Modern trends Edward E. Wallach, M.D., Associate Editor

Transcription

1 Modern trends Edward E. Wallach, M.D., Associate Editor FERTILITY AND STERILITY Copyright <f') 1995 American Society for Reproductive Medicine Vol. 64, No, 5, November 1995 Printed on acid-free paper in U. S. A. Ethical and legal issues in human embryo donation* John A. Robertson, J,D,t School of Law, University of Texas at Austin, Austin, Texas Objective: To identify main ethical and legal issues that arise with donation of embryos left over from IVF treatments of infertility or created from separate gamete donations, Design: Analysis of ethical commentary, advisory committee reports, statutes, court cases, and legal commentary relating to gamete and embryo donation and assisted reproduction to assess their effect on donation of created or leftover embryos, Results: Donation of surplus embryos or embryos created from separate gamete donations would help a subset of infertile couples to form families, A program undertaking embryo donation will have to coordinate the donation of embryos from its own patients or other programs or arrange for separate gamete donations to form embryos. The main ethical issues concern the effect on offspring, consent and counseling of donors and recipients, avoidance of mixing embryos or gametes from different sources, and payment of donor expenses, The main legal issues concern whether embryo donation is viewed as gamete donation or adoption; the rearing rights and duties of donors and recipients in resulting offspring; liability; and compensation issues; and the legality of monetary compensation for donors. Donation of embryos for research raises separate issues. Conclusion: Human embryo donation is an ethically and legally acceptable way for infertile couples to form families, Fertil Steril 1995;64: Key Words: Embryo donation, embryo adoption, leftover embryos, spare embryos, created embryos, monetary compensation, commodification, liability, donor coordination, rearing rights and duties Donation of excess embryos from IVF treatment to infertile couples has long been possible, but until recently few IVF programs have offered this option. With thousands of frozen embryos potentially available for donation and a growing demand for less expensive infertility treatments, embryo donation is now likely to occur with greater frequency. Embryo donation, however, poses ethical, legal, and psychological issues that need attention before the practice becomes widespread. This article surveys those issues and identifies how an embryo donation program might best resolve them. Received March 13, * Supported in part by grant 1 R01 HG of the National Center for Human Genome Research, National Institutes of Health, Bethesda, Maryland, t Reprint requests: John A. Robertson, J.D., 727 East 26th Street, School of Law, University of Texas, Austin, Texas (FAX: ), VoL 64, No.5, November 1995 THE NEED FOR EMBRYO DONATION One example of the need for embryo donation is couples in which neither partner can produce healthy or viable gametes, but the woman has sufficient uterine capacity to undergo pregnancy and childbirth. To ascertain this status, tests to determine whether each member separately meets the criteria for sperm or oocyte donation should be performed, as well as tests to determine the woman's capacity to carry a pregnancy to term. If each partner separately meets the criteria for donor gametes, there are two ways to proceed. One way would be to obtain separate egg and sperm donations, with the donor sperm used to fertilize the donor eggs and the resulting embryos placed in the woman's uterus. In this case, the donor embryo would be an embryo created as the result of two separate gamete donations, most likely from two persons who are not known to each other. The cost Robertson Ethics, law and embryo donation 885

2 would be that of egg donation, with the additional cost of obtaining donor sperm. A second way to treat the couple's gametic insufficiency is to obtain embryos that had been produced by another couple in their own attempts at pregnancy through IVF, but that they no longer need or want. With thousands of IVF embryos currently in storage, an ample supply of embryos is potentially available for donation to couples with double gametic insufficiency. In that case, the embryo donation would come from a couple who produced the embryos in their own efforts to overcome infertility. The cost to the recipient couple would be the cost of recipient monitoring, embryo thawing, and embryo transfer-considerably less than the cost oftwo separate gamete donations or even the IVF treatment of the donor couple who served as the biologic source of the embryos being donated. A second example of demand for donor embryos are older single women whose eggs are no longer viable, lesbian couples for whom donor insemination has not worked, and couples who are candidates for IVF or egg donation but lack the means to pay for it. In the latter case, the importance of one or both parents having a genetic tie with the child they rear will be less important than having access to a procedure that enables them to gestate and raise a child. Couples with gestational capacity who would prefer postnatal adoption but lack the means to adopt, are given low priority by adoption agencies, or cannot otherwise find a suitable infant to adopt also could benefit from embryo donation. At present there are no figures on the number of persons in each category who are seeking embryo donation. However, some large IVF programs report one or two requests per week for donor embryos. If donor embryos were readily available and the practice were known more widely, it is likely that more couples and individuals would, because of the low expense of the procedure, seek embryo donation. As demand grows, embryo donation is likely to fill an important niche in the array of assisted reproductive techniques available to infertile couples. WILLINGNESS TO DONATE EMBRYOS Demand for embryo donations will to a large extent be a function of the supply of donor embryos. If many persons are willing to donate embryos, there is a greater likelihood that other infertile couples will seek this method of forming families. On the other hand, if few couples are willing to donate, embryo donation will playa very minor role in assisted reproduction. Of course the willingness to donate embryos will not be a factor for couples who obtain separate egg and sperm donations to produce embryos. 