1. 1 Research & Development Committee Brenda Cuccherini, Ph.D., MPH Office of Research & Development January 2007

2. 2 Word of Caution This talk is based on the DRAFT R&D Committee Handbook Unlikely but requirements may change before the USH signs it into policy

3. 3 "I'm not a bit changed--not really. I'm only just pruned down and branched out. The real ME--back here--is just the same." Lucy Maud Montgomery Ann of Green Gables

4. 4 Equal But