What are the ownership rights for gametes and embryos?

Advance directives and the disposition of cryopreserved gametes and embryos

Guido Pennings

1 Department of Philosophy, Pleinlaan 2, Lok. 5C442, Free University Brussels, 1050 Brussels, Belgium


    Introduction
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
IVF has become a routine procedure for the treatment of infertility. One of the by-products of the typical IVF treatment is the creation of supernumerary embryos. More embryos are brought into existence than can be safely replaced in the first cycle. The remaining embryos are frozen to be used later if the first trial proves unsuccessful or when the couple wants another child. However, not all embryos are replaced and not all parents indicate what should be done with them. The accumulation of frozen embryos has resulted in impressive numbers of embryos stocked in the freezers of the large fertility clinics. The exponential growth of their number urges on the ethical reflection on the fate of these embryos.

Two questions are generally raised in this context: (i) who should decide and (ii) what should be done. Although the disposition of the embryos has received much more attention in the literature due to the special moral status attributed to the embryo, both questions also apply to gametes. The issue is the extent to which the gamete providers have the right to decide the destination and use of their genetic material. Advance directives, as will be argued, are a valuable, though limited, tool for gamete providers to exercise their decisional authority into the future.


    Informed consent and advance directives
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
It has become the standard solution to leave the decision about stored gametes to the gamete providers and about embryos to the persons for whose reproduction they are created (Royal Commission on New Reproductive Technologies, 1993Go; Ethics Committee of the American Society for Reproductive Medicine, 1994Go). The individual or couple is asked to give written instructions concerning the disposition of the gametes or embryos. The right to decide the fate of the genetic material by the gamete providers or intentional parents is considered a fundamental right. The high status of the right is due to the special link that is made between the genetic material and the identity of the person. The second factor that increases the weight of the right to decide is the importance and centrality of reproduction in the life plan of a person or couple. The right protects the fundamental interest of individuals in controlling the application of their reproductive capacities. The use of genetic material, especially for procreation, without the person's informed consent is considered to be a serious violation of that person's autonomy.

Competent patients have a right to informed consent. Ordinarily, patients are competent both when they authorize treatment and when they receive treatment. In exceptional circumstances there may be a larger time gap between the moment of decision and the moment of execution of the decision. Precisely for those situations, the patient, while competent, can issue a directive that tells the physicians what should or can be done in the future when he or she is no longer competent. These `instructions for the future' are known as advance directives. In itself, the idea is not new. In fact, a will may be considered as the paradigmatic example of an advance directive. In a will, the person lays down in writing how his property should be distributed after his death. In the last two decades, advance directives have become accepted as a basis for medical decision-making (Sass, 1998Go). They originate in the context of end-of-life treatment. People have the right to refuse treatment, even when this treatment is necessary to save one's life. The reasoning goes that they should also have this right at a time when they can no longer decide for themselves. The directives are recognized as an `extension of the decision-making authority of competent patients' (DeGrazia, 1999Go). Having the right in the present is not sufficient to ensure having the same right in the future but, obviously, a person can only project a right in the future if he has that right in the present. The same reasoning can be applied to the disposition of gametes and embryos: the right to dispose of them is so fundamental that people should be allowed to decide the fate of their genetic material at all times.

Advance directives in the context of gamete and embryo disposition are equivalent to donor cards for organ donation. It can be argued that prior directives are even more important than donor cards since no country has a presumed consent or opting out policy for the donation of gametes and embryos. Given the primary decisional authority attributed to the gamete providers and/or intentional parents, it is of uttermost importance that the patients give instructions concerning the disposition of their gametes and embryos. The request for advance directives from all patients should be part of the procedure for any fertility treatment that includes cryopreservation of gametes and embryos. However, the purpose of advance directives, e.g. the extension of the autonomy of the patient, should be kept in mind. It seems that the advance directives are now looked upon as mainly serving practical goals, i.e. relieving the clinic from all `abandoned' gametes and embryos and providing the clinic with indisputable proof in conflicts with the patients. The present discussion concerns the contingencies for which dispositional directives should be asked and the understanding of what constitutes appropriate use (Emanuel, 1994Go).


