Research Protections Office UnivResearch Protections Office University of Vermontersity of Vermont

Change to Procedures for Change to Procedures for Committee Review of Committee Review of

Resubmissions of Grant Resubmissions of Grant ApplicationsApplications

Research Protections Office University of Vermont

AgendaAgenda

► Institutional ObligationsInstitutional Obligations►RegulationsRegulations►Old ProcessOld Process►New ProcessNew Process

Research Protections Office University of Vermont

Obligations to Match Protocols to Obligations to Match Protocols to the Grant Proposalthe Grant Proposal

►Regulations have always required that Regulations have always required that the institution certify that all funded the institution certify that all funded proposals that involve human subjects proposals that involve human subjects and animals have a matched protocol and animals have a matched protocol which has been reviewed and approved which has been reviewed and approved prior to releasing the funds. The prior to releasing the funds. The regulations do not advise institutions how regulations do not advise institutions how to manage this comparison and to manage this comparison and subsequent certification. Follows are the subsequent certification. Follows are the regulations:regulations:

Research Protections Office University of Vermont

Regulations for Vertebrate AnimalsRegulations for Vertebrate Animals

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

Research Protections Office University of Vermont

Regulations for Human SubjectsRegulations for Human Subjects

►Department of Health and Human Department of Health and Human Services (HHS) regulations at 45 CFR Services (HHS) regulations at 45 CFR 46.103(f) require that each application 46.103(f) require that each application or proposal for HHS-supported human or proposal for HHS-supported human subject research be reviewed and subject research be reviewed and approved by the Institutional Review approved by the Institutional Review Board. Board.

Research Protections Office University of Vermont

Regulations for BiosafetyRegulations for Biosafety

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

Research Protections Office University of Vermont

Old ProcessOld Process

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

Research Protections Office University of Vermont

Old Process - ExampleOld Process - Example

► For instance, a new competitive grant receives a just-in-time For instance, a new competitive grant receives a just-in-time request. The PI submits the protocol and grant for review. request. The PI submits the protocol and grant for review. The initial grant was not funded but, the PI resubmits to the The initial grant was not funded but, the PI resubmits to the sponsor with some changes to the grant. The PI receives a sponsor with some changes to the grant. The PI receives a fundable score, so he/she submits another protocol which fundable score, so he/she submits another protocol which might or might not be identical. This second submission is not might or might not be identical. This second submission is not funded. The PI submits a second time and receives a just-in-funded. The PI submits a second time and receives a just-in-time request and therefore submits a third protocol which time request and therefore submits a third protocol which may be identical to either of the first or with minor may be identical to either of the first or with minor differences. differences.

► So at this point the PI has submitted three protocols to the So at this point the PI has submitted three protocols to the Committee for review and approval for one grant with none or Committee for review and approval for one grant with none or minor differences. In some cases, it is not even the last minor differences. In some cases, it is not even the last submission that is funded and then it becomes difficult for the submission that is funded and then it becomes difficult for the Committees and the PI to be sure which protocol to leave Committees and the PI to be sure which protocol to leave open.open.

Research Protections Office University of Vermont

New ProcessNew Process

► At this time, we have changed the current At this time, we have changed the current requirements regarding submission of protocols to requirements regarding submission of protocols to RPO Committees that correspond to resubmission of RPO Committees that correspond to resubmission of grant applications. grant applications.

► Each Each new grant application and/or renewal to new grant application and/or renewal to continue (competing renewals)continue (competing renewals) will still require a new will still require a new protocol for review. protocol for review. Supplements and resubmissionsSupplements and resubmissions will now require only an amendment to the previously will now require only an amendment to the previously approved protocol. We have modified each of our approved protocol. We have modified each of our amendment forms to provide for the resubmission, amendment forms to provide for the resubmission, review of the resubmitted grant and any associated review of the resubmitted grant and any associated changes to the grant and protocol, and these will be changes to the grant and protocol, and these will be handled under the amendment review mechanism. handled under the amendment review mechanism. PIs will no longer need to submit a full protocol PIs will no longer need to submit a full protocol and new cover form for review!and new cover form for review!

Research Protections Office University of Vermont

New ProcessNew Process

Research Protections Office University of Vermont

ClosingClosing

When in doubt about what is required When in doubt about what is required for resubmissions, please contact the for resubmissions, please contact the appropriate Research Review appropriate Research Review Administrator for the Committee you Administrator for the Committee you are working with at:are working with at:

Research Protections OfficeResearch Protections Office

656-5040656-5040

Thank youThank you