Ethical and legal issues in cryopreservation of human embryos

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1 FERTILITY AND STERIUTY Copyright c 1987 The American Fertility Society Vol. 47, No.3. March 1987 Printed in U.s A. Ethical and legal issues in cryopreservation of human embryos John A. Robertson Baker & Botts Professor of Law The University of Texas at Austin, School of Law, Austin, Texas. Some in vitro fertilization (IVF) programs in the United States, Australia, Great Britain, and Europe are offering cryopreservation of human embryos as a component of infertility treatment. Although still experimental, the freeze-thawing of embryos is likely to prove effective and eventually. be incorporated into routine IVF practice. This communication reviews legal, ethical, and policy issues that arise for society and for physicians and patients considering human embryo freezing. ADVANTAGES OF CRYOPRESERV ATION Embryo freezing enhances the ability to initiate pregnancy through IVF. Cryopreservation of embryos allows all eggs to be retrieved and inseminated after superovulation, with the excess of embryos required for IVF transfer stored for later use. By ensuring more embryos for transfer, cryopreservation is expected to increase pregnancies per laparoscopy in IVF treatment by 8% to 12%.1 Patients will also find the reduced physical, psychological, and financial costs of IVF treatment on subsequent cycles attractive. Many patients undergoing IVF are likely to freeze excess embryos. Cryostorage of embryos will also facilitate such novel means of family formation as egg and embryo donation and gestational surrogacy. Persons at risk of loss of ovarian function may also select this technique to ensure genetic offspring. Indeed, couples not ready to form a family might bank embryos as insurance against future sterility or age-related birth defects. Embryo freezing may also facilitate embryo biopsy and preimplantation diagnosis and treatment of genetic defects. In the more distant future Grobstein speculates that cryopreservation may play a role in space exploration and migration to distant planets. 2 REQUIREMENTS FOR EMBRYO CRYOPRESERV ATION Early research suggests that embryo freezing will prove as successful in human beings as in animal breeding, in which a substantial industry now exists. Freezing at both early and late cleavage stages for indefinite periods appears feasible. Successful pregnancies have been reported after freeze-thawing of human embryos in the United States, Australia, and the Netherlands. A growing number of IVF programs are now offering cryopreservation on an experimental basis. Successful cryopreservation, however, will require special skills and equipment and may place additional burdens on an IVF program. 1 A controlled biologic freezer capable of cooling accurately to subzero temperatures and liquid nitrogen storage system are necessary. Embryologists experienced in cryopreservation of animals are essential for a successful program. Additional counseling of patients about the implications of embryo freezing is needed. Finally, an efficient system for tracking patients, including accurate means of storage and recontact of patients at periodic intervals, is also needed. Although every IVF program may not wish to take on these burdens, the space and equipment investment is relatively low and can be rapidly amortized in large programs. Given patient demand, many IVF programs are likely to incorporate human embryo freezing into infertility practice. The result is that thousands of embryos will be stored for varying periods across the country in Vol. 47, No.3, March 1987 Robertson Ethicalllegal issues in embryo cryopreservation 371

2 IVF clinics and embryo banks. In time an entire industry devoted to embryo banking with regionalized storage facilities and transport of embryos may emerge. Because embryos are genetically unique living human material that can initiate pregnancy, widespread cryopreservation has medical, social, ethical, and legal significance. Numerous questions about decisional authority over stored embryos need resolution if cryopreservation is to be successfully integrated into infertility treatment. LEGAL STATUS OF HUMAN EMBRYO CRYOPRESERVATION Although still experimental, cryopreservation of human embryos is legally acceptable in most western countries. A number of uncertainties and unresolved questions exist. The main legal questions concern not the acceptability of freezing but particular questions of dispositional authority, length of storage, posthumous use, inheritance rights, and family relations after embryo donation and surrogacy. No jurisdiction has yet legislated directly on embryo freezing, although official advisory bodies or commissions have addressed certain aspects of human cryopreservation in some countries. The Warnock Committee, which has conducted the most extensive review of issues in embryo freezing, endorsed cryopreservation when certain conditions were met. 3 Official advisory bodies and commissions in Australia, Ontario, and Israel have also approved cryopreservation in principle and made recommendations for length of storage, disposition of embryos, the need for prior licensing, and the like. 4,5 Most recently, the Ethics Committee of the American Fertility Society endorsed cryopreservation as an experimental procedure. 6 In the United States cryopreservation is legally available as an adjunct to infertility practice, although federal research funding for cryopreservation is not currently provided. 