1. Scope Recommendations for the responsible inclusion of special groups of data subjects in 1+MG such as minors, persons not able to consent, minorities, vulnerable persons and groups, and deceased persons. The recommendations are directed towards researchers, research ethics committees (RECs), and 1+MG data centres and oversight bodies. 2. Objectives − To identify existing approaches and best practices for inclusion of special groups. − To develop 1+MG minimal requirements for inclusion of

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... cial subjects. 3. Background The term 'special subjects' in the context of 1+MG project applies to a diverse set of potential research subjects: minors, persons with diminished capacity to consent, persons not able to consent, other vulnerable groups, deceased persons etc. These special subjects in at least some respects are incapable of deliberating or acting based on their own plans or are controlled by others. To respect a person representing special group means to protect him/her to ensure that the person is not subjected to abuse, exploitation, or discrimination. Usually, definitions of vulnerability combine two aspects: (1) lack of ability, capacity, means and/or willingness to protect one's own interests, and (2) exposure to the possibility of being harmed, especially through exploitation. As outlined in the Declaration of Helsinki, vulnerable groups and individuals "may have an increased likelihood of being wronged or of incurring additional harm" (WMA, 2013). In case of involving vulnerable persons and groups in research "specific protections should be provided for vulnerable subjects and vulnerable populations, based on the general principle of acting in their best interest" (ESHG, 2003). There is ongoing discussion in the field of research ethics regarding the usefulness of the concept of vulnerable groups. CIOMS Guidelines advise to "avoid considering members of entire classes of individuals as vulnerable" (CIOMS, 2016) and instead suggest looking at specific characteristics and situations that may render perso [...]