D3.9 Final version of guidance on standards and practices for protecting data privacy

In the present deliverable, we performed a content analysis of reports from IMI ND projects, including guidance documents on informed consent, data management plans, research study documentation, and other reports relating to patient privacy. This content analysis identified cross-cutting themes in how projects address patient privacy and informed consent. All projects had a strong awareness of the need to ensure privacy and confidentiality, with key responsibility often assigned to clinical sites and principal investigators. Reidentification and capacity to consent were frequently identified as ethical concerns for projects, with project reports describing the methods and measures used to ensure respect of confidentiality and autonomy.