1. Office of Science Human Subjects Working Group Meeting November 13, 2009 Libby White DOE Program Manager Protection of Human Research Subjects

2. Office of Science THANK YOU! Denise and Sylvia –Have provided SUPERB: Technical Support for the Human Subjects Protection Function Logistics and Travel Support for Meetings/Reviews

3. Office of Science Overview Focus and Other Key Topics for Today Background on HS Protection Responsibilities within DOE Update on FY 2009 Activities and FY 2010 Plans

4. Office of Science Focus and Other Key Topics for Today

5. Office of Science Today’s Focus – Community Members Input from DOE Community IRB Members –Bill Nebo, LLNL IRB –Tim Ledbetter, PNNL IRB –Janeanne Snow, SNL IRB Four Case Studies Roundtable – what works and what doesn’t Input from USC Community IRB Member and Executive Director, USC OPRS –Malena Avila Hough, USC IRB –Susan Rose, Executive Director, Office for the Protection of Research Subjects

6. Office of Science Other Key Topics Human Terrain Mapping –Overview and Summary of Recent Meetings –2 of 4 Community Member Case Studies –Update from Participating Sites Best Practices for Reviewing Classified Research –Developed by Terry Reser and Sherry Davis Lunchtime Update by Ivor Pritchard of OHRP

7. Office of Science Background on HS Protection Responsibilities within DOE

8. Office of Science Background on HS Responsibilities within DOE DOE Human Subjects Protection Program Responsibilities : –Overseeing/ensuring the protection of human subjects in research conducted at DOE institutions, supported with DOE funds, and conducted by DOE personnel. –Includes approximately 400 active human subjects research projects Conducted by 12 DOE sites and 33 outside organizations Total of over 1.2 million human participants Total cost of approximately $110 million All DOE employees, contractors, and financial assistance recipients share the responsibility to protect the rights and welfare of human research subjects. The Secretary of Energy is responsible for the conduct of DOE-related human subjects research ( DOE Order 443.1A).

9. Office of Science Secretarial delegation gave the Office of Science lead oversight responsibility in 1991. –Susan Rose, first program manager –Lasting contributions include the DOE HSWG, CBeIRB, Resource Book, and more 2007 update to Order gives Under Secretary for Science overarching responsibility with NNSA having parallel responsibilities for its sites. –NNSA HSR Program Manager, John Ordaz –SC and NNSA work together on issues associated with NNSA Sites Office of Intelligence and Counterintelligence engagement for intelligence-related HS research Background (cont.) – Shared Responsibility

10. Office of Science Background (cont.) – Shared Responsibility DOE Site Human Subjects Protection Programs –12 participating sites Reporting Relationships –Institutional Official : Reports to Director – 11 Other - 1 –IRB: Reports to Institutional Official – 9 External IRB – 3 –Human Subjects Administrator : Reports to the IRB Chair - 6 Reports to the Institutional Official – 1 Reports to ESH Section Head – 2 Reports to the Director of Health Services - 2 Reports to General Counsel – 1

11. Office of Science Background (cont.) – Shared Responsibility Central Beryllium IRB –Established in 2001 –Jointly funded by DOE’s Office of Health, Safety, and Security (HSS) and the Office of Science (SC) –Brought expertise and consistency to the review of all DOE- funded/conducted beryllium HS research. 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. –Thank you to Becky (Administrator), Dave (Chair), and Members!

12. Office of Science FY 2009 Activities and FY 2010 Plans

13. Office of Science Key FY 2009 Activities - Review External Program Review October 2008 3 external reviewers Reviewed paper and electronic files, and met with BER management, and NNSA, HSS, and DOE site personnel with whom we work Key Recommendations Continue to provide educational materials and training to DOE sites. Also provide IRBNet to interested sites (in progress). Expand Role and Membership of Central DOE IRB (in progress). Closely follow human subjects research conducted by DOE sites that is funded by other agencies through work for others projects, such as HTM (in progress). Work with DOE sites to institute a program of QA/QC for all ongoing projects (in progress).

