Optimising cohort data in Europe

2.2.1. Beneficence and non-maleficence The Belmont report provides guidelines for research involving human subjects and as such, has still a dominant role in bioethics. The principle of beneficence specifies that researchers should at any time, take measures to secure participants' wellbeing by maximising possible benefits while minimising possible harms (Gopichandran and Elango, 2018). Beneficence is an obligation to act for the benefits of others and thus an opposite corollary of the requirement of non-maleficence, which refers to the obligation of not inflicting harm on others (Moerenhout et al., 2020; Appelbaum et al., 2020). In health care settings, the principle of beneficence also includes the duty to promote the good health of participants (Dupras et al., 2019). These concepts are applied to various contexts within the cohort research domain. In health surveillance and data collection through communication technologies, public health research should improve the health of the target population, so that identifying with precision the extent to which target populations are covered becomes crucial. In the context of feedback communication given to participants and on the basis of the principle of beneficence, justice and respect for the person, validated, verified and clinically useful research data should be communicated to the participants, if they wish so (Bilkey et al., 2019). However, communicating results (for instance a potential genetic disease) may cause feelings of stigmatisation and exclusion. Therefore, the beneficence of communicating results should be done carefully, considering the social and personal impact of these results. Outside themedical domains, what exactly constitutes participants' wellbeing and benefit in the context of cohort studies is a matter of debate. In general, benefit corresponds to the end of what participants would choose if they were rational, well informed and aware of the potential implications of their choices (Cech, 2018). However, participants are not rational but socially and culturally embedded into their communities and hence, take decisions in accordance with their values and beliefs (Lehner-Mear, 2020). Participants' benefits and wellbeing thus depend on the extent to which their individual values, needs and beliefs are taken into account and integrated in their decision-making (Murtagh et al., 2018). Moreover, cohort studies in general and big data in particular, rely on the impetus to discover previously unseen links in the data. As a result, even for researchers, it is not possible to determine the ends and the potential benefits and harms of research in advance (Pastorino et al., 2019; Appelbaum et al., 2020; Manrique de Lara and Pelaez Ballestas, 2020). Hence, in cohort studies and big data there are considerable difficulties in evaluating the extent of beneficence in advance. There is also a growing concern that Belmont’s principles (including beneficence) do not correspond to the actual shifts in participatory research. Namely, new communication technologies have radically changed the parameters, procedures and modalities of participation (Richterich, 2018). Geolocation devices and wearables for instance, allow participants to voluntarily report their data (McRae et al., 2020). Some researchers even consider that media platforms’ terms of use and service can be considered as proxies for