2. Eliminate Two Layer IRB and IACUC Review of Human and Vertebrate Animal Research - Institutions receiving federal funds for research with human subjects or vertebrate animals are required to maintain a Federal-wide Assurance (FWA) or Animal Welfare Assurance (AWA) with the DHHS Office of Human Research Protections (OHRP) or Office of Laboratory Animal Welfare (OLAW), respectively. Institutions thereby accept the responsibility to form qualified internal committees who operate under the appropriate regulations to review research protections. Despite this fact, some federal sponsors (e.g. DoD, FDA) still require two layers of regulatory approval from 1.) the Awardee’s IRB/IACUC and 2.) the Sponsor’s IRB or IACUC. These dual review requirements are typically not allowed to be conducted in parallel. The secondary review adds additional time and significant administrative burden to investigators, sponsors, and research administration. Elimination of the secondary IRB/IACUC review harmonizes with not only the need for standardized award terms and conditions, but also the recent proposed changes to the Common Rule related to single IRB review.
Idea No. 64