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Work Package 3

Ethics, legal, Regulatory and Governance

WP3 has 3 goals

  1. Practical approaches to Identifying and addressing barriers to implementing existing recommendations for ERCs addressing data sharing and use of biosamples in the research response to EIDs.

  2. Controller to X contracts, DTAs, and regulatory compliance solutions for data protection.

  3. Transparent, actionable governance for cohort data and sample reuse (DACs).

In WP3, CONTAGIO constitutes a transversal platform for all the WPs, in the preparation ahead of the epidemic, to facilitate the process of ethics, regulatory, legal issues and governance structures, which will allow upfront implementation, and mechanisms, including contractual agreements, to rapidly react and initiate natural history cohort studies for EIDs. What is related to sharing datasets and biobanking between the cohorts of the different institutions that are part of the network will be deepened, providing answers to questions such as: How will consent from individual patients be secured (e.g., broad consent during epidemics)? How will the confidentiality of individuals and communities be protected? Who will have the ownership or custodianship of datasets and samples? Who will benefit from the findings of any further research conducted on such data and samples? There was concern about maintaining respect for legitimate interests of countries and communities that share data and samples; about the adequate, transparent and fair governance mechanisms of data sharing and biobanks, including the selection of priority research on samples; and about the forms that benefit sharing could and should take when questions on further research using shared data and samples arise.

© 2025 CONTAGIO is funded by the European Union’s Horizon Europe Programme under Grant Agreement

N. 101137283.

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