October 18, 2021
NOT-OD-20-153 - Request for Information (RFI) on Clarification of Institutional Responsibilities Regarding Grant to Protocol Congruency
NOT-OD-10-049 - Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals
Office of The Director, National Institutes of Health (OD)
In this Notice, the NIH Office of Laboratory Animal Welfare (OLAW) clarifies the requirements and responsibilities for contract to protocol congruence review. The expectation for congruence review is institutional verification that the information reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) is consistent with that contained in the proposal to be funded.
The 21st Century Cures Act, Section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of animals and to make revisions, as appropriate, to reduce the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of animals. One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research in response to the 21st Century Cures Act is to provide clarification on existing guidance on contract to protocol congruence review. On July 29, 2020, the NIH issued an RFI in Guide Notice NOT-OD-20-153 to solicit input from the public on the institutional responsibilities for conducting contract to protocol congruence review. The NIH received 16 comments during the 90-day comment period that ended October 29, 2020.
Requirement for Congruence Review
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) IV.D.2. and V.B., requires institutions to verify, before award, that the IACUC has reviewed and approved the components of the contract related to the care and use of live vertebrate animals. In addition, Health and Human Services Acquisition Regulations (HHSAR) solicitation provision 352.270-5a and contract clause 352.270-5b require offerors to comply with the PHS Policy, including providing verification of IACUC approval for activities involving animals described in the technical proposal, prior to receiving an award.
Protection of animal welfare is a responsibility carried out by the Peer Review Panel and IACUC.
Please visit OLAW’s website on contract to protocol congruence review for more information.
Responsibility for Congruence Review
It is the institution’s responsibility, not the IACUC’s, to ensure congruence review by verifying that the information the IACUC reviews and approves is consistent with that contained in the proposal to be funded. NIH contractors are collaborative partners with NIH and both parties have mutual obligations and responsibilities as stewards of Federal funds to ensure compliance with all Federal requirements. 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. While the IACUC may perform the contract to protocol 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).
Timing and Verification of Congruence Review by IACUC Approval
Proposals must include verification of IACUC approval of components related to the care and use of animals, including the date of the most recent approval (PHS Policy IV.D.2). Prior to award, the Contracting Officer will notify contractor(s) of the requirements for an Assurance and for verification of IACUC approval. The date of IACUC approval must not be more than 36 months prior to receiving an award involving animals. The offeror verifies that there is congruence between the contract and the IACUC-approved protocol when the IACUC approval date is provided. The signature of the offeror’s authorized representative on the proposal legally binds the institution, stipulating that the IACUC has approved all animal activities covered in the contract award and that the award is predicated upon maintaining compliance with all applicable terms and conditions of the contract. The NIH will not make an award for research involving animals until the institution and all performance sites are operating in accordance with an approved Animal Welfare Assurance and the offeror has provided verification of IACUC approval for all proposed animal activities.
IACUC approval and congruence review of animal activities is required once for all contracts involving animal activities and is expected to occur prior to award. Once completed, no further congruence review is required for subsequent contract modifications. IACUC approval and congruence review must be completed post award and prior to conducting proposed animal activities on any contract modified to include animal activities where IACUC approval and/or congruence review was not completed prior to initial contract.
Methods for Conducting Contract to Protocol Congruence Review
There is no explicit requirement to do a side-by-side comparison of an entire proposal and the IACUC protocol, and institutions are free to devise a workable mechanism by developing and implementing an appropriate system of policies and procedures to prevent inconsistencies between the information. Implementation of a procedure for comparison of key elements of the contract and the protocol by appropriately qualified individual(s) is one way to prevent inconsistencies. Institutions may opt to conduct congruence review using multiple sections of the proposal in addition to the VAS. However, review of a well-written VAS, which appropriately addresses all four required criteria, may reduce administrative burden by minimizing the need to review multiple sections of the proposal for congruence. Completion of all four criteria in the VAS portion of the Technical Proposal is required prior to award for work proposed involving animals at every performance site. A one-to-one relationship between the proposal and the approved protocol is not required, and more than one protocol may be associated with one proposal and vice versa.
Office of Laboratory Animal Welfare (OLAW)