1. Office of Research & Development (ORD) Local Accountability of Research 2009 Baltimore, Maryland January 13-14, 2009 “Meeting the Current Challenges of Research” Presented by the Office of Research Oversight (ORO) Dr. Tom Puglisi, Chief Officer Dr. Joan Porter, Deputy Chief Officer “Meeting the Current Challenges of Research” Presented by the Office of Research Oversight (ORO) Dr. Tom Puglisi, Chief Officer Dr. Joan Porter, Deputy Chief Officer

2. 2 Research Compliance Officers (RCO) Face “Many New Requirements and Challenges” Quick review of Why? – What? – When? – How? – Who? –Where? Quick review of Why? – What? – When? – How? – Who? –Where? Time for your questions and ORO advice to you and Time for your questions and ORO advice to you and Time for our questions to you and your advice to ORO and others... Time for our questions to you and your advice to ORO and others...

3. 3 Why – do we need to do this? To ensure compliance in VA research for stellar and ethical achievement in research To ensure compliance in VA research for stellar and ethical achievement in research To protect and benefit our veterans to the greatest extent possible To protect and benefit our veterans to the greatest extent possible Generated with stimulus from Secretary in great detail and focused. Generated with stimulus from Secretary in great detail and focused.

4. 4 What – are we supposed to do? ORO requirements ORO requirements Explained by the Executive Career Field (ECF) launched for FY 2009 Explained by the Executive Career Field (ECF) launched for FY 2009 All types of research — human subjects, animals, biotechnology, and safety All types of research — human subjects, animals, biotechnology, and safety

5. 5 What... continued Conduct audits and reviews to ensure compliance with all VA and other Federal requirements for the conduct of research including Conduct audits and reviews to ensure compliance with all VA and other Federal requirements for the conduct of research including – Annual audits of all active studies to insure that informed consent has been properly obtained and documented for each subject since the previous audit, and – Regulatory compliance audits for all active studies at least every 3 years. Sample Informed Consent Audit Template

6. 6 ECF specified all RCOs must be in place by Dec. 31, 2008. ECF specified all RCOs must be in place by Dec. 31, 2008. –This may not happen by then – hiring delays, transitions, etc. Details are needed for all the work to be accomplished until new hiring or transfers can be completed. Details are needed for all the work to be accomplished until new hiring or transfers can be completed. The first year of informed consent reporting for protocols in place for Jan. 1 – May 31, 2009 The first year of informed consent reporting for protocols in place for Jan. 1 – May 31, 2009 The first year to begin protocol audit reporting is Jan. 1– May 31, 2009. Report July 1 on completed audits for all protocols that will expire in Jan. 1 – May 31, 2009. The first year to begin protocol audit reporting is Jan. 1– May 31, 2009. Report July 1 on completed audits for all protocols that will expire in Jan. 1 – May 31, 2009. When – does this need to be done?

7. 7 RCOs will serve as local resources for regulations, policies, memoranda, alerts, and other VA and Federal requirements related to research compliance. RCOs will serve as local resources for regulations, policies, memoranda, alerts, and other VA and Federal requirements related to research compliance. Will serve as non-voting members of the Institutional Review Board, Institutional Animal Care and Use Committee, Biosafety Committee, and Research and Development Committee. Will serve as non-voting members of the Institutional Review Board, Institutional Animal Care and Use Committee, Biosafety Committee, and Research and Development Committee. Provide education to investigators and research staff regarding regulations and policy requirements. Provide education to investigators and research staff regarding regulations and policy requirements. How – can we assure compliance?

8. 8 How... continued Assure prompt reporting with all applicable policies to ORO Assure prompt reporting with all applicable policies to ORO Promptly forward all auditing and monitoring reports on any non-compliance to Facility Director and ORO Promptly forward all auditing and monitoring reports on any non-compliance to Facility Director and ORO – Copies to the Veterans Integrated Service Network (VISN) Research Compliance Officer, Chief of Staff, Associate Chief of Staff for Research, Research & Development Committee Chair, Institutional Review Board Chair, Chief Officer of Research & Development.

