Contract to Protocol Congruence Review

PHS Policy and the NIH Grants Policy Statement (NIH GPS, chapter 4.1.1.2) require the institution to verify, before award, that the IACUC has reviewed and approved those components of grant applications and contract proposals related to the care and use of animals. This is not an explicit requirement for the IACUC to do a side-by-side comparison of an application/proposal and the IACUC protocol. However, institutions are responsible for ensuring that the information the IACUC reviews and approves is congruent with what is in the application/proposal. Institutions are free to devise a workable mechanism to accomplish this end. One method to prevent inconsistencies between the information submitted to PHS and that on the IACUC protocol is to implement a procedure for direct comparison. Some institutions have delegated this responsibility to a particular office or position (e.g., sponsored programs or compliance office); others ask departmental chairs to verify consistency. [A11]

Yes, with rare exception.

The IACUC must review and approve the proposed use of animals described in the application or proposal prior to the conduct of any PHS-supported animal activity (PHS Policy V.B.). Approval is valid for a maximum of 3 years. A brief description of the animal activities planned for the 4^th and 5^th year of the award period should be provided in the animal protocol recognizing that the experimental details and procedures will be refined or amended at a later time or at the time of the 3-year renewal.

Because the scientific enterprise is not static, the need for changes to animal protocols is anticipated and can occur at any time during the life of the protocol. Significant changes to previously approved animal activities require prior IACUC approval. For guidance on what is considered a significant change, see FAQ D9.

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.

Additional OLAW Guidance regarding IACUC review of grant applications can be found at FAQ D10, previous OLAW Commentary, and OLAW Online Seminar The 2016 Vertebrate Animals Section, Grants Policy, and Congruence.