Broad Consent—Are We Asking Enough?

Biobanks and health data repositories provide rich reservoirs of information for use in biomedical research. These repositories depend on participants donating identifiable health data and biospecimens that may be used in perpetuity by unlimited numbers of researchers for unnamed research topics. Since 1991, U.S. federal regulatory provisions, collectively known as the Common Rule, have required informed consent of participants in federally funded human subjects research, but recent changes to the Common Rule now sanction “broad consent” in the repository research context. Broad consent is not defined in the revised Common Rule; thus, researchers and their institutions are left to determine ad hoc what broad consent means and requires. Without leadership and guidance from the U.S. Department of Health and Human Services, stakeholders with potential conflicts of interest will reach their own conclusions and craft new and varied standards for consent. The result will be uneven protections for participants.