Grant and Contract to Protocol Congruence Review

Grant to Protocol Congruence Review

Introduction

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. 

In NOT-OD-22-005, OLAW clarifies the requirements, responsibility, timing, and conduct of the grant to protocol congruency review for NIH grant applications proposing research with live vertebrate animals.

Policies and Laws

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."

Federal Register 67(152): Laboratory Animal Welfare: Change in PHS Policy on Humane Care and Use of Laboratory Animals

Guidance

Helpful Resources & References

• Guidance on Significant Changes to Animal Activities: OLAW Special Seminar, August 21, 2014
• Implementing Guidance on Significant Changes: One Institution's Experience: OLAW Online Seminar, September 8, 2016
• NOT-OD-14-126: Guidance on Significant Changes to Animal Activities
• 21st Century Cures Act: Updates and Your Questions Answered (recorded webinar)
• Congruence Review (recorded webinar)

Contract to Protocol Congruence Review

Introduction

One of the actions identified in the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF, 928.32 KB)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

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.”

"(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

FAQs

Grant to Protocol Congruence Review

• Does OLAW expect the IACUC to notify NIH when there is a change in an animal activity supported by PHS funds?
• Is the IACUC required to review the grant application?
• Is the IACUC responsible for judging the scientific merit of proposals?
• 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?

Contract to Protocol Congruence Review

• Is the IACUC required to review the grant application?
• 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?