Office of Research & Development (ORD) Local Accountability of Research 2009 Baltimore, Maryland January 13-14, 2009 “Meeting the Current Challenges of Research” “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 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 Why – do we need to do this? To ensure compliance in VA research for achievement of excellent research. To ensure compliance in VA research for achievement of excellent research. To protect and benefit our veterans to the greatest extent possible. To protect and benefit our veterans to the greatest extent possible.

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

5 What are RCOs supposed to do? What – are RCOs supposed to do? 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 ensure 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.

6 ECF specified all RCOs must be in place by Dec. 31, ECF specified all RCOs must be in place by Dec. 31, –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, The first “year” of informed consent reporting for protocols in place for Jan. 1 – May 31, The first “year” to begin audit reporting is Jan. 1– May 31, Report June 1 on completed audits for all protocols that will expire in Jan. 1 – May 31, The first “year” to begin audit reporting is Jan. 1– May 31, Report June 1 on completed audits for all protocols that will expire in Jan. 1 – May 31, When – does this need to be done?

7 Each RCOs will serve as a local resource for regulations, policies, memoranda, alerts, and other VA and Federal requirements related to research compliance. Each RCOs will serve as a local resource for regulations, policies, memoranda, alerts, and other VA and Federal requirements related to research compliance. Each RCO will serve as non-voting member of the Institutional Review Board, Institutional Animal Care and Use Committee, Biosafety Committee, and Research and Development Committee. Each RCO will serve as non-voting member of the Institutional Review Board, Institutional Animal Care and Use Committee, Biosafety Committee, and Research and Development Committee. ORO will also provide education to investigators and research staff regarding regulations and policy requirements. ORO will also provide education to investigators and research staff regarding regulations and policy requirements. How – can we assure compliance? continued...

8 How – can we assure compliance? 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; Facility Chief of Staff; Associate Chief of Staff for Research; Research & Development Committee Chair; Institutional Review Board Chair; and the Office of Research & Development. continued …

9 How – can we assure compliance? 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 & security auditing – coming soon ORO is committed to education by its Research Compliance Education staff — at least five 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 , phone, etc. ORO is committed to education by its Research Compliance Education staff — at least five 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 , phone, etc. ontinued …

10 How – can we assure compliance? 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: 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:

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12 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 or Title 38. (HR decides.) Position Levels can be GS or Title 38. (HR decides.) The ORO’s Research Compliance Officer Education Program staff (five new positions in Central Office). The ORO’s Research Compliance Officer Education Program staff (five new positions in Central Office). ORO Regional Officers also receive reports of serious non- compliance and yearly Certification Reports (July1) by Medical Center Directors to ORO on compliance in the conduct of research. ORO Regional Officers also receive reports of serious non- compliance and yearly Certification Reports (July1) by Medical Center Directors to ORO on compliance in the conduct of research. Who – are the key persons here? continued …

13 Who – can be an RCO? No researchers No researchers No voting members of Institutional Review Boards, Institutional Animal Care and Use Committees, Research and Development Committees, etc. No voting members of Institutional Review Boards, Institutional Animal Care and Use Committees, Research and Development Committees, 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 continued …

14 Who – can be an RCO? 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!

15 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 many 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 many individuals, but report to the Medical Center Directors! VISN RCOs report to VISN Directors. VISN RCOs report to VISN Directors. Where – do I report?

16 Questions on Why? – What? – When? – How – Who? – Where? What do you want to convey to ORO? ORD? DUSHOM? The Under Secretary for Health? The Secretary? What do you want to convey to ORO? ORD? DUSHOM? The Under Secretary for Health? The Secretary? What do you want to convey to your researchers and research staff to help them? ??????????????????????? What do you want to convey to your researchers and research staff to help them? ???????????????????????