CENTRAL IRBS

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CENTRAL IRBS

• Human Subjects Working Group Meeting
• May 8, 2008
• Betsy Ellis and Becky Hawkins

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CENTRAL IRBS

• Oak Ridge Associated Universities (ORAU) runs
• Oak Ridge Site-Wide IRB (ORSIRB)
• Central Beryllium IRB (CBeIRB)
• Rationale
• History
• Operations

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CENTRAL IRBS Rationale

• ORSIRB evolved passively to serve multiple DOE
  sites as the result of poor audit results
• CBeIRB was deliberately set up to be nationwide
  as result of limited knowledge of health effect
  of Be in the medical community

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ORSIRB History

• 1950 AEC/ORINS obtain consent of hospital
  patients treated with radioisotopes
• 1950-60s Internal ORAU oversight of human
  subjects research (HSR)
• 1967 ORAU Committee on Human Subjects (CHS)
  established with 2 external members
• 1969 DHHS approved institutional assurance as
  required by USPHS
• 1970 AEC approves ORNLs request for ORAU CHS to
  review ORNLs (HSR)
• 1972 ORAU/ORNL CHS established under General
  Institutional Assurance
• 1975 45CFR46 implemented
• 1984 DHHS/OPRR approves joint ORAU/ORNL MPA
• 9/15-16/98 DOE SC audit of ORAU/ORNL CHS program
  found deficiencies
• 1999 ORAU proposes DOE Oak Ridge Site-wide IRB
• 6/7/01 DOE-ORO establishes funding for ORSIRB
• 2002-present DOE-ORO provides funding for ORSIRB
  based on ORAU request
• 2003 and 2006 ORSIRB granted FWA

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ORSIRB Audit

• Results pertinent to formation of central IRB for
  Oak Ridge
• Lack of Operations Office (OR) leadership in
  providing direction for human subjects protection
  program (HSPP)
• Influx of former worker programs onto OR site
  from other agencies or subcontractors without
  notification of DOE (HQ or OR), facilities or
  ORAU/ORNL IRB
• Increased work load of ORAU/ORNL IRB with no DOE
  funding

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ORSIRB Audit

• Recommendations to DOE-OR
• Clearly describe and define the HSPP at OR sites
• Designate DOE-OR management official responsible
  for HSPP
• Reflect HSPP in DOE-OR functional chart and
  mission
• Designate DOE-OR POC for HSPP
• Educate DOE-OR at all organizational levels as
  appropriate
• Establish process to screen all work coming to
  all OR facilities for human subjects
  participation regardless of funding
• Funded by Contracts, Subcontracts, CRADAs,
  Grants, WFO
• Apply these recommendations to all site offices
  and facilities for which DOE-OR has
  responsibility

7
ORSIRB Results

• ORAU
• convenes and manages single ORSIRB to serve all
  DOE-OR contractors
• holds MPA
• Administration of IRB becomes part of DOE
  contract with ORAU
• DOE-OR
• funds administration of IRB
• designates liaison to IRB
• informs all OR contractors of new ORSIRB and of
  their responsibility to gain advance approval to
  conduct human subjects research

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ORSIRB Central IRB Sites
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ORSIRB Central IRB Sites
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ORSIRB Operations
Function ORAU ORNL Y12 ETTP
Funding 50 40 5 5
IRB Administrator Yes No No No
Human Subjects Coordinator Yes Yes Yes Yes
FWA Yes Yes No No
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ORSIRB Operations
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CBeIRB Rationale/Purpose

• DOE obligation to ensure Be studies are conducted
  with
• Highest ethical standards
• Information given to worker
• allows informed choices
• is consistent across the DOE complex
• Minimal impact on quality of life
• Insurability
• Employability
• Privacy/Confidentiality
• Lack of knowledge in the medical and scientific
  community about Be issues

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CBeIRB Membership

• Expertise in Be issues
• Ethics
• Industrial Hygiene
• Toxicology
• Epidemiology
• Occupational Health
• Representation from workers with BeS or CBD to
  serve as community members
• Be Site IRB Representation 3 sites, 3 year
  rotation

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CBeIRB History

• 1998 DOE Former BE Workers Medical Surveillance
  Program established in response to 42 USC Sec
  7274i
• 12/8/99 Final rule for CBD Prevention Program (10
  CFR 850.36) published
• 2000 Draft order for formation of CBeIRB
• 2001 Former worker programs and Be research
  activities increase
• 3/01 DOE announces formation of CBeIRB
• Assured with OHRP under same FWA as ORSIRB
• 12/01 First meeting of the CBeIRB

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CBeIRB Operations

• DOE identifies protocols for review
• CBeIRB interacts with
• PI
• Institutional IRB at which PI is located
• DOE site
• Initial review of new protocols
• Continuing annual (at least) review
• Institutional IRB
• DOE Site IRB
• CBeIRB only if change in Be component or at its
  discretion

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CBeIRB Operations
Former Worker Program Principal Investigator
NIH/OHRP DOE
DOE SC DOE HSS
Principal Investigator Doing Be Research
ORAU Institutional Signatory Official

Principal Investigators Institutional IRB
DOE Site IRB
CBeIRB Chair
CBeIRB Administrator

• CBeIRB Membership
• Ethics
• Epidemiology
• Industrial Hygiene
• Toxicology
• Genetics
• Be Site IRB Representation
• Worker Representation

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CBeIRB DOE sites
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