Ensuring protocol and grant congruency

by Farah Moulvi, MSPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you live post from the final day of the 2011 IACUC Conference and the PRIM&R Blog Squad. The Blog Squad is composed of members who are devoted to blogging prior to, live from and after the PRIM&R’s conferences.

When faced with comparing information in an IACUC protocol to federally funded grant proposals some institutions find the issue particularly challenging. As such, the 2011 IACUC Conference session titled, Ensuring Consonance Between Grants and Protocols: Who, How, and When? caught my attention.

According to Section IV.D.2 of the Public Health Services Policy on Humane Care and Use of Laboratory Animals (Policy), “applications or proposals…from institutions which have an approved assurance on file with OLAW shall include verification of approval…by the IACUC of those components related to care and use of animals“ In theory, it may sound easy, but how does one actually put that policy statement into action?

The Policy does not elucidate how the IACUC is intended to review and approve the animal care and use components of the grant proposal. There is no specific requirement that mandates comparing the information in the grant proposal to the IACUC protocol form information to verify the congruency. It is up to each institution to come up with a process to review the grant proposal itself and/or compare it with an approved IACUC protocol.

The institution also has to determine who should be assigned such a task. Should this verification be performed by IACUC members, administrative staff, the IACUC chairperson, or the chairperson of the department? Or, is a cross-divisional collaborative approach warranted?

At my institution, the IACUC is assigned this responsibility. The primary reviewing member of the IACUC compares the protocol application form with the federal and major funding agency grant proposal, ensuring that the following items match: the title of project, the research investigator’s name, the species, animal numbers, and overall procedures.

My IACUC has also instituted a “One Protocol, One Grant ” policy, whereby a single IACUC protocol cannot be used to represent the animal use activities of multiple grants. Conversely, though, a single research grant may be represented by more than one IACUC approved protocol. If a grant, not originally declared in the IACUC application, is awarded later in the three-year approval period of the protocol, the investigator must inform the IACUC by submitting an amendment form for full committee review.

Each PHS grant recipient institution must ensure consistency between the original proposal and the protocol form submitted to the IACUC. Moreover, the signature of the authorized institutional official on the grant application form constitutes a declaration that the IACUC has reviewed and approved all animal-related activities in the grant application.

There are other polices in addition to PHS policy that also apply. For example, the National Institute of Health (NIH) Grants Policy considers its awardee institutions collaborative partners that share obligations as stewards of Federal funds to comply with all Federal requirements.

The Ensuring Congruency session reviewed the requirements for assuring agreement between grants and protocols and discussed mechanisms for to achieving this goal. The word “congruent” was defined in context; reviewing for congruency does not require an exact match. A good standard is to match the research design methods sections in the grant and the vertebrate animal section in PHS 398 research plan section F.

When it comes to dealing with instances of incongruity, it’s important to address whether differences between the two documents could be considered a change in scope. If so, would they require confirmation of approval from the funding agency? Differences between the two documents that might raise these questions include change in specific aim of the research, substitution of animal models, change of study location, shift in the disease under examination, or a change in the investigator. I was pleased to hear that grant management offices typically respond quickly when an investigator contacts them regarding such changes.

To become familiar with the intricacies of these situations, I recommend reading OLAW’s frequently asked questions, NIH grants’ policy pages, and NIH’s Instructions for Completion and Peer Review of the Vertebrate Animal Section (VAS) in NIH Grant Applications and Cooperative Agreements.

I also encourage you to share what mechanism your institution has developed for assuring consonance between grants and IACUC protocols, as well as your overall experiences, challenges and solutions.