to bioethical dilemmas, and that all potential answers depend on one's individual values.

  • SELECTED BIBLIOGRAPHY

    1. Biomedical Politics, 1991 Kathi Hanna ed., Washington, D.C.: National Academic Press.

    2. Colbern, "The Fetus: Medicine, Law and Mortality", WASHINGTON POST, Oct. 18, 1988 pp. 17.

    3. _________, "Live Fetus Research Debate", WASHINGTON POST, April,10, 1973 pp. 9.

    4. Council on Scientific Affairs and on Ethical and Judicial Affairs. 190 "Medical Applications of Fetal Tissue Transplantation." JAMA 263 (Jan. 26):565-570.

    5. Fine, "The Ethics of Fetal Tissue Transplants", Hastings Center Report 18 (June-July 1988):5-8.

    6. Hilts, "U.S. Aids See Shaky Legal Basis for Ban on Fetal Tissue Research", NEW YORK TIMES, Jan. 30, 1990.

    7. Kearney, D. Vawter, & K. Gervais, "Fetal Tissue Research and the Misread Compromise", Hastings Center Report, (September-October 1992):7-12.

    8. Lacayo, "Pro-Choice? Get Lost: Antiabortion Views Are A Must at Health and Human Services", Time, Dec. 4, 1989 pp. 43.

    9. Mahowald, J. Silver and R. Ratcheson, "The Ethical Opinions in Transplanting Fetal Tissue", Hastings Center Report 17 (Feb. 1987).

    10. Margaret S. v. Edwards, 597 F. Supp. 636(1984) aff'd 794 F. 2d 994 (5th Cir. 1986).

    11. Report of the Human Fetal Tissue Transplant Research Panel Bethesda, Md: Dept. of Health and Human Services, National Institutes of Health, (December 1988).

    12. Robertson, "Fetal Tissue Transplants (Symposium on Fetal Tissue Transplantation)" Washington University Law Quarterly Summer '88 v66 p.443-498.

    13. __________, "Rights, Symbolism, and Public Policy in Fetal Tissue Transplants" Hastings Center Report 18 (Dec. 1988):5-12.

    14. Roe v. Wade 410 U.S. 113 (1973).

    15. Saltus, "White House Left in Awarkward Spot on Fetal Research", BOSTON GLOBE, Sept. 22, 1988 pp. 24.

    16. Sarkos, "The Fetal Tissue Transplant Debate in the United States: Where is King Solomon When You Need Him", The Journal of Law & Politics vol 7 wntr. '91 p. 379-416.

    17. Terry, "Ethical & Legal Issues in Transplantation", Washington University Law Quarterly Summer '88 v66 p. 523-551.

    18. Uniform Anatomical Gift Act 1(2) 8A U.L.A. 30, 30 (1987). Waxman, H. a bill in the House of Representitives "Research Freedom Act of 1990." H.R. 5456, 101st Cong., 2d Sess., 136 Cong. Rec. H7168.


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