886 Robertson Ethics, law and embryo donation Will couples who have created embryos as part of their own IVF treatment be willing to donate excess or unwanted embryos to infertile couples? Will they donate to couples who cannot afford to undergo IVF or egg donation as well as to couples with double gametic insufficiency? The willingness to donate excess embryos will be a function of the creating couple's success or failure in meeting their own reproductive goals; their view of embryo status; their feelings about the possibility of having genetic offspring with whom they will have no contact; and their willingness to help other infertile couples. Although the weight and mix of these factors will vary with individual couples, a discussion of each factor will help illuminate the situations in which donation of excess embryos is or is not likely to occur. A key factor, of course, is whether the couple producing embryos has realized their own reproductive plans. A couple that has had the number of children they desire through IVF and has additional embryos is clearly in a position to donate, whereas a couple that has yet to achieve pregnancy and offspring is not. Until both members of a couple with frozen embryos are certain that they do not need all of their stored embryos, either because they have their desired number of children or have decided against further efforts at pregnancy, they are unlikely to donate embryos to infertile couples. Where couples have decided that their stored embryos are no longer needed for their own reproductive plans, their willingness to donate will be strongly influenced by their attitudes toward embryos. A couple that views embryos as having the status of persons is likely to prefer donation of excess embryos to an infertile couple over discard, longterm storage, or donation for research. Even if they do not hold the right-to-life view that embryos are already persons, they may still view their embryos as "new human life" and prefer that they be given the chance to live rather than be discarded or donated for research. In other cases, the emotional con~"' nection that some couples feel with their embryos may make them reluctant to donate them to others. A willingness to help other infertile couples also may be a factor in decisions to donate excess or unneeded embryos. Couples who themselves have struggled successfully with infertility and IVF undoubtedly feel great sympathy for couples less fortunate than they. This sympathy may incline them to donate, especially if they view embryos as persons or new human life that should be protected. Finally, a prime determinant of willingness to donate excess embryos will be the couple's fears and fantasies about the consequences of their act. If donation of their embryos is successful, they will have additional genetic offspring in the world. Many clin- Fertility and Sterility

3 ics, however, may be unwilling to inform the donating couple about the outcome of their donation, leaving them uncertain about whether they do have genetic offspring. For many people this situation would be too ambiguous and psychologically charged for them to tolerate, and they will choose not to donate. On the other hand, if they feel they can live with this uncertainty and accept that they may have children whom they will not know, they are more likely to donate. Some clinics offering embryo donation may be willing to inform the donating couple if a pregnancy and birth occurs. These clinics also may be willing to facilitate an "open" donation, in which all involved parties meet each other. Such situations may appeal to some donor and recipient couples because they do not have to live with the ambiguity or anonymity about the results of donation. However, they then would face complicated issues about how to manage or tolerate a relationship to genetic offspring that are less-or more-than they want. These uncertainties could deter some couples from donating unwanted embryos, even when successful donations are disclosed. COORDINATION AND SCREENING OF EMBRYO DONORS AND RECIPIENTS Given a demand for embryo donations and the willingness of some couples with excess embryos to donate them, questions of coordinating donors with recipients as well as screening embryo donors and recipients will arise. The simplest case would involve an IVF program that evaluates potential recipients and matches them with donor embryos from its own roster of patients. The program would inform its IVF patients of the option to donate unwanted embryos and then provide donated embryos to couples seeking embryo donation. A more complicated situation would arise if the evaluating program does not have donor embryos available. If donor eggs are available, the program might then coordinate separate gamete donations to create embryos. The program also might make arrangements with other programs or storage facilities to obtain unwanted frozen embryos for the recipient couple or, alternatively, refer the couple to another program to complete the donation. In the future, donor embryos might be shipped across state or even national lines for placement in the recipient at another location. Commercial embryo banks, akin to existing sperm banks, might develop to coordinate donation and placement of donor embryos. An important issue in any donor embryo program is the need for genetic and infectious disease screening of the donors to prevent transmission of disease Vol. 64, No.5, November 1995 to the recipient or offspring. If the embryo donation occurred by way of separate sperm and egg donation, the screening