    Restrictions imposed by the social and moral order
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
Advance directives only make sense if there are several options among which people can choose. The presentation of different options in itself implies a recognition of the pluralism of moral background theories on reproduction and responsible parenthood. A society that shares a unique substantial worldview on how gametes and embryos should be used, has no need for advance directives since the decision will not be left to the individual. Society will impose the dominant view on all residents by means of the legislation. Advance directives place the disposition of gametes and embryos to a large extent into the private sphere of the gamete providers. However, even if we all agree that individuals may determine the use of their gametes in the future by means of advance directives, we still have to decide which options will be offered. The general statement that individuals have the right to dispose of their genetic material is misleading if it suggests that they have an unlimited freedom of choice. All countries limit the options for the disposition and use of gametes and embryos. In countries like Germany and Brazil, the couple has very little freedom to direct the disposition of their embryos. Other countries present specific rules. The Norwegian law, for instance, states that fertilized eggs may only be used for implantation into the woman from whom they originate (no donation is allowed) and that all research on fertilized eggs is prohibited. Donation for research is not possible for French couples either, since all experimentation on embryos (except therapeutic) is forbidden (Article L-152-8). Similar restrictions apply to gametes.

Most conflicts between the gamete providers on the one hand and the fertility centre and/or the state on the other hand are not directly about the control of the gametes or embryos but about the use of these gametes and embryos for certain kinds of treatment. For instance, people have the right to choose an extension of the storage period of their embryos but only up to the age limit set on the IVF treatment. The options are framed in a set of more general medical (safety, efficiency, etc) and moral rules. The moral principles are supported by background theories that express a view on the meaning and significance of procreation, marriage, sexuality and the family. Nowhere is the influence of the background theories more evident than for postmortem applications. The controversy about the acceptability of these applications can to a large extent be traced to different conceptions of procreation as a parental project. The opponents believe that the parental project stops with the death of one of the partners and that postmortem use should not be an option. The proponents, in contrast, think that the project may continue to exist with the surviving partner. Nevertheless, both parties will probably agree that some kinds of postmortem use cannot be fitted into an acceptable view on the parental project. For instance, a man who indicates that after his death his spermatozoa should be used to impregnate a surrogate cannot be seen as working on a parental project since neither he nor his present partner will be the future parents of the child. We only have to consider some extreme possibilities to know that the use of gametes is not only a matter of personal desire and individual decision making. As Aziza-Shuster (1994) pointed out: `But what if he had directed the bank to release his spermatozoa to 1000 women to maximize his chances to procreate?... He could also have bequeathed his spermatozoa to impregnate his daughter or his mother, or even a gorilla' (Aziza-Shuster, 1994Go). The question is not whether societal rules should restrict individual wishes but to what extent they should do so.

In countries where no legislation exists concerning the disposition of cryopreserved material, every fertility centre is free to extend or limit the options. In the other countries with legislation, fertility centres can restrict the legal options further. The latter right is based either on the right of conscientious objection of the physician or on the right of the institution to manage its activities according to the moral principles that express its religious or moral denomination. I think that the procedure for the management of genetic material in a pluralistic society should try to respect the individual beliefs as much as possible by settling for a minimal set of enforced restrictions. Still, a balance should be reached between the rights of the [physician in a] fertility clinic and the rights of the patient. There is general agreement that the patient's right to decide cannot be a positive claim right to treatment. The physician is not obliged to do whatever the patient requests. An equilibrium between the autonomy of the treatment provider and the autonomy of the patient can be found by emphasizing the distinction between the agreement to freeze and the agreement to use the material for certain purposes. The programme should clearly state at the start of the treatment and before freezing which kinds of treatment they consider acceptable. If a clinic stipulates in the consent form that embryos will not be replaced after the death of the male partner, patients cannot request this act but, if the patients later change their minds, they should have the right to transfer their embryos to another clinic that accepts to do so. Patients can avoid the institutional policy by taking themselves and their material out of the institution. Strictly speaking, a fertility centre has no right to restrict the options of the patients, it can only circumscribe their own participation and collaboration. The distinction can serve to avoid conflicts not only when patients and clinic disagree on treatment options but also on the acceptable forms of disposition. A programme may state that they do not accept destruction of embryos due to ethical principles but this only means that they may refuse to destroy embryos themselves. The clinic cannot block the transfer of the embryos to another clinic that accepts destruction. The privileged status of the right to dispose favours a system in which the gamete provider has the right to transfer his or her material. It would lead us too far to elaborate on the merits of the transfer of material and the referral of the patient as instruments to defuse the conflicts between patients and fertility centre but it is clear that these solutions are not acceptable for all (Corrigan et al., 1996Go).


