PI Congruency Tips
PIs are advised to take the following steps after the submission of a research proposal (grant, award, contract, subaward, etc.) to facilitate timely congruency review.
1. If you receive a high priority score, OSP recommends consulting with your Program Officer to see whether you are within funding range. If you receive an indication that the application is potentially fundable, please conduct a review of your IACUC protocol(s) to confirm that all the studies in the proposal are included in an IACUC-approved protocol. The self-review should focus on the six areas identified in Section III.C.
2. If all proposed studies are not included in the IACUC protocol, modify the IACUC protocol, or submit a new protocol or early renewal, if necessary. Please plan ahead as IACUC requires about 3-4 weeks to approve a major amendment, or 4-8 weeks to approve a new protocols or renewal.
3. If the current protocol is set to expire before or within a few months of the award start date, it is advisable to submit a new protocol or an early renewal of the IACUC protocol.
4. A detailed description is not required for studies planned for years 4 and 5 of the grant or for alternative approaches to be taken if the planned studies are not successful. For this exception to the congruency requirement, OLAW/NIH has advised a brief description of such studies in lieu of a detailed experimental design in the IACUC protocol is acceptable. A detailed description of these studies with IACUC approval will be required prior to initiating them by amending or renewing the IACUC protocol.
5. Studies conducted at outside or off-site institutions: The UMMS PI should ensure that non-UMMS collaborators planning to conduct off-site live animal studies (via contract/subaward), or producing not off the shelf research reagents (e.g., antibody production) provide their approved IACUC protocol to the UMMS IACUC for review and approval. NIH requires that all external collaborators must have IACUC approvals from NIH assured entities. UMMS investigators must complete an off-site protocol form or amend their approved protocol by completing Form J.