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Human Subjects Research at DOEand

Role of Central DOE IRB

Elizabeth (Libby) WhiteDOE Program Manager

Protection of Human Research Subjects

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DOE’s Human Subjects Research Portfolio• Includes approximately 400 active human subjects

research (HSR) projects

• Conducted by 12 DOE sites/laboratories and 33 outside organizations

• Over 1.2 million human subjects• Approximately $110 M/year in Federal funding

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HSR Conducted at DOE Sites/Labs

Scope

• Both domestic and international

• Funded by DOE and by outside organizations, including: DoD, HHS, DHS, DOS, and other Federal agencies, as well as universities and private organizations

• Includes clinical, socio-behavioral, and biomedical/other research

Richland, WA

Los Alamos, NM

Idaho Falls, ID eley, CA

Argonne, IL Batavia, IL Aiken, SC

Ames, IA

Albuquerque, NM

Livermore, CA

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HSR Conducted at DOE Sites/Labs (cont.)

Clinical Research

-Melanoma and Other Mortality Rates in DOE Laboratory Employees

-Manhattan Project Plutonium Workers Health Study

-Beryllium Workers Health Study-Leukemia case-control Studies-National Runners/Walkers Health Study-Effects of Occupational Exposure on

Human Sperm-Effects of Cigarette Smoke on Release

of Calcium from Bone in Humans

Socio-Behavioral Research

-Public Confidence in Government Law Enforcement Agencies’ Ability to Prevent Terrorist Attacks

-Assessment of Experiential Learning in Game-based Virtual Environments

-Physicians’ Perception of Vaccine Issues

Bio-medical/Other Research

-Imaging Studies of Cocaine of Abuse, ADD, and Binge Eating and Brain Dopamine Response

-New Techniques for Detection of Ovarian/Endometrial Cancer

-Antibody Profiling for Forensic Applications

-Methods for Detecting Stowaways in Large Containers Shipped into the U.S.

Richland, WA

Los Alamos, NM

Idaho Falls, ID eley, CA

Argonne, IL Batavia, IL Aiken, SC

Ames, IA

Albuquerque, NM

Livermore, CA

Examples

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HSR Funded by DOE andConducted by Outside Organizations

• Both domestic and international

• Also includes clinical, socio-behavioral, and

biomedical research

• Two of the largest programs funded by DOE and

conducted by outside organizations are health studies on:

1) Atomic bomb survivors in Japan; and 2) DOE’s 400,000+ former workers.

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Health Impacts of Radiation Exposure in Atomic Bomb Survivors

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Health Impacts of Radiation Exposure in Atomic Bomb Survivors (cont.)

• The Radiation Effects Research Foundation (RERF) is believed to have the longest history of any ongoing international research program. DOE and its predecessor agencies have provided support since 1947.

• Funded jointly by the Japanese Ministry of Health, Labor, and Welfare and by DOE (DOE funding is $14 M/year).

• There are 3 cohorts being studied through 63 HSR protocols:– The Life Span Study Cohort (120,000 individuals) – studies of

disease that has led to/leads to the death of A-bomb survivors– The Adult Health Study Cohort (includes 23,000 of the 120,000)

– research and provision of periodic health exams – Genetics Study Cohort (77,000 children of survivors) – studies of

mortality, birth defects, sex ratio, cancer incidence, chromosome aberrations, molecular genetics

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DOE Worker Health Studies• Range of projects looking at health impacts of previous work at

DOE sites.

• The largest DOE-funded study is the Former Worker Medical Screening Program, which has been ongoing since 1996 and provides targeted medical screening to DOE’s 600,000+ former workforce, based on work history and occupational exposures.

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DOE-specific Requirements for Researchers • All research conducted with DOE funding, at DOE site(s), or by

DOE personnel must comply with DOE Policy and Order 443.1A, Protection of Human Research Subjects.

• No such research can be conducted without both a Federalwide Assurance (FWA) and approval by the cognizant IRB.

• All human subjects research using personally identifiable information (PII) must comply with DOE requirements for the protection of PII (see checklist).