    A conditional directive
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
Advance directives are conditional rules: they take effect only if the patient is unable to participate directly in the decision at the time that action has to be taken. Article 5.9 of the HFEA Code of Practice phrases this as follows: `Anyone consenting to storage must: b. state what is to be done with the gametes or embryos if he or she dies, or becomes incapable of varying or revoking his or her consent' (Human Fertilisation and Embryology Authority, 1990Go). It is inappropriate to appeal to advance directives when patients remain competent to guide their own care. The conditional nature of advance directives has far-reaching consequences for the organization of the procedure. Ideally, advance directives should only be asked to cover contingencies in which the patient is decisionally incapacitated, unconscious, comatose, demented or suffering from a debilitating mental illness. Since in ordinary situations the patients are still competent at the end of the storage period, the condition to apply the advance directive is not fulfilled. However, the large majority of cases in which the clinic has to rely on the advance directives of the patients does not concern death or mental illness but lack of response and untraceability of the patients. This reality makes it necessary to extend the advance directives to all situations in which no current informed consent can be obtained.

Advance directives have a special relevance for the cryopreservation of gametes as fertility insurance. Embryos are frozen to increase the success rate per stimulation cycle and to diminish the burden for the woman undergoing the treatment. They come into existence as part of a fertility treatment. Gametes, on the other hand, are frozen to preserve the possibility of having genetic offspring in the future. Apart from men who decide to have a vasectomy, the largest group of people who seize the opportunity of storing their gametes are cancer patients whose fertility is threatened by chemotherapy or radiotherapy. Compared to the general population of fertility patients, this group has a diminished life expectancy. Given the risk of death in the following years, advance directives are indispensable in this context. Some highly controversial cases were precisely about patients who died before they had expressed a wish about the disposition of their gametes. Although it can be argued that in exceptional situations the advance directives should not be asked before the production of the sperm sample, it is strongly recommended that a provisional directive is available before freezing. A provisional directive is better than none at all. However, we should not focus on the formal aspect of giving consent. The decision made in a period of considerable psychological stress and physical discomfort does not necessarily express the autonomy of the patient. Therefore, the decision should be raised again some time afterwards (Bahadur, 1996Go).

Although most authors present the advance directives as conditional rules, they do not select the events that trigger their application according to the competence or autonomy of the patients. The Ethics Committee of the ASRM (1994) states that dispositional directives should be asked for the following contingencies: death, divorce, unavailability, disagreement, passage of time and arrears in paying storage fees. The main reasons for requiring prior agreements are to prevent judicial involvement and litigation, to minimize disputes and to implement the decisional authority of the gamete providers (Robertson, 1989Go; Ethics Committee of the ASRM, 1994). It will be argued that the autonomy of the gamete providers is not served by asking advance directives for circumstances in which the patients are still competent.


    Informed consent at the end of the storage period
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
The discussion about the disposition of embryos is focused on whether the advance directives should be applied without confirmation at the end of the storage period. Although the question is equally relevant for the disposition of gametes, it is considered much less urgent and important because of the relatively minor moral value accorded to the gametes. The main arguments for supporting the application of the unconfirmed instructions, are: (i) asking for confirmation exerts pressure on the patients; (ii) asking for confirmation implies that the patients are not taken seriously as autonomous decision-makers at the moment of freezing; and (iii) the patients have the right and the possibility to revoke their decision at any time during the storage period. These arguments can be countered in general by rejecting the presentation of the inquiry by the clinic as a request for confirmation. The procedure proposed here has two parts: there is the advance directive at the moment of freezing to cover those future events in which no informed consent can be obtained (including disappearance and `no answer') and there is the informed consent at the moment of execution of the decision or at the end of the storage period. The informed consent asked at the end of the storage period is no confirmation since the question was not asked before. The advance directives are solely for those contingencies in which the patients can no longer decide. In addition, the arguments can also separately be refuted.

