Work Package 3
Ethics, Regulatory, Legal, and Governance
Lead:
María Consuelo Miranda (UIS)
Centro de Investigaciones Epidemiológicas
UNIVERSIDAD INDUSTRIAL DE SANTANDER
BUCARAMANGA, COLOMBIA
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Co-Lead:
Lauren Maxwell (UKHD)
Heidelberg Institute of Global Health (HIGH)
UNIVERSITÄTSKLINIKUM HEIDELBERG
Heidelberg, Germany
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The overall aim of WP3 is to establish a transversal platform for all WPs to address the ethical, regulatory, legal, and governance challenges to data and sample sharing, in preparation for epidemics. The primary aim of this work package is to implement a robust, sustainable system for sharing data from Infectious Diseases (ID) cohorts, ensuring these mechanisms are in place to enable a prepared and effective epidemic response. Our approach to meet WP3 objectives in addressing the ethical, regulatory, legal, and governance challenges to regional data sharing has been practical and across all CONTAGIO consortium WPs.
WP3 is designed to achieve the following objectives:
Objective 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 (Task 3.1).
Lead: Maria Consuelo Miranda (UIS team)
Objective 2: Controller to contracts, DTAs, and regulatory compliance solutions for data protection (Task 3.2).
Lead: Fruzsina Molnár-Gábor (UHEI team)
Objective 3: Transparent, actionable governance for cohort data and sample reuse (DACs) (Task 3.3).
Lead: Caitlin Naylor (IDDO team)
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Sub-objective: To harmonise the existing data flow for sharing cohort datasets via the ReCoDID Cohort Browser, liaise with Cohort Study teams to encourage FAIR sharing and provide support in addressing any potential issues.
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Contributors: EMBL, UC, UPCH, SOSECALI, FIOCRUZ
Coordination: Elena Rey (UIS)
Transparency: Progress of each task is documented in the monthly consortium presentations. The group meetings are scheduled once a month, every second Thursday, with minutes available in the project Google Drive.
WP3 Contact Information:
Email: mcmirandamontoya@hotmail.com