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

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

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

ORSIRB: History 1950 AEC/ORINS obtain consent of hospital patients treated with radioisotopes s 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 CFR46 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

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

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

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

ORSIRB: Central IRB Sites

ORSIRB: Operations FunctionORAUORNLY12ETTP Funding50%40%5% IRB AdministratorYesNo Human Subjects Coordinator Yes FWAYes No

ORSIRB: Operations

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

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

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 ) 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

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

CBeIRB: Operations Principal Investigator’s Institutional IRB NIH/OHRP DOE DOE SC DOE HSS DOE Site IRB Principal Investigator Doing Be Research CBeIRB Chair CBeIRB Administrator ORAU Institutional Signatory Official CBeIRB Membership Ethics Epidemiology Industrial Hygiene Toxicology Genetics Be Site IRB Representation Worker Representation $ Former Worker Program Principal Investigator

CBeIRB: DOE sites