central irbs human subjects working group meeting may 8, 2008 betsy ellis and becky hawkins
TRANSCRIPT
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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 ORNL’s request for ORAU CHS to review ORNL’s (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
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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
ETTPHuman Studies
Coordinator
NIH/OHRPDOE
Oak RidgeOperations
B&W Y-12Human Studies
Coordinator
Portsmouth
ORNLHuman Studies
Coordinator
ORISEHuman Studies
Coordinator
IRB Administrator/IRB Secretary
Rocky Flats
Nevada TestSite
Fermi
Paducah
IRB Chair
ORAUInstitutional Signatory
Official
PrincipalInvestigatorsThomas Jefferson
PrincipalInvestigators
Non-DOEPrincipal
Investigators
ORSIRB Membership
• Ethics• Epidemiology• Psychology• Toxicology• Genetics• Occupational Health• Community
$
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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
PrincipalInvestigator’s
Institutional IRB
NIH/OHRPDOE
DOE SCDOE HSS
DOE Site IRB
Principal InvestigatorDoing Be Research
CBeIRB ChairCBeIRB
Administrator
ORAUInstitutional
Signatory Official
CBeIRB Membership
• Ethics• Epidemiology• Industrial Hygiene• Toxicology• Genetics• Be Site IRB Representation• Worker Representation
$
Former Worker ProgramPrincipal Investigator
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CBeIRB: DOE sites
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