Decisional authority of gamete donors over embryos created with their gametes

Abstract

In the ongoing discussion on the rights and obligations of gamete donors, scant attention has been paid to the decisional authority of gamete donors over the disposition of the embryos created with their gametes. This paper analyses four different positions: three cases relate to the disposition options for surplus or unused embryos by the first recipients, and one case relates to the use of the embryos stored by the first recipients for procreation.

We conclude that the gamete donor causally contributes to the creation of the embryos and thus becomes indirectly responsible. To avoid that donors would become accomplices to an activity to which they morally object, a qualified generic consent mentioning types of research should be obtained. No consent from the donor is required for the destruction of the embryos.

The cancellation of the agreement by anonymous or identifiable gamete donors should not be possible for embryos in storage for reproduction by the recipients. The interests in not becoming a genetic parent against one’s wishes do not outweigh the damage done to recipients who would no longer be able to use their embryos. Known donors, on the contrary, should be able to withdraw their consent up to the moment of transfer of the embryos based on the greater harm caused to them as a consequence of attributional parenthood. They should also be able to veto transfer of the embryos to other people than the original recipients.

Introduction

IVF patients frequently have leftover embryos after their fertility treatment. In most countries, patients have three options for the disposition of their embryos: to donate to research, to donate to others for reproduction, and to discard. Research indicates that there are large numbers of cryopreserved embryos created with donor gametes left unused by the recipients [1] [2]. The question is what decisional authority gamete donors should have about the disposition of embryos created with their gametes. There is considerable variation of opinion although traditionally recipients were given the right to decide. The general consensus regarding donations of other body material is that the donor has the sole right to make decisions about the use of his/her material. An important difference with other material is that, if everything goes well, the gamete is integrated into an embryo.

For the analysis of this topic, we consider a donation as an agreement by the donor with another party (clinic, bank, recipient, etc.) for the transfer of gametes. This agreement includes rights and obligations, conditions, and restrictions that bind all parties in the agreement. The agreement also indicates the purpose for which the gametes are donated: reproduction, research, or both.

Embryos for research

In those countries where embryos can be created for research, gamete donors are recruited who donate specifically for those research projects. They receive all the relevant information about the project in order to be able to give informed consent. When donors donate for reproduction and the recipients later decide to donate the embryos for research, they are not informed or consulted at all. A study in the USA showed that about 30% of the consent forms indicated that leftover embryos could be donated for research and 8% for stem cell research [3]. A control of stem cell lines in use in research revealed that, for a considerable number of the lines created with donor gametes, it could not be demonstrated that consent had been obtained from the gamete donor [4].

Little is known about the attitude of gamete donors on this issue. One study surveying this point indicated that 41% of egg donors did not feel at ease with giving recipients complete decisional authority over the embryos [5]. A later study, on the contrary, found that the overwhelming majority of the egg donors (95%) were comfortable with recipients making the disposition decisions [6]. The same percentage also accepted the use of the embryos for research in general and stem cell research in particular [6]. The studies indicated that a small minority (below one in four) of egg donors did not want the embryos created with their eggs to be used in research [5] [7] [8].

There is considerable variation in the guidelines or legislations regarding this issue. About a decade ago, a fierce debate took place in the USA as some important research institutes and organizations adopted opposite positions. The National Institutes of Health (NIH) maintained that no consent had to be obtained from gamete donors [9]. The persons responsible for the creation of the embryos are responsible for the disposition of the embryos. In contrast, the National Academies of Sciences (NAS) and the International Society for Stem Cell Research (ISSCR) explicitly requested consent by the gamete donor [10] [11]. In Europe, legislation differs between countries. Belgium and France do not demand consent from gamete donors, while the Scandinavian countries do [12].

The main argument to give decisional authority to the gamete donor is that he/she has the right to decide what can be done with his/her body material on the basis of the principle of respect for autonomy. The donor donates to help others to start a family; use of embryos made with his/her gametes for research deviates from this agreement. The donors are misled or deceived when the embryos are used for research [13]. In addition, most embryo research is highly controversial, and there is little doubt that some donors morally object to it [14]. When the embryos are used for research, some donors are collaborating in an activity that goes against their preferences and values [15].