Unnecessary pressure
The patients know that they will be contacted again to state the disposition of their embryos when the storage ends. The use of a certain degree of coercion to obtain consent from the gamete providers is justified since they are responsible for their gametes and embryos. Moreover, their argument can be used against the proponents of the unconfirmed application of the instructions themselves since asking every patient to give advance directives before the treatment starts, and requesting an answer as a necessary condition for freezing, also puts pressure on the patients. If all instances of coercion were wrong, it would not be allowed to force patients to indicate clear dispositions at the start. Finally, the patients can still ignore the request for informed consent simply by not answering.

Autonomy and the validity of the advance directive
The question remains whether autonomous persons can be asked to tell what should be done with their gametes and embryos at the end of the storage period. It is one of the major expressions of autonomy to be able to bind oneself in the future (Feinberg, 1986Go). A promise can serve as a paradigmatic example here. Since we consider the limiting of the future options as acceptable in ordinary life, there seems to be no reason to oppose an advance directive for the end of the storage period. However, a number of shortcomings and pitfalls are directly connected to the passage of time. These elements are strong indications that the authority of advance directives should be limited. The reasons can be divided in two groups: the internal (moral and psychological) and the external (legal and social) changes.

One of the most important factors in the decision process is the difficulty of grasping the future situation. A necessary condition to determine what you will desire in the future is to bring the situation clearly to your mind. The complexity of the task is mainly due to the need to take into account all the intermediate changes. An important element is the occurrence of major alterations in the value structure of the person between the decision and the time when it applies. Suppose a couple decides at the moment of freezing to donate their embryos anonymously to another couple. This decision may be due to their limited ability to know what it is like to be a parent. The couple may hold the view that the genetic link between parents and children is of little importance compared to the emotional and psychological relationship. Having children of their own, they may come to attach a much greater importance to the genetic link. They now look at their previous convictions as a psychological protection they built against the possibility of treatment failure and the subsequent need to rely on adoption or gamete donation. The treatment (whether or not successful) and the ensuing emotional and relational experiences may lead to drastic changes in the needs and interests of the patients.

The difficulty of picturing the situation can be partially diminished by transferring the consent from before the treatment to just before freezing. If the question is put before the patients at a time when they do not know whether there will be embryos at all, whether the embryos are of sufficient quality and whether there will be enough embryos to have some stored, it will be very difficult for patients to make up their minds. At a moment in the treatment process when they would be delighted by the news that they have embryos that can be replaced, they have to decide how to dispose of them. It seems that at least these unknown facts can be avoided by postponing the decision until just before freezing.

The bias introduced by the temporal distance to the decision process is an additional reason for caution. Since the situations at which the advance directives are directed, are by definition not actualized but only possible, there may be a tendency both of the counsellor and of the patients not to think seriously about the matter. The hypothetical nature of the events (what if you have embryos, what in case you have all the children you want) may reinforce the perception that the advance directive is part of the ritual rather than a potentially important decision. Psychological research has shown that temporal distance influences both the perception of the seriousness of the event and the perception of the probability of the event (Kok, 1983Go).

Extensive counselling is the obvious method to reduce the threat of these psychological factors to the validity of the advance directives. It is essential that the counselling for advance directives is done as thoroughly and according to the same standards as the counselling for informed consent (Emanuel, 1994Go). `The moral importance of an advance directive should increase to the degree to which it replicates a thoughtful, informed, contemporaneous decision by the patient' (Lynn and Teno, 1995Go).

