Original Title: État des connaissances : Modalités de consentement et options de disposition des embryons conservés à la suite d’un processus de fécondation in vitro

Authors' objectives: In Québec, the only province that has adopted a legislative framework specifically for assisted procreation (AP), which was recently amended1 , individuals involved in a parental project must indicate their intentions regarding the disposition of embryos that exceed their reproductive needs as soon as IVF treatments begin. They must also contact the AP centre on an annual basis to reiterate their intentions regarding the preservation of the embryos or, if applicable, their disposition. It is the responsibility of clinicians to obtain the consent of individuals involved in parental projects to this effect and to inform them that if there is no contact for more than five years, the disposition of the embryos will be carried out according to their intentions previously expressed in writing. However, when the time comes for the actual disposition of preserved embryos, clinicians often feel unease about the validity of consent obtained only at the beginning of the treatments. The literature mentions that the consent of the individuals involved in a parental project obtained at that moment might not be considered fully informed because of the uncertainties surrounding the treatment and outcomes of IVF itself. Furthermore, the perspective of individuals involved in parental projects regarding their embryos tends to change over time, hence the importance of an ongoing consent process. Bearing in mind that a stored embryo is, by its very nature and potentiality, unique biological material, its disposition raises ethical concerns both for clinicians and individuals involved in parental projects, for whom this is more often than not a difficult choice to make. To support the teams at AP centres throughout the disposition process of stored embryos that are no longer part of a parental project, the Ministère de la Santé et des Services sociaux (MSSS) asked the Institut national d’excellence en santé et en services sociaux (INESSS) to produce a state of knowledge report concerning current practices in other jurisdictions with respect to consent processes for various disposition options.