recommended separately for sperm and egg donors should occur. That screening would include a family history for each donor, known genetic diseases, and screening of egg and sperm donors for human immunodeficiency virus (HIV) and other infectious diseases. The American Society of Reproductive Medicine's (ASRM) guidelines for donor sperm require using frozen sperm that had been quarantined until the donor had been retested after 6 months for HIV (1). However, a second HIV test usually is not done on the egg donor because of the inability to freeze and quarantine donor eggs. With donor embryos that have been created as part of another couple's IVF treatment, the donor couple will have been screened initially for HIV and other conditions but not as extensively as sperm and egg donors. The most cautious donor embryo programs might require that persons wishing to donate excess embryos return for additional screening, including another HIV test, so that the screening will approximate that which occurs in separate sperm and egg donation. If couples are not willing to return for additional screening, the program might then choose not to use their embryos. Depending on the supply of donor embryos, however, some programs might proceed without a second HIV test, as in the case of ovum donation. In that case the recipient couple must be fully aware of and consent to the limited screening that has occurred. Whether the more cautious approach should set the standard of practice will depend on the attitudes of physicians and recipients toward risk and the effect of more intensive screening on the availability of donor embryos. Screening of potential recipients should follow the medical screening performed on candidates for egg donation, for example, assuring that the woman is fit medically to have an embryo placed in her uterus, and carried to term. Persons who view embryo donation as "embryo adoption" also might argue for social and psychological screening of the recipient couple akin to the social screening that adoption agencies perform in selecting adoptive parents. It is not clear, however, that social screening beyond that required of candidates for IVF or for gamete donation should be required. Although sometimes termed an "embryo adoption," the procedure of embryo donation is not equivalent to postnatal adoption of a born infant and therefore need not entail as rigorous social screening. If the recipient couple is otherwise acceptable for infertility treatment, requiring them to pass parental fitness tests that are not required of other infertility patients would appear to be discriminatory. Robertson Ethics, law and embryo donation 887

4 SUCCESS RATE The success rate of embryo donation will depend primarily on the viability of donated embryos. If donated embryos are created from separate egg and sperm donations, the success rate should approach that of egg donation, which is higher than basic IVF because most donor eggs come from younger healthier women. Success rates in the 30% range for deliveries of children per retrieval cycle reasonably might be expected with embryos freshly created from separate sperm and egg donations (2). The success rate for donations of excess or unwanted embryos, however, is likely to be considerably less. Excess embryos-those not previously chosen for transfer-may be of poorer quality. They may have been frozen for long periods and could be damaged in the freezing and thawing process. They also may be from older women whose eggs are generally of poorer quality than younger women. No doubt screening and grading protocols for donor embryos will develop. The rigor of those tests could affect the availability of suitable embryos, the frequency ofthe practice, and its success rate. Even with a success rate approximating that of basic IVF (16% ofivf retrievals in the United States yield offspring), embryo donation will be advantageous for couples likely to seek it, for their chances of pregnancy and childbirth with donor embryos are better than other alternatives (2). In addition, embryo donation for recipients is medically less risky than IVF because it does not involve ovarian hyperstimulation or egg retrieval. It also costs considerably less. These advantages are likely to appeal to many couples who could benefit from embryo donation. ETHICAL ISSUES The placing of embryos created with the egg and sperm of two individuals in the uterus of a third person, who then carries the embryo to term and rears it with her partner, is a novel reproductive arrangement that raises several ethical issues. Although none of these issues poses a major ethical barrier to embryo donation, they do show the need for care and attention to donor, recipient, and offspring needs at every step of the way. Is Embryo Donation Ethical? The ethical status of embryo donation depends upon one's assessment of assisted reproduction generally and the effects of this particular form of assisted reproduction on affected parties. There is a consensus in most of the world that IVF is an ethically acceptable practice and a growing acceptance that both donor sperm and donor egg techniques are 888 Robertson Ethics, law and embryo donation an ethically acceptable part of assisted reproduction. The question to be asked is whether embryo donation presents ethical risks or problems beyond those presented in those other practices. The answer to this question is clearly no. Embryo donation involves no additional manipulations of embryos beyond those involved in IVF, even if separate gamete donations are used to create the donated embryos. Indeed, embryo donation is arguably more respectful of embryos than IVF, because it offers an opportunity for stored embryos to be implanted that might otherwise be discarded. With its close similarity to existing reproductive techniques, it does not present such a deviation from accepted understandings of reproduction and parenthood that it threatens the welfare of offspring or participants beyond the threats posed by other assisted reproductive practices. What