OHRP Exception Determination: Single IRB (sIRB) Requirements
On October 8, 2020, the Office for Human Research Protections (OHRP), on behalf of the Department of Health and Human Services (HHS), issued an exception determination (as permitted by 45 CFR 46.114(b)(2)(ii)) stating that certain categories of cooperative research supported or conducted by HHS and subject to the 2018 Requirements are not required to comply with the 2018 Requirements’ single IRB mandate. The full text of the determination can be accessed here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/october-2020-exception-determination/index.html
The VCU HRPP will require documentation of any exception to the single IRB requirements to be submitted at the time of IRB submission. Please contact irbreliance@vcu.edu for any questions.
Categories Announcements and Updates