Notice of Clarification of Institutional Responsibilities Regarding NIH Grant to Protocol Congruence Review
Notice Number:
NOT-OD-22-005

Key Dates

Release Date:

October 18, 2021

Related Announcements

NOT-OD-20-153 - Request for Information (RFI) on Clarification of Institutional Responsibilities Regarding Grant to Protocol Congruency

NOT-OD-10-128 - Clarification on the Roles of NIH Scientific Review Groups (SRG) and Institutional Animal Care and Use Committees (IACUC) in Review of Vertebrate Animal Research

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

In this Notice, to reduce regulatory burden, the NIH Office of Laboratory Animal Welfare (OLAW) clarifies the requirements, responsibilities, timing, and conduct of the grant to protocol congruence review for NIH grant applications proposing research with live vertebrate animals.

Background

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 laboratory 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 research 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 and requirements for grant 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 grant to protocol congruence review. The NIH received 16 comments during the 90-day comment period that ended October 29, 2020. Comments from stakeholders included supporting the elimination of grant to protocol congruence review based on the misconception that grant to protocol congruence review has no impact on animal welfare or research integrity. Stakeholders also drew parallels with the misconception that the Health and Human Services eliminated grant to protocol congruence review for Institutional Review Boards (IRBs) to justify eliminating grant to protocol congruence review.

Please visit OLAW’s website on grant to protocol congruence review for more information.

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., and the NIH Grants Policy Statement (NIH GPS 4.1.1.2) require recipient institutions to verify, before award, that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the components of grant applications related to the care and use of animals.

Protection of animal welfare is a responsibility carried out in every phase of the grant process, including during review by the Scientific Review Group (SRG) and IACUC. The primary role of SRGs is assessing scientific merit, while IACUCs focus on evaluating animal welfare and providing local oversight of institutional animal care and use programs. These functions are not mutually exclusive because it is not entirely possible to separate scientific value from animal welfare and thus, some overlap is inevitable. During the initial peer review of applications, the SRG verifies that any proposed research with animals is scientifically appropriate, including the suitability of the animal usage and protections for research with animals. However, peer review by SRGs is not intended to supersede or substitute IACUC review and approval, but rather complement it. While the SRG considers the appropriateness of the proposed animal procedures to the investigator's scientific goals, the primary goal of the IACUC is to assure that the procedures involving animals comply with all federal animal welfare requirements and the PHS Policy.

Responsibility for Congruence Review

NIH grant recipients 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. Therefore, 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 to be funded. While the IACUC may perform the grant 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).

The requirement for institutions to verify, before award, congruence between what the IACUC has reviewed and approved and the proposed animal research in the grant is similar to the requirements of the Final Rule on the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. Under the revised Common Rule, NIH no longer requires IRB review of the entire grant application. However, recipients are required to certify to NIH that the IRB has reviewed and approved all NIH-supported non-exempt human subject research (i.e., through the review of protocols; see NOT-OD-19-055).

Timing and Verification of Congruence Review by IACUC Approval

The NIH Grants Policy Statement (4.1.1.2.) requires congruence review prior to the initial grant award. Competing applications must include verification of IACUC approval, including the date of the most recent approval, of the components related to the care and use of animals (PHS Policy IV.D.2). The requirement for congruence review prior to award is also applicable to Type 2 renewal applications. Such verification may be filed at any time prior to award unless specifically required earlier by the funding component. Because obtaining IACUC approval may take several weeks, institutions may want to begin the IACUC review and approval process as soon as the applicant is notified that the impact score or percentile appear to be in a fundable range. Although congruence review may be conducted and IACUC approval filed after grant application submission, institutions must submit verification of IACUC approval prior to award when NIH requests it during Just-in-Time (JIT) procedures. Institutions are not required to wait to conduct IACUC and congruence review until JIT notification.

Congruence review facilitates compliance and high standards of animal welfare by ensuring what the IACUC approves is consistent with the information submitted in the application and identifying discrepancies between the grant and approved animal protocol. When the institution verifies IACUC approval, the approval must be for the information originally submitted in the application or include notification of any significant changes required by the IACUC. The institution verifies that there is congruence between the grant and the IACUC-approved protocol when it provides the IACUC approval date, usually as part of the JIT pre-award submission. The signature of the Authorized Organization Representative on the grant application certifies that the organization will comply with all applicable Federal laws and regulations, including required certifications and assurances referenced in the application, which includes verification of IACUC approval of all animal activities prior to award, and any terms and conditions of individual grant awards.

The NIH will delay an award for research involving live vertebrate animals until the recipient organization and all performance sites are operating in accordance with an approved Animal Welfare Assurance and the recipient has provided verification of IACUC approval for all proposed animal activities. No costs for activities with live vertebrate animals may be charged to NIH grants without valid IACUC approval.

Regarding IACUC review, principal investigators may provide only a brief description in the IACUC protocol of the animal activities planned for the 4th and 5th year of the award period, if the experimental details and procedures will be refined or amended later or during the 3-year renewal. Because the scientific enterprise is not static, changes to proposed animal activities are anticipated and can occur at any time during the life of the IACUC-approved protocol.

  • Delayed Onset of Animal Activities: In rare cases, IACUC review is conducted later in the life cycle of a grant, and congruence review must be conducted and IACUC approval filed prior to conducting animal activities. For instance, 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. 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 for animal activities until a valid IACUC approval date has been provided to the funding component.
  • Change in Scope: The NIH GPS 8.1.2.5 allows the investigator to make changes in the project’s methodology and approach without prior approval by NIH grants management. However, the recipient must obtain prior approval from the NIH funding component for a change in scope of the approved project. In some cases, the change in scope involves changes in the animal activity requiring amendments to the IACUC-approved protocol and IACUC review (see OLAW FAQ). Once the initial congruence review is completed prior to award, there is no requirement to conduct further congruence review due to a change in scope.

Methods for Conducting Grant to Protocol Congruence Review

There is no explicit requirement to do a side-by-side comparison of an entire application 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 grant and the protocol by appropriately qualified individual(s) is one way to prevent inconsistencies. Institutions may opt to review multiple sections of the grant application, including the research strategy and Vertebrate Animals Section (VAS), to conduct congruence review. However, review of a well-written VAS, which appropriately addresses all three required criteria, may reduce administrative burden by minimizing the need to review multiple sections of the grant application for congruence. A one-to-one relationship between the grant and the approved protocol is not required, and more than one protocol may be associated with one grant and vice versa.

 

Inquiries

Please direct all inquiries to:

Office of Laboratory Animal Welfare (OLAW)
Telephone: 301-496-7163
Email: olaw@mail.nih.gov


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