August 11, 2020
On July 20, 2020, the Office for Human Research Protections (OHRP) issued guidance titled, “Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements.” In that document, the term “2018 Requirements” refers to the Common Rule as published in the July 19, 2018 edition of the e-Code of Federal Regulations. The 2018 Requirements were originally published on January 19, 2017 and further amended on January 22, 2018 and June 19, 2018. The term “2018 Requirements” refers to the Common Rule as published in the July 19, 2018 edition of the e-Code of Federal Regulations, originally published on January 19, 2017 and further amended on January 22, 2018 and June 19, 2018. The OHRP document provides guidance on the elimination of the requirement in section 45 CFR 46.103(f) of the pre-2018 Requirements that each application or proposal for research undergo IRB review and approval as part of the certification process. It also addresses the requirement in the 2018 Requirements for certification of each proposed research study prior to initiation.
A notice of availability about this OHRP guidance (https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-15808.pdf) was on file at the Office of the Federal Register for public inspection on July 20, 2020. That notice of availability was scheduled to be published in the Federal Register on July 22, 2020 and available online at federalregister.gov/d/2020-15808, and on govinfo.gov.
The OHRP guidance document can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/elimination-of-irb-review-of-research-applications-and-proposals/index.html. It finalizes the OHRP draft guidance (dated July 19, 2028) that was made available for public comment through a notice in the Federal Register on July 25, 2018 (83 FR 35278).