Secondly, there may be all kind of changes in the social and legal situation which may nullify the directive. The problems caused by the modification of regulations in the UK can illustrate this point. In 1991, the law limited the storage period to 5 years. However, a few months before the end of that period in 1996, an extension for another 5 years was accepted on the condition that the gamete providers requested the extension. This change in the storage conditions made it morally obligatory to ask all patients with cryopreserved embryos whether they desired the extension. In fact, all changes in the applicable law and in the institutional policies may make a difference for the decision. Suppose that the couple agreed to the donation of their embryos to others but that in the meantime the anonymity of the donors is no longer guaranteed. Alterations in the options offered at the clinic before the moment of implementation should also be mentioned to the patients. For instance, if the clinic did not allow post-mortem use of genetic material, this policy may change afterwards. The additional option should not be withheld from the patients who still have embryos stored.

Major changes in the therapeutic efficiency and safety can take place between the time of freezing and the time at which the directive is to be implemented. For instance, at present the success rate for people with one or two embryos frozen is small. It was found that fear of treatment failure was cited as the reason for delay to return for replacement in 32% of the group with a single embryo remaining in storage (Lieberman et al., 1996Go). If the patients estimate the chance of success as insufficient to justify the effort and stress of another cycle, they may decide to dispose of their embryos. However, suppose that in the meantime a new method is discovered to increase the chances of pregnancy. This change should be mentioned to the patients because it is relevant to their choice. With an increased success rate, the couple may ask for continued preservation for their own use or for replacement. Similarly, the available knowledge concerning the safety of certain procedures, like oocyte freezing and the use of immature spermatozoa, may increase to such a degree that the procedure could make the transition from experimental to therapeutic treatment. This evolution would be relevant for those people who have genetic material stored under such form.

The legal and policy changes are not an intrinsic difficulty for advance directives. If such changes do not occur, the validity of the directives stands untouched. The psychological biases, on the other hand, strongly recommend caution. Two arguments settle the issue. Firstly, there is no reason why the early disposition should be followed if the patient remains competent. A physician should not start looking for a donor card if the person who is now considered as a candidate donor, is able to consent to the donation. Similarly, we should not look up the consent form dating from the start of freezing if we can ask consent now. Secondly, the decision taken by the gamete providers before the treatment will almost certainly be less rational and less informed than the decision just before the execution. A rational decision is adjusted to the situation and leads to the realization of the person's or couple's wishes and plans. The rationality is hampered by the uncertainty of the future situation and by the ignorance of the future wishes and desires. Both elements reduce the adequacy of the advance directive and support the submission of an updated consent.

The patient as an imperfect decision-maker
People who defend the application of the advance directives at the end of the storage period always refer to the possibility of every person to change his or her directives at any time. In principle, a person can always revoke the original statement and issue a new one that corresponds with the new value structure or the new situation. It seems logical that people inform the clinic and change their directives if an alteration in the value ranking or in the psychological appreciation of the situation takes place. However, `in practice, people may neglect to do so due to time constraints, procrastination, forgetfulness, or laziness' (DeGrazia, 1999Go). Procrastination can play a role in the process of deliberation (I will think about it later) as well as in the communication of the decision to the clinic (I will tell them next time I'm there). Procrastination may be irrational but it is still a personality trait people exhibit to a smaller or larger degree. This tendency may be stronger if the patients consider the task at hand as extremely difficult or disagreeable, if they have no recipe to lead them through the process and when they hope that the obligation to make a decision will simply go away if ignored (Sabini and Silvers, 1982Go). In a sense, they may even be right about the last belief: if they keep putting off the decision, the decision will be made for them. Moreover, if the couple does not feel confident about their decision, they may keep it under consideration. They postpone the notification of the clinic of the modification because they might always change their minds again before the end of the storage period. Structuring the decision process may help against procrastination. An obvious method to do this and simultaneously to prevent loosing touch with patients is to write to the couple at regular time intervals, for instance each year (France, 1994Go; Brinsden et al., 1995Go). This strengthens the relationship with the clinic and keeps the existence of their gametes and embryos at the front of the patients' minds. They are not allowed to `forget' their embryos. The letter from the clinic a short time before the end of the storage period may prompt a response by setting a clear and well-defined end point.