is unique about embryo donation is that a child will be born to a couple that has no parental genetic tie with it. In this respect embryo donation is different from most other collaborative forms of assisted reproduction because they all involve one or both rearing parents being the genetic parent of the child. In sperm donation, for example, the rearing mother both provides the egg and gestates. In egg donation, the gestational and rearing mother will not be the genetic mother, but the rearing male will be the genetic father. In gestational surrogacy, both rearing parents will be the genetic parents, even though the genetic mother will not have carried the pregnancy. In full surrogacy, the rearing woman will have no biologic connection with the child, but the rearing man will be the genetic father. The unique features of embryo donation, however, do not make it ethically more problematic. The child born to embryo donation appears no more likely to suffer social or psychological harm than children born through other donor or surrogate techniques. Depending on how one views the importance of gestational versus genetic parental ties to offspring, it could be seen as more-or less-advantageous than other assisted reproductive procedures. In any event, however, it is difficult to see how any particular child born of embryo donation could be harmed by the procedure, because the couple cannot have their own genetic offspring and without embryo donation the child would not have been born at all. One cannot reasonably claim that his birth was wrongful because he was born to loving parents who have no genetic tie to him. From the child's perspective, embryo donation appears to be preferable to postnatal adoption because the rearing mother also will have carried the pregnancy, and the rearing father committed himselfto its birth before implantation. Even though the child results from an embryo that (unless Fertility and Sterility

5 created from separate gamete donations) was "given away" by its parents, such a child is much less likely to feel the rejection or abandonment that is a salient issue for some adoptive children. Nor are donors or recipients harmed by the novel aspects of embryo donation. Couples who donate embryos will have to accept that they might have genetic offspring whose existence or characteristics may not be disclosed. If the psychological issues raised by this contingency are not addressed adequately, the donating couple could experience sadness, anxiety, or longing, but the donor's risk of psychological turmoil appears to be no greater than the risks that gamete donors and surrogates face. It is always possible, of course, that some donors will feel a special attachment to their embryos that makes embryo donation more painful than other forms of gamete donation. Similarly, the recipients also will have fully to accept raising a child to whom they are not genetically related. Yet such arrangements exist in postnatal adoption and, to a lesser extent, in egg and sperm donation and traditional surrogacy, in which one partner will not be the genetic parent of the child whom they rear. With embryo donation, there is the added advantage of gestation and birth by the rearing mother and the psychological commitment throughout the pregnancy ofthe rearing father. The benefits to the recipient couple of rearing a child whom the woman has gestated would appear clearly to outweigh the special burdens of forming a family in this way. Performing Embryo Donation Ethically Although embryo donation is generally ethically acceptable, it could be conducted in ways that minimize or maximize ethical risks. To assure that embryo donation is done ethically, the following issues need attention. Informed Consent and Counseling An essential requirement of ethical embryo donation practices is to disclose fully to donors and recipients all the risks and uncertainties in the procedure. For donors, this will include informing them of the social, psychological, and legal uncertainties of a donation, including the risks that a birth will not occur, that in many clinics they will not be informed of the outcome, and that they will most likely not have any knowledge of or contact with a child who is their genetic offspring. They should be offered counseling to work through these issues and should be rejected as donors if they have not adequately resolved them. The recipients should also be informed fully about the likelihood that pregnancy and birth will not oc- Vol. 64, No.5, November 1995 cur; the extent to which genetic and infectious disease screening tests have been done; the risks of disease in cases in which screening has not occurred; the psychological uncertainties involved in this novel parenting arrangement; the extent to which the donors will be informed of their identity, the child's birth, and any ongoing contact with the child; and legal uncertainties about parentage. They too should be offered counseling and should be screened to assure that they are prepared psychologically to handle the situation of rearing a child who is not genetically theirs. Disclosure to Child Embryo donation is ethically acceptable because it helps infertile couples and does not harm offspring. It enables a child who would not otherwise exist to be born in a situation in which the benefits of existence are likely to far outweigh the psychological and social uncertainties of being raised by gestational but nongenetic parents. An important determinant of the child's well being may be its parents' willingness to disclose its origins as an embryo donated by another couple or as an embryo created from separate gamete donations. In those cases where the origins are disclosed, the question of providing information about the genetic parents or even meeting them at some future time also may have to be addressed. The question of disclosure versus secrecy of origins is an unresolved issue in assisted reproduction with donors and surrogates that also arises with embryo donation. Many psychologists and