Research Protection Review Committees

1. Research Protections Review & FundingNancy Stalnaker, Director& Donna Silver, Assistant DirectorUVM Research Protections Office UVM Research Protections Office

2. Research Protection Review Committees Institutional Committees on Human Research in the Medical/Behavioral Sciences (aka CHRMS/CHRBS, IRB) Institutional Animal Care and Use Committee (aka IACUC) Institutional Biosafety Committee (aka IBC) Biosafety Human Subjects Vertebrate Animals UVM Research Protections Office

3. How We Got Here: Bad Things Happened Biosafety HumanSubjects VertebrateAnimals • Life article - animal experimentation without pain relief • Poor animal welfare • Use of pets (dogs & cats) in experiments • Nazi Experimentation • Tuskegee syphilis study • Henrietta Lacks • Genetic Engineering concerns • Scope expanded to safety for lab personnel and the environment UVM Research Protections Office

4. Why we still need to be here: it is necessary and the right thing to do… Biosafety Human Subjects Vertebrate Animals • Regulatory Requirements • Ethical Foundation • (humane care & use) • Bad Things Could Happen • Regulatory Requirements • Ethical Foundation • (environment & humanity) • Bad Things Could Happen • Regulatory Requirements • Ethical Foundation • (rights & welfare) • Bad Things Could Happen UVM Research Protections Office

5. Grant To Protocol Flow – RPO & SPA Operating Procedure UVM Research Protections Office

6. New Funding UVM Research Protections Office

7. Fellowships UVM Research Protections Office

8. Renewals UVM Research Protections Office

9. Continuations or Supplements (not renewals) UVM Research Protections Office

10. How does each Committee conduct Initial Review? Human Subjects Vertebrate Animals Biosafety Designated Member Full Full Full Member Staff Review simultaneous All members get to review and call for a full review Exempt Expedited Verification of Approval is Required Prior to Award In all three Committees the level of review is commensurate with the level of risk. UVM Research Protections Office

11. When to Submit a New Protocol for Initial Committee Review - by Funding Source? Human Subjects Vertebrate Animals Biosafety Departmental Funds: submit protocol at any time (amendment is required if later associated with a different funding source) FAHC Industry Sponsored: submit protocol at any time Associated with a Submitted Grant Application when a) approval is required before the sponsor will award the project, e.g. – NIH “Just-In-Time” Request: call RPO Administrator AS SOON AS YOU KNOW GRANT IS IN FUNDABLE RANGE or AGENCY REQUESTS and submit protocol ASAP; or b) sponsor will award project but SPA requires approvals before award set-up: submit protocol as soon as you know project will be awarded UVM Research Protections Office

12. How does each Committee conduct Amendment Review? Human Subjects Vertebrate Animals Biosafety Member/Staff Full Member/Staff Full Full Member Staff Designated All members get to review and call for a full review Administrative Expedited Exempt Verification of Approval is Required Prior to Award In all three Committees the level of review is commensurate with the level of risk. UVM Research Protections Office

13. Changes to the Scope of Work • If there is a change in the scope of work from what was in the original proposal, you may need to go back to your sponsor for prior approval. • Your SPA contact can help you make this determination. UVM Research Protections Office

14. How does each Committee conduct Continuing Review? Human Subjects Vertebrate Animals Biosafety Member Member Full Full Full Member Staff Designated All members get to review and call for a full review Administrative Expedited Exempt Verification of Approval is Required Prior to Award In all three Committees the level of review is commensurate with the level of risk. UVM Research Protections Office

15. Committee review of Safety and Noncompliance Human Subjects Vertebrate Animals Biosafety Animal Welfare Concerns Unanticipated Problems & Noncompliance Incidents/Accidents Committee determinations of significant noncompliance or other unanticipated problems may require reporting to the sponsor depending upon the sponsor requirements. UVM Research Protections Office

16. Other things the Committees do: Training/Education Human Subjects Vertebrate Animals Biosafety Required Training Required Training Required Training Provide Education Provide Education Provide Education Conduct Monitoring Visits Semiannual Inspections Risk Assessments UVM Research Protections Office

17. Institutional Relationships Human Subjects Vertebrate Animals Biosafety VP for Research and SPA Office of Animal Care and Management UVM Risk Management Concentra (Occupational Health) VP for Research and SPA Cancer Center Review Office of Clinical Trials Clinical Research Center FAHC Billing Compliance UVM & FAHC Risk Management Procurement Services VP for Research and SPA UVM’s Environmental Health & Safety Office UVM Risk Management UVM Research Protections Office

18. Where is each Committee with InfoEd? Biosafety Electronic Submission Only Human Subjects Paper Submission Only Vertebrate Animals Electronic Submission Only • Tracking approvals • All protocol materials in system • Sending all correspondence • Generation of Agendas & Minutes with push to members • Electronic review by members • Electronic sign off by chairs • Tracking approvals • Minimal protocol materials in system • Sending some correspondence • Generation of Agendas/Minutes not pushing yet Tracking approvals All protocol materials in system Sending all correspondence Generation of Agendas & Minutes with push to members Electronic review by members Electronic sign off by chairs Last piece is to let PIs submit through InfoEd. UVM Research Protections Office

19. Conclusions Human Subjects Vertebrate Animals Biosafety • All research funded and unfunded falls under the Research Protection Office • We must ensure that funded research grants match the corresponding protocol • All changes to protocol funding requires submission of a protocol amendment • Funds are not released until there is a protocol approval or an amendment approval to change funding UVM Research Protections Office

20. Link Page Research Protections Office http://www.uvm.edu/rpo/ Human Subjects Research Manual http://www.uvm.edu/~irb/?Page=education/researchmanualintro.htm Vertebrate Animal Research Manual http://www.uvm.edu/~iacuc/education/research%20manual/researchmanual.htm Biosafety Research Manual http://www.uvm.edu/ibc/ResearchManual/researchmanual_final.htm UVM Research Protections Office