14. Office of Science Key FY 2009 Activities/FY 2010 Plans - Workshops FY 2009 Workshops –Fall 2008 Workshop Focused on case studies presented by DOE sites on tough IRB decisions; Also included a presentation by Ivor Pritchard, Acting Director for OHRP, on social and behavioral research –Spring 2009 Workshop Focused on continuous improvement, including: 1) implementation of a QA/QC program to monitor ongoing projects between annual IRB reviews; 2) protection of PII; and 3) succession planning. Included a presentation by Julie Kaneshiro, Policy Team Lead at OHRP, on new/upcoming OHRP guidance FY 2010 Workshops -Fall 2009 HSWG Workshop -Expanded Community Member Workshop – Spring 2010 (?)

15. Office of Science Key FY 2009 Activities/FY 2010 Plans - Establishment of Central DOE IRB (January 2010) Expand Scope of Central Beryllium IRB –Continue review of all beryllium-related HS research –Become DOE IRB of record for entire Former Worker Medical Screening Program –Other areas in the future to potentially include nano-technology- related HS research, classified HS research, and other evolving topics

16. Office of Science Key FY 2009 Activities/FY 2010 Plans - Establishment of Central DOE IRB 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) –Expand number of DOE workers represented (3 members and 3 alternates) –Include representation from FWP screening providers (2 members, with 2 alternates) –Include a consultant with expertise in protection of personally identifiable information

17. Office of Science Key FY 2009 Activities/FY 2010 Plans – Establishment of Central DOE IRB Administrative Changes –CDOEIRB will report to DOE HQ –Shared funding/management by 3 HQ offices: Office of Science (SC) Office of Health, Safety, and Security (HSS), and National Nuclear Security Administration (NNSA) –Institutional Official will be senior official from the DOE Office of Science –DOE Leadership will be represented by a team of Senior DOE Management Liaisons (one representative from each of the funding organizations) Issue appointment letters to the Chair and Vice Chair, once selected by Board members; Ensure appropriate allocation of funding/resources to the CDOEIRB; Determine the scope of Board activities; and Serve as (or designate a representative from their organization to serve) ex-officio members. –Day-to-day interaction with the Board will be by a lower-level CDOEIRB Management Team (Libby White (SC), Mary Fields and Isaf Al-Nabulsi (HSS), and John Ordaz (NNSA)

18. Office of Science Key 2009 Activities/FY 2010 Plans Clarification of IRB Requirements - Unanticipated Problems SC -23/NA-1 Requested that each DOE Site IRB: 1) review IRB Operating Policies and Procedures and: –Expand as necessary to address unanticipated problems. –Be certain to include a requirement for immediate notification of appropriate parties when there is potential loss or compromise of PII. –Outline range of the IRB’s possible actions in response to reports of unanticipated problems 2) examine and verify that protocol(s) already approved by the IRB have clear and detailed plan(s) for protecting PII in accordance with Federal/DOE requirements

19. Office of Science Key 2009 Activities/FY 2010 Plans Clarification of IRB Requirements – Unanticipated Problems 3) ensure new protocols comply with PII protection requirements. 4) see checklist for IRBs to use in determining whether HS research protocols are in compliance with DOE requirements for the protection of PII. Thanks to Dena, Mary, and Isaf for your leadership in this area!

20. Office of Science Key 2009 Activities/FY 2010 Plans Getting a Handle on DOE’s Involvement in HTM Human Terrain Mapping (HTM): –Research activity conducted primarily for military or intelligence purposes in countries prone to violence and/or political instability –Includes observations, questionnaires, and interviews of representatives of targeted groups, as well as modeling and analysis of collected data –May become basis for DOD’s actions in these locations SC, NNSA, and IN are working with the new administration to pursue a Secretarial Policy Memo regarding DOE labs’ involvement in HTM and to update the DOE Human Subjects Protection and WFO Orders. In the meantime, SC (1/15/09 memo) and NNSA (12/08/08 memo) will consider HTM proposals that limit DOE lab involvement to modeling & analysis of de-identified data. –Leadership by Oak Ridge on effective process for review/approval –ORISE developing Share Point site to facilitate tracking/approval process.