therapists familiar with these issues recommend openness with the child and the infertile couple's own family as the approach most likely to prevent long-term psychological problems and assure successful family relationships (3). In their view, an open approach is most conducive to establishing trust within the family and working through psychologically charged issues of nongenetic parentage. Some couples, however, are reluctant to be so open. Although some programs might wish to condition their willingness to accept couples as candidates for embryo donation on their acceptance of full disclosure, this is not a precondition that should be required by law or professional standards, just as adoption agencies cannot mandate disclosure by adoptive parents. However, virtually all adoption workers strongly advocate doing so. A better approach is to present couples with information concerning the advantages of disclosure and openness and let them choose what best fits their need. If disclosure does occur, the child eventually may want to have information concerning his genetic par- Robertson Ethics, law and embryo donation 889

6 ents. To allow such information to be provided, nonidentifying information about the donor couple should be provided as part ofthe donation. The donor couple also should indicate ifthey would permit later contact with a child who desires to meet them. Mixing Embryos Some programs offering embryo donation might consider transferring embryos from more than one donor source in a single cycle in an effort to increase the chances of pregnancy. This is most likely to occur when only one or two donor embryos are available from one couple and the program wishes to transfer enough embryos to maximize the chance of pregnancy. The main problem with this procedure is that it could leave the child without accurate information about who his genetic parents are. Although later DNA testing ofthe child and donors could accurately identify the donor source, the additional expense and complexity involved may discourage such testing, thus leaving the couple and child without accurate information about genetic parentage. The absence of such information could create later identity problems for both the child and the donors and possibly could prevent necessary medical treatment from being obtained. A more cautious approach would be to use egg and sperm from only one source and to place only embryos from one source in the uterus of an embryo donation recipient at one time. Monetary Compensation for Embryos An important ethical issue concerns monetary payments to donors for donation of their embryos. In countries where payments to sperm and egg donors are not permitted, the question of paying embryo donors will not even arise. In the United States, where sperm and egg donors are paid routinely, some couples who donate embryos may request payment as well. They would argue that if donors of egg and sperm are paid, they too should be paid for their donations. Not only did they undergo the same physical risks, but they also have paid a considerable sum to produce the embryos that are being donated. Indeed, if they are not paid, the recipients of the embryo donation will be able to achieve pregnancy and have offspring at a far lower cost than that incurred by the donating couple. Despite these arguments, many persons would argue that no money should be paid for embryo donations because of the appearance it gives of selling embryos and thus monetizing or commodifying human life. In addition, payments might induce couples to donate embryos that they otherwise would have discarded, left in storage, or used themselves. 890 Robertson Ethics, law and embryo donation If the payments cover or reduce significantly the costs ofthe IVF cycle that produced them, it could be a strong inducement to donation. For these reasons, many persons argue that paying donors for their embryos is unethical and even urge its legal prohibition (4). The problem of payment remains if selling embryos for profit is banned but payment of expenses associated with the donation is permitted. Donor embryos would be available only because another infertile couple provided the resources necessary to create them. One could reasonably argue that the expenses of donation thus include the cost of creating embryos in the first place, and thus some portion of those expenses should be paid by the recipient. Others would argue that because these costs already have been incurred, they are not an expense of the donation and therefore should not be reimbursed to the donating couple. The question posed here is one of justice or equity between the recipient and the donating couple. The donor couple will have paid a great deal-approximately $7,000 to $9000-for the cycle of IVF that produced the embryos that are being donated, whereas the recipient couple pays only the cost of monitoring the recipient's cycle, embryo thawing, and embryo transfer-approximately $3,000. It would seem fair to ask the recipient couple to pay a share of the cost of producing embryos, allocated on a per embryo basis based on the cost of the IVF cycle in which the embryos were produced. Is there a way to have recipients pay the costs of producing the embryos that they receive, without giving the appearance of selling embryos or creating undue inducements to donate? If direct payments to the donating couple are not permitted, it may be possible for the recipient couple to pay into a fund that will be used to lower the cost of IVF for couples who cannot afford it. Although not a perfect solution, this will help make the balance between recipient and donor costs more equitable. LEGAL ISSUES Embryo donation raises several legal questions that programs and persons participating in embryo donation need to consider. The legal uncertainty now surrounding embryo donation is not so significant. Gamete Donation or Adoption A key legal question is whether embryo donation is or should be regarded legally as a donation of gametes or as an adoption. If treated as a gamete donation, no screening of the recipients' fitness to be parents beyond that required of other recipients of gamete donations will be necessary, unless clinics Fertility and Sterility

