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

Office of Science Background Central Beryllium IRB (CBeIRB) –Established in 2001 –Jointly funded by DOEs 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.

Office of Science Opportunity - Scope 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?

Office of Science Opportunity - Membership 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?.

Office of Science Opportunity –DOE Site IRBs - 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).

Office of Science Administrative Change 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 Beckys shoes –ORAU will still be responsible for meeting and travel logistics, and Becky will serve as SME.

Office of Science Questions? Ideas? –Contact: Isaf Al-Nabulsi, HSS, , or Libby White, SC, , or