Journal of Advanced Nursing, 1993,18,1172-1177 The ethical use of fetal tissue for transplantation and research M Terese Verklan MSN RN C Doctoral Candidate, and Research Associate, Umoersify of Pennsylvania, 117 N 15th Street, p5O3, Philadelphia, Pennsylvania 19102, USA Accepted for pubbcahon 20 November 1992 VERKLAN M T (1993) ]oumal of Advanced Nursmg 1 8 , 1 1 7 2 - 1 1 7 7 The ethical use of fetal tissue for transplantation and research The exercise of organ and tissue transplantation is a conunon occurrence m our soaety Expectations of future advances in this arena are raising many ethical, moral and public-policy questions The scientific data base supporhng the usefulness of fetal tissue to repair or reverse disease is modest, and uses are speculative Should fetal tissue transplantation research proceed and, if so, under what conditions? This paper exarrunes the issues related to the use and proQorement of fetal tissue for research and transplantation A COMMON OCCURRENCE Dunng the last decade, high-technology medical/biosaence research and practice has made the exercise of organ and tissue transplantation a common occurrence m our tertiary health care centres As skill levels grow and the possibilities appear to have ever-fewer linuts, the expectations of future advances have raised many ethical, moral and public-pohcy questions The saentific data base supportmg the usefulness of fetal tissues to repair or reverse disease in humans or in animals is modest indeed and, for the vast majonty of the conditions in which its use has been proposed, still largely speculative (MacDonald 1990) For many, the question being raised is although we can do this, should we do this should fetal tissue transplantation research proceed and, if so, under what conditions (Walters 1988)? This paper will examme the issues related to the use and procuranent of fetal tissue for transplantation and research Phases of ethical concern Three phases of ethical concern relating to the use of fetal hssue for research can be delineated. The 6rst phase, lasting qjproximately from 1970 to 1978, can be charactaized as an era of response to liberalized abortion laws (Walters 1958) Concern revolved around the possibility that 1172 research may be performed upon intact previable fetuses, either m utero or ex utero post-abortion The second phase, approximately from 1978 to the early 1980s, focused upon the new techniques developed for prenatal diagnosis The third phase was signaled by the adoption, m October 1983, of a committee report on "Ethics m Medical Research Involving the Human Fetus and Human Fetal Tissue' by the Australian National Health and Medical Research Council (Walters 1988) The Australian report broke new ground m discussing the transplantation of human fetal tissue into already-born patients, the propagation of fetal cells m tissue culture, and recommending that fetal tissue be able to be used for these purposes, but only if harvested after the fetus had died and only with the pnor consent of the pregnant woman (Australia, National Health and Medical Research Council 1984) In 1984, the French National Ethics Committee discussed the use of 'tissues fi-om embryos or from dead human fetuses for therapeutic, diagnostic, or saentific ends' (Walters 1988) They specifically asserted that the use of fetal tissue be transplanted into those patients who had no other recourse through existing alternative treatments The Counal of Europe's Parliamentary Assembly, strongly influenced by the French report, adopted Recommendation 1046 m 1986, which devoted much attention to formulating rules for the therapeutic use of tissue from dead, externalized human fetuses (Courtal of Eurojw, Parliamentary Assembly 1986) Ethical use of fetal tissue The United States Congress became interested in fetal research in the early 1970s when it was reported that researchers, funded by monies from the National Institute of Health, were engaging in transplanting fetal tissue to aUeviate Parkinson's disease and diabetes The report, which appeared dunng the vigorous debate over abortion that preceded the Supreme Court's decision m Roe vs Wade (1973), aroused suffiaent public attention that both Houses of the US Congress enacted legislation on the subject and eventually established the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research Gonsen 1989) The Committee's first task was to investigate and study research involving the living fetus, and to recommend whether and under what circumstances such research should be conducted or supported by the Department of Health, Education and Welfare (1988) Four months later, the 'Report and Recommendations on Research on the Fetus' was completed The Department of Health and Human Services also