7 impose their own screening requirements. A court hearing to certify parental fitness and to ratify the donors and recipients' decision will not take place, as it would if embryo donation were treated as a postbirth adoption. Despite a common practice of interchangeably using the terms "embryo donation" and "embryo adoption," the actual process seems closer to gamete donation than to postnatal adoption and legally would most likely be so regarded. The most significant point is that there is no "child" to be adopted because in most legal systems embryos are not legal persons (5). In addition, only a small percentage of IVF embryos implant and come to term. The chance that any donor embryo will eventuate as a child is low, nor are they the result of a 9-month pregnancy and delivery, as are adopted children. Thus the special protections that the postbirth adoption system provides to adoptive children and relinquishing mothers are unnecessary for embryo donation. Indeed, to require such special review for embryo donation would be anomalous, given our practices with egg and sperm donations. Because embryo donation can occur via separate egg and sperm donation, in which no special review is needed, the fact that the gametes have come together previously to form donor embryos does not justify different treatment than is accorded separate egg and sperm donations. Legally, courts and legislatures are likely to agree. Legal Status and Rearing Rights and Duties Because it is highly unlikely that the rules for postbirth adoption would apply to embryo donation, the most important legal questions concern the legal status of resulting offspring and the rearing rights and duties attendant upon that status. At the present time a degree oflegal uncertainty exists because only two states explicitly have recognized embryo donation, and only three states legally have recognized egg donation (6-8). However, 30 states by statute recognize sperm donation, and there is good reason to think that the intentions of the donating and receiving parties in embryo donation will be given legal effect. Texas and Florida are the only states that presently have statutes that explicitly recognize embryo donation (9, 10). Both states make the recipient woman and her spouse, when they consent in writing, the legal parents for all purposes and the donating couple the legal parent for no purpose. The statutes are silent as to status and rearing relationships if the donation is to an unmarried couple, a same sex couple, or to a single woman. They also do not address arrangements in which the donors and recipients agree to share rearing of resulting offspring. Vol. 64, No.5, November 1995 It is reasonable to expect that other jurisdictions will follow the Texas-Florida model when their courts or legislatures face disputes over rearing rights and duties in offspring born of embryo donation (11). Such an intention-based model for donations involving married couples is recognized in every state that has statutes or court decisions for sperm or egg donation (13). Because donor and recipient intentions in both sperm and egg donation are for the recipient to be the sole legal rearing parent and the donor to have no rearing role, there is no reason why these same intentions would not be recognized for embryo donation as well, however the embryo is formed. This analysis of the law suggests that persons interested in being donors or recipients of embryo donations may proceed with a reasonable, although not 100%, certainty that their intentions to have the donor(s) relinquish all rearing rights and duties and for the recipient couple to take on all rearing rights and duties will be respected, with the prior agreement among donors and recipients concerning rearing rights enforced if disputes later arise. A couple may donate their embryos with reasonable, although not 100%, assurance that they will not be held accountable at a later time for rearing costs or responsibilities for a child born of gametes or embryos that they have donated to an infertile couple. At the same time, the possibility exists that they will not have the opportunity to discover whether a child has been born and, if so, to have any contact with that child or to play any parental or rearing role at all. Similarly, couples who receive an embryo donation can proceed with reasonable, although not 100%, certainty that they will be the legal parents for all purposes and need not fear later claims by donor(s) to have access to their genetic offspring. By the same token, however, they will be responsible for all costs related to rearing the child, including the costs that arise if the child is born handicapped. They cannot escape those duties because the child is not genetically theirs. Although this is clearest in the case of the wife who has gestated the child, it also is true in the case of the father who gives written consent to the donation. For example, if the recipient husband later divorces his wife, he will not be able to escape support obligations to a nongenetic child born of embryo donation. Such children also may be considered his heirs for estate purposes. The arguments in favor of an intention-based approach to determining legal parenthood in embryo donation are strongest when the child is born to a married couple, but they also exist when the donation is to a single woman, an unmarried couple, or a same sex couple. Although not a traditional two Robertson Ethics, law and embryo donation 891

