Informational Risk, Institutional Review, and Autonomy in the Proposed Changes to the Common Rule
In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act (HIPAA). We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research.