The authors who do not request consent from donors argue that the research takes place on embryos, entities that fundamentally differ from what the donor has donated [16]. In addition, donors relinquish all rights at the moment of donation, and the decision from then on lies with the “owners” of the embryos. This reasoning assumes that the donor is not morally involved in what happens to the embryos. Support for this reasoning can be found in the “voluntary intervention” principle. According to this principle, the donor is discharged from moral responsibility by the disposition decision of the recipients [17] [18]. The gamete donor causally contributed to the creation of the embryos, but the causal chain does not continue to the research phase because of the autonomous decision of the recipients. Other theories of responsibility attribute partial moral responsibility to the donor because he/she contributed to the creation of the embryos and because he/she could have foreseen the use of the embryos for research (at least some embryos will be directed at research) and has not taken steps to prevent this from happening [19]. These newer theories are gaining momentum in the last decades because the underlying metaphysical assumptions of the former theories seem untenable [20]. Following the latter position, a donor should be asked to consent to prevent involvement in something to which he/she morally objects.

An important question is how this will be organized. The minimal procedure is that the donor is informed about the possible use of the embryos for scientific research but his/her consent is not asked [21] [3]. In fact, the donor also has the possibility of refusal since he/she can refrain from donating if he/she disagrees with this option. The second option is that the donor is informed and provides consent [22]. In this procedure, the donor can be accepted as a donor even when he/she rejects scientific research. He/she can be matched with recipients who do not want to donate their embryos to scientific research. The most far-reaching option is that gamete donors are counseled like research donors and embryo donors and are given the possibility to indicate for which research project that they accept the embryos to be used. This option comes with some serious practical problems. The donor would have to give consent at the moment of donation because recontacting is difficult and delicate. Most of the time, many years will have passed before the embryos are used for research, and it will be impossible to predict which research will be running then. Counseling donors will also be hampered by the fact that they donate for reproduction and will mostly be interested in the aspects and implications related to that goal. Moreover, the information regards a double hypothetical situation: the donor does not know whether there will be embryos left in the future and he/she ignores whether the recipients will donate the embryos for research. When the measures to prevent a donor from becoming involved in research against his/her will are driven too far, the risk increases that embryos will not be used that donors would have accepted to be used for research. Demanding a contemporaneous full consent at the moment of use in research, for instance, would have this effect, especially in countries where donors are anonymous. Experience with IVF patients with frozen embryos showed that large numbers did not reply or could not be tracked at the end of the storage period and there is no reason to expect that the response rate would be higher for gamete donors [23]. From no response or untraceability, one cannot conclude that the donors would not accept the use of the embryos for research.

Still, if we take the autonomy of the donor seriously, a very broad consent for scientific research is insufficient. An intermediate position would be to enable donors to approve the use of the embryos for general types of research. Such system has been adopted in Belgium for embryo donors for similar reasons [24]. These broad categories include, for instance, genetic testing, embryonic stem cell research, and freezing techniques. This implies that donors and recipients have to coincide on the types of research for which the embryos can be used. If new controversial research lines are introduced (such as genome editing or stem cell–derived gametes), these would have to be added to the possible types for which the donor should provide consent. As a consequence, embryos already in storage without approval for such new research cannot be used.

This qualified generic consent for embryo research should be supplemented with a more specific consent in certain situations. Scientific research may include parts that have direct implications for other interests of the donor, beside the involvement in the use of the embryos. In the debate on stem cell research, several authors pointed at the fact that a genomic analysis is performed on stem cell lines and that this analysis may reveal health information of the donor [25]. Moreover, these stem cell lines continue to exist for many years, and the genetic information will be available for an extended time [15]. The recent developments in genomic testing and the use of large genetic databases allow people to trace the identity of the donor and his/her close genetic relatives [26]. This point of more specific consent is independent from the research on embryos: it applies to all genetic testing, including in the context of embryo research. The possible violation of the privacy of the donor is sufficient reason to ask specific consent for the genetic analysis and the use of the data. Merely informing the donors that such information will be collected, as stated by the Ethics Committee of the American Society for Reproductive Medicine, will not do [27].

