Guidelines:
Background and recommendations
- The donation of genetic material whether sperm, oocyte or (pre implantation) embryo, in order to create a child raises a number of ethical as well, as social, religious, and legal issues.
- Genetic material donation has been mainly used to treat infertility for which no other treatment exists, or if costs are less, whether male (with sperm donation), female (with oocyte donation), or affecting both parties in the couple (with embryo donation). These conditions may be genetic, congenital, or iatrogenic, eg after chemotherapy for cancer, which may result in testicular or ovarian failure. Gametes donation has also been used in grave genetic disorders in order not to transmit a grave disease to the offspring, for single women or women in female couples wishing to have a biological child, for the achievement of postmenopausal fertility in older women, or in the management of habitual abortion.
- Some countries forbid genetic material donation to single or same sex couple women. There is no evidence in published studies of a negative impact on the offspring. Legislative choice, rather than medical indication, have impacted its choice.
- In order to ensure safety for recipients and offspring of genetic material donation, many countries have and all should have regulation regarding the cryo-preservation (banking) of sperm and embryos, the screening of donors and standards in the laboratory, the quality of the medical management, and rules respecting safety when collecting gametes and embryos. Finally, advance decisions by legislation or contract concerning the disposal of genetic material and accurate record keeping are essential.
- Screening of donors means to assure that donors of genetic material are healthy persons of normal reproductive age who are free from sexually transmitted diseases and known hereditary disorders. Thorough screening should follow national and internationally approved guidelines, and the result of abnormal test made available to the donors, with counseling when necessary. Genetic material from a dead person should not be used unless a written statement by the donor exists. When this is sudden or unexpected genetic material cannot be obtained from the deceased. Members of the medical team involved in the management of a recipient should not be donors.
- Although the term donation implies non payment, some compensation is often offered. Donation of genetic material should be altruistic and free from commercial exploitation. Reasonable compensation for legitimate expenses is common. If the monetary compensation markedly exceeds expenses, this may risk undue inducement for donation. In particular, compensation for sperm and oocyte donation is sometimes disproportionate, which raises further ethical issues, beyond the additional risks for oocyte donation.
- Exchange of services has been offered in some countries, especially for obtaining oocytes, where IVF cycles, (or rarely) female sterilization is provided without charge in exchange of oocytes. This raises the concern of undue inducement for donation, which means that appropriate consent is not obtained. Furthermore, this creates a conflict of interest for a donor that could lead to withholding information, which would otherwise make her unsuitable as a donor. Because an IVF patient undergoes the risk of ovarian stimulation, the added risk for additional donation may be minimal but must be considered. In any case, obtaining oocytes from a source outside, especially from resource poor countries, where one cannot check the standard of protection of the donor is unethical, and presents the danger of abuse
- Gametes and embryo donation may be intended to be anonymous or not. Careful counseling that acknowledges the potential of the child identifying his/her genetic origins is essential. If donation is between friends or family members, the risk of undue influence of the friend or family on the decision of the donor exists. In addition, anonymity of the donation may be more difficult to ensure in this setting. The more direct the donation, the higher the chance of the offspring obtaining knowledge about his/her origins in the future, whatever parental intentions regarding confidentiality. Even if the intention of the recipient is not to inform the child, there is always a risk of the origins being revealed unintentionally or in situations of disagreement in the family in a way that is not in the child’s best interests.
- Many countries have specific legislation pertaining to gametes and embryo donation, making clear the legal parenting of the intended parents and the lack of legal responsibility of the donor(s). Otherwise, the prospective recipients and donors may seek independent legal advice, and enter into a consent agreement that outlines the critical issues involved and delineates the rights and responsibilities of all parties
- Several models exist internationally with regards to anonymity of the gametes donors; in some countries this is compulsory (and guaranteed for donors), whilst in others, donors must undertake to give their identity to the offspring at legal maturity if/when informed by their legal parents. Although a culture of openness has replaced this of secrecy over the recent years at least in some countries, there is no available research to firmly prove the superiority of one model to the other. Direct donation, eg from friends, or family members is also possible.
- With familial donation, donation between siblings raises the least confusion, whilst donation from gestational parents to child or especially child to parent raises the most.
- A major issue in all gamete donations is protection of the interests/welfare of the potential child, as well as of those of the recipient(s) and the donor and his or her partner. The relation between the biological and social parents is enshrined in law, whenever permitted
- No genetic material should be used for donation without appropriate screening and quarantine, and the formal written consent of the recipient(s), after appropriate implication counselling, and full explanation of the local legal status. Withdrawal of consent may be appropriate till the gametes or embryos are used, but not after use.
- The number of donations from any single donor should be limited in order to avoid the danger of genetic consanguinity and/or incest.
- Use of donated genetic material to extend the natural reproductive lifespan of women must take into account the significant potential risk to the individual as well as the offspring. Counselling about the potential influence of parental age on the child development must be included.
- Donation should be unpaid and only reasonable reimbursment given, in order to avoid commercialisation of reproduction and undue inducement of donors.
- The potential donor and the recipient should be encouraged to address the question of eventual disclosure to the child with appropriate counseling.
- The management of donated gametes and embryos should be regulated by a professional or national authority.
- Donation of genetic material should be altruistic and free from commercial exploitation. Reasonable compensation for legitimate expenses is appropriate. Exchange of services (egg sharing) should only be permitted in a system where no financial gain is possible for the donor