mstituted a moratonum on therapeutic transplants of tissue from aborted fetuses pendmg the conclusions of a study of saentific, legal and ethical issues raised by such transplants (Helierstem 1988) Unresolved dilemma The dilemma continues to be heated and unresolved because it relates to human subjects It has always been difi&cult to distinguish between what is moral and what is considered immoral In traditional Catholic medical ethics, under the pnnaple of totality, the removal of an organ from a living person was spontaneously classified as 'mutilation of the body', smce physical hfe, and so the body itself, was seen as a gift entrusted to the human person by a loving Creator, no one would have the nght to jeopardize or mutilate the body without sufiEicient reason (Ulshafer 1988) Organ procurement was viewed as not being beneficial for the donor The introduction of a second moral pnnaple, that of love or Chnstian chanty, created an alternative viewpoint The issue of tissue donation should not only be viewed under the paradigm of mutilation but should also be seen as a taking of nsks m order to help another m need (Ulshafer 1988) EARLIEST MENTION OF RESEARCH ETHICS The earliest mention of research ethics is found m the wntings of a Roman physician Celsus commenting on the practice of vivisection of condemrwd criminals Gonsen 1989) It IS not cruel to mflict on a few cnminals sufferings which may benefit multitudes of lrmocent people throughout the ages' Obviously, pubhc sentiment is not aligned with this mode of thinking, as evidenced by the level of emotion preapitated by the Nuremberg trials of Nazi physicians Our sensibilities are not aroused by procedures utilizing cadaverous tissue, provided that respect for the dead is maintained Leonardo da Vma performed pioneer studies of the fetus by dissecting the cadavers of pregnant women and dead fetuses (Australia, National Health and Medical Research Counal 1984) We accept removal of tissue from a cadaver, either for pathological analysis, research or transplantation as authonzed by the Anatomical Cift Act Oonsen 1989) Similarly, the National Commission recommends that, 'Use of the dead fetus, fetal tissue and fetal matenal for research purposes should be permitted, consistent with local law, the Anatomical Gift Act and commonly held convictions about respect for the dead (1976) Clinically, the fetus is defined as a post-embryonic organism, from about 8 weeks' gestation to term, contained withm the body of a pregnant person (Pntchard et al 1985) There is no doubt that the product of human reproduction is not humcin, this is based on biology It is the term person that raises controversy Genetic distmctness can be delineated from the moment of conception, however, the moment that personhood exists continues to be debated Regardless of personhood status, another facet that needs to be addressed is the issue of whether the fetus IS alive or dead and, if alive, whether the fetus is viable or not Fetal death All major reports concerning the use of fetal tissue have generally agreed on the concept of death, although they may have different approaches m their defiruhons of fetal death The United Kingdom's Peel Committee bnefly deftned fetal death as the state in which the fetus shows none of the signs of life (UK, Department of Health and Soaal Secunty, Scottish Home and Health Department and Welsh Office 1972) The National Commission adopted death of the organism, rather than the death of all cells and tissues (US Department of Health, Education and Welfare 1976) Cessation of the heart beat is the usual sign of death mentioned by the Australian Committee, while the mterruption of the blood's arculation constitutes the cntenon of death according to the French Committee (Walters 1988) It IS noted that little consideration is actually devoted to the viability-^ionviability distinction Viability of the fetus is defined m Roe vs Wade (1973) as 'ability to survive ex utero, albeit with artifiaal aid' 1173 MT Verklan Those fetuses that are considered nonviable are alive but dying The probability of success m transplantation mcreases through use of tissue from a livmg fetus, and may be greater when the fetus is viable rathw than nonviable (Mahowald 1989) Thus far, social policy has excluded donation of vital organs or tissue from hve donors, even when death is imminent (US Department of Health and Human Services 1986) A departure from the longstanding precedent opposed to such retneval (even if requested by a dying donor), such as by usmg viable or even nonviable (hvmg) fetuses as transplant 'donors', could only be justified on grounds that the human fetus is not a person whose hfe should be supported until natural death occurs (Mahowald 1989) Another issue