21. Office of Science Key 2009 Activities Review of the Radiation Effects Research Foundation

22. Office of Science Key 2009 Activities Review of the Radiation Effects Research Foundation RERF is believed to have the longest history of any ongoing international research program, with DOE and its predecessor agencies having provided support since 1947. Funded jointly by the Japanese Ministry of Health, Labor, and Welfare and by DOE (DOE funding is $14 M/year). –NAS receives approximately $2M of the $14M total, primarily to hire and pay for positions of 9 U.S. employees working at the RERF (including the Chief of Research & Associate Chief of Research). There are 3 cohorts being studied through 63 HSR protocols: –The Life Span Study Cohort (including 120,000 individuals) – investigates disease that lead to the death of A-bomb survivors –The Adult Health Study Cohort (includes 23,000 of the 120,000 individuals above) – provides periodic health exams –Genetics Study Cohort (approximately 77,000 children of survivors) – study mortality, birth defects, sex ratio, cancer incidence, chromosome aberrations, molecular genetics –

23. Office of Science Key 2009 Activities Review of the Radiation Effects Research Foundation Research involving human subjects must be approved by one or both of the RERF IRBs: –The Human Investigation Committee (HIC) –The Ethics Committee for Genome Research (ECGR). RERF follows both U.S. and Japanese human subjects guidelines. –Japanese guidelines are included in national guidelines for: 1) epidemiologic research; 2) human genome/gen analysis research; and 3) protection of personal information. The DOE HSPP conducted a 2-part review of the RERF’s program for the protection of humans subjects. –Mid-August 2008 – informal QA consultation; –Late June/early July– formal review with 6-person bi-national panel of experts

24. Office of Science Key 2009 Activities Review of the Radiation Effects Research Foundation We asked the reviewers to look at and comment on: –Impression of the RERF program. What is your assessment of the RERF’s commitment to the protection of human research subjects? –Are the RERF’s written procedures for the protection of human research subjects complete and in compliance with DOE and U.S. federal HS protection requirements? –Do RERF’s actual processes follow these written procedures? –Are the tissue repositories and human tissue specimens handled in such a way that protects the privacy and confidentiality of the individuals who contribute tissues/tumors? –Are interactions between RERF’s IRBs and the investigators adequate? Are investigators provided sufficient information about IRB expectations and requirements and are reviews timely? –Are the role(s) of the two IRBs clear and appropriate? –Do you have any recommendation(s) for improvement?

25. Office of Science Key 2009 Activities Review of the Radiation Effects Research Foundation Summary of Findings: -RERF has an exceptionally high level of commitment to the protection of the rights and welfare of its unique research population -Overall, its practices meet and in some cases exceed U.S. and DOE HS protection requirements. -Opportunities for improvement include written procedures, formal training of IRB members and researchers, and IRB membership (addition of a representative of the clinical staff and an A-bomb survivor or representative of the F1 generation)

26. Office of Science FY 2010 Plans Self Assessments, External Reviews, Accreditation BNL/Stony Brook – AAHRPP accreditation application DOE/OHRP QA Consultations – –2 DOE Sites Other Reviews/Self assessments?

27. Office of Science FY 2009 Accomplishments/FY 2010 Plans Webpage Updates DOE Human Subjects Webpage –Continuously updated –Recent updates include HTM-related informational materials DOE Site Webpage Updates in FY 2009 –INL –LLNL –Others Please continue efforts to update DOE Site Webpages to showcase Human Subjects Protection Programs

28. Office of Science FY 2009 Accomplishments/FY 2010 Plans Human Subjects Newsletter 2 excellent issues in FY 2009! 2 planned issues in FY 2010 –Share Ideas with Gloria Caton

29. Office of Science FY 2009 Accomplishments/FY 2010 Plans Human Subjects Research Database Thank you to all sites for your recent submissions and to Don Watkins and Betsy Ellis for your work to revamp the database http://www.orau.gov/hsrdreport/

30. Office of Science “Conducting research on fellow humans is a privilege, and ensuring their protection is our joint responsibility. Given the public trust and funding invested in DOE facilities, we....should not merely meet regulations, but aspire to become leaders in this field.” Anna Palmisano, March 2008