Change to Procedures for Committee Review of Resubmissions of Grant Applications

1. Change to Procedures for Committee Review of Resubmissions of Grant Applications Research Protections Office University of Vermont

2. Agenda • Institutional Obligations • Regulations • Old Process • New Process Research Protections Office University of Vermont

3. Obligations to Match Protocols to the Grant Proposal • Regulations have always required that the institution certify that all funded proposals that involve human subjects and animals have a matched protocol which has been reviewed and approved prior to releasing the funds. The regulations do not advise institutions how to manage this comparison and subsequent certification. Follows are the regulations: Research Protections Office University of Vermont

4. Regulations for Vertebrate Animals • Public Health Service (PHS) requires that “Applications or proposals (competing or non-competing) covered by this Policy from institutions that have an approved Assurance on file with OLAW shall include verification of approval (including the date of most recent approval) by the IACUC of those components related to the care and use of animals… If verification of IACUC approved is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications. Research Protections Office University of Vermont

5. Regulations for Human Subjects • Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(f) require that each application or proposal for HHS-supported human subject research be reviewed and approved by the Institutional Review Board. Research Protections Office University of Vermont

6. Regulations for Biosafety • No specific regulations. NIH Guidelines For Research Involving Recombinant DNA Molecules (NIH Guidelines) state: “Section I-D.  As a condition for NIH funding of recombinant DNA research, institutions shall ensure that such research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the NIH Guidelines.” Research Protections Office University of Vermont

7. Old Process • To meet these requirements, the Committees have required that a protocol and corresponding grant be submitted for review for each new competitive grant submission. The same logic was applied to resubmissions of these same grants. As funds became increasingly difficult to obtain, researchers have had to resubmit their grant proposals, in many cases, up to three times. This has resulted in multiple protocol submissions to allow the mandated review of grant to protocol. Research Protections Office University of Vermont

8. Old Process - Example • For instance, a new competitive grant receives a just-in-time request. The PI submits the protocol and grant for review. The initial grant was not funded but, the PI resubmits to the sponsor with some changes to the grant. The PI receives a fundable score, so he/she submits another protocol which might or might not be identical. This second submission is not funded. The PI submits a second time and receives a just-in-time request and therefore submits a third protocol which may be identical to either of the first or with minor differences. • So at this point the PI has submitted three protocols to the Committee for review and approval for one grant with none or minor differences. In some cases, it is not even the last submission that is funded and then it becomes difficult for the Committees and the PI to be sure which protocol to leave open. Research Protections Office University of Vermont

9. New Process • At this time, we have changed the current requirements regarding submission of protocols to RPO Committees that correspond to resubmission of grant applications. • Each new grant application and/or renewal to continue (competing renewals) will still require a new protocol for review. Supplements and resubmissions will now require only an amendment to the previously approved protocol. We have modified each of our amendment forms to provide for the resubmission, review of the resubmitted grant and any associated changes to the grant and protocol, and these will be handled under the amendment review mechanism. PIs will no longer need to submit a full protocol and new cover form for review! Research Protections Office University of Vermont

10. New Process Research Protections Office University of Vermont

11. Closing When in doubt about what is required for resubmissions, please contact the appropriate Research Review Administrator for the Committee you are working with at: Research Protections Office 656-5040 Thank you Research Protections Office University of Vermont