University of Pennsylvania EHRS IBC Protocol Review Process Charles E' Benson, Ph' D'

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University of PennsylvaniaEHRS IBCProtocol
Review ProcessCharles E. Benson, Ph. D.
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University of Pennsylvania
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Recombinant DNA Research

• 2002 _at_ Penn

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IBC-rDNA Protocol Submissions
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University of Pennsylvania IBC Registration

• Electronic filing
• Application on-line
• EHRS pre-screening
• Database entry
• Distribution to Committee/Chair
• Committee recommendations
• Written investigator notification

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3 Types of IBC-rDNA Review
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Full IBC Review

• All BSL-2 or higher experiments
• Experiments involving toxins or immune modulators
• Large volume (gt10L.) rDNA experiments
• Biosafety Level (down-grade) requests
• IBC member recommendation
• ALL Human Gene Transfer research

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IBC Human Gene Transfer Protocol Submissions

• Points to Consider (Appendix M, rDNA Guidelines)
• Clinical Protocol
• Investigators Brochure
• Penn rDNA registration document
• Enough copies for entire committee (12)

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IBC Human Gene Transfer Protocol Actions

• Full Approval
• Requires Principal Investigator to notify IBC in
  writing BEFORE initiating protocol

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IBC Human Gene Transfer Protocol Actions

• Full Approval
• Interim Approval
• response from investigator
• Minor actions
• Response is reviewed at EHRS
• Major actions
• Application is re-distributed to committee

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IBC Human Gene Transfer Protocol Actions

• Full Approval
• Interim Approval
• Reconsideration
• Investigators response to committees concerns
  is discussed at a Convened meeting

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IBC Human Gene Transfer Protocol Actions

• Full Approval
• Interim Approval
• Reconsideration
• Rejection / Termination
• IRB is notified

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Special thanks to

• Harriet Izenberg
• BSO
• University of Pennsylvania

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The Ideal review processQuestions to consider

• What would speed the process?
• Who really needs to review the registration
  document?
• What would help move the review process through
  the necessary channels?
• Are electronic signatures acceptable?
• What happens when a PI does not register the work
  or deviates from the registered work?

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And finally .

• Must the whole committee review each document?