US-EU Scientific Research Collaborations: Sage Bionetworks’ Experience Navigating the Complex Regulatory Landscape.

Abstract

We applaud the effort to reform the European Data Protection rules and its attempt to support scientific research while protecting the rights and interests of research participants. We highlight elements of the proposal that might benefit from additional clarification: What type of data used in scientific and biomedical research is not considered “personal data?” Biomedical research is often focused on analyzing health and genomic data. However the very same combination and depth of that data that gives it such scientific utility can also sometimes make it identifiable. Use of de-identified or pseudonymised health and genomic data in research should be further explored, and policy should balance the need for individual privacy with the societal benefits of large-scale health research on integrated individual data sets. Compliance with the specificity of traditional informed consents usually precludes secondary use of research data. We argue that consent forms should include options to approve re-use of specimens and data for follow-on research. What are appropriate safeguards for electronic data transfer and international research collaborations involving pseudonymised genomic and health data? Clear codes of conduct and seals of approval with institutions (and not only countries) must be developed by the Commission promptly. Lastly, we believe that the goal of personalized medicine can only be achieved if we empower research participants to contribute their data or specimen to the effort they select and influence research directions. It is therefore vital to provide clear signals that individuals are in charge of their own data, either to keep it private to themselves or to share it with researchers, and that citizen-driven studies that embrace reuse of data be specifically allowed under European Data Protection rules.