RESEARCH PROTECTIONS REVIEW & FUNDING Nancy Stalnaker, Director & Donna Silver, Assistant Director UVM Research Protections Office 6/3/2013 UVM Research Protections Office.
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RESEARCH PROTECTIONS REVIEW & FUNDING Nancy Stalnaker, Director & Donna Silver, Assistant Director UVM Research Protections Office 6/3/2013 UVM Research Protections Office 1 Research Protection Review Committees Institutional Committees on Human Research in the Medical/Behavioral Sciences (aka CHRMS/CHRBS, IRB) Human Subjects 6/3/2013 Institutional Animal Care and Use Committee (aka IACUC) Vertebrate Animals UVM Research Protections Office Institutional Biosafety Committee (aka IBC) Biosafety 2 How We Got Here: Bad Things Happened Human Subjects Vertebrate Animals • Nazi Experimentation • Tuskegee syphilis study • Henrietta Lacks • Life article - animal experimentation without pain relief • Poor animal welfare • Use of pets (dogs & cats) in experiments 6/3/2013 UVM Research Protections Office Biosafety • Genetic Engineering concerns • Scope expanded to safety for lab personnel and the environment 3 Why we still need to be here: it is necessary and the right thing to do… Human Subjects Vertebrate Animals • Regulatory Requirements • Regulatory Requirements • Ethical Foundation • Ethical Foundation (humane care & use) (rights & welfare) • Bad Things Could Happen • Bad Things Could Happen 6/3/2013 UVM Research Protections Office Biosafety • Regulatory Requirements • Ethical Foundation (environment & humanity) • Bad Things Could Happen 4 Grant To Protocol Flow – RPO & SPA Operating Procedure 6/3/2013 UVM Research Protections Office 5 New Funding 6/3/2013 UVM Research Protections Office 6 Fellowships 6/3/2013 UVM Research Protections Office 7 Renewals 6/3/2013 UVM Research Protections Office 8 Continuations or Supplements (not renewals) 6/3/2013 UVM Research Protections Office 9 How does each Committee conduct Initial Review? Human Subjects Full Member Staff Expedited Exempt Vertebrate Animals Full Designated Biosafety Full All members get to review and call for a full review Member Review simultaneous Verification of Approval is Required Prior to Award In all three Committees the level of review is commensurate with the level of risk. 6/3/2013 UVM Research Protections Office 10 When to Submit a New Protocol for Initial Committee Review - by Funding Source? Human Subjects Vertebrate Animals Biosafety 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 6/3/2013 UVM Research Protections Office 11 How does each Committee conduct Amendment Review? Human Subjects Full Member Expedited Vertebrate Animals Staff Full Exempt Designated Member/Staff All members get to review and call for a full review Biosafety Full Member/Staff Administrative Verification of Approval is Required Prior to Award In all three Committees the level of review is commensurate with the level of risk. 6/3/2013 UVM Research Protections Office 12 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. 6/3/2013 UVM Research Protections Office 13 How does each Committee conduct Continuing Review? Human Subjects Full Member Expedited Vertebrate Animals Staff Full Exempt Designated Member All members get to review and call for a full review Biosafety Full Member Administrative Verification of Approval is Required Prior to Award In all three Committees the level of review is commensurate with the level of risk. 6/3/2013 UVM Research Protections Office 14 Committee review of Safety and Noncompliance Human Subjects Unanticipated Problems & Noncompliance Vertebrate Animals Animal Welfare Concerns Biosafety Incidents/Accidents Committee determinations of significant noncompliance or other unanticipated problems may require reporting to the sponsor depending upon the sponsor requirements. 6/3/2013 UVM Research Protections Office 15 Other things the Committees do: Training/Education Human Subjects Required Training Provide Education Conduct Monitoring Visits 6/3/2013 Vertebrate Animals Required Training Biosafety Required Training Provide Education Provide Education Semiannual Inspections Risk Assessments UVM Research Protections Office 16 Institutional Relationships Human Subjects • • • • • • • VP for Research and SPA Cancer Center Review Office of Clinical Trials Clinical Research Center FAHC Billing Compliance UVM & FAHC Risk Management Procurement Services 6/3/2013 Biosafety Vertebrate Animals • • • • VP for Research and SPA Office of Animal Care and Management UVM Risk Management Concentra (Occupational Health) UVM Research Protections Office • • • VP for Research and SPA UVM’s Environmental Health & Safety Office UVM Risk Management 17 Where is each Committee with InfoEd? Human Subjects Paper Submission Only Vertebrate Animals Electronic Submission Only Biosafety Electronic Submission Only • Tracking approvals • Tracking approvals • Tracking approvals • Minimal protocol • All protocol • All protocol • Sending all correspondence • Generation of Agendas & Minutes with push to • Sending some correspondence • • Generation of Agendas/Minutes not pushing yet 6/3/2013 materials in system system materials in system • materials in Sending all correspondence Generation of Agendas & Minutes with push to members members • Electronic review by members • Electronic review by members • Electronic sign off by chairs • Electronic sign off by chairs Researchis Protections LastUVMpiece to letOffice PIs submit through InfoEd. 18 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 6/3/2013 UVM Research Protections Office 19 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 6/3/2013 UVM Research Protections Office 20