1. R ESEARCH P ROTECTIONS R EVIEW & F UNDING Nancy Stalnaker, Director & Donna Silver, Assistant Director UVM Research Protections Office 6/3/2013UVM Research Protections Office1

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) Human SubjectsVertebrate Animals Biosafety 6/3/2013UVM Research Protections Office2

3. How We Got Here: Bad Things Happened Human SubjectsVertebrate Animals Biosafety Nazi Experimentation Tuskegee syphilis study Henrietta Lacks Life article - animal experimentation without pain relief Poor animal welfare Use of pets (dogs & cats) in experiments Genetic Engineering concerns Scope expanded to safety for lab personnel and the environment 6/3/2013UVM Research Protections Office3

4. Why we still need to be here: it is necessary and the right thing to do… Human Subjects Vertebrate Animals Biosafety Regulatory Requirements Ethical Foundation (rights & welfare) Bad Things Could Happen Regulatory Requirements Ethical Foundation (humane care & use) Bad Things Could Happen Regulatory Requirements Ethical Foundation (environment & humanity) Bad Things Could Happen 6/3/2013UVM Research Protections Office4

5. Grant To Protocol Flow – RPO & SPA Operating Procedure 6/3/2013UVM Research Protections Office5

6. New Funding 6/3/2013UVM Research Protections Office6

7. Fellowships 6/3/2013UVM Research Protections Office7

8. Renewals 6/3/2013UVM Research Protections Office8

9. Continuations or Supplements (not renewals) 6/3/2013UVM Research Protections Office9

10. How does each Committee conduct Initial Review? Biosafety Human Subjects Vertebrate Animals Member Full Staff Designated Member Full In all three Committees the level of review is commensurate with the level of risk. All members get to review and call for a full review Exempt Expedited Review simultaneous Verification of Approval is Required Prior to Award Full 6/3/2013UVM Research Protections Office10

11. When to Submit a New Protocol for Initial Committee Review - by Funding Source? Biosafety Human Subjects Vertebrate Animals 1)Departmental Funds: submit protocol at any time (amendment is required if later associated with a different funding source) 2)FAHC Industry Sponsored: submit protocol at any time 3)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 6/3/2013UVM Research Protections Office11

12. How does each Committee conduct Amendment Review? Biosafety Human Subjects Vertebrate Animals Member Full Staff Designated Member/Staff Full In all three Committees the level of review is commensurate with the level of risk. All members get to review and call for a full review Exempt Expedited Verification of Approval is Required Prior to Award Full Member/Staff Administrative 6/3/2013UVM Research Protections Office12

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. 6/3/2013UVM Research Protections Office13

14. How does each Committee conduct Continuing Review? Biosafety Human Subjects Vertebrate Animals Member Full Staff Designated Member Full In all three Committees the level of review is commensurate with the level of risk. All members get to review and call for a full review Exempt Expedited Verification of Approval is Required Prior to Award Full Member Administrative 6/3/2013UVM Research Protections Office14

15. Committee review of Safety and Noncompliance Biosafety Unanticipated Problems & Noncompliance Human Subjects Vertebrate Animals Committee determinations of significant noncompliance or other unanticipated problems may require reporting to the sponsor depending upon the sponsor requirements. Animal Welfare Concerns Incidents/Accidents 6/3/2013UVM Research Protections Office15

16. Other things the Committees do: Training/Education Biosafety Required Training Human Subjects Vertebrate Animals Required Training Semiannual Inspections Conduct Monitoring Visits Provide Education Risk Assessments 6/3/2013UVM Research Protections Office16

17. Institutional Relationships Biosafety VP for Research and SPA Cancer Center Review Office of Clinical Trials Clinical Research Center FAHC Billing Compliance UVM & FAHC Risk Management Procurement Services Human Subjects Vertebrate Animals VP for Research and SPA Office of Animal Care and Management UVM Risk Management Concentra (Occupational Health) VP for Research and SPA UVM’s Environmental Health & Safety Office UVM Risk Management 6/3/2013UVM Research Protections Office17

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 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 Last piece is to let PIs submit through InfoEd. 6/3/2013UVM Research Protections Office18

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 6/3/2013UVM Research Protections Office19

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/researchman ual.htm Biosafety Research Manual http://www.uvm.edu/ibc/ResearchManual/researchmanual_final.htm 6/3/2013UVM Research Protections Office20