Optimising cohort data in Europe

informed consent (Taylor and Pagliari, 2018). The Belmont report predates modern social technologies, and as such, can no longer provide an efficient basis for understanding the social contract between the participant and the researcher. Such issues reflect the tension between the ethical principle of beneficence and the principle of autonomy. Health care practitioners in general, and researchers in particular, tend to focus more on the beneficence criteria while participants’ autonomy makes them comparatively uneasy (Mouton Dorey et al., 2018). For instance, researchers are not always sure that participants are able to interpret results correctly and suggest that they would prefer to select aspects of the information that could be communicated beforehand (OECD, 2019; Moerenhout et al., 2020). Health care practitioners are often wary of letting participants altering or adding information (Yuzbasioglu et al., 2018). In other words, their approach is not only based on beneficence but also adopts a paternalistic perspective. 2.2.2. Autonomy and informed consent Autonomy is related to self-governance, to make intentional and voluntary choices and plans of actions based on one’s own deliberations to achieve certain goals. Informed consent is a legally binding expression of autonomy in research ethics, as it requires researchers to ensure that participants take fully weighted, informed and independent decisions (Borry et al., 2018). For cohort data studies, a major hurdle for informed consent is that the complex highly specific and technical nature of the (medical) knowledge involved makes it difficult to inform participants adequately and to determine what should be communicated and how (Dobrick et al., 2018). This is because the capacity for autonomous choice does not depend on adequate information only. Instead, other factors are likely to come into play such as language, time constraints, lack of personal resources, the researchers’ communication skills and the expectations within the researcher-participant relationship (Umbach et al., 2020; Vayena et al., 2018; Richterich, 2018; McRae et al., 2020). Individual autonomy is also culturally dependent: in certain communities, participants can give informed consent for research and receive medical treatment only with the agreement of their communities and family (Zawati et al., 2018). In genomics and biobanks, broad consent can harm confidentiality and thus reduce autonomy (Coppola et al., 2019). Namely, it is not clear how broad consent can really be implemented while still maintaining the autonomy of the participant (Minari et al., 2018). It is however not always possible to obtain fully informed, autonomous consent from a participant, especially in cases where participants lack the capacity for rational agency (e.g. elderly patients) (Gold et al., 2018). In some cases, presumed consent or silent consent schemes are necessary, especially when participants do not have the full decision-making capacity (Thorogood, 2020). This occurs because (individual) autonomy