8 partner heterosexual married couple, the parties in these transactions will have relied on the promises of the others in shaping their reproductive and family situations and legally should be able to count on those promises being binding. Many psychologists familiar with these issues think that children born in such novel situations do adapt well if they are reared in a loving household. The case for overriding the parties' intentions in those situations to protect the best interests of the child is weak. An intention-based approach to rearing rights and duties also should prevail in situations in which the parties intend to have the donor(s) participate to some specified extent in rearing offspring. Thus, if the donation is made on the written assumption that the donors will have some financial responsibility for offspring, as well as some rearing rights, then that agreement also should be enforced if either party breaches it after birth has occurred (11). Given the paucity of statutory recognition of embryo donation, it is essential that persons participating in embryo donation execute documents and agreements that explicitly state their intention to take on or relinquish rearing rights and duties in resulting offspring. Execution of these documents will have great legal significance. They should not be entered into without legal advice. Once they are executed, a transfer of rights regarding the embryo and resulting child most likely will occur without further review by a court or agency. Liability and Compensation Issues Some attention also should be paid in arranging embryo donations to tort liability issues. The question here is whether the donor(s) or program would be liable if the child resulting from embryo donation were born with a genetic or infectious disease or if the recipient contracted an infectious disease as a result ofthe donation. Although some plaintiffs' lawyers might argue that the embryo in that case is a "defective product" for which the progenitors and program are strictly liable, courts are likely to reject treating the embryo as a "product" to which product liability rules apply. A more likely basis of liability would be negligence. If donor(s) failed to disclose known information about their family history or risk status for HIV, and disease or disability related to the nondisclosed information were transmitted to the child or recipient, they would be liable under ordinary theories of negligent or intentional injury. A negligence claim against physicians and the program for inadequately screening the couple and embryo for genetic and at risk factors is more likely (14). However, if the program has screened donors according to ASRM guide- 892 Robertson Ethics, law and embryo donation lines for gamete donation, the mere fact that a child was born handicapped would not cause liability. Nor would they be liable for transmission of HIV if the recipient couple had been informed that a second HIV test for the donor couple had not been performed and still agreed to accept the donation. These possibilities show the importance offull disclosure of all risks in clear written form so that recipients are aware fully that genetic and infectious disease screening cannot be 100% effective. Clear written disclosure will inform the parties and minimize the risk oflegalliability. Transfer of Dispositional Control of Embryos In cases where existing embryos are donated for use by infertile couples, the donation technically may be made to a third party-a physician or a program-with the understanding that that party would make the embryos available to infertile couples. It is essential that both gamete sources consent in writing to the donation. Once the donation to a third party occurs, which will ordinarily be marked by execution of a written form, the third party has dispositional authority over the donated embryos. However, the scope of its control is subject to the terms and conditions of the donation. If the embryos have been donated solely for use by an infertile couple, the third party would not be free then to use them in research or discard them. The documents that are signed should be clear about the precise scope of dispositional authority that the third party has been granted over donated embryos and should specify what disposition may occur if transfer to an infertile couple is not possible. In many cases, donation of existing embryos to the program, to a couple, or to an individual might occur without limit on the transferee's dispositional authority. In those cases the person(s) gaining authority over the embryos will be free to dispose of them as they choose, including discard, use in research, attempt to initiate pregnancy, or transfer of some or all of their dispositional authority to another party. To avoid misunderstanding and later disputes, the exact terms and scope of the dispositional authority transferred to another should be specified in writing. In other cases the donor couple may set conditions on how donated embryos are to be used. Because they have the right to decide in favor of donation, they also should have the right to set limits on how their donated embryos will be used. On the other hand, some restrictions on their ability to set such conditions also would appear reasonable. For example, donor(s) should not be able to require that implanted donor embryos never be aborted. Once implantation occurs, the recipient should be free to Fertility and Sterility

9 make all choices that she would have if she had become pregnant coitally or with her own gametes. Understandings about what mayor may not be done before implantation and during pregnancy with donated embryos should be spelled out clearly. Legal Status of Monetary Compensation for Embryos As an ethical matter, paying couples for donating their embryos generally is disfavored because of the symbolic connotations of selling embryos and the possibility of coercive inducements. Carried to an extreme, commercial embryo banks would buy up unwanted embryos from couples going through IVF, sort and classify them, and distribute sales catalogues describing their characteristics, as some commercial sperm banks now do with sperm. Purchasers would then choose the desired embryos from the catalogue or, indeed, from photographs of the donors, pay the price, and then have the embryos shipped by overnight express to the recipient's program. In