Donation to others

The donor donated to enable non-specified others to realize their wish for a child. If the first recipients no longer need the embryos created with his/her gametes and do not object to donation themselves (the embryo will most likely also contain a gamete of a partner), they may donate these embryos to others. People find it easier to donate embryos made with donor gametes than embryos entirely made with their own genetic material [28]. Some donors seemed to be concerned about the possibility that these “secondary” recipients would be insufficiently screened, but there is no reason to suspect that their screening would be worse or different [5]. Since this disposition falls within the original agreement, there is no reason to inform the donors about it, let alone to ask their permission for it. An exception has to be made for known donors. Known donors are defined here as donors who have a personal and long-term social relationship with the recipient(s). Donors whose identity is known to the recipients at the moment of treatment but who do not have such personal and long-term relationship (e.g., they have been recruited online or through social media) are not included in this category. For oocyte donation, they are mostly sisters or good friends of the female partner. A considerable proportion of them want to donate exclusively to a specific recipient [29] [30]. They have several reasons for this preference: trust in the recipient as a future parent, a personal or genetic relationship with the recipient, etc. If a known donor wants to restrict the use of his/her gametes to a particular recipient and thus indirectly the embryos created with them, he/she should be able to stipulate this in the agreement.

Discard

In principle, a donor may want to stipulate that embryos made with his/her gametes cannot be destroyed. He/she might claim that destruction demonstrates a lack of respect for the donation. However, the decision to discard will in most cases be a well-considered decision by the recipients based on good reasons and thus not show a lack of respect for the donor. The donors have to trust the recipients not to take this decision lightly. This is corroborated by the finding that many patients really struggle with the decision and find it very hard to make a final disposition decision [31]. Moreover, a prohibition on discarding the embryos may force recipients to perform, what they consider to be, senseless (unlimited preservation) or unacceptable (donation to others) actions. The conclusion is that donors should know that some embryos made with their gametes might be discarded but that they cannot oppose this decision.

Withdrawal of consent

Above we have considered the decisional authority of gamete donors related to embryos that will no longer be used by the original recipients. A much more contentious situation is created when a gamete donor is given decisional authority over embryos kept in storage for possible future use by the original recipients. Decisional authority includes the right to withdraw consent. Withdrawal of consent in those situations implies that the embryos can no longer be used for reproduction. That right is attributed to the donor in a number of countries. The law in Finland, for instance, stipulates that gametes cannot be used for reproduction without the consent of the donor up to the moment of transfer of the gametes into a woman’s womb [32]. Similar reasoning is adopted in the HFEA Code of Practice in the UK [33]. These rules do not distinguish between a gamete donor and a partner. The gamete donor and the partner who provided the other gamete are treated equally. To tackle this case, we need to clarify a number of points.

An agreement is not without obligation: it implies minimally an engagement to honor the agreement, also from the side of the donor. “Withdrawal of consent” (the terminology found in the literature) means that the agreement is revoked unilaterally. Framing this decision in terms of “withdrawal of consent” is inappropriate since a person who withdraws consent (to a medical intervention, participation in research, etc.) will normally not be asked to provide reasons. Breaking an agreement, on the contrary, has to be justified.

There are different approaches to adjudicate embryo disputes: the contemporaneous mutual consent approach, the contractual approach, and the balancing of interests approach [34]. In ethics, balancing the interests of the different parties is the most commonly adopted approach. If the contract can be broken without major damage to another party and with a (more) positive outcome for the requesting party, cancelation or change can be considered.

But at which point can a cancelation or revision of the agreement no longer be demanded? Several “points of no return” can be distinguished: the moment of donation, attribution to a specific recipient, fertilization, and transfer to a woman’s womb [33]. The discussion mainly regards fertilization [35]. This point of no return is based on the idea that the gamete has been used and there is no way back. There is obviously no way back to a gamete, but there may still be a way back in terms of use. If a donor changes his/her mind about the use of his/her gametes after fertilization, reproduction with his/her gametes can be prevented by discarding the embryos. However, this option causes considerable harm to the single woman or recipient couple since they will have to look for alternatives such as starting a new IVF treatment, looking for a new donor, etc. These alternatives all bring large costs in terms of time, money, and psychological distress [36]. Moreover, in some cases, there are no alternatives. Women before cancer treatment often have their eggs fertilized with donor sperm. If the donor can withdraw consent, the whole procedure would be for nothing (if indeed she turns out to be infertile) and her chances of genetic parenthood would be gone. Here a balance between the interest of the donor not to become a genetic parent against his/her will seems to weigh less heavily than the interest of the intentional parent(s).

