In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) offers the following clarification and guidance:

The issues raised in this scenario are matters of institutional compliance with longstanding NIH Grants Policy and with the PHS Policy. The relevant requirements are as follows:

NIH Grants Policy Statement (GPS) states “NIH will not make an award for research involving live vertebrate animals unless the applicant organization...provide[s] verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals in accordance with the requirements of the [PHS] Policy...Verification of the IACUC review may be filed at any time before award unless required earlier...the IACUC should ensure that the research described in the application is consistent with any corresponding protocols reviewed and approved by the IACUC1.”

PHS 398 Application Instructions specify “Any modification of the Research Plan section of the application, required by the IACUC, must be submitted with the follow-up [IACUC] verification2.”

PHS Policy requires the IACUC to review “those components of PHS-conducted or supported activities related to the care and use of animals” and the institution to provide “verification of approval by the IACUC of those components related to the care and use of animals.” PHS Policy reiterates the 398 Instruction “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 IACUC3.”

After a grant is awarded, the GPS requires prior approval by the NIH funding component when an investigator wishes to substitute one animal model for another4.

In this scenario, the IACUC requested several changes to the protocol and this information was not provided in the IACUC letter of verification to the NIH. If these changes constituted a modification of the Research Plan section of the application, then they are required to be submitted to the NIH as part of the verification.

Note verification of IACUC approval is submitted by the institution to the relevant Grants Management Officer (GMO) assigned responsibility for the grant application by the NIH Institute or Center, and not to OLAW.

The scenario further describes Great Eastern findings that there were animal studies in the grant that were not described in the protocol. This situation is an obvious violation of applicable requirements cited above. Apparently the investigator decided not to perform some of the studies, but substituted studies using a different animal model, which were approved by the IACUC. Since the PHS 398 requires identification of the species in the Research Plan, if the investigator decided to change species prior to receiving the grant award he or she should have notified the GMO. A change in animal model by the investigator post award is an action that, per the terms and conditions of the GPS, is considered a change in scope and therefore requires prior approval by the relevant GMO of the NIH awarding component (not OLAW). The 1995 OLAW guidance, referenced in two of the scenario responses, concerning criteria in determining what constitutes a “significant change” is in the context of whether IACUC review is required for changes that investigators might potentially make to approved protocols5.

NIH grantee institutions are collaborative partners with NIH; both parties have mutual obligations and responsibilities as stewards of Federal funds to ensure compliance with all Federal requirements. Institutions that rely upon statements by investigators that the grant application matches the IACUC protocol and have determined that this is an ineffective method of assuring compliance with Federal rules have a responsibility to develop and implement an appropriate system of policies and procedures to ensure compliance.

With regard to the NIH modular grant format, modular applications and awards employ a simplified process for developing and reviewing application budgets, documenting approved budgets, and making post-award budgetary changes. There are no changes regarding submission of information or policies concerning animal care and use under the Modular Grant procedures.

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