Written By: Larry Iten, Rebecca Rousselle, Holly Sommers
Office of Research Administration
As most investigators know very well, federal awarding agencies, including the National Institutes of Health (NIH), require that grantee institutions verify the status of Institutional Review Board (IRB) approval for any grant involving human subjects research and Institutional Animal Care and Use Committee (IACUC) approval for any grant involving animal subjects research before they will issue any Notice of Grant Award.* For NIH, this is done through OSP via the Just-In-Time (JIT) process.
It is also the case that investigators may already have active protocols with the IRB and/or IACUC, as appropriate, under which they intend to cover the activity of a new grant or contract.
Before such existing IRB or IACUC approval can be used to cover a new grant (and be provided to a funding agency as evidence of approval for that grant), please remember that a formal amendment must be filed with and approved by the IRB and/or IACUC, as appropriate, to add the new grant to the existing protocol.
For IRB submissions, the IRB should first be consulted to determine if the new grant and its research procedures may be added to the existing approved study, or if it must be submitted separately. This will depend on how clearly the new activity fits in with the existing study. If the IRB agrees with an amendment, the PI on the IRB submission must also agree to add the new research methods (if any) to the existing protocol document, or submit a separate addendum document. Then, the IRB must conduct a grant-to-protocol review to evaluate the activities described in the grant application with respect to the activities in the protocol document(s) and other materials. Therefore, when filing an amendment to add a grant, please be sure to provide the complete grant application – including the “Human Subjects” section – in the “Funding” section of the amended eIRB application. Once approved, the IRB will issue a letter approving the addition of the new grant to the existing protocol.
For IACUC submissions, the IACUC should also be consulted to determine if the new grant can appropriately be added to an existing protocol or if the scientific research and new procedures require an entirely new protocol. The grant-to-protocol comparison for congruence is then conducted specifically checking the species used, the approximate numbers of animals to be used, and the specific procedures to be conducted on the animals. Once approved, the IACUC will add the grant as part of a new species segment within the existing IACUC approval. This new species segment of the protocol will align with the specific grant number being added.
It is important to remember that OSP cannot verify IRB or IACUC approval of a new grant on an existing protocol until the appropriate amendment has been filed with and approved by the IRB and/or IACUC, as appropriate.
The same requirements apply at the time of proposal submission. By submitting a proposal to a funding agency, OSP is certifying the accuracy of the information being submitted to that agency. Therefore, when submitting a new proposal, if an IRB/IACUC amendment has not already been filed and approved, the IRB and IACUC sections of the application must be marked as “pending.” IRB and/or IACUC approval should not be indicated in these cases since required amendments have not yet been approved, and the new award is not yet formally covered by the existing protocol.
To expedite submission of JIT materials or any other confirmation to an agency that a grant has IRB or IACUC approval, if a new award is being added to an existing protocol (either IRB or IACUC), please provide the amendment approving the addition of the new award when providing protocol approval materials to OSP. (For IRB submissions, please provide the original approval that shows the approval dates, along with the amendment approving the new grant.) Provision of these materials will help eliminate questions and expedite submission of materials to the sponsoring agency.
*See Notice NOT-OD-15-129 (and related Notice NOT-OD-15-128) for NIH policy on “Delayed Onset” human subjects research.