7 A few states have broadly worded fetal research laws that may appear to impinge on clinical uses of embryo freezing. But these laws were not passed to regulate embryo freezing and should not be interpreted to ban medically acceptable research or clinical uses ofthe technique. If they were so interpreted, they would likely be struck down as an unconstitutional interference with procreative liberty.8 ETHICAL ISSUES IN CRYOSTORAGE OF HUMAN EMBRYOS Embryo freezing raises a number of ethical issues, aside from practices such as egg and embryo donation and surrogacy that it might facilitate. A major issue is whether freeze-thawing of human embryos produces a higher rate of abnormal or defective births and thus will damage resulting offspring. Although freeze-thawing damages some embryos, the work with animals and early human data strongly suggests that a high rate of deformities is unlikely. Only the hardiest and healthiest embryos are likely to survive freezethawing, be implanted, and come to term.l Embryo freezing will not be attractive if a high rate of handicaps occurs. A second ethical concern arises for the minority that views the preimplantation embryo itself as a subject of rights. Because freeze-thawing may damage blastomeres and render some embryos nonviable, this minority views freezing as a direct harm or wrong to embryos. Persons who object to cryopreservation on this ground often oppose IVF as well. 9 The majority view, however, is that embryos, while deserving special respect, do not themselves have the rights or status of persons and therefore cannot be wronged. 6 Because most embryos do not implant, freezing might not damage embryos that would have implanted and come to term. In fact, freeze-thawing seems to increase the overall rate of embryo survival. Embryos that would not have been transferred (or created in the first place) may now be stored and transferred at a later time. Thus cropreservation may reasonably be viewed as showing special respect for embryos. A third ethical issue is the psychological effect on offspring of suspended development before implantation. While suspending human development at early cleavage stages is a new development for human beings, it is akin to freezing sperm or other tissue and should not itself be psychologically problematic for offspring. For example, freezing at an early cleavage stage would not have the same impact that suspending development of a child or adult already embedded in a set of human relations would. Yet suspended development could have psychological importance in several situations. If the period of suspension were long, it could lead to rearing by older parents or nonbiologically rei at- 372 Robertson Ethical/legal issues in embryo cryopreseruation Fertility and Sterility

3 ed persons. Freezing could also lead to novel and problematic relations with genetic parents as a result of embryo donation and gestational surrogacy. Policies about length of storage, decisional authority over stored embryos, and the relations among the participants in embryo donation and surrogacy must address the questions about offspring welfare that arise with these uses of cryopreservation. A final set of ethical concerns in human embryo freezing is more broadly philosophic or even theologic. Some persons view embryo freezing as an unacceptable intrusion into natural processes of reproduction, or the next step on a slippery slope toward a Brave New World of governmental genetic engineering. Such concerns have arisen since the inception of IVF and are not a sufficient basis for prohibiting the practice. Indeed, such views support leaving decisions about embryo freezing to private sector actors. Moral condemnation alone is an insufficient basis for public prohibition when strongly different moral judgments exist. Individuals who find freezing objectionable need not participate in the practice. In sum, the emerging moral consensus is that cryopreservation of human embryos is now acceptable as an experimental procedure, and if transferred thawed embryos achieve an acceptable rate of healthy births, cryopreservation would be ethically acceptable as a routine part of infertility treatment. Important ethical and legal questions remain, however, about who may properly exercise decisional authority over stored embryos and the limits of that authority. DECISION MAKING AUTHORITY OVER CRYOSTORED EMBRYOS The couple or persons providing the egg and sperm would have primary decision-making authority over the embryos that were cryostored at their request. Their right to transfer their decision-making authority to others, such as the embryo bank or storage facility, is also almost certain to be recognized. Although law and ethics have not directly addressed this issue, such a result is strongly suggested by precedents concerning control and disposition of organs, semen, blood, and other body parts. lo A person's interest in having or avoiding biologic heirs also supports the gamete providers' authority over embryos formed from their gametes. While persons do not have unlimited freedom (property or ownership) in their body parts, the gamete providers, rather than others to whom they have not transferred their authority, have whatever property or quasi-property rights of ownership in embryos is legally available. Some right would also exist to transfer their authority to others, who would step into their shoes in deciding the disposition of stored embryos. For implementation of their authority it is essential that persons give instructions at the time of storage concerning disposition of embryos if they do not choose to have the embryo thawed for transfer to the egg provider. These instructions could include consulting them at a later time for further instructions about continued storage or disposition (every 5 years according to Warnock).3 They should also include specifications if they die, divorce, are~unavailable for later consultation, or fail to pay storage -charges. Advance instructions will avoid the problem that arose in the Rios case, in which a wealthy couple died in a plane crash without instructions about disposition of their cryopreserved embryos. 