• Human Terrain Mapping-related research must comply with the December 2009 DOE Secretarial Policy Memo (see memo), which limits DOE site involvement to analysis and modeling of de-identified data.

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DOE’s Institutional Review Boards (IRBs)

• 9 DOE Sites have internal IRBs

• 3 DOE Sites use external IRBs

• DOE’s Central IRB serves as the IRB of record for:

1) Beryllium-related studies sponsored or funded by DOE facilities or involving the DOE workforce; 2) The Former Worker Medical Screening Program; 3) Multisite research involving the health and/or productivity of current workers at DOE facilities; and4) Possibly future research studies on emerging issues and/or technologies.

Oak Ridge, TN Richland, WA

Los Alamos, NM

Idaho Falls, ID Upton, NY • Berkeley, CA

Argonne, IL Batavia, IL Aiken, SC

Ames, IA

Albuquerque, NM

Livermore, CA

HSR Leads at DOE Sites

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Central DOE IRB….

Roles and Responsibilities

• Senior DOE Management Liaisons: team of senior DOE managers who will ensure sufficient resources, determine scope of IRB activities, & approve modifications to the SOPs and recommendations for resolution of unanticipated problems/adverse events - Anna Palmisano, SC; Pat Worthington, HS, and Frank Russo, NA.

• CDOEIRB Management Team: responsible for day-to-day interaction with the Board - Libby White (SC-23), Mary Fields & Isaf Al-Nabulsi (HS-10), and John Ordaz (NA-1);

• CDOEIRB Administrative Team: Chair (Jim Morris), Vice Chair (John Knezovich), and Administrator (Becky Hawkins)– Chair: appoints members/alternates, determines (with input of Vice

Chair/Administrator) scope of review required, leads the meetings, assures timely review of research protocols.

– Vice Chair: acts in the Chair’s absence and assists with Board activities, as requested by the Chair

– Administrator: primary point of contact for the CDOEIRB; assists in the determination about type of review required and who will serve as primary/secondary reviewers; schedules meetings; distributes meeting materials and meeting minutes.

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Central DOE IRB….

Roles and Responsibilities

• CDOEIRB Members: – Complete initial DOE-required training following appointment.– Complete refresher DOE-required training every three years, as required.– Attend scheduled meetings.– Review materials distributed by the Administrator prior to scheduled

meetings.– Participate as primary or secondary reviewers or conduct expedited

reviews when requested by the Chair, Vice Chair, or Administrator.

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Central DOE IRB….

Membership• Individuals with medical/scientific backgrounds; • An attorney;• A psychologist;• Community members with varying backgrounds;*• Current/former workers from DOE sites;* • Coordinators from several of the FWP Program projects;*• Administrator or Chair from 3 DOE Site IRBs;*

• Alternates/Non-voting members:

– Each member who is a community member, current/former worker, FWP coordinator, or DOE Site IRB Chair/Administrator will have an alternate*.

– The alternate may vote if the primary member is not available. – When the voting member rotates off the Board, the alternate will have the option

of taking his/her place.

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Central DOE IRB….

Membership Terms• 3-year terms;• Additional terms may be served if desired/re-elected by the Board;• It is preferred that:

– No more than 2 consecutive 3-year terms be served by any one member, including the Chair and Vice Chair;

– Those in positions with alternates serve only 1 term.

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Central DOE IRB….

Current Projects:

– Genetic and Exposure Factors in Beryllium Sensitization and Chronic Beryllium Disease (National Jewish Hospital);

– Chronic Beryllium Disease Screening and Determination of Risk Factors in Former Axys Technologies Employees (National Jewish Hospital);

– Former Worker Medical Screening Program: 2 nationwide and 6 regional screening projects for DOE’s 600,000+ former workforce, conducted at local medical clinics around the country (8 consortia of universities, labor unions, and commercial organizations with experience in administration of medical programs).

Expected New Project:

– Assessing the Health and Productivity of the U.S. Department of Energy Employees: Providing a Baseline for Benchmarking and Understanding the Impact of an Aging Workforce (University of MD).