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Developing an Ethical and Legal Interoperability Assessment Process for Retrospective Studies.
Anne-Marie Tassé1, Emily Kirby1, Isabel Fortier2
11 Public Population Project in Genomics and Society, McGill University and Genome Quebec Innovation Centre , Montreal, Quebec, Canada .
This study introduces a new process to assess if research data is ethically and legally compatible for sharing across international studies. This ensures data sharing respects legal and ethical standards for research collaborations.
Area of Science:
- Bioethics
- Health Informatics
- Data Science
Background:
- International research consortia aim to share data for health benefits.
- Combining heterogeneous data requires addressing data harmonization and ethical/legal interoperability.
Purpose of the Study:
- Propose a rigorous process to assess ethical and legal interoperability of data sets for research use.
- Develop a comprehensive filter to verify legal and ethical restrictions on data sets.
Main Methods:
- Analysis of the international ethical and legal framework for retrospective data use.
- Four-step process: finding, comparing, establishing principles, and refining existing processes.
- Methodologies included literature/policy reviews, expert consultations, and a case study.
Main Results:
- Developed an interoperability assessment process for retrospective research data.
- Created a filter to verify legal and ethical restrictions, including consent, recontact, and waiver of consent.
- The process ensures data sets are ethically and legally interoperable for research collaborations.
Conclusions:
- The proposed assessment process facilitates the creation of virtual "mega-cohorts" by ensuring ethical and legal compliance.
- Integrates a filter into data access processes to uphold basic legal and ethical precepts in research.
- Enhances the ability of researchers to collaborate and share data across international studies while respecting ethical guidelines.
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