Summarized, two positions can be taken concerning the reach of advance directives. The `tolerant' stance accepts that there may have been a change of mind in the patients that they did not communicate to the fertility centre. It accepts that people may have to be pushed to make a decision and to impart the conclusion of their deliberation to the clinic. This stance takes into consideration the weakness and imperfection of people as decision-makers. Consequently, the clinic should try to maintain contact with the patients and should at least write to the patients a short time before the directive will be implemented.

According to the `strict' stance, the statements or directives issued by the patients are valid as long as they are not revoked. If the patients are still competent and do not take steps to review their instructions, there is no reason to doubt the moral authority of the advance directives (Rosenwaks and Davis, 1997Go; Englert, 1998Go). `It is the right and obligation of competent persons who change their views and preferences to let others know, and if they do not do so they carry the risk of being misunderstood and mistreated' (Sass, 1998Go). Consequently, there is no need for the clinic to approach the patients again.

The two positions differ on the extent to which the psychological failings and faults should be taken into account when organising the consent procedure. The difference only affects those situations where the decision is made at the end of the storage period. The `tolerant' stance takes exactly the same position towards the advance directives as the `strict' stance in those cases in which the condition of decisional incapacity is fulfilled. If the patient dies, disappears, fails to answer or becomes incompetent, the last directives known to the fertility centre should be applied.


    Shared responsibility of the couple and the fertility centre
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
A very disturbing finding that is mentioned by most people who have direct experience with embryo cryopreservation, is that a considerable number of the patients disappear or do not answer the letters sent by the clinic (Saunders et al., 1995Go; Ruiz et al., 1996Go; Edwards and Beard, 1997Go). In the study of Lieberman et al. 11.9% did not react to the call of the fertility centre to make their wishes known and the same number were no longer living at the last known address (Lieberman et al., 1996Go). In the patient group of Saunders et al. 38% did not answer and 10% had disappeared (Saunders et al., 1995Go). A recent survey in Texas showed even 49% who did not respond and 12% of the letters were returned as undeliverable (Brzyski, 1998Go). These two factors explain the overwhelming number of cases in which no recent updated informed consent could be obtained.

The attitude of some patients towards the destination of their embryos is astonishing at first sight. If they find their embryos as important as the ethicists say they do, then why do they not take the opportunity to decide their fate? The comparison with similar decisions may help us to understand this phenomenon. People show a general reluctance to make choices in such matters. Organ donation can illustrate this point. In most countries, a considerable group agrees to the use of their organs for transplantation. However, the number of people who carry a donor card or who have registered as organ donors is very limited (Hessing, 1990Go). Similar experiments have been conducted to increase the prevalence of formal advance directives for the end-of-life decisions (Hare and Nelson, 1991Go). Even after extensive counselling, the number of people who are prepared to complete written directives is small. When we return to the attitude of patients towards their embryos after this roundabout route, a different explanation is suggested. The reluctance of people to dispose of their embryos does not (necessarily) express detachment from their genetic material or indifference towards the fate of their embryos. The attitude toward the decision rather shows uncertainty, a desire to keep their options open and to avoid irreversible statements and a general uneasiness and unfamiliarity in thinking about these issues. This attitude makes people put off the decision until the last minute or even until it is too late. This hypothesis is corroborated by the survey of Brzyski (1998) who found that about half of the responders had no plans regarding their cryopreserved embryos and by Lieberman et al. (1996) where 34% of the couples did not know whether they intended to use their embryos in the future. On the other hand, even this should not come as a surprise since quite a number of couples wrestle for years with the question of whether or not to have another child.

When the embryos were destroyed in the UK in 1996, some authors pointed the finger at the fertility centres who `had failed to take all reasonable steps open to them over the years to keep in contact with their patients' (Ross, 1996Go). This, however, is a very one-sided perspective. There is no obvious reason why the obligation to keep in touch should lie solely on the side of the fertility centre. The question of initiative should not be addressed as a clash of obligations between two parties. The clinic should help the patients to exercise their right to decide and, simultaneously, the patients should make an effort to fulfil their duties. Both parties have an obligation to maintain contact. The centre has a duty of care towards the patients. Their wellbeing should be one of the clinic's main objectives. Obtaining explicit informed consent shows care and prudence by the clinic. The demand of informed consent at the moment of disposition should be seen in the same perspective as the offer of counselling. By offering counselling the clinic tries to help the patients to make the best decision and it cannot do this by taking a completely passive stance. Legally the written directives might do but it does not show a great deal of concern for the patient if the clinic leaves it at that. However, the fertility centre is no detective agency and cannot be expected to perform elaborate searches for patients. Most informed consent forms mention the obligation of the patients to inform the clinic of every change of address. The clinic discharged its duty when it made a reasonable effort to stay in touch. It cannot be blamed for failing if this happens due to negligence by the patients.

