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Contract to Protocol Congruence Review

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 grant to protocol congruence review. Because the contract to protocol congruence review requirement originates from the Health and Human Services Acquisition Regulation and the review process is different from the grant to protocol congruency review process, OLAW is also providing guidance on this topic. 

In NOT-OD-22-006, OLAW clarifies the requirements, responsibility, timing, and conduct of the contract to protocol congruency review for NIH contract proposals involving research with live vertebrate animals.

Policies and Laws

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PHS Policy IV.D.2.: Institutions That Have an Approved Assurance
"Applications or proposals (competing and noncompeting) covered by this Policy from institutions that have an approved Assurance on file with OLAW shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals. For competing applications or proposals only, such verification may be filed at any time prior to award unless specifically required earlier by the funding component. If verification of IACUC approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the IACUC. The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official.”

PHS Policy V.B.: "PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution...has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals...No award shall be made until...the institution or institutions have provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals."

Health and Human Services Acquisition Regulations 352.270-5a Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals
"Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval."
 

Health and Human Services Acquisition Regulations 352.270-5b: Care of Live Vertebrate Animals
"(c) the Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy)..."

 

 

Guidance

Notice Number Description Date
NOT-OD-22-006 Notice of Clarification of Offeror Responsibilities Regarding Contract to Protocol Congruence Review October 18, 2021
NOT-OD-10-049 Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals April 19, 2010

Resources

FAQs

FAQ D.10 Is the IACUC required to review the grant application?

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]

FAQ D.20 Does the IACUC have to review proposed animal research activities at the time of grant award if the animal research activities will not be conducted until year 4 or 5 of a grant?

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 4th and 5th 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.

Webinars

Webinar Link Webinar Date
The 2016 Vertebrate Animals Section, Grants Policy, Congruence March 10, 2016

Articles

Title Description Date
Lab Animal 32(9) A mouse isn't a rat, but what's the big deal? 2003