addition to commercializing human life, such practices could create unrealistic expectations of children or increase the likelihood that they would be perceived as commodities to serve their parents' interests. The dangers of overcommercializing an early form of human life are important concerns that any system of gathering and distributing donor embryos must face. Because state and federal laws against buying and selling tissue and organs for transplants do not extend to embryos, laws banning the sale of embryos would have to be passed (15, 16). At present only eight states-florida (17), Louisiana (18), Massachusetts (19), North Dakota (20), Maine (21), Michigan (22), Minnesota (23), and Rhode Island (24)-appear to have enacted such laws. As a result, in most states no law would prohibit a commercial sperm bank from buying embryos and then selling them to infertile couples or to programs needing embryos for research. Even if additional laws against buying and selling embryos are enacted, the question of paying the donating couple part of the cost of producing the donated embryos will have to be faced. If a system of commercial embryo banks develops, regulations to minimize these risks without unduly hampering free exchange may be needed. DONATION OF EMBRYOS FOR RESEARCH In addition to infertile couples who need donor embryos, researchers may request couples to donate excess embryos for research. Although medical research intended to benefit offspring could be done on embryos that have been donated to infertile couples, most research uses of donor embryos will not involve Vol. 64, No.5, November 1995 embryos that are used to initiate pregnancy. In that case, the most ethically problematic aspects of embryo donation -concerns about the effect on offspring-vanish, because no child will be born as a result. Instead the issue becomes one of respect for embryos and assurance that embryo donors will not be treated unfairly. When is it ethical to perform research on excess embryos? What limits, if any, on embryo research are justified? The National Institutes of Health Human Embryo Research Panel and ethical advisory bodies in other countries have set forth a number of circumstances in which donor embryos may ethically be used in research (25). These norms specify the types of research that may then occur, the review procedures required, donor recruitment methods, and the extent to which expenses or fees of donation can be paid. At present the current absence of laws against buying and selling embryos would permit embryo dealers or brokers in most states to buy excess embryos and sell them for use in privately funded research. If such practices occur, regulation of the practice is likely to follow. CONCLUSION The role that embryo donation will play in treatment of infertility is not yet clear. If limited to couples in which both partners have gametic insufficiency, it will have a modest role. However, embryo donation also may be sought as a less expensive alternative to IVF or egg donation for couples for whom full or partial genetic parentage is not a primary concern. A major factor determining the frequency of embryo donation will be the willingness of couples who have undergone IVF to donate unwanted embryos. When embryo donation does occur, it is important that it be carried out in a way that is respectful of all parties. This means full disclosure of medical, ; social, and legal risks, and disclosure of the psychologically problematic aspects for donors, recipients, and offspring of this form of collaborative reproduction. With careful attention to the issues discussed here, embryo donation may be practiced in an ethically and legally sound way that is mutually satisfying for all parties. Acknowledgments. The author gratefully acknowledges the comments of Susan Cooper, Ph.D., and Edward Wallach, M.D., on an earlier draft. REFERENCES 1. The American Fertility Society. New guidelines for the use of semen donor insemination Fertil Steril1990;53(Suppl 1):1S-13S. Robertson Ethics, law and embryo donation 893

10 2. The American Fertility Society, Society for Assisted Reproductive Technology. Assisted reproductive technology in the United States and Canada: 1992 results generated from the American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 1994;62: Mahlstedt PP, Greenfeld DA. Assisted reproductive technology with donor gametes: the need for patient preparation. Fertil Steril1989;52: Radin ME. Market-inalienability. Harvard Law Review 1987; 100: Robertson JA. In the beginning: the legal status of early embryos. Virginia Law Review 1990; 76: Fla. Stat. Ann. sec (2) (West, 1986 and Supp., 1995). 7. Tex. Family Code Ann. secs A, 12.03B (West Supp., 1995). 8. Okla. Stat. Ann. tit. 10, sec. 544 (West Supp., 1995). 9. Fla. Stat. Ann. sec (2) (West, 1986 and Supp., 1995). 10. Tex. Family Code Ann. sec B. (West Supp., 1995). 11. Robertson JA. Children of choice: freedom and the new reproductive technologies. Princeton: Princeton University Press, 1994: Shultz M. Reproductive technology and intent-based parenthood: an opportunity for gender neutrality. Wisconsin Law Review 1990; 1990: United States Congress, Office of Technology Assessment. Infertility: medical and social choices. Washington, DC: Government Printing Office, 1988: Stiver v. Parker, 975 F.2d 261 (6th Cir. 1992). 15. National Organ Transplant Act, 42 U.S.C.A. No. 274(e). 16. Note, Regulating the sale of human organs, Virginia Law Review 1985; 71: Fla. Stat. Ann. sec (2) (West, 1994). 18. La. Rev. Stat. Ann. sec. 9:122 (West, 1991). 19. Mass. Gen. Laws Ann. ch. 112, sec. 12J(a)(IV) (West, 1983). 20. ND Cent. Code sec (4) (1991). 21. ME Rev. Stat. Ann. tit. 22, sec (West, 1992). 22. Mich. Compo Laws Ann. sec (West, 1992). 23. Minn. Stat. Ann. sec (West, 1989). 24. RI Gen. Laws sec (1994). 25. Human Embryo Research Panel, National Institutes of Health. Report of the Human Embryo Research Panel. Bethesda, MD: National Institutes of Health, Robertson Ethics, law and embryo donation Fertility and Sterility