The patients, on the other hand, have a responsibility for their genetic material. They agreed to freeze their gametes and embryos and they should be prepared to decide about the disposition. By not responding to the appeals for a decision, they are in fact transferring the decisional authority and burden to the clinic (Veeck, 1997Go). This is unfair because this puts the clinic in a very difficult position. Because of the refusal of the patients to decide, the fertility centre has to dispose without having received authorization.


    Divorce and the right to change one's mind
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 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
Up till now, the couple was considered as a unit talking with one voice. However, a couple consists of two people who each have an opinion on the disposition. The general principle guiding the decisions concerning embryos is that it is a joint decision. This principle is based on the idea that an embryo is part of a parental plan made by two people who have an equal interest in the embryo. Although differences of opinion are normal also in close relationships, the partners are supposed to surmount these differences in a final destination. A major threat to the consensus within the couple is separation and divorce. Not only is divorce a very common event, it is a situation of intense conflict in which rational and serene deliberation about the fate of embryos does not come easily. Nevertheless, it will be difficult to argue that divorce and separation have a negative impact on the ability to decide what is in one's own interests. The situation is completely blocked; no compromise can be offered because the options are mutually exclusive (i.e. one cannot respect the directives of both partners) and because any action will frustrate one of the parties. Two solutions seem to be preferred by the institutions. Firstly, in the consent form signed by the parents, the clinic states that the embryos will be destroyed in case of disagreement. Disposal or destruction, however, is not a neutral solution. Destruction of the embryos inevitably entails the violation of the right to procreate of the partner who wanted to use them for this purpose. This means that as a general principle the right not to procreate is given priority over the right to procreate (Robertson, 1991Go, 1999Go). The second solution adopted by a number of fertility centres is to have the patients decide in advance what should be done in case of divorce. Such `separation agreements' are sometimes used to solve divorce problems before the actual divorce. The agreement may stipulate property divisions as well as issues of custody and maintenance of the children (Baumrin, 1998Go).

When we are talking of the directives of one person, we assume that the most recent directive is valid. If a person changes his or her mind and informs the clinic, the last directive always supersedes any previous document. However, the right to change one's mind is seriously restricted if both partners have to agree on the disposition. Like contracts, joint agreements cannot be changed unilaterally in normal circumstances. This poses two serious problems. First of all, some very fundamental rights, like the right to procreate and the right not to procreate, may be inapplicable due to the prior agreements. `A person should not be forced to have his or her genetic material created into a child' (Forster et al., 1999Go). Everyone seems to share this position but what happens if there is an advance agreement that gives the control over the embryos to the partner? By signing the contract, one party looses the right not to procreate. Whatever the disposition laid down in the pre-treatment agreement, one of the rights will be pre-empted. The authority of the advance agreements becomes absolute if no subsequent changes are permitted. If there are no neutral solutions, should we give priority to the right to procreate or to the right not to procreate?

The second problem is that the basic right to change one's mind is overridden by pre-treatment directives. In 1998, the American Bar Association adopted a proposition (that was later indefinitely postponed) stating that the party wishing to procreate after a divorce should gain control of the frozen embryos (Forster et al., 1999Go). One of the arguments for this proposition is that both parties originally, i.e. at the start of the IVF treatment, intended to procreate. However, `one's intention and consent to undergo a medical procedure to procreate should not be forever binding. People should be free to change their minds and withdraw their consent at any time' (Forster et al., 1999Go). The problem can be described as a conflict between two aspects of autonomy. On the one hand, there is the right to make voluntary commitments and to bind ourselves in the future (Feinberg, 1986Go). On the other hand, there is the `ability to change our minds in the light of new ideas, beliefs, and desires' (Radden, 1994Go). The right to change one's mind conflicts with the pre-treatment agreement. A choice has to be made: or we accept the right to change our minds and pre-treatment agreements have only limited value, or we attribute a substantial authority to pre-treatment agreements which seriously restricts the right to change our mind. Personally I tend to give greater weight to the right to change one's mind. Consider the case of a couple that agreed on the donation of their embryos to anonymous others. Suppose one partner later objects to this destination and wants to discard the embryos. Would we enforce the agreement in the name of autonomy? Would we enforce the instruction because he or she, as an autonomous person, consented to it five years ago?

