A patient-centred approach to embryo donation for research
Timing set to obtain consent
There are differences between countries regarding whether the informed consent forms regarding embryo donation for research should be signed prior to the first treatment [17], during treatment [18] or after treatment is completed [19]. Evidence showing changes in couples’ willingness to donate embryos for research supports the idea of a two/three-stage process to obtain full informed consent [9, 10, 20]. It also reinforces the argument that it should be signed only after the infertility treatment is completed, as recommended by the Ethics Committee of the American Society for Reproductive Medicine [19].
There is a wide debate about the meaning of informed consent and what is needed to guarantee its legitimacy and validity [21, 22], in a context where the relationship between freedom of action and choice, on the one hand, and the influence of medical expertise and advice, and the social context, on the other, emerge as an important topic of reflection [22]. Overall, it is important that the consent is effectively informed (which requires an understanding of its content as well the comprehension of the oral and written information provided), voluntary (without any pressure or coercion, external or internal, concerning decision-making) and reflected (preceded by time to think about the decision) [5, 23, 24]. These elements are especially relevant when the decision process involves the search for consensus among partners [25].
Silva et al. [26], for example, also discuss the conditions under which informed, voluntary and reflected consent is conceptualized and implemented. They have suggested that informed consent should not be seen as the result of a purely rational and autonomous process of decision-making, based on a deep assessment and understanding of the information provided by health professionals, as it is also guided by feelings of trust in these professionals [22]. Interactions and relationships can enhance, as well as restrict, the autonomy to consent [27]. Consent is regarded as a perceived and experienced process constructed through interactions between individuals and their social contexts, where emotions, desires and feelings shape patients’ responses and decision-making. It is conceived as an ongoing process rather than as a discrete act of choice taking place in a given moment of time [20], which calls attention to the importance of being revocable at any time.
The process of informed consent may constitute an opportunity for humanization, democratization, accountability and transparency of processes and decisions [19, 28] concerned with ART by fostering dialogue and trust between health professionals and patients [29, 30] and providing a space for reflecting about cryopreservation and decision-making regarding embryo donation for research. However, it can also be reduced to a formality that may be guided by legitimate medical strategies to manage risks, expectations and responsibilities in the field of ART [30, 31].
Thus, attention must be drawn to the need to promote an in-depth analysis of the clinical, social and political contexts that influence the consent process [21], including the relational and interactional aspects [22], the changes over time due to fluctuations in the information exchanged with the health professionals, and variations in the social networks or in the reproductive trajectories of patients [9, 20]. The responsibility of scientific and medical institutions, health professionals and researchers regarding the provision of accurate and timely information that is attentive, responsive, and tailored to patients’ needs should be highlighted, in a context where a decrease in patients’ willingness to donate embryos for research over time is being observed [10, 20]. Investment in information provision is especially important, taking into account that the majority of patients highlighted feelings of trust and reciprocity towards the health professionals who contacted with them, as well as confidence in the medical and scientific institutions.