11 Consideration of these options will require extensive counseling and discussion with couples. In considering various contingencies, couples will have to clarify the meaning or significance that stored embryos have for them. Only IVF programs able to undertake this counseling should engage in cryostorage. TRANSFER OF DECISION MAKING AUTHORITY Several other questions follow from this initial assignment of property or quasi-property rights in stored embryos. One question is the storing couple's right to transfer decisional authority over cryostored embryos to others. The jointdecision-making authority of the gamete providers could be transferred to one of them, to the storage facility, or to others. In general a person who receives authority from the gamete providers (or their transferee) may exercise the same rights of disposition that the gamete providers did concerning continued storage, discard, donation, and research. However, the transferee's right to discard or donate for transfer may be restricted if he or she lacks a reproductive interest in the embryo. The gamete providers need to specify at the time of storage dispositional alternatives if joint decision-making is not possible. In the case of death, a workable solution would be to have au- Vol. 47, No.3, March 1987 Robertson Ethical/legal issues in embryo cryopreservation 373

4 thority pass to the survivor, with instructions specified about disposition in case of the survivor's death. In the case of divorce or separation the parties should specify that the embryo will be discarded, donated to the storage facility, or disposed of as the parties otherwise agree. They might also agree to transfer control to the storage facility in case of disagreement, as Warnock recommends.3 An important question concerns their right to designate or transfer decisional authority over the embryo to others if one or both of them dies. Transfer of decisional authority to the survivor of the couple, or to the storage facility if the survivor dies or is unavailable, is a workable solution that will be adopted by many couples and programs. However, some persons may wish to designate another person, for example, to assure that the decedent's wishes concerning remaining embryos are followed. Law, policy, or practice should not prematurely exclude this possibility. A final question is whether the gamete providers' right to transfer dispositional control of embryos permits them to receive money or other consideration for doing so. While many people object to the symbolic connotations of "selling" embryos, few laws appear to prohibit directly the receipt of consideration at the present time. 8 However, official bodies in Britain and Australia have recommended against payment for gametes, embryos, and surrogacy and thus are likely to legislate against the practice if payments do occur.3 The question of payment is most likely to arise when the recipient or transferee of an embryo is asked to pay a fee to cover acquisition and storage costs. Because creation of embryos is expensive ($700 to $1000 per embryo in many American programs) and cryopreservation charges will arise, it is not necessarily unreasonable to ask the recipient of an embryo donation to share production and storage costs. Recoupment of costs can be distinguished from payments that reflect "profit" or other monetary gain from embryo donation. The parallel with organ donation is instructive. The recipient of an organ transplant, rather than the donor family, pays the costs of maintaining brain-dead cadavers and surgically removing donated organs. Such payments are consistent with a firm policy against the buying and selling of organs.12 A similar policy with embryo donations might permit the recipient to share the costs of embryo production and storage. POSTHUMOUS THAWING AND EMBRYO TRANSFER Cryostorage also raises the possibility of thawing and transfer to a uterus after one or both of the gamete providers has died. Such a disposition may be specified by the gamete providers at the time of storage or in their will or by the survivor of the two, or result from a transferee's donation of the embryo to an infertile couple. The posthumous birth of children has occurred to a limited extent-fathers have died after conception and mothers in childbirth-but it remains controversial. For example, the postmortem use of stored sperm has been problematic in France and several other countries. 13 With cryopreservation of human embryos, transfer to the uterus, implantation and birth may not occur until long after the gamete source or sources have died. If cryostorage is widely practiced, there will be many more occasions to thaw and transfer embryos posthumously. Some persons have questioned the desirability of posthumous transfer because of the feared impact on offspring of being raised by single or elderly parents or by parents who are not genetically related (as in the case of posthumous embryo donation). None of these concerns seems adequate to prevent couples storing embryos from providing for posthumous transfer. Reliance on them would be inconsistent with other accepted practices, such as embryo donation itself and elderly men fathering children. Moreover, a policy that prevents existence altogether hardly protects offspring, when rearing by nongenetically related, single, or elderly parents does not alone render a child's life not worth living. Indeed, prohibition on posthumous transfer of stored embryos might violate procreative rights of the gamete providers to reproduce after death. However, the inheritance rights of children born posthumously from stored embryos must be clarified for this practice to occur. The ability to transfer thawed embryos to a uterus posthumously means that all biologic heirs may not be in utero or be born at the time of death, the usual requirement for a person to be the legal heir of a decedent. Should embryos "en ventre sa frigidaire" be treated like embryos "en ventre sa mere?,,14 The possibility has enormous implications for estate planning and the orderly administration of probate. If persons born posthumously from frozen embryos are considered heirs, estates could be 374 Robertson Ethical/legal issues in embryo cryopreservation Fertility and Sterility

5 tied up as long as embryos are cryostored. Delays in settling estates could be enormous. A workable policy to ensure the efficient administration of estates would be that no embryos not in utero at the time of death would qualify under intestacy statutes (which control when there is no will) or under wills that devise property to "heirs," "children," or other designations that could include posthumous offspring from thawed embryos. However, a person's stated wish to transfer property to biologic offspring born posthumously has some appeal, particularly when the surviving wife carries the embryo. Thus an exception to the proposed inheritance policy might be considered when the testator specifically devises property to offspring "born from embryos stored at time of death." However, the risk of long delays in settling estates will still exist unless a time limit for thawing and transfer after death is specified. LENGTH OF STORAGE Assuming that indefinite storage of embryos is clinically feasible, the length of storage should be determined in the first instance by the gamete providers and embryo banks. Although most couples will thaw embryos to initiate pregnancy within a few months or years, situations leading to storage for 5, 10, or more years can easily be imagined. Embryo banking early in marriage to protect against later sterility or birth defects could also lead to long storage. Embryo banks may be of two minds concerning indefinite storage. As long as charges are being paid, they might have no objection to and even desire lengthy storage. After all, the business of embryo banking is to bank embryos for paying clients. However, IVF programs offering cryopreservation as an adjuvant infertility treatment may wish to reduce the administrative burdens of maintaining many embryos and periodically recontacting the storing parties concerning disposition. It may be administratively easier for some programs to set a time limit of 2 to 5 years, at the end of which the storing couple will be contacted and asked to decide about discard or donation to infertile couples or researchers. If the couple is not available, previously given instructions for disposal of remaining embryos will then be followed. Couples seeking longer storage may bank their embryos elsewhere. With clear instructions concerning disposition at key decisional points, there is no need for law or public policy to specify the maximum length of storage. Indeed, such limits might interfere with the procreative goals of persons who desire longer storage and with the business of banks willing to serve them: Storage limits recommended by various official bodies therefore need further consideration. Warnock, for example, recommended a maximum of 10 years for storage of embryos, after which time decisional authority would pass to the storage facility.3 Other bodies have recommended limits such as 5 years or not beyond the reproductive life of the storing woman. 6 Concerns about clinical efficacy will not support time limits if indefinite storage is compatible with thawing and healthy birth. Nor is a time limit needed to avert complications in the case of the death or divorce of the storing parties as long as clear instructions about these contingencies are given at the time of storage. Storage limits also do not protect offspring born after long storage, because the alternative for them is no life at all. Indeed, policies limiting the length of storage could unfairly discriminate against women. A time limit based on the woman's reproductive capacity would prevent continued storage and eventual transfer to a surrogate of embryos stored shortly before a woman had to undergo a hysterectomy for medical reasons. Yet she still has an important reproductive interest in the stored embryos despite her inability to gestate, as does her spouse or partner. Similarly, 5- or 10-year limits might impair the reproductive interests of both men and women. DISCARD OIJ. NONTRANSFER OF FROZEN EMBRYOS Although cryopreservation avoids the current IVF dilemma of not inseminating or transferring all fertilized eggs, the question of discard or nontransfer of embryos will inevitably arise even with cryopreservation. If the couple no longer wishes embryos thawed for transfer to the egg source, they may wish them to be discarded rather than donated to others. Although many IVF programs insist on transferring all fertilized eggs to the uterus, this is not a legal requirement. Legally, the gamete providers, their transferees, and the storing facilities may discard embryos that they do not wish trans- Vol. 47, No.3, March 1987 Robertson Ethical/legal issues in embryo cryijpreservation 375

6 ferred to a uterus. Destruction or discard of an embryo is not covered by homicide or feticide laws, because it would not be destruction of a live-born person or fetus.8 Although embryo discard is a legal option, some persons have argued that respect for human life requires the embryos either not be created or that they be donated to others if they will not be transferred to the uterus of the woman providing the egg. The minority that views the preimplantation embryo as a person or moral subject in its own right holds that there is a moral obligation to transfer all embryos to a uterus. Other persons argue for a duty to transfer all embryos on symbolic grounds, rather than as a question of moral duties owed embryos themselves. David Ozar, a philosopher, has articulated this position as follows: 15 The value that we as individuals and as a community attach to human life... is nurtured in many subtle ways in our habits