Work Package 15 activities started in month 13. The main objective is to develop guiding principles for how to make cohort resources as widely useful as possible to the research community, whilst considering ELSI issues. This will include the development of guiding principles for cohort access policies for primary studies and secondary data use and a concept for data protection policy.
Supporting this is a need to understand how large medical cohorts currently manage access to their resources and protection of their data. The idea is not to start from scratch, but to base work on real-life examples. This includes existing relevant policies and direct contact with the large medical cohorts identified in WP3; analysis using two structured extraction forms: one focused on data access and the other on data protection and then sorting information into final themes and subthemes.
Based on the activities mentioned above, we successfully submitted milestones 9 and 10 on July 31st, 2025.
Milestone 9: Definition of assessment criteria
Through a series of internal discussions between the WP15 task leaders (FSJD & IARC), we defined 8 different assessment dimensions relevant to evaluating access and secondary data use in large medical cohort (LMedC) studies: Accessibility, Scientific Merit & Feasibility, Ethics & Consent, Data Security & Confidentiality, Data Ownership and Use of Results, Legal & Compliance, Sustainability & Fairness and finally, Technical Modalities.
Milestone 10: Assessing governance models and first recommendations
We developed a scoring system using a dual-method approach, building on the work completed for M9. The system is based on a series of Yes/No questions, with the responses translated into a rating (low, medium, or high) depending on how many criteria are met. This approach allowed to compare different cohorts in terms of governance model (e.g.: clarity and fairness). Based on the conducted assessment of three cohorts (clinical (national), population (national) and European), we proposed the first recommendations for the development of a harmonised data access and protection policy for large medical cohorts. These principles aim to protect participants while supporting research advancements in secondary-data use and ensuring long-term sustainability.
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