Stanford University Administrative Panel on Biosafety

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Stanford University Administrative Panel on
Biosafety

• Ellyn Segal, Ph.D.
• Biosafety Manager

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Stanford Facts

• more than 2,400 externally sponsored research
  projects
• total budget for sponsored research support at
  660 million during 2000-2001
• 4,000 graduate students
• 8,180 acres
• 678 major buildings
• about 25,000 trees on the Stanford campus, with
  the Coast Live Oak the most common

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IBCs What do they do in reviewing research?

• Containment levels per NIH Guidelines
• Personnel and environmental safety/adequacy of
  facilities, training
• Ensure review flow process followed (RAC, IRB)
• Institutional and investigator compliance report
  adverse events, surveillance

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Driving Forces

• Issues as they relate to rDNA, infectious
  organisms
• Guidance and regulations offered by CDC, NIH
• Cal/OHSA

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Relationship of Stanford IRBs and IBC
Regulatory Administrative
Board of Trustees of the Leland Stanford Junior
University
President of the University
Provost of the University
Vice Provost and Dean of Research and Graduate
Policy
Assoc. Vice Provost for Environmental Health and
Safety
Associate Dean of Research
Administrative Panel On Biosafety
Research Compliance Director
Biosafety Manager
IACUC
Research Compliance Associate Director
Education Specialist
Sr. IRB Manager IRB 1 (Medical)
Sr. IRB Manager (Medical)
IRB Manager IRB 3 (Medical)
IRB Manager IRB 4 (Medical)
IRB Manager IRB 2 (Non-medical)
IRB 1
IRB 4
IRB 3
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Administrative Panel on Biosafety

• Charge to the APB http//researchcompliance.stanfo
  rd.edu/biosafety/charge.html
• Review all University research and teaching
  activities involving use of biohazardous agents
  (BL2,3) and rDNA that requires approval
• Advises University and recommends policies for
  procedures involving acquisition, use, training,
  transfer, storage, disposal and emergency
  response for all biosafety activities
• Review and comment on proposed external
  regulations dealing with biosafety

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• Membership
• appointed by the Vice-Provost and Dean of
  Research. Mandated by NIH to contain at least
  five members including BSO, two members from
  community
• Chair David Relman, M.D., Ph.D.
• Currently have 11 voting members on panel
• 2 community members
• 6 Stanford faculty (2 M.D., 3 M.D. Ph.D., 1
  Ph.D.)
• 1 Graduate student
• 2 Ex-Officio (D.V.M., BSO)
• and
• 2 non-voting members

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Biosafety Manager

• Pre-review all submitted proposals
• Communicate with submitting PI prior and
  subsequent to full panel review
• Liaison between APB and Research Compliance
  Office
• Tracking of proposals
• Member of APB (IBC)
• Ex-officio member of IRB, IACUC

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The Stanford APB

• Meets monthly
• BSO handles renewals, administrative approvals,
  communications
• Panel reviews approximately 100 proposals per
  year- gt90 rDNA/infectious agents (non-Gene
  Transfer). GT proposals take 30 of time.

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Gene Transfer

• Review process more complicated RAC approval
  first, but IBC review can be in parallel
• Compliance with surveillance, data reporting, and
  adverse event reporting
• Multiple rounds of review by IRB and IBC of same
  proposal
• Who does what?
• Science
• Ethics
• To the patient
• Sponsor
• Conflict of interest

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Issues

• Role of Sponsor
• Communication amongst sponsor, FDA, and
  institutional IRB/IBC
• Timeframe for reporting SAE/AE from outside
  institutions in multi-site study
• Determination of relationship of SAE/AE to study
• Role of IBC/IRB?
• Definitely /possibly /not related
• Opinion of Protocol Director vs. Sponsor

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IBCs What Should they be doing?

• Should be more than a checklist, more than an
  administrative panel
• Gene Transfer review and consider the science
  with respect to the project and the patient
• Do not solely rely on RAC review and comments for
  initial approval
• Do not solely rely on FDA/OBA for evaluation of
  project as it proceeds

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IBCs (Section IV-B-2-a)

• Additional expertise desirable
• Expertise in biological safety, and physical
  containment
• Knowledgeable in institutional commitments and
  policies, applicable law, professional standards,
  community attitudes, and environment
• Laboratory technical staff

Borrowed from PRIMR Conference, Shipp,
McClelland Prentice
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• RAC Conducts public review and discussions of
  science, safety, and ethics of basic and clinical
  rDNA research
• IBC discussions of science, safety, and ethics
  of basic and clinical rDNA research

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