and mores, and in our institutions. Thus... widespread public acceptance of a practice in which human embryos are made when it is efficient and economical to make them and disposed of when it is efficient and economical to dispose of them (might) have an effect on the community's valuing of human life in other contexts, an impact that would put the life of those already born at risk when tradeoffs of efficiency and economics did not favor them. We know far too little to predict that something like this will certainly occur. But we also know far too little to predict that it certainly will not. Certainly enough is at stake that we would be foolish not to acknowledge the risk. Only reasons of economy and efficiency support a policy of disposal. In response, it may be argued that Ozar overinflates the symbolic effects of embryo discard and undervalues its procreative importance for gamete providers. At a time when more powerful symbols of human life-fetuses-may be killed in utero, the additional devaluation of human life from embryo discard appears to be minimal. After all, early cleavage embryos lack human form, are not sentient, and are not yet clearly individual. Moreover, this position ignores the reproductive and personal significance of potential biologic offspring for the gamete source.8 A person's interest in avoiding biologic heirs, even if they do not rear them, is significant and deserves respect. A desire to symbolize respect for human life may not be sufficient to justify laws or public policy overriding this very personal interest. Nevertheless, the power of the state to take such a position may exist. In the United States a person's constitutional right to avoid conception and pregnancy would not necessarily provide a right to have stored embryos discarded. That right may not encompass a person's wish to avoid biologic heirs when no rearing duties are imposed, as might occur with a law requiring that unwanted embryos be donated to willing recipients.8 Although mandatory embryo donation laws may be within state power, the need for them can be questioned. The social importance traditionally assigned to blood relationships argues for allowing gamete providers to discard unwanted embryos. IVF programs, however, are legally free to encourage or require all patients to accept transfer of stored embryos or permit donation for transfer to others. DONATION OF EMBRYOS FOR TRANSFER Although embryo donation for transfer to an infertile couple may occur independent of freezing, cryopreservation increases the likelihood of donation, because synchronization of menstrual cycles is facilitated. Although few infertile couples will lack both egg and sperm and thus need an embryo donation, such cases will occasionally occur. Widespread embryo banking with shipment to distant points will increase the choice of prospective recipients, just as sperm banking does. At the present time there appears to be no ethical or legal barrier to such donations. Embryo donations enable embryos that would otherwise have been discarded to be transferred and possibly brought to term. The separation of genetic from gestational and rearing parents that results is not so harmful to offspring that donation should be prohibited in all cases. But for the donation the offspring would never have existed. Indeed, embryo donation provides a closer link with rearing parents than does post birth adoption because the rearing mother will also have gestated. Legally, no states have laws specifically regulating embryo donations and few that apply by analogy. Although sometimes referred to as embryo "adoptions," legal provisions applying to postbirth adoptions of children do not apply to 376 Robertson Ethical/legal issues in embryo cryopreservation Fertility and Sterility

7 donation of preimplantation embryos. Thus no prior agency or court review of parental fitness is legally required. Embryo donations are so close to sperm and egg donations that they should be treated similarly. IVF programs and physicians, however, should use due care in arranging embryo donations, as they would in using donor sperm. They should require the donating couple to execute a form relinquishing their rights and interests in the embryo. The recipient should sign a form acknowledging the donation and agreeing to rear any children born as a result. Records of the transactions should be maintained in case the offspring is accorded a legal right to learn of his or her genetic roots. 6 As a legal transaction, the donating couple transfers their decisional authority over the embryo and rearing rights and duties in resulting offspring to the recipient. The recipient assumes rearing rights and duties in the embryo that she gestates and brings to term. The genetic parents are eliminated as rearing or social parents, with the gestational parent and her consenting partner taking on rearing rights and duties. The offspring becomes the legitimate child of the recipient couple for all purposes unless specified otherwise. 8 Although legislation specifying this result is probably desirable, it is likely that an embryo donation agreement will be recognized by courts adjudicating disputes about custody, support, visitation, and inheritance even in the absence of legislation. Indeed, Warnock and other advisory groups have recommended a similar result in the case of embryo donations for transfer. 3 An exception to the donor and recipient's right to settle rearing relationships in resulting offspring might arise from the offspring's interest in knowing his or her genetic roots. Because adopted children and offspring of donor sperm often have strong desires to learn their genetic roots, offspring born of embryo donations might also wish to know their genetic parents. Although most states do not currently give adopted children this right, laws permitting offspring to learn their genetic identities would appear to be a valid ground for overriding promises of anonymity or confidentiality in the donation contract. 