Master Alliance Provisions Guide (MAPGuide)

IMI 2 Joint Undertaking Model Consortium Agreement

  • Information sharing & data safety | Data management

Appendix 2: Actions involving Personal Data and/or Human Samples

  1. Personal Data and Human Samples Collection and Informed Consent: When Personal Data and/or Human Samples are introduced to the Action by or on behalf of a Beneficiary, such Beneficiary must ensure that: (1) the Personal Data and the Human Samples are Processed in accordance with all laws, rules, regulations and guidelines applicable to their collection, use, handling, disposal and further Processing, including – without limitation – data protection legislations; (2) if applicable, the Personal Data and Human Samples are collected with voluntarily given informed consent of the Donors of the Personal Data and Human Samples covering the activities of the Action, including the collection, processing, storage, use and transfer including the addressees of the transfer of the Personal Data and Human Samples as provided for under the Action, such informed consent must be revocable any time with effect for the future; (3) the responsible ethics committee/Institutional Review Board (IRB) has given its approval to the collection, processing, storage, use and transfer of the Personal Data and Human Samples under the Action, and (4) if applicable, the Donors of the Personal Data and Human Samples have not withdrawn their informed consents. (Appendix 2, §3.1)
  2. Limited Scope of Personal Data and Human Samples That Can Be Used in the Action: Beneficiaries will not introduce to the Action Personal Data and Human Samples that are collected for reasons unrelated to the Action, with limited exceptions. (Appendix 2, §3.4) Personal Data and Human Samples shall be accessed only for the purpose of the Project and the corresponding agreements, i.e. the Grant Agreement and the Consortium Agreement. Further Processing of such introduced Personal Data and Human Samples by the accessing Beneficiary for own purposes or for purposes of Third Parties is not permitted, unless expressly permitted in the informed consent. (Appendix 2, §3.5(1))
  3. Use of Personal Data and Human Samples in the Action: Beneficiaries are responsible for their Processing, storing, using and transferring of Personal Data and/or Human Samples in compliance with the applicable Data Protection Legislation and for purposes that are consistent with the consent obtained, if applicable. (Appendix 2, §4.1)