Clarifying Animal Protocol Congruence Reviews for Grants and Contracts

Funding News Edition: November 17, 2021
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If you include research with live vertebrate animals in your grant application or contract proposal, make sure you understand and follow requirements for protocol congruence reviews. The NIH Office of Laboratory Animal Welfare (OLAW) issued two Guide notices on October 18, 2021:

What Is Protocol Congruence Review?

If you aren’t already familiar with animal protocol congruence review, here’s a quick explanation. Before award, your recipient institution must verify that your institutional animal care and use committee (IACUC) has reviewed and approved the components of your application or proposal related to the care and use of animals. Check the following policies:

  • Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) Sections IV.D.2. and V.B. require protocol congruence review.
  • NIH Grants Policy Statement (NIH GPS 4.1.1.2) and Health and Human Services Acquisition Regulations solicitation provision 352.270-5a and contract clause 352.270-5b both require institutions to comply with the PHS Policy.

Summary of the Two Clarification Notices

This section of the article gives you an overview of several key points from the two OLAW Guide notices linked above, but you should read the notices in full for complete details on clarified requirements, responsibilities, timing, verification, and methods for congruence review.

The goal is to reduce the administrative burden on you, your institution, and your IACUC while maintaining the integrity and credibility of research findings and protection of research animals. Congruence review ensures that public funds are used to promote the highest level of scientific integrity, public accountability, and social responsibility as reflected in humane animal care.

As both notices emphasize, it is the institution’s responsibility, not the IACUC’s, to ensure that the information the IACUC reviews and approves is consistent with that contained in the application or proposal to be funded. While the IACUC may perform the congruence review, it is not a required IACUC function and may be performed by other qualified institutional personnel with responsibility designated to a specific office or position (e.g., sponsored programs or compliance office).

Your required timing and verification of IACUC congruence review differs by award type:

  • Grants. Type 1 competing and Type 2 renewal applications must provide verification of IACUC approval, including the date of the most recent approval, of the components related to the care and use of animals. Your institution may file verification at any time before award unless the funding component requires it earlier. Check the first Guide notice above for details on how to handle delayed onset animal activities, changes in scope, and more.
  • Contracts. Before award, your contracting officer will notify your institution of the requirement for an Assurance and verification of IACUC approval. The date of IACUC approval must be no more than 36 months before award. Check the second Guide notice above for details.

For both award types, there is no explicit requirement to do a side-by-side comparison between the application or proposal and the IACUC protocol. Your institution is free to develop its own appropriate system of policies and procedures to prevent inconsistencies between the information. As one example, your institution could implement a process for appropriately qualified individuals to compare key elements.

Your institution may opt to review multiple sections of the application or proposal for congruence review. As an example of a different approach that may reduce your administrative burden and minimize the need to review multiple sections, your process could focus on review of a well-written Vertebrate Animals Section which appropriately addresses all required criteria.

Contact Information, Learn More

Direct your questions about congruence review or animal research to OLAW at olaw@mail.nih.gov or 301-496-7163.

Find NIAID’s guidance and advice on Research Using Vertebrate Animals.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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