White Paper V1: Gaps and requirements

Among other work and research carried out in WP2/T2.1, The White Paper will also incorporate the work of the ELSI Officer (T2.4), who will assemble the relevant ELSI documentation before the start of each case study (ethics review approvals/amendments, information sheets and consent forms, incidental findings policies, material transfer agreements etc.) A clear statement on the ethics of the case studies explicitly confirming verification/documentation of consent, incidental findings, and ethics review confirmations will be included in the annual reports of the ELSI Officer. These reports will incorporate the following related to HUMANS: 1. Detailed information on the informed consent procedures that will be implemented for the participation of humans (including the follow-up of the cohorts and the consultation to the stakeholders) must be provided. These will be kept on file and provided to IMI JU upon request. 2. If applicable, details on incidental findings policy must be provided. 3. The concerned consortium members must confirm that opinions/approvals by ethics committees and/or competent authorities for the research with humans have been obtained prior to the start of the research in T5.6 and are kept on file. They must be provided to IMI JU upon request. the annual reports of the ELSI Officer will also incorporate the following related to HUMAN CELLS (all of the information/documentation will be provided to IMI JU upon request):1. In case human cells/tissues are obtained within the project, details on cell/tissue types must be kept on file. The concerned consortium members must confirm that the specific approval has been obtained prior to the start of the research activity raising ethics issue and that it is kept on file. 2. In case human cells/tissues are obtained from another project, details on cell/tissue types must be kept on file. The concerned consortium members must confirm that authorisation has been obtained from the primary owner of cells/tissues (including references to ethics approval) prior to the start of the research activity raising ethics issue and that it is kept on file. 3. In case human cells/tissues are obtained from a biobank, details on the cell/tissue types and on the biobank and access to it, must be kept on file prior to the start of the research activity raising ethics issue. 4. The concerned consortium members must confirm that they have obtained all the relevant documents for using, producing or collecting human cells or tissues (e.g., ethics approval, import licence, accreditation/designation/authorisation/licensing) prior to the start of the research activity raising ethics issue and that they are kept on file.