A crucial point in this balancing exercise is the importance of forced parenthood. In conflicts between ex-partners about the disposition of cryopreserved embryos, the right to reproduce of one partner (usually the woman) is balanced against the right not to reproduce of the other partner (usually the man). Both rights are mainly understood in the purely genetic sense, i.e., the right to have or not to have genetically related offspring. In almost all court decisions, the right not to reproduce prevailed and the embryos were discarded. Can this conclusion be extended to the present setting?

An important question is what the harm of becoming a genetic parent against one’s will consists of. First, there is the general concern that a person’s body material is used without his/her approval. There is also the belief that a child is created who has a genetic link with the person. The genetic link as such has no positive or negative meaning: the value depends on the social and moral norms of the persons evaluating the link. A donor who does not see a genetic relationship as something that generates certain expectations, rights, and obligations will feel fine with the creation of such link. A person who in contrast believes that a genetic relationship entails certain rights and duties will be harmed if such relationship is created against his/her will. However, the donor is not the only person judging the genetic link. At least three parties can and will judge: the donor him/herself, his/her social environment, and/or the child. This may explain why some donors do not want it to be known that they are donors (others may see him or her as a parent even if they are not seen as such within the gamete donation system) and do not want to be identifiable (others, including the offspring, may see the donor as the parent of an identified person). This may also explain why some female partners find it difficult to cope with the idea that their partner was a sperm donor in the past [37]. This idea closely links up with what Cohen has called “attributional parenthood”: “a harm that stems from the social assignment of the status of parent to the provider of genetic material that persists notwithstanding the fact that the legal system has declared him or her a nonparent” [38].

The position of the ex-partner (almost always the man) and the gamete donor vary considerably in this regard. The gamete donor has indicated by becoming a donor that he/she did not consider the genetic link as important for a parental relationship [39]. The ex-partners, on the contrary, both expressed the importance that they attributed to the genetic relationship with their offspring by starting an IVF procedure. During the fertility treatment, they both build expectations and formed visions of a future family and a relationship with a future child [40]. A child born from the embryos created during such treatment may be seen as “their” child, as the result of their previous parental project. In the case of Evans versus UK, the ex-partner of Evans explicitly refused to allow treatment of Evans outside their joint treatment [41]. The ex-partner will usually know that he has become a genetic father when a child is born to his partner and most of the time so will his social network. Even when he is not the legal father, he, his social environment, and the child may still believe that rights and obligations are connected to the genetic link. The consequences are much smaller for an anonymous or identifiable donor. Parenthood is an abstract fact: there will (presumably) be a child born somewhere who has a genetic link with the donor. The weight of attributional parenthood for anonymous or identifiable donors justifies the destruction of gametes that are still in storage but does not justify the destruction of embryos created with his/her gametes. The retrospective abolition of anonymity through the search of genetic databases for donors who donated anonymously significantly increases the harm to the donor as a consequence of the attributed parenthood.

A known donor, on the contrary, is much more similar to an ex-partner since the donor and his/her social network, most of the time, have personal contact with the child and know about the genetic link. It is imaginable that a known donor changes her mind about the further use for reproduction of her gametes still in storage after the birth of a child since she then experiences in real life what it is to be a known donor. A known donor thus has a much stronger reason to cancel the agreement. He/she should have the right to block the further use of the embryos. The recipients may regret the withdrawal of the donor, but, like the ex-partners, they have to accept the decision.

Conclusion

Gamete donors contributed to the creation of embryos intended for reproduction. If recipients want to donate surplus embryos to science, they should have the consent of the donors because this use deviates from a basic premise of the original agreement. Respect for autonomy of the donor, in combination with a number of practical concerns, leads to the conclusion that a qualified generic consent mentioning types of research at the moment of donation suffices. Simultaneously, more specific consent should be obtained if the scientific research jeopardizes other interests of the donor such as the privacy of genetic information.

The cancelation of the agreement to contribute to the reproduction of the recipients by anonymous or identifiable gamete donors can only be accepted up to fertilization. The interests in not becoming a genetic parent against one’s wishes do not outweigh the damage done to recipients who would no longer be able to use their embryos. Like ex-partners, known donors should be able to withdraw their consent up to the moment of transfer of the embryos based on the harm caused by attributional parenthood. They should also be able to veto transfer of the embryos to other people than the original recipients.

Compliance with ethical standards

Conflict of interest

The author declares that he has no conflict of interest.