Advarra, a regulatory review solutions and clinical research technology provider for sites and sponsors, has been awarded an Indefinite Delivery, Indefinite Quantity (IDIQ) contract worth $13,999,465.00 from the National Institutes of Health’s (NIH’s) National Institute of Allergy and Infectious Diseases (NIAID). It entails providing project management and administrative oversight as the institutional review board (IRB) of record for the Biorepository Protocol and U.S. domestic sites for specified NIAID studies throughout the course of individual studies.
 
Advarra solutions aim to enable collaboration, transparency, and speed needed to optimize trial operations, ensure patient safety and engagement, and reimagine clinical research while improving compliance.
 
Industry sponsors and contract research organizations (CROs) may be aware of the anticipated FDA single IRB (sIRB) mandate. To comply with the 21st Century Cures Act, the FDA released a Notice of Proposed Rulemaking (NPRM) in September 2022 entitled  “Institutional Review Boards; Cooperative Research.” The NPRM specifically indicates FDA’s intention to require (with few exceptions) any U.S. institution participating in multi-center clinical trials to rely on the review of an sIRB selected by the sponsor. The NIH sIRB policy already became effective in 2018 for NIH-funded research. The Federal Policy for the Protection of Human Subjects (or the “Common Rule”) implemented its sIRB mandate for nearly all federally funded human research in 2020. Once the FDA’s sIRB mandate is in effect, it will apply to non-federally funded research, meaning nearly all multisite research conducted in the U.S. will require sIRB review.