research protection review committees
DESCRIPTION
Research Protections Review & Funding Nancy Stalnaker, Director & Donna Silver, Assistant Director UVM Research Protections Office. Research Protection Review Committees. Institutional Committees on Human Research in the Medical/Behavioral Sciences (aka CHRMS/CHRBS, IRB). - PowerPoint PPT PresentationTRANSCRIPT
UVM Research Protections Office 1
RESEARCH PROTECTIONS REVIEW & FUNDING
Nancy Stalnaker, Director&
Donna Silver, Assistant DirectorUVM Research Protections Office
6/3/2013
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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 Subjects Vertebrate Animals Biosafety
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How We Got Here: Bad Things Happened
Human Subjects Vertebrate 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
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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
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Grant To Protocol Flow – RPO & SPA Operating Procedure
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New Funding
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Fellowships
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Renewals
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Continuations or Supplements (not renewals)
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How does each Committee conduct Initial Review?
BiosafetyHuman Subjects Vertebrate Animals
MemberFull Staff Designated MemberFull
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
ExemptExpeditedReview simultaneous
Verification of Approval is Required Prior to Award
Full
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When to Submit a New Protocol for Initial Committee Review - by Funding Source?
BiosafetyHuman 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 time3) 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
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How does each Committee conduct Amendment Review?
BiosafetyHuman Subjects Vertebrate Animals
MemberFull Staff Designated Member/StaffFull
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
ExemptExpedited
Verification of Approval is Required Prior to Award
Full Member/StaffAdministrative
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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.
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How does each Committee conduct Continuing Review?
BiosafetyHuman Subjects Vertebrate Animals
MemberFull Staff Designated MemberFull
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
ExemptExpedited
Verification of Approval is Required Prior to Award
Full MemberAdministrative
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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
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Other things the Committees do: Training/Education
Biosafety
Required Training
Human Subjects Vertebrate Animals
Required Training Required Training
Semiannual InspectionsConduct Monitoring Visits
Provide Education Provide Education Provide Education
Risk Assessments
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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
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Where is each Committee with InfoEd?Biosafety
Electronic Submission Only
Human SubjectsPaper Submission Only
Vertebrate AnimalsElectronic 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.6/3/2013
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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
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Link Page
Research Protections Officehttp://www.uvm.edu/rpo/
Human Subjects Research Manualhttp://www.uvm.edu/~irb/?Page=education/researchmanualintro.htm
Vertebrate Animal Research Manualhttp://www.uvm.edu/~iacuc/education/research%20manual/researchmanual.htm
Biosafety Research Manualhttp://www.uvm.edu/ibc/ResearchManual/researchmanual_final.htm
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