Last summer, the United States Department of Health and Human Services (HHS) sought comments on potential revisions to the Common Rule after over two decades of virtually no change. In the advanced notice of proposed rule making related to the Common Rule, HHS sought to address concerns about institutional review boards’ (IRBs) review of informational risk, or those risks related to unauthorized release of research subject data, with the goal of balancing the protection provided by IRBs to human subjects with the progression of research. HHS looked to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its privacy and security standards as a potential framework to ensure these protections. In addition, HHS focused on the heightened risk in areas such as genetic research and sought feedback on future use biospecimens (such as tissue) and consent requirements...