During the final days of the Obama Administration, the U.S. Department of Health and Human Services (HHS) released the final text for its changes to the Common Rule, the regulations that govern research with human subjects, completing a revision process started in 2011. The Common Rule, which was last updated in 1991, affects research supported by 16 federal departments and agencies, including the Departments of Health and Human Services, Agriculture, Defense, Education, Commerce, Labor, and Veterans Affairs, as well as the National Science Foundation.
Overall, the changes look to be a positive development for the social and behavioral science research community. According to the executive summary, “The final rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research.” The rule maintains several proposals from the earlier Notice of Proposed Rulemaking (NPRM) that aimed to reduce the oversight burden on researchers conducting studies that pose no or minimal risk to participants (like a lot of social and behavioral science research). It also declines to adopt several provisions that were controversial in the biomedical research community (although supported by some in the social sciences), including consent requirements surrounding work with de-identified biospecimens, which is likely to lead to a less contentious reception overall.
Read on for COSSA’s full analysis of the changes.