Authors' results and conclusions: RESULTS: The legislative and clinical-administrative frameworks for various aspects of AP activities, including the disposition of preserved embryos, vary from one country to another. They reflect their individual sociocultural and political contexts. These dimensions also influence the definitions given to preserved embryos and the terms chosen to refer to them. However, the terms used in legal texts and guidelines do not necessarily reflect the perceptions or what these entities represent for professionals at AP clinics, nor even for the individuals involved in parental projects. Yet what embryos represent for the latter and the moral status granted to them influence the decision-making process regarding their ultimate disposition. Deciding on the disposition of preserved embryos that exceed reproductive needs is a difficult step for individuals involved in a parental project, regardless of the preferred option: embryo disposal, donation for the purposes of research or improvement or teaching of AP techniques, or donation for the reproductive needs of a third party. Individuals involved in parental projects are usually informed at the beginning of the IVF process of the different disposition options permitted in their jurisdiction, so that they can prepare for this eventuality or express their intentions in this regard at that point. The reasons ‒ of different types ‒ given by some for choosing one option or another are often similar to those given by others to justify refusing an option. In any event, the fact that these embryos originally conceived as part of a parental project are destined for another purpose reflects a certain paradox that such individuals face when making this decision. 3 In the grey and scientific literature reviewed, it is widely supported that it is important to offer support that is adapted to the individuals involved in a parental project at different key moments during their IVF process regarding the eventual disposition of the embryos remaining at the end of their project. A periodic confirmation of their intentions at different times during the IVF process can also reassure clinicians that the expression of their consent is as informed, validated and ongoing as possible. Regardless of the timing prescribed for the consent process, the literature stresses the importance of providing individuals involved in a parental project with all the information required to adequately support their decision-making process, particularly regarding the maximum authorized period for embryo storage in jurisdictions that have chosen to provide a corresponding legal framework (generally between five and ten years, sometimes with the possibility of a justifiable extension). They should also be informed of the fate of their preserved embryos if there is no prolonged contact between them and the AP centre or if they did not previously express their intentions regarding these embryos. These procedures related to the storage duration for embryos and consent concerning their disposition, which vary in their restrictiveness, present several advantages and disadvantages. However, none seem to easily address the concerns that arise from the disposition of preserved embryos. For this reason, the process for obtaining free and informed consent from individuals concerning this matter must be adequately supported, regardless of the option chosen. Discussion between clinicians and individuals involved in a parental project provides an opportunity to convey relevant information, the individuals’ understanding of which must be verified. Furthermore, this exchange should be used to provide insight into the values individuals attribute to preserved embryos and to explore their uncertainties about this decision. The consent process for each disposition option has its own particularities and accompanying issues. The option of disposal of preserved embryos, which is available to individuals involved in parental projects in all the countries examined except Italy, presents the fewest consent-related issues. The decision-making process for embryo donation for research purposes or improvement or teaching of AP techniques requires, in principle, that the individuals be provided with several pieces of information, including those related to the specific use that will be made of the embryos. As this is generally not always possible, it is difficult to ensure that consent (or the withdrawal of consent) is fully free and informed. However, further information must be conveyed to these individuals, which, based on the literature reviewed, seems to be missing. There are many issues surrounding the donation of embryos for a third party’s reproductive needs, such as access to information about genetic origins for persons born as a result of a donation, donation to a known third party, respect for privacy, and not knowing the outcome of a donation. The reviewed literature highlights the need to provide specific support to those choosing such an option, including adapted counseling and peer support, so that they can make an informed decision. The inherent subtleties of the various disposition options and their implications for the consent process require that AP centre team members be well equipped to support individuals involved in a parental project throughout their decision-making process CONCLUSIONS: Based on this state of knowledge report, it appears that making decisions about the disposition of preserved IVF embryos is a difficult step for individuals involved in parental projects, especially because of the potential for these embryos to become human beings. These individuals must therefore be adequately supported in this decision-making process so that it is carried out in a free, informed and ongoing manner. However, it seems that the regulatory and normative framework of these decisions, as clear as it may be, does not, by itself, alleviate the difficulties encountered by clinicians who must accompany such individuals in their decision-making process, given the sociocultural, clinical and organizational aspects that can influence the process. Supporting clinicians that accompany individuals involved in parental projects at the different key moments in this complex decision-making process is therefore essential so that they can carefully provide the many pieces of information that the individuals need and discuss these with them. Tools ‒ usually in the form of guidelines and practice guides ‒ have been developed for clinicians in some jurisdictions. However, consolidating various types of tools into a single kit appears to be an attractive option to adequately support professionals at AP centres. Such a toolkit should promote obtaining free, informed and ongoing consent, and therefore could include: • guidelines that determine and rule on the best counselling practices; • a help guide on obtaining consent and standardized consent forms; • decision support tools for individuals involved in parental projects. To support toolkit implementation, a mechanism to provide clinicians with access to a reflection forum that brings different perspectives together could be beneficial, in order to support them in not only accompanying individuals grappling with decisions regarding the disposition of their unused embryos, but also in putting the necessary structures and processes in place at clinics and implementing the various practices to adequately guide the embryo disposition consent process. Such a toolkit should make it possible to promote respect for the decision-making autonomy of individuals involved in parental projects, particularly by addressing social values, the risk of inequities, and organizational and clinical dimensions.

Authors' methods: A literature search was conducted by a scientific information advisor (librarian) in collaboration with a scientific professional. The main concepts used to develop the strategy were the disposition of embryos preserved following in vitro fertilization, as well as the consent processes associated with this disposition. The PubMed, Embase, PsycINFO, and CINAHL bibliographic databases were queried on September 10, 2020. The search criteria included any type of study published in English or French between 2010 and 2020. To ensure that changes in standards and practices in an evolving field were considered, publications from 2015 onwards were retained for the purpose of this report, although articles published before 2015 that were considered essential were also included. The Google and Google Scholar search engines were also used to find relevant documents. The other information sources consulted were the websites of national and international organizations, regulatory bodies, health technology assessment agencies, government agencies, and professional associations or organizations in various jurisdictions. Details of the search strategy are presented in Appendix A. Documents such as guidelines, ethical opinions and relevant legal doctrine were reviewed. Data from the scientific literature were extracted and classified using the NVivo software program.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/modalites-de-consentement-et-options-de-disposition-des-embryons-conserves-a-la-suite-dun-processus-de-fecondation-in-vitro.html

Year Published: 2021

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/modalites-de-consentement-et-options-de-disposition-des-embryons-conserves-a-la-suite-dun-processus-de-fecondation-in-vitro.html

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec