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

• 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

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: Central IRB Sites

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

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

$

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 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

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

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

CBeIRB: DOE sites