Plans for Central DOE IRB (CDOEIRB) Mary Fields and Isaf Al-Nabulsi, HSS Libby White, SC

1. HSS Office of Health, Safety and Security Plans forCentral DOE IRB (CDOEIRB)Mary Fields and Isaf Al-Nabulsi, HSSLibby White, SC

2. Background HSS Office of Health, Safety and Security Central Beryllium IRB (CBeIRB) • Established in 2001 • Jointly funded by DOE’s Office of Health, Safety, and Security (HSS) and Office of Science (SC) • Brought expertise and consistency to the review of all DOE-funded/conducted beryllium HS research • As a result, beryllium research and former worker medical screening projects now have informational materials and consent forms that are clear, accurate, and consistent re: CBD, Be sensitization, benefits and risks of screening, EEOICPA, etc.

3. Opportunity - Scope HSS Office of Health, Safety and Security Expand IRB Focus • Continue review of all beryllium-related HS research • Become DOE IRB of record for entire Former Worker Medical Screening Program (recommended by reviewers of DOE HQ HSPP, October 2008) • Other areas in the future?

4. Opportunity - Membership HSS Office of Health, Safety and Security Expand IRB Membership • Maintain core membership of experts in occupational medicine, industrial hygiene, immunology, bioethics, epidemiology, and public health, as well as community members • Expand number of DOE site IRBs represented (3 members and 3 alternates from other DOE sites, who become members as members rotate off) • Expand number of DOE workers represented (3 members and 3 alternates, who also become members as worker representative members rotate off) • Include representation from FWP screening providers (2, with 2 alternates) • Other areas in the future?.

5. Opportunity –DOE Site IRBs HSS Office of Health, Safety and Security - Greater opportunity to serve on C DOE IRB - Less burden with regard to Former Worker Medical Screening Program • Initial and continuing review by DOE site IRB(s) no longer necessary • C DOE IRB to make available copies of all materials submitted by PI, as well as IRB approval(s), on IRB Net - Potential for additional expansion in scope means that the C DOE IRB could assist Site IRBs in the future with addressing future complex-wide issues/challenges (i.e., nanotechnology).

6. Administrative Change HSS Office of Health, Safety and Security Move administration of IRB from ORAU to HQ • Concern by external organizations that no DOE site/lab involved in worker studies/the FWP should administer an IRB responsible for reviewing/approving such studies. • Joint funding by SC and HSS • Institutional Official will be DOE HQ management • Members will be selected by DOE HQ • Biggest challenge will be finding an administrator not affiliated with any DOE site to fill Becky’s shoes • ORAU will still be responsible for meeting and travel logistics, and Becky will serve as SME.

7. Questions? Ideas? HSS Office of Health, Safety and Security • Contact: • Isaf Al-Nabulsi, HSS, 202-586-8589, or isaf.al-nabulsi@hq.doe.gov • Libby White, SC, 301-903-7693, or elizabeth.white@science.doe.gov