8 In the meantime, IVF programs participating in embryo donations should maintain records on donors so that such information is available if the right is later granted to offspring. SURROGATE GESTATORS IVF programs cryopreserving embryos may occasionally be asked to thaw the embryo and place it in the uterus of a woman who has agreed to be a surrogate carrier for the woman providing the egg. The main indication for surrogacy arises when the woman providing the egg lacks uterine function or is unable to complete pregnancy because of hysterectomy, endometriosis, incompetent cervix, or other medical factors. (Surrogacy for career or life-style "convenience" is discouraged at the present time.) Surrogacy is thus an alternative to embryo discard or donation when the woman providing the egg is unable to maintain a pregnancy herself. Cryopreservation greatly facilitates gestational surrogacy because it avoids the need for synchronizing the surrogate's cycle with egg retrieval from the egg source. Surrogacy is the most controversial of all the new collaborative reproductive techniques because of the intensity and length of the surrogate's contribution and the importance of the gestational bond to mothers, offspring, and society. Such a placement is not illegal and is not necessarily unethical or undesirable if the surrogate has knowingly chosen this role. Although most surrogates to date have also provided the egg (in essence a preconception agreement to be inseminated and relinquish rearing rights and duties at birth to the father and his partner), the use of surrogates to gestate the embryo of another couple has occurred and will increase with cryopreservation. The legal issues in surrogate gestation are still being clarified and controversy remains. Although the birthing woman has always been considered the legal rearing mother, the separation of female genetic and gestational parentage will cause this presumption to be reevaluated. Indeed, in the one known case of a surrogate gestator in the United States, a court permitted the genetic mother to be listed as the mother on the birth certificate and recognized as the rearing mother. 8 Surrogate gestation itself is not illegal in most countries, although some American states may penalize money payments to surrogates under state baby-selling laws or refuse to enforce custody or behavior provisions of surrogate contracts. l6 However, such laws may be subject to constitutional challenge, because payment and contract enforcement is usually necessary to en- Vol. 47, No.3, March 1987 Robertson Ethical/legal issues in embryo cryopreservation 377

8 able an infertile couple to reproduce in this way.8 Other countries may not permit surrogacy at all. Warnock, for example, condemned surrogacy and recommended criminal penalties for persons arranging surrogate transactions. 3 A major issue with surrogate gestation is whether the surrogate who changes her mind can abort or refuse to relinquish the child at birth. A surrogate who has not provided the egg is less likely to be free legally to breach her agreement. If she aborts contrary to contract, she would probably be liable for damages for destruction of the couple's embryo. Her claim to retain custody at birth is also less compelling, because she never would have received the couple's embryo for gestation unless she had agreed to relinquish the child at birth.8 Gestational surrogacy is best viewed, as the Ethics Committee of the American Fertility Society recommended, as a clinical experiment until more data on its effects are available. 6 It is not unethical for a program to offer surrogacy as an option for placement of stored embryos when a valid need arises and the surrogate is adequately informed. In such cases the couple and their brokering agents rather than the IVF program storing embryos will probably recruit the surrogate. The IVF program should ensure that the surrogate is freely consenting and is medically fit to carry a child. A copy of the agreement between the parties should be examined and placed in the medical records of each. The program should also cooperate with research studying the effects of surrogacy on the parties involved. Physicians who object to such arrangements or who have doubts about the validity of the surrogate's consent may choose not to participate in surrogate gestation. DONATION FOR RESEARCH Cryopreserved embryos may also be donated for research, if the storing couple no longer wishes them transferred to initiate pregnancy. In most cases embryos donated for research will be discarded after completion of the research. In a few cases, however, transfer to a uterus may occur, in effect making it a donation for research and possible transfer. The question of embryo research has been controversial in Australia, Great Britain, and, to a lesser extent, the United States. To avoid controversy, many researchers are reluctant to conduct studies on human embryos. However, developments in IVF and other fields will increasingly draw researchers to human embryos as vehicles for research in infertility, contraception, genetics, cancer, and other fi~lds. Despite the cautious approach taken to embryo research, a consensus recognizing the ethical and legal acceptability of embryo research can be identified. Official and advisory bodies in the United States, Great Britain, Canada, and Australia have considered embryo research and found it acceptable in well-designed studies approved by institutional review boards.17 Most of these bodies would limit extracorporeal embryo research to 14 days. They would also permit transfer to a uterus when there is reasonable grounds for thinking that the resulting offspring will be healthy. With the exception of Victoria in Australia, they would even permit research on embryos created solely for that purpose. 