There is one exception to the right to change one's mind that is worth mentioning in this context. The partners should not have the right to revoke their consent if this choice was a material condition for the start of the treatment (Robertson, 1989Go). A decision is a material condition when that specific disposition is a necessary condition for the other partner to start treatment and freeze embryos. This seems unlikely for most advance agreements concerning the disposition of embryos but it might be true in special cases. If it applies, the consent of both partners should be considered as a promise. Promises, as opposed to vows, are morally binding because others may come to rely on them and count on the other's `faithful adherence to the earlier agreement' (Radden, 1994Go). In those cases, the prior agreement is a binding commitment. An instance of such a promise in the context of assisted reproduction is the declaration of a sperm donor to release his name to the adolescent child. Since the parents choose that donor because of the promise he made and because they intend to act on that promise for instance by telling the child of the way it was conceived, the donor should not be allowed to revoke his consent (Pennings, 1997Go).

The disagreement that results from a change of mind should be solved by balancing the rights and interests of all the parties involved. A third party will have to be brought in to adjudicate the conflict. The court looks like the most obvious solution. Firstly, it is a recognized independent institution that has been given this task in a democratic constitutional state. Secondly, if another institution, like a clinic, would decide, the party that feels wronged by the verdict will probably bring the case before the court anyway. Bringing the conflict before the court is certainly not an ideal solution (it would be preferable if the partners could reach an agreement) but it may still be the best solution. If the validity and moral power of the pre-treatment agreements is too low to justify legal enforcement, the balancing of the interests of the parties by the courts may in general lead to greater justice than sticking to the contracts. The arguments that we mentioned earlier to restrict the authority of the advance directives also serve to limit the value of prenuptial or pre-treatment contracts for the disposition of embryos.


    Conclusions
 Top
 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
Advance directives extent the authority of the patients concerning the disposition of their gametes and embryos. The options among which people may choose are embedded in a framework of medical, social and moral principles. Since the right is considered as fundamental, the wishes of the patients should have priority on the policy of the institute, which stored the genetic material. Conflicts about the use of the material can be solved be transferring patient and material to another fertility centre that agrees to participate in the chosen treatment.

Advance directives are very useful instruments to know what should be done with the genetic material in case the patients become incompetent or unavailable. However, their validity and moral authority can never reach the same level as the current informed consent by a competent and autonomous person. If the fertility centre and the patients make an effort to fulfil their obligations, such an updated consent can be obtained.

The management of cryopreserved embryos is the joint responsibility of both the fertility centre and the intended parents. The patients fail their obligation towards their gametes and embryos and towards the clinic when they disappear or do not respond to requests for informed consent by the fertility centre. These patients should, for all practical purposes, be considered as incompetent and the originally stated destination should be honoured. The clinic, on the other hand, should only rely on advance directives if really necessary. Advance directives are conditional guidelines that only take effect when the patient is no longer able to decide what should be done. If the individual is competent at the end of the storage period, he or she should be offered the possibility to give an actual informed consent, which renders void all previous ones. Both the complexity of giving advance consent for a distant and uncertain future and the weakness of humans as decision-makers are reasons for taking a supportive attitude toward the patients.


    Notes
 
This debate was previously displayed on Webtrack, February 2, 2000


    References
 Top
 Introduction
 Informed consent and advance...
 Restrictions imposed by the...
 A conditional directive
 Informed consent at the...
 Shared responsibility of the...
 Divorce and the right...
 Conclusions
 References
 
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