HHS May Delay Common Rule Implementation

On October 7, the White House Office of Information and Regulatory Affairs issued a notice that it is reviewing a rule that would delay the implementation date for most of the changes to the Common Rule, the set of regulations governing research involving human participants, by one year, pushing the effective date for the changes from January 2018 to January 2019 (see COSSA’s analysis of the changes, which were announced in January of this year). The delay would still allow “the use of three burden-reducing provisions during the delay year,” but there is little clarity on what those provisions are or when more details will be made available.

One hint may be found in a letter sent by four higher education associations in June that asked for a year-long delay in the compliance date for most of the changes to the regulations, while allowing burden-reducing provisions to move forward. The letter identified those provisions as “certain exclusions and exemptions, elimination of the continuing review requirement for certain types or stages of research and elimination of IRB [internal review board] review of grant applications.” If the Department of Health and Human Services (HHS) concurs with the recommendations in the letter, the provisions allowed to go into effect as originally scheduled may well include several of the changes that aim to make research involving human participants less burdensome for low-risk social and behavioral research.

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