commonly raised with respect to utilizing hve fetus tissue, regardless of the status of 'person', is that of the possibility of fetal sentiency or capaaty to feel pam Although relatively little is known regardmg development of the nervous system and the capaaty for expenenang pam, research has demonstrated that human and animal neonates have the capaaty to feel pam It then becomes morally relevant to consider the possibibty that the younger fetus may also have this capaaty If retneval of tissue from livmg fetuses were ever permissible, it would be morally mcumbent on the 'retnevers' to conduct the procedure m a manner that avoided pam on the part of the fetus such as through the use of analgesics (Mahowald 1989) What of the research that may be directed toward a fetus that IS about to die? The fact that this fetus is about to be aborted seems to provide an opportunity for us to learn much about fetal physiology, the pharmacology of drugs, etc Gonsen 1989) Jonsen feels that moral judgement in these cases is not absolute and lies somewhere in the middle of the spectrum between vivisection and autopsy does the imminence of abortion make a morally relevant difference with respect to fetuses m utero, is it permissible for some fetuses to be subjects of research that would not be done on fetuses that eventually will be bom? The consensus statement of a panel of experts who addressed the issues in 1986, as weU as that of a National Institutes of Health (NIH) panel that considered it m 1988 to 1989, assumes that only tissue from dead fetuses shall be used for transplantation (Mahowald 1989) As mentioned above, a moratonum exists on the funding for fetal research USE OF HUMAN FETAL TISSUE The use of human fetal is not in itself objechonable Considered without regard to the cause of fetal death. 1174 tissue from a deceased human fetus is entitled to the same treatment and respect as that from a dead child or adult, neither more nor less (Greelye^ a/ 1989) Transplantation is govemed by the Uniform Anatomical Gift Act wbch, in the case of a fetus, provides that either parent may dorute the fetal remams as long as the other parent does not object (Uniform Anatomical Gift Act 1988) The only relevant difference between fetal tissue from a spontaneous abortion and tissue from the cadaver of an adult IS that the fetus was never m a position to choose whether its cadaver should be used (Greely et al 1989) The deceased's relatives are often approached regardmg organ donation. The fact that the deceased is a fetus that has been sjx)ntaneously aborted should not alter the ethical considerations behind that deasion Applying the legal and ethical constraints that govern the use of cadavers to the use of human fetal tissue affirms that fetuses have moral value, are at least a potential human life and should be treated with dignity (Uniform Anatomical Gift Act 1988) The means through which human fetal tissue becomes available is polemic Fetal tissue from spontaneous abortions may not be an optimum tissue source, owmg to the increase in abnormalities often noted The amount of viable tissue that is potentially recoverable is limited, as most of these abortions occur outside the hospital under poorly controllable situations Ectopic pregnanaes have been proposed as a fetal tissue source because of the type of surgical procedure performed and the lack of abnoimalities associated with the condition From an ethical pomt of view, surgical removal of an ectopic pregnancy is comparable to therapeutic abortion for maternal health, with the added caveat that the arcumstances are already fatal for the fetus (Mahowald 1989) Abortion Some who oppose the use of fetal tissue for research and transplantation do so because of compbaty m abortion the use of even dead fetal tissue for transplant as compliaty m and co-operation with moral evil, 'a morally unacceptable collaboration with the abortion mdustry' (National Conference of Catholic Bishops 1990) This position presumes the need for proxy consent for donating the aborted tissue, furthermore, it asserts that a woman who intentionally aborts a pregnancy forfeits her role m determining the fate of the aborted fetus and, therefore, cannot give proxy consent (Smith 1990) Even if one accepts the premise that abortion is a moral evil, it does not follow that use of fetal remams makes one morally responsible for or an acccnnplice to abortions that Ethical use of fetal tissue occur independently of the need to obtam tissue for transplant (Robertson 1990) The key eirhical issue is whether fetal remains from the 1 6 million abortions performed annually m the United States to end unwanted pregnanaes should be discarded or used for clirucal research or therapy when medically appropnate (Robertson 1990) From a simple utilitanan viewpoint, the potential good that may be acbeved through transplantation or research outweighs the harm that is possibly inflicted by an elective abortion One may argue that a truly pro-life position favours the affirmation of life that transplantation entails, while adcnowledgmg the negation of hfe that abortion implies (Mahowald 1989) A small proportion of opponents argue that sanctioned use of fetal tissue will lead to an mcrease in the amount of induced abortions If endorsement of the procedure leads to widespread increase in elective abortions, to a reduced sense of the v2Jue of humain life, and to exploitation of women, it is possible that such an array of undesirable consequences would outweigh the potential benefit of the techruque (Mahowald 1989) At this time the claim is viewed as too speculative and has been regarded by the NIH panel as highly unlikely (Consultants to the Advisory Committee to the Director of the NIH 1988) Justification Does the end justify the means? The intention is crucial to the moral relevance of the relationship (Mahowald 1989) If a link IS established between the therapeutic use of fetal tissue and matemal deasions to abort, the wider ethical support for fetal tissue transplantation would be narrowed (Smith 1990) The willingness of women to donate fetal hssue after abortion does not mean that successful fetal hssue transplants will lead to abortions that would not otherwise have occurred (Robertson 1990) As the pnmary incentive for obtaming an elective abortion is to terminate an unwanted pregnancy, it would simply be conjecture to presume that widespread practice conceming abortion would change Furthermore, the persuasive analogy between organ transplantation and fetal tissue transplant, founded on the understanding that the cause of death is irrelevant as long as the potential medial use of the available organs or tissue did not contnbute to the death, would be significantly weakened, if not destroyed (Smith 1990) Part of the NIH panel's supporhng rationale for fetal tissue transplantation is the fact that abortion is legal and that these aborhons woidd occur regardless of their use m researdi (Consultants to the Advisory Committee to the Director of the NIH 1988) The pahent or researcher utilizing the fetal tissue has not intended the abortion to occur In the UK, the transplantation of fetal tissue from mduced abortions has been permitted smce July 1989, based on the perceived separation of abortion and the use of fetal tissue (Dickson 1990) When the deasion to abort has already been made by others, a deasion not to trcinsplant seems less in keepmg with a pro-life position than its opposite (Mahowald 1989) Authorization Although the assumption is that the fetal tissue obtained for transplants and research will be obtained under legal practices, it remains unclear as to who may actually authorize this tissue for use The NIH panel concluded that matemal consent is suffiaent for the use of the hssue and is the most appropnate mode of transfer of fetal tissues, based on the congruency of our society's traditions, laws, poliaes and practices, includmg the Uniform Anatomical Gift Act jind concurrent federcJ research regulations (Consultants to the Advisory Committee to the Director of the NIH 1988) The 'Statement of Dissent' by Bopp & Burchaell rejected this position and maintamed matemal forfeiture of the proxy role (Smith 1990) This view disregards any contmumg interest the mother may have m the disposition of that fetus' tissue It also mistakenly assumes that a person who disposes of cadavenc remains acts as a guardian or proxy for the deceased, who has no mterests, rather than as a protector of their own interests in what happens to those remains (Robertson 1990) A third elective for obtammg fetal tissue would be to institute routine screerung and utilize all aborted fetuses unless there were explicit matemal objections A fourth ophon, which would preserve some of the intent of informed consent and significantly reduce any conflict of interest for parental deasions about donation, would accord authonty for donation to independent third parties, for example, medical examiners or coroners, while allowing either parent the nght of veto (Caplan 1987) ISSUE O F C O N S E N T Although the issue of consent is unresolved, guidelmes for the procurement of fetal tissue for transplantation and research have been formally delineated The caregiver or researcher interested m the fetal hssue is prohibited from undertaking any role that involves participation m the woman's deasion to abort or to donate the hssue Those involved in perfoimmg the aborhon procedure are also not allowed to benefit from the ensumg use of the fetal hssue 