3
Mar2016

Recently, PRIM&R hosted a webinar titled Grant and Protocol Congruency for IACUCs, presented by Pat Brown, VMD, MS, Diplomate ACLAM, and Richelle Scales, CPIA.

It is an institution’s responsibility to ensure that the research described in a grant application is congruent with any corresponding protocols approved by the institutional animal care and use committee (IACUC). IACUC administrators and other institution staff are tasked with ensuring approved animal research protocols are in agreement with the grants that sponsor them. During this basic-level webinar, presenters discussed considerations for congruency reviews from the perspectives of the Office of Laboratory Animal Welfare and a research compliance analyst.

This webinar provided attendees with the tools to understand, articulate, and enforce the requirements and process for achieving grant and protocol congruence, including recent changes to the Vertebrate Animals Section (VAS) of National Institute of Health (NIH) grant applications; as well as those needed to identify the roles, relationships, and responsibilities of the IACUC, the sponsored projects office, and investigators in facilitating congruence.

After the webinar, the speakers answered some of the questions from webinar attendees that time didn’t allow us to answer live. We’re pleased to share those answers with the readers of Ampersand. If you’re interested in viewing the entire webinar, you may purchase access to the recording.

1. What are the responsibilities for congruency review after the first year of a multi-year award? For example, if a congruency review (for all animal use) is conducted prior to year one of an NIH award (and found to be congruent), are additional reviews required for the year two, etc. awards? I raise the question because the original protocol would likely expire during a multi-year award.
Pat_BrownPat Brown (PB): NIH grants policy requires congruence review prior to award. NIH also expects ongoing IACUC review and approval of the animal activities as required by the PHS Policy. Once the award is made, IACUC review and approval must continue but additional congruence review is not required.

2. A principal investigator (PI) has IACUC approval for Aims 1 and 3. Aim 2 is not in the protocol because it won't be performed until a much later date. How do we indicate this in the congruency approval?
PB: The least burdensome approach to meet the requirement for congruence is to ask the PI to add a brief description of Aim 2 to the approved protocol and acknowledge that the protocol will be amended to include the details of Aim 2 prior to its start. The grant and protocol are now congruent.

Richelle_Scales3. My institution allows many grants to be on one protocol, so the animal numbers on the protocols may be much larger than on the grant. Is this all right?
Richelle Scale (RS): This is ok. Protocols will have increased numbers where there are multiple grants. As long as you can sort out which procedures are for which grants for the purposes of reporting, this should be fine.

4. If a three-year grant proposes animal activities in each year but the PI wishes to submit a protocol for only year one, would it be appropriate to seek a restricted award for year one?
PB: NIH will not issue a restricted award for this situation. The least burdensome approach to meet the requirement for congruence is to ask the PI to add a brief description of the activities to be conducted in years two and three to the approved protocol and acknowledge that the protocol will be amended to include the details of the activities in years two and three prior to their start. The grant and protocol are now congruent.

5. Regarding the example given in the webinar of incongruence noted because the dose of anesthetic differs between the protocol and the grant: is this not the purpose of the revised VAS requirements? What if the protocol dose was required by the local IACUC? This seems like an issue that should rest with the local IACUC and should be considered non-significant for purposes of confirming congruence.
RS: Generally, an inconsistency between the grant and protocol that is specific in detail should be corrected so that it “matches;” however, the example used of an inconsistency in anesthetic dose is a subjective example—it could be determined as significant enough to warrant revision, or insignificant by the IACUC or attending veterinarian and therefore considered congruent. I would tend to agree that this could be decided at the institution as to whether this is considered “a need for revision”.

PB: NIH is looking for significant modifications made by the IACUC that would alter how the PI is going to be conducting the research with the animals. Refinements, such as modification to an anesthetic or an analgesic is well within the IACUC's role and not something that NIH would need to be informed of. What is most important is that what's written in the IACUC protocol is what must be done during the study. If there is a discrepancy, it's important to make sure that the IACUC protocol is defining which drugs are going to be used.

6. In the past we have had direct communication with the Office of Laboratory Animal Welfare(OLAW) who said we must conduct congruence reviews for all PHS grants, including training grants. Is this a change in your guidance?
PB: Yes. To reduce the burden of unnecessary reviews, training grants where no independent research with animals is supported do not require a congruence review.

7. OLAW FAQ 2 says that "the awardee must provide verification of project-specific IACUC approval for the production of antibodies." Will IACUC approval from the company suffice?
RS: Verification of IACUC approval from the company is sufficient in our office; we ask that the approval includes the PHS Assurance number as well.

