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TABLE OF CONTENTS


Introduction:

PHS Policy and the NIH Grants Policy Statement (Part II, Terms and Conditions) require institutions 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.  The process is referred to as “Congruency Review” and is performed by the UNC Office of Animal Care & Use (OACU) which serves as the administrative office for the IACUC.

Excerpt from section 4.1.1.2 “Verification of IACUC Approval” of the NIH Grants Policy Statement:

“It is an institutional responsibility to ensure that the research described in the application is congruent with any corresponding protocols approved by the IACUC.”

The following funding agencies require Congruency Review:

  • National Institutes of Health (NIH)
  • All NIH subdivisions (e.g. NCI, NHLBI, NIAID, NIDDKD, NIAAA, etc.)
  • National Science Foundation (NSF)
  • US Department of Health & Human Services (DHHS)
  • USDA National Institute of Food and Agriculture
  • American Heart Association (AHA)
  • American Cancer Society (ACS)
  • Department of Veterans Affairs (VA)
  • March of Dimes (MOD)
  • Cystic Fibrosis Foundation (CFF)
  • Susan G. Komen for the Cure

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Congruency Policies & Procedures:

Overview:

For the NIH and other sponsors utilizing JIT notices:

  • The Office of Animal Care & Use (OACU) is automatically notified anytime an NIH award is changed to “Just-In-Time (JIT) Request Received” in RAMSeS.  The OACU will contact the PI at this time to initiate the review. The OACU strives to complete all Congruency Review requests within 5 business days depending on current volume. If a PI receives notice that their grant is likely to be awarded based on their impact score, it is advisable to initiate the congruency review as soon as possible to avoid a delay.
  • A congruency review can be requested using this web form located on the IACUC website: https://research.unc.edu/iacuc/grant-congruency/request-for-review/

Ensuring that all animal activity outlined in a grant application has been approved by the IACUC is an institutional responsibility; however, the Office of Animal Care and Use (OACU) has been tasked with this responsibility. The grant application/protocol congruency reviews will be performed by OACU staff members. OACU staff will review grants that have a high probability of being funded.

Regardless of the time and/or methods by which the review is requested, OACU staff will perform a side by side comparison of the grant application and the corresponding IACUC protocol(s). PIs should ensure that their grant application has been uploaded into RAMSeS for review. Grant applications will be reviewed by OACU staff in the order in which they were received or in order of priority. Grant applications will be reviewed within one week of receiving a request from the PI or email notification from RAMSeS. Grant applications requiring review on an emergency basis will be given priority and reviewed immediately. OACU staff will make every attempt to accommodate funding/award deadlines but PIs should allow sufficient time for OACU staff to review the grant application.

All animal work outlined in the grant application must be approved by the IACUC in a corresponding IACUC protocol(s). OACU staff will focus on the following areas of the grant application and corresponding IACUC protocol(s) during the side by side comparison of the documents:

  • Species
  • Procedures (including custom generation of antibodies contracted off-site)
  • Drugs (Agents, Dosages and Route of Administration)
  • Experimental Endpoints
  • Method(s) of Euthanasia

PIs will be contacted with the results of the grant congruency review no later than 24 hours of completion of the grant review, or sooner, as necessary. If there are no discrepancies between the animal work described in the grant application and the corresponding IACUC protocol(s), an email will be sent to the PI indicating that the documents were congruent.

Resolution of Discrepancies Between the Grant Application and the IACUC Protocol:

If an OACU staff member identifies discrepancies between the grant application and the IACUC protocol, the PI will be emailed with a detailed description of the discrepancies and suggestions on how the discrepancies can be resolved. Discrepancies between the grant application and the IACUC protocol(s) are usually resolved by providing an explanation or submission of a new amendment or protocol.

If resolution of the discrepancies requires submission of a new amendment or protocol, the Chair of the IACUC has initiated a process by which grant application and animal protocol congruency can be established with potentially minimal delays. Specifically, in instances where there is a lack of congruency between the grant and an IACUC protocol, the PI can submit an amendment with rapid turnaround request. Such amendments will be processed as quickly as possible. If an amendment is not sufficient and a full protocol is required in order to establish congruency, or if a protocol is currently under review, the protocol will be processed by the IACUC Chair and a Division of Comparative Medicine (DCM) veterinarian in order to ensure a rapid and thorough review. If this protocol review does not coincide with the monthly IACUC meeting, the protocol will be reviewed by designated member review rather than full Committee review. Please be aware that all efforts will be made to accommodate funding/award deadlines, but federal regulations require all IACUC members to receive a copy of all submitted amendments and full protocols. Upon receipt and review, any IACUC member can request a full Committee review which requires review of the amendment or protocol at the next scheduled monthly IACUC meeting, and this may delay time to approval.

Open communication will be maintained between OACU staff and the PI until all discrepancies have been resolved and the grant application and IACUC protocol(s) are determined to be congruent. Once the PI has resolved all of the discrepancies, OACU staff will email the PI indicating that the documents are now congruent.

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Custom Antibody Vendors:

The Office of Laboratory Animal Welfare (OLAW) considers the generation of custom antibodies to be an activity covered by Public Health Service Policy. Antibodies are considered customized if produced using antigen(s) provided by an investigator or at the request of an investigator (i.e., not purchased as a pre-made catalog item off-the-shelf).  Consequently, if antibody production will be subcontracted, the investigators must use vendors which are PHS-assured.  USDA-registration is required if rabbits or other USDA-covered species are used.  AAALAC accreditation is strongly preferred.  If the subcontractor is located in a foreign country, AAALAC accreditation is required.

The following is a pre-approved list of custom antibody vendors with PHS Assurance.  If your lab will be contracting one of these companies to manufacture custom antibodies, the OACU will require a Memorandum of Understanding be issued to and completed by the contracted company.  Please contact Rebecca Dye in the Office of Animal Care and Use if you will be contracting this work and to receive a copy of the MOU and guidance on the process.

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