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Why is this step important
A properly designed informed consent is crucial for data reuse. Without it, archiving, sharing, etc may not be possible.
To accommodate FAIR data principles (Findable, Accessible, Interoperable, and Reusable) The FAIR principles encourage making data more useful for both immediate research purposes and future secondary purposes, such as replication, validation and meta-analysis, while still protecting participants' privacy and rights. To accommodate for the FAIR data principles in the Informed Consent (IC) for health research data, the IC must include specific information that addresses not only both the immediate use of the data but also and its potential future uses in a way that aligns with GDPR requirements. The FAIR principles encourage making data more useful for both immediate research purposes and future secondary purposes (like replication, validation, or meta-analysis), while still protecting participants' privacy and rights.
Current Research Purpose: The IC should clearly explain the primary purpose for which the health data is being collected (e.g., a specific clinical study, disease research, or a longitudinal health survey).
Potential Future Use: To align with the FAIR principles, the IC should also mention the possibility that the data may be used for future research purposes, which may not yet be fully known at the time of data collection. However, the scope of future research should be described as broadly but as clearly as possible, respecting GDPR’s transparency principle.
FAIR Data Goals: The IC should include a statement that aligns with the goals of FAIR data, explaining that the data will be made findable, accessible, interoperable, and reusable by other researchers and stakeholders in the scientific community.
Data Registries or Repositories: If applicable, the IC should state that the data will be deposited into data repositories or registries that adhere to FAIR principles, allowing it to be discoverable and reusable by others.
Who Will Access the Data: Provide clarity on who will be allowed to access the data. This includes mentioning both internal and external researchers and potential data-sharing partnerships.
Controlled vs. Open Access: Explain whether the data will be made available via open access (where anyone can access the data) or via controlled access (where only approved researchers or organizations can access it).
Cross-border Data Transfers: If the data may be shared internationally, the IC must comply with GDPR’s rules on cross-border data transfers. Explain if the data will be shared with researchers outside the EU and what safeguards are in place to protect the data in international transfers.
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