Reconsidering Open-Ended Consent for Biospecimen and Health Record Research in the United States and Europe

Abstract

Translational and other modern forms of biomedical research often use stored biospecimens and the health records of individuals whose biospecimens will be used in research. As part of the enrollment process for biobank-based research, individuals are frequently asked to provide informed consent for access to and use of their current and future health records. Although individuals might readily agree to give researchers access to their current health records, they might not realize that their future health records could contain new stigmatizing or embarrassing information. Reasonable limits on future health record disclosures in both the U.S. and Europe can address health privacy concerns without impeding research.