1175 MT Verklan Permission to donate the hssue can cmly be obtained after the woman has deaded to undergo an elechve aborhon These rules will ensure that tissue donation is not a prerequisite to havmg the aborhon performed, and they will prevent the prospect of donating fetal remains from tnfluencmg the deasion to abort, a clearly preferable pobcy when an adequate supply of fetal hssue is available from elechve family plannmg aborhons (Robertson 1990) Although not an expbat law, the woman should not benefitfromthe use of the fetal hssue This may encourage exploitahon of pregn2inaes, with the end result that women are paid to supply fetal hssue for research or transplantahon Federal regiilations currently prohibit federally funded research projects from offermg women 'inducements' to parhapate m fetal-hssue research (Greely et al 1989) The Nahonal Organ Transplant Act now makes payment of 'valuable considerahon' for the donahon or distnbuhon of specified fetal organs and 'any subparts thereof (which arguably mdudes tissue and ceUs) a federal crime (Robertson 1990) Although the Uniform Anatonucal Gift Act (1988) allows organ donation to specific persons for medical purposes, some feel the act should be amended to bar the designahon of a reapient of fetal hssue (Greely et al 1989) Tradihonally, relahves have been encouraged to donate an organ when a close family member is m need Simply because of that relahonship there may be a moral obligahon to do all that is possible to relieve the suffenng or save the life of that loved one There have been several mstances where a woman has conceived m order to supply hssue for a parent or an ofiFsprmg These situahoris mvolve conflicts related to consent, the donor benefitmg from the use of the fetal hssue, encouragmg an aborhon that would not have occurred, queshons of viabibty and personhood, etc Advocates of 'pro-choice' maintam that the woman has an absolute nght over her body, this may extend to her fetus as well The legal system has persistently msisted that organs and hssue be provided on a voluntary basis, even when the prospechve donor is a close relahve (US Department of Health and Human Services 1986) Potenhally, tbs could also be used to support the woman's desire to donate fetal hssue to a speafic reapient ETHICALLY PERMISSIBLE It may be presumed that the demand for fetal tissue will increase as the soenhfic/medical knowledge base escalates and the profiaency of related techniques spirals It appears that the use of fetal hssue for transplantahon purposes is etbcally permissible wlwn (Counal on Saentific Affairs 1176 and Counal on Ethical and Judiaal Affairs 1990) (a) the guidelmes of the Counal on Ethical and Judiaal Affairs on clinical mveshgation and organ transplantation are followed as they pertain to the recipient of the fetal tissue transplant, (b) fetal tissue is not provided in exchange for finanaal remunerahon above what is necessary to cover reasonable expenses, (c) the recipient of the tissue is not designated by the donor, (d) a final decision regardmg abortion is made before discussion of the transplantation use of fetal tissue is initiated, (e) deasions regarding the techruque used to mduce aborhon, as well as the timmg of the abortion m relation to the pregnant woman, (f) health care personnel involved m the termination of a parhcular pregnancy do not parhapate in or receive any benefit from the transplantation of hssue from the abortus of the same pregnancy, and (g) informed consent on behalf of both the donor and the recipient is obtamed m accordance with appbcabie laws Although surgery to obtain fetal hssue for transplantahon purposes is not presently being done, the bkebhood of this occumng m the near future is high Nurses need to be aware of the moral issues surrounding the procedure m order to examine their own moral conflicts and dilemmas It has been recommended that nurses providing abortion counsellmg should not ask pahents about fetal donation, and those with moral objechon to abortion should not be required to assist at the operahons to transfer fetal cells (Gero & Giordano 1990) Once the patient has made a deasion to abort the fetus and donate fetal hssue, the nurse still has an obligation to care for the woman The Intemahonal Code of Nursing Ethics emphasizes that nursmg service is 'unrestncted by considerations of nationality, race, creed, colour, age, sex, pobtics, or soaal status' and that 'the values, customs and spintual bebefs of the mdividual are to be respected' (Thompson & Thompson 1985) If the pahent has come to terms with fetal tissue transplcintation, the nurse cannot refuse to provide care because of personal disagreement with the treatment modality (Gero & Giordano 1990) CONCLUSION Although there is a