Assessment of the CoBraD PUCs against ethical and legal standards

This report will release a first assessment about the compliance of CoBrad Pilot Use Cases PUC with the essential regulatory ethical and legal framework identified under T21 Precisely the document will report a how the consortium ensures respect for research or study participants and for human dignity and fair distribution of the benefits and burden of research and how consortium will protect the values rights and interests of the research participants particularly with reference to vulnerable groups children disable people b how the consortium ensures GDPR compliance concerning to research which involves processing of personal data regardless of the method used eg interviews questionnaires direct online retrieval etc c whether the PUCs have obtained the necessary opinionsapprovals by local and national ethics committees andor competent authorities for the research with humans performed in the pilot studies first study subject approvals package