A Notice to Research Investigators Receiving Public Health Services (PHS), American Heart Association (AHA), or National Science Foundation (NSF) Monies to Conduct Live Vertebrate Animal Research
A required procedure at the University of Pittsburgh (the University) to align with the Public Health Service Policy for Verification of IACUC Approval is referred to as an IACUC Congruency Review. The University of Pittsburgh IACUC (the IACUC) policy for this review process can be found here.
The link for submitting materials to initiate congruency reviews for grants and contracts funded by the PHS, AHA, and NSF can be found here.
Why is a Congruency Review Needed?
The NIH has very strict requirements for animal research that they fund, and NIH grants policy requires a verification that all major procedures in the grant have been approved by the IACUC. Specific guidance on PHS protocol congruence review can be found here, and specific guidance on contract-to-protocol congruence review can be found here. It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by an IACUC. AHA- and NSF-funded projects also have this requirement. More information on IACUC protocol submission, review and approval can be found here.
How Does This Work?
In short, any vertebrate animal work indicated on an award--regardless of the year in which it will occur--must have IACUC approval before funds can be released. For vertebrate animal work indicated as occurring in years 1-3 of an award, the work should be well-described in an approved IACUC protocol from the institution conducting the work, including major procedures and project design.
If the animal work will be done at the University, a protocol approved by the IACUC must describe the procedures indicated in the Research Methods/Specific Aims and Vertebrate Animals sections of the award.
If no approved protocol exists to cover this work, the PI must either submit a new protocol to cover the work or submit a modification to an existing protocol to cover the work. If the animal work is to be completed at another institution as part of a subaward, then that institution must provide the approved IACUC protocol to the University for verification that the procedures listed in the award are approved in that institution's protocol. It is the PI’s responsibility to provide the appropriate approvals from collaborating institutions. If requested, the Animal Research Protections Office (ARP) can assist with this process.
Once the approved documents are provided, ARP will verify that all major procedures listed on the award are approved in the pertinent IACUC protocols. This is not a side-by-side comparison, as the IACUC may require some changes from what the grant has listed, but all major procedures need to be matched. For example, if a surgical procedure is described in the grant, but not in an approved protocol, the procedure must be added. If that procedure lists that analgesic A will be used, but the IACUC has approved the use of analgesic B, no changes will be needed.
What If the Animal Work is Not Anticipated to Occur Until Later in the Award?
PHS policy requires all animal work to be covered in an approved IACUC protocol, including that which is planned for years 4 or 5 of an award. In these cases, NIH has issued guidance that only a summary of the later work is necessary to comply with this policy. This is the preferred and more expediated method of completing this requirement. However, other options do exist:
- In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. IACUC review may be delayed if the animal activities will not occur until a year or later in the award period as part of the research design described in the grant application or contract proposal (e.g., the initial development of a drug or device with subsequent animal testing projected into the future). In these circumstances, the funding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract for animal activities until a valid IACUC approval date has been provided to the funding component.
- If the initial Notice of Award did NOT include a special term and condition indicating that no funds may be drawn from the grant or contract for animal activities until a valid IACUC approval date has been provided to the funding component, but you cannot obtain IACUC approval for the work because of the nature of the study design, you MAY be able to have the Notice of Award amended. Please contact the IACUC office at IACUC@pitt.edu for additional information on this process.
Still have questions?
Questions about the required review process can be submitted to IACUC@pitt.edu.