9. 9 How... continued ORO issuing instructions as soon as possible on how to conduct and report ORO issuing instructions as soon as possible on how to conduct and report –Informed consent auditing –Human subjects protocols auditing –Animal protocol auditing – coming soon –Safety auditing – coming soon ORO is committed to education — at least 5 major training sessions for RCOs per year; web-site information; ListServ reports, new handbooks as necessary; revisions to audit worksheets; RCO telephone calls regularly; counseling via email, phone, etc. ORO is committed to education — at least 5 major training sessions for RCOs per year; web-site information; ListServ reports, new handbooks as necessary; revisions to audit worksheets; RCO telephone calls regularly; counseling via email, phone, etc.

10. 10 How... continued RCOs follow their job descriptions — samples have been distributed for RCOs in facilities and VISNs by the ListServ and ORO’s Research Compliance Officer Education Page at: http://www1.va.gov/oro/pa ge.cfm?pg=142. RCOs follow their job descriptions — samples have been distributed for RCOs in facilities and VISNs by the ListServ and ORO’s Research Compliance Officer Education Page at: http://www1.va.gov/oro/pa ge.cfm?pg=142. http://www1.va.gov/oro/pa ge.cfm?pg=142 http://www1.va.gov/oro/pa ge.cfm?pg=142 ORO/Research Compliance Education Page

11. 11 Research Compliance Officer(s) in each VA facility with any research protocols. Research Compliance Officer(s) in each VA facility with any research protocols. Research Compliance Officers in each VISN Research Compliance Officers in each VISN Position Levels can be GS 11-15 or Title 38. Position Levels can be GS 11-15 or Title 38. The ORO’s Research Compliance Officer Education Program staff (5 new positions in Central Office) The ORO’s Research Compliance Officer Education Program staff (5 new positions in Central Office) ORO Regional Officers also receive reports of serious non- compliance and yearly report (July 1) on compliance in the conduct of research. ORO Regional Officers also receive reports of serious non- compliance and yearly report (July 1) on compliance in the conduct of research. Who – are the key persons here?

12. 12

13. 13 Who – can be an RCO? No researchers No researchers No voting members of IRBs, IACUCS, Research and Development Committee, etc. No voting members of IRBs, IACUCS, Research and Development Committee, etc. No Associate Chiefs of Staff for Research and Development No Associate Chiefs of Staff for Research and Development No Administrative Officers No Administrative Officers

14. 14 Who... continued RCO can be a part-time RCO ONLY with the approval of the Under Secretary for Health! RCO can be a part-time RCO ONLY with the approval of the Under Secretary for Health! JUST ISSUED! Memo signed Friday, January 9, 2009 — A copy of this memo detailing procedures for requesting a waiver was sent out to the ListServ and can be found on ORO’s website!

15. 15 Waiver for Full-Time RCO Case by case basis for RCO position to be either part-time or combined with other related duties. Case by case basis for RCO position to be either part-time or combined with other related duties. Facility Director goes through the VISN Director Facility Director goes through the VISN Director –Then to CRADO and Chief Officer, ORO –Through Deputy Under Secretary for Health for Operations and Management –Through Principal Deputy Under Secretary for Health for Operations and Management –The through the Under Secretary for Health for approval/disapproval. Description and justification is required. Description and justification is required.

16. 16 RCOs in facilities report to Medical Center Directors! Not the Chief of Staff, not associate Chiefs of Staff for Research and Development, not Administrative Officers, not Directors of Financial Compliance — They work with all this individuals, but report to the Medical Center Directors! RCOs in facilities report to Medical Center Directors! Not the Chief of Staff, not associate Chiefs of Staff for Research and Development, not Administrative Officers, not Directors of Financial Compliance — They work with all this individuals, but report to the Medical Center Directors! VISN RCOs report to VISN Directors VISN RCOs report to VISN Directors Where – do RCOs report?

17. 17 Questions on Why? – What? – When? – How? – Who? –Where? What to convey to ORO? ORD? DSHOM? The Under Secretary for Health? The Secretary? What to convey to ORO? ORD? DSHOM? The Under Secretary for Health? The Secretary? What to convey to your researchers and research staff to help them? ??????????????????????? What to convey to your researchers and research staff to help them? ???????????????????????