PB: OLAW supports Richelle’s office’s process as she has described it.

8. Is it correct that the IACUC should not feel pressured to review a related amendment, for example, within 48 hours to support a Just-In-Time (JIT)?
PB: NIH grants staff understands that obtaining IACUC approval may take more than 48 hours. Verification of IACUC approval should be provided at the earliest date available and based on reasonable expectations for IACUC review. IACUCs should not be pressured by PIs to review and approve a new protocol or amend an existing one because of a JIT request.

9. Would having the investigator include a brief description of alternative methods, but then requiring an amendment before alternative method procedures be submitted, reviewed, and approved (prior to the work being completed), potentially cause confusion during protocol review by USDA, AAALAC, etc.? How would the IACUC appropriately review and approve the protocol with the description of alternative methods without the detailed description of the procedures?
PB: Outside review by USDA, AAALAC or others should not be an issue as long as the brief description of the alternative methods acknowledges that the protocol will be amended to include the details of those methods if they are needed. The IACUC’s review and approval is acknowledging that these activities will only proceed after future amendments are submitted.

10. During the JIT congruence review, the reviewer is notified that some of the pilot studies listed on the grant were not funded. What is the next step?
PB/RS: If NIH does not plan to support the pilot studies described in the grant, a note should be filed with the institution's record of the grant congruence review. If the IACUC has already reviewed and approved the protocol including the pilot studies, the IACUC should be informed so that the protocol can be revised. If the PI has plans for another source to fund the pilot studies, the reviewer should get clarification from the PI and the IACUC should be informed of the alternative funding plan. NIH has stated in its policy guidance that PIs must be forthcoming and timely in conveying to the IACUC any modifications related to project scope and animal usage resulting from the NIH review and award processes. For more information, see NIH’s notice on the clarification on the roles of NIH scientific review groups (SRGs) and IACUCs in Review of Vertebrate Animal Research.

11. What if the grant describes animal work for years one through four but the animal protocol only covers the first three years? Must the PI describe all four years on his or her animal protocol? What happens if the work in the later years depends on the success of the first two years?
PB: There has to be congruency between what's in the grant and what's in the IACUC protocol, recognizing that the description of the proposed fourth year work does not need the same level of detail that the IACUC is approving for the first three years. A brief description of the plans for the fourth year with an explanation that this will be refined and more detail provided for IACUC review prior to the start of the work is sufficient to achieve congruency.

12. What should be done during a congruency review when you have an approved IACUC protocol, but the only statement listed in the VAS of the funded grant is one sentence which states nude mice will be used on the study?
PB: This would be an example of an incomplete VAS and the application should have been flagged during NIH peer review for clarification prior to award.

RS: You can verify that nude mice are listed in the approved protocol and also review the aims in the grant and determine if the aims are congruent with the protocol.

13. Regarding the subaward scenario that was referenced in the webinar: if the institution is the direct federal awardee but subawards all of the animal work to another entity (i.e., company in the scenario you discussed), who is responsible for conducting congruence review?
RS: The awardee conducts the congruence review of all approved protocols going to the subaward recipients.

PB: OLAW agrees with Richelle. The institution that accepts the funds verifies, by providing the IACUC protocol approval date, that there is congruence between what is in the grant application and what has been approved at the institution where the activity is going to be conducted. NIH Grants Policy Statement requires that awardees have a formal written agreement with subawardees that addresses the negotiated scientific, administrative, financial, and reporting requirements of the grant.

14. How do you suggest I document the congruency review? Do you suggest using a checklist or providing a formal letter to the PIs? What do I do with protocols that have already received their funding? Should I do a retrospective congruency review?
RS: At University of California, Berkeley, we provide a formal letter to the PI and Sponsored Projects Office/Grants Office. We call it a "certification letter" as it certifies that the grant is congruent with the protocol. The letter includes the PI's name, the grant agency name and number, the title of the grant, the number/title of the approved protocol, the grants office number assigned to it, and the most recent approval date of the protocol. Our office keeps a record of the letters but not of the grants. The Grants office keeps record of both grant and certification letters.

PB: If the activities approved by the IACUC are already funded and a review was not done prior to award, the best approach is to do the congruency review for the grants that are still active. If there are any discrepancies found between the grant and the IACUC approved protocol, ask the PI for clarification and follow the steps we have outlined in the webinar.

PRIM&R would like to thank Dr. Brown and Ms. Scales for sharing their expertise.

If you were unable to attend this webinar and are interested in purchasing the archive, you may do so here.

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