Introduction
The National Institutes of Health (NIH) released an important request for information (RFI), NOT-OD-23-152, on flexibilities for streamlining IACUC review of protocols and significant changes. Let’s explore the key highlights of NOT-OD-23-152, shedding light on the proposed guidance that the Office of Laboratory Animal Welfare (OLAW) is seeking comments on. For context, we will first summarize the current options for the review of protocols and significant changes.
Options for Review of Protocols and Significant Changes
According to the PHS Policy and Animal Welfare Regulations, IACUCs are responsible for reviewing funded or supported animal activities and proposed significant changes in ongoing activities. They must decide to approve, require modifications, or withhold approval. Two methods of review are available: Full Committee Review (FCR) and Designated Member Review (DMR). FCR occurs at a convened meeting, where approval is obtained with a majority vote. DMR allows a qualified member designated by the chairperson to review and approve the protocol, require modifications to the protocol, or request FCR. These review processes ensure proper evaluation of animal activities while allowing flexibility and efficiency.
Additional Options for Significant Changes
The IACUC must use FCR or DMR to approve significant changes in ongoing animal activities that may negatively impact animal welfare. Examples of significant changes include changes from nonsurvival to survival surgery; changes resulting in greater pain, distress, or degree of invasiveness; changes in housing or animal use in a location that is not part of the animal program overseen by the IACUC; changes in species; changes in study objectives; changes in principal investigators; or changes that impact personnel safety.
Additionally, an IACUC-approved Veterinary Verification and Consultation (VVC) policy can be implemented for specific significant changes in previously approved activities. The VVC policy should include IACUC-defined eligible significant changes, IACUC-approved references for each VVC-eligible change, an IACUC-authorized veterinarian(s) to verify (through consultation) requested significant changes are compliant with the VVC policy, and a method for documenting the consultation and verification of protocol changes.
An increase in previously approved animal numbers is another significant change, but it can be handled administratively in keeping with an IACUC-approved policy. The IACUC-approved policy for administrative changes must specify the conditions when increases in animal numbers may be handled administratively, the limits of increases in animal numbers, and the title and name of each authorized individual. In addition, the policy must require that the study objectives and rationale for using animals are unchanged by the increase.
Proposed Guidance for Streamlining the Review of Protocols and Significant Changes
The RFI lists various potential flexibilities that may be used to streamline DMR, DMR subsequent to FCR, VVC, and administrative handling of an increase in previously approved animal numbers. It is important to review the RFI for more information on these potential flexibilities.
Submitting a Response
After reviewing the potential flexibilities, you can submit a formal response on the RFI webpage listed in the RFI by October 11, 2023 at 11:59 pm ET.
