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November 12, 2020
On November 12, 2020, OHRP issued “OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements: Options for How New Sites Added to Ongoing Cooperative Research Can Follow the Same Version of the Common Rule.” The guidance responds to questions from the regulated community on how institutions can maintain consistency in the version of the Common Rule that applies to a cooperative research project in situations where an Institutional Review Board (IRB) approved the study at one or more sites before the general compliance date of the 2018 Requirements (i.e., the revised Common Rule), and other sites are added after the general compliance date of the 2018 Requirements. The guidance can be accessed on OHRP’s website at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-maintaining-consistency-regarding-the-applicability-of-the-2018-or-pre-2018-requirements.