17 Thus there is no question that stored embryos created to treat infertility may be donated for research before discard. Such research does not harm embryos and thus does not raise the ethical problems of research with nonviable abortuses and dying persons. If done for valid purposes, it is as consistent with respect for embryos as is research with human subjects generally. A few American states have broadly drawn fetal research laws that might appear to prohibit any embryo research. However, unless narrowly interpreted, such laws are vulnerable to constitutional challenge as an interference with first amendment and procreative rights.17 IVF programs that offer cryopreservation should therefore inform couples storing embryos of their right to donate them for research if they do not wish them thawed and transferred to a uterus. This option should be explored at the time of initial storage and when later decisions are made. By analogy to organ donation, request for donation of embryos for research should be considered in all cases in which embryos will not be placed in a uterus. 18 Such requests will be helpful to researchers who need discarded embryos to conduct studies that will benefit infertile couples and others in the future. Donation of embryos for research may also provide meaning for couples when the embryo cannot be placed in the woman or donated to an infertile couple. It will also lessen the need to create embryos solely for research, although it will not eliminate this controversial issue altogether. 378 Robertson Ethical/legal issues in embryo cryopreservation Fertility and Sterility

9 REGULATION OF CRYOPRESERVATION As an experimental procedure involving human subjects, cryopreservation of human embryos currently should be conducted according to a research protocol that has been reviewed and approved by an institutional review board or similar body. Some countries may require that such review occur on a national rather than local level. In the United States this review is conducted at a local level only. Federal funding (currently unavailable for any research with human embryos) would require some form of national approval. Once cryopreservation is routinely practiced, no special regulatory oversight seems needed. Such review is not necessary for IVF or for highly risky procedures such as heart transplants. It would be anomalous to single out cryopreservation for special licensing when accepted medical procedures of greater risk do not require this, for cryopreservation does not appear to impose risks that justify special concern. In the United States IVF programs wishing to cryopreserve human embryos are free to do so, as long as they meet institutional requirements for review of human subjects research. Some countries, however, might opt for a special license requirement for physicians or programs wishing to conduct IVF and variations such as cryopreservation. The Warnock committee recommended such an approach for Great Britain, and several countries including Australia and Israel now take such an approach. 3 In most countries the main regulatory mechanism will be professional practice standards and competition for patients rather than direct governmental regulation. The experience with human sperm banking, while mixed, suggests that the private sector can ensure high-quality services and avoid major problems that warrant governmental intervention. IVF programs and embryo banks, for example, have strong incentives to comply with professionally determined standards for freezing equipment, counseling patients, recordkeeping, and the like. Given the legal rights of patients storing embryos, they are likely to respect the decisional authority of the gamete providers. Although some embryo banks may be unwilling to meet all patient demands, alternative bankiag facilities are likely to be available. Reliance on the private sector, however, assumes that it will develop reasonable standards of practice and ensure that valid patient and societal interests are considered in providing this service. It would be helpful if the professional groups directly involved with infertility practice and embryo freezing convened special advisory or ethics committees, with interdisciplinary membership, to monitor developing practices. Future developments in the embryo banking industry may also require monitoring. In litigious societies such as the United States the threat of lawsuits against IVF programs and embryo banks for negligent destruction of em" bryos or disregard of decisional authority should ensure compliance with professional standards and patient desires. This solution to the regulatory problem, however, requires that there be a legal remedy for negligent destruction of embryos and mistakes in recordkeeping. This remedy should not unduly add to insurance costs or be difficult to pursue by aggrieved patients. However, the legal right to recover for negligent loss of embryos is not yet clearly established. In the Del Zio case in 1979 a New York jury awarded $50,000 to a couple when a physician deliberately destroyed an embryo to prevent an experimental transfer. 19 However, the basis for the award was the intentional infliction of emotional distress, rather than destruction of a property or quasi-property interest in embryos or future offspring. Whether compensation for negligent destruction or misidentification of cryopreserved embryos will be available is unclear. Because there is no way to show that particular embryos would have implanted and gone to term, negligent loss cannot be equated with wrongful death of a child or fetus. Moreover, the loss is purely psychological and ordinarily will not occur in the presence of the parent, a situation that the tort system does not usually recognize. 2o In addition, given the uncertainty of successful pregnancy with any stored embryo, damages may be too small to support the costs of suit in most cases. The courts will inevitably be drawn into determining whether negligent destruction of embryos is actionable. Because the storing couple does have an important procreative interest at stake, some remedy for negligent destruction seems justified. Legal concepts of tort and property may have to evolve to take care of this situation. A practical solution would be to have the couple and storage bank set liquidated damages for negligent destruction of embryos in the initial storage i I, I ~ : Vol. 47, No.3, March 1987 Robertson Ethical/legal issues in embryo cryopreseruation 379