pauaty of information supportmg the usefulness of human fetal tissue to repair damage in humans, transplantation of organs and hssue is one of the major contnbuhons of high-technology medicine, both today and in the future The ethical objechons appear insuffkient to contmue a moratonum on peer-reviewed research and clinical tnals of transplants The issue of 'what can be done with the fetal remams' needs to be completely separated from the abortion issue Because the aborh<Hi Bhtcal use offetal tissue and subsequent research use occur mdependently, views about the lmmorabty of aborhon do not necessarily detemune views of the morality of research with tissue from aborted fetuses (Robertson 1990) By adhenng to the guidelines for the ethical use of tissue, both the mother and the fetus will be protected from unnecessary nsks or harm Nurses must become aware of the ethical issues, and develop a firm resolution with respect to any moral dilemmas As guidelines continue to develop and pnshne issues evolve, nursing must play an active, educated role to ensure that ethical practices and patient nghts continue to be upheld References Australia, Nahonal Health and Medical Research Council, Medical Research Ethics Committee (1984) Ethics in medical research involving the human fetus and human fetal tissue Medical Journal of Australia 140,610-620 Caplan A (1987) Should foetuses or infants be utilized as organ donors? Bioethtcs 1,119-140 Consultants to the Advisory Committee to the Director of the National Institutes of Health (1988) Report of the Human Fetal Tissue Transplantation Research Panel National Institutes of Health, Washington, DC, December Council of Europe, Parliamentary Assembly (1986) Recommendahon 1046 (1986) on the use of human embryos and foetuses for diagnostic, therapeutic, saentific, mdustnal and commeraal purposes Adopted by the Assembly, ThirtyEighth Ordinary Session, Eighteenth Sithng, 24 September Council on Scientific AfiFairs and Council on Etbcal and Judiaal Affairs (1990) Medical applications of fetal hssue transplantation Journal of the Amencan Medical Association 263, 565-570 Dickson D (1990) Fetal tissue transplants win UK approval Science 245, 464-465 Gero E & Giordano J (1990) Etbcal considerahons m fetal tissue transplantahon Journal of Neurosaence Nursmg 2 2 , 9 - 1 2 Greely H T , Hamm T , Johnson R, Pnce C R., Weingarten R & Rafiin T (1989) The ethical use of human fetal hssue in medicine The New England Journal of Medicine 320, 1093-1096 Helierstem A W (1988) Fetal research and fetal-hssue research policy debate but no resolution FJ Public j^atrs 2,3041-3042 International Council of Nurses Code of Etbcs (1985) In Bwethical Decision Making for Nurses (Thompson JE & Thompson H O eds), Appleton-Century-Crofts, Norwalk, Cormechcut, pp 209-211 Jonsen A.R (1989) Transplantation of fetal tissue an ethicist's viewpoint Clinical Research, 215—219 MacDonald A S (1990) Foetal neuroendocnne hssue transplantation for Parhnson's disease an inshtutional review board faces the ethical dilemma Transplantation Proceedings 22, 1030-1032 Mahowald M B (1989) Neural fetal tissue transplantation Should we do what we can do? Neurologic Climes 7, 745-757 Nahonal Conference of Catholic Bishops (1990) Report of the Human Fetal Tissue Transplantation Research Panel vol II Appendix E 42 PntchardJ A , MacDonald P C &GantNF (eds) (1985) W/Wiams Obstetrics 17th edn Appleton-Century-Crofts, Norwalk, Cormechcut Public Law 93-348, 202b, Nahonal Research Act of 1974 Research on the Fetus, US Department of Health, Education and Welfare, publication no (5)76-127 (1976) Nahonal Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Robertson J A (1990) The ethical acceptability of fetal hssue transplants Transplantation Proceedings 22,1025—1027 Roe vs Wade, United States Supreme Court 410 US 113,93 S Ct 705 22 January 1973 Smith M L (1990) Ethics issues and fetal tissue transplantation Cleveland Clinic Journal of Medtane 57, 251-254 Ulshafer T R (1988) A catholic respective on religion and organ transplantation Delaware Medical Journal 60, 505-507 Uniform Anatomical Gift Act, 2 (b), 2 (c), Umform Laws Annotated 34, Revised UAGA 3 (a), (b), 8A ULA 9 (1988) In Uniform Laws Annotated West, St Paul United Kmgdom, Department of Health and Soaal Secunty, Scottish Home and Health Department and Welsh Ofi&ce (1972) The Use of Fetuses and Fetal Matenal for Research Report of the Advisory Group Her Majesty's Stationery Office, London United States Department of Health and Human Services (1986) Report of the Task Force on Organ Transplantation Public Health Service, Health Resources and Service Administration Walters L (1988) Ethical issues m fetal research a look back and a look forward Clinical Research, 209-214 1177