Implementation of Common Rule Changes Delayed

This month, the U.S. Department of Health and Human Services announced an interim final rule that will delay implementation of changes to the Federal Policy for the Protection of Human Subjects, known as the Common Rule. The U.S. Department of Health and Human Services (HHS) finalized the updated Common Rule on January 19, 2017. The new rule removes the previous exemption that excluded from IRB review research on public officials and candidates for public office that used methods like educational tests, surveys, interviews, or observation of public behavior without participation by the investigator. APSA opposed this change.

The new Common Rule was originally scheduled to go into effect on January 19, 2018. However, HHS announced an interim final rule on January 17, 2018, that would delay the implementation of the rule until July 19, 2018, to “provid[e] regulated entities additional time to prepare to implement these revisions.” HHS notes that until that date, regulated entities are expected to comply with the Common Rule originally published in 1991 and available in the 2016 Federal Register here. HHS also notes that departments and agencies “are also in the process of developing a notice of proposed rulemaking…seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019).”