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RESEARCH PROTECTIONS REVIEW & FUNDING

Nancy Stalnaker, Director&

Donna Silver, Assistant DirectorUVM Research Protections Office

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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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