10 contract. A sum based on the cost of creating the embryo might be a reasonable basis for most losses. The apparent valuing oflife that occurs here is no more offensive than provisions in accident or life insurance policies. The private sector, however, may not adequately consider the larger societal ramifications of cryopreservation. Grobstein and others have suggested that an ongoing national commission or other deliberative body should be convened to consider the ethical and social issues that arise with cryopreservation and other novel reproductive techniques. 2 Such bodies can play useful roles in identifying consensus and problems that need to be addressed. It is not clear, however, that a national body is needed to consider further developments with embryo freezing. As discussed previously, cryopreservation poses few unique ethical and social issues, although it does facilitate extensions of IVF that may need further examination. Further developments in this field are likely to occur without such a deliberative body. CONCLUSION Technical advances in the safety and efficacy of human embryo cryopreservation may lead to incorporation of cryostorage into routine IVF practice. Many persons undergoing IVF are likely to choose cryopreservation of embryos not transferred during an IVF treatment cycle. 1 Embryo banking on a wide scale in many countries will probably result. Review of legal and ethical issues shows that cryopreservation as an experimental and eventually as an established procedure is ethically and legally acceptable in most countries now offering IVF. The couple providing the gametes for the embryos exercises primary decisional authority over stored embryos and their disposition when thawed. Their right to store, transfer, discard, and donate to infertile couples or to research has wide legal and ethical acceptance. Indeed, some countries, such as the United States and Canada, may permit placement of a thawed embryo in a surrogate. For effectuation of the couple's decisional authority, it is essential that couples state their dispositional desires at time of storage in case they are not available at later decisional points. This review has shown that cryopreservation of human embryos is less problematic ethically and legally than has originally been thought. Only the suspension of further cleavage after conception and before placement in a uterus distinguishes embryo freezing from IVF and other noncoital techniques though it does facilitate the use of some controversial techniques that can occur without freezing. Suspension of embryonic development, however, turns out to have few risks for offspring and enables embryos that would have otherwise been discarded to be placed in a uterus and brought to term. Although the possibility of long storage and posthumous transfer requires continued attention, the case for cryopreservation of human embryos to treat infertility is strong. REFERENCES 1. Trounson A: Preservation of human eggs and embryos.. Fertil Steril 46:1, Grobstein G, Flower M, Mendeloff J: Frozen embryos: policy issues. N Engl J Med 312:1584, Report of the Committee of Inquiry Into Human Fertilisation and Embryology. Warnock, M (Chairwoman). London, Her Majesty's Stationary Office, 1984, p Victoria Committee to Consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization. Report on the disposition of embryos produced by IVF, Ontario Law Reform Commission, The Ethics Committee of The American Fertility Society: Ethical considerations of the new reproductive technology. Fertil Steril 46 (Suppl 1) U.S. Department of Health, Education and Welfare (HEW), Ethics Advisory Board. HEW support of research involving human in vitro fertilization and embryo transfer. 44 Fed. Reg. 35, 033, Robertson JA: Embryos, families and procreative liberty: the legal structure of the new reproduction. S California Law Rev 59:501, Hearings Before the Subcommittee on Investigations and Oversight of the House Committee on Science and Technology. (Statement of Reverand Donald McCarthy.) 98th Congress, 2d Session. 1984, p Andrews L: My body, my property. Hastings Center Report 16:18, Australia dispute arises on embryos. New York Times, June 11, 1984 (A30, column 4) 12. National Organ Transplant Act of Dionne, Widow wins Paris case for husband's sperm. New York Times, August 1, 1984 (A96, column 4) 14. Wadlington W: Artificial conception: the challenge of family law. Virginia Law Review 69:488, Ozar D: The case against thawing unused frozen embryos. Hastings Center Report 15:10, Doe v. Kelley, 100 Mich. App. 169,207 N.W.2d 428, Robertson Ethical/legal issues in embryo cryopreservation Fertility and Sterility

11 17. Robertson JA: Embryo research. Western Ontario Law Rev 24:15, U.S. Department of Health and Human Services: Report of the Task Force on Organ Transplantation, Organ Transplantation: Issues and Recommendations, 1986, p No (S.D.N.Y. 1978) (memorandum decision) 20. Dillon v. Legg, 441 P2d 912 (Calif. 1986) Received December 5, Reprint requests: Mr. John A. Robertson, Baker & Botts Professor of Law, School of Law, The University of Texas at Austin, 727 East 26th Street, Austin, Texas Vol. 47, No.3, March 1987 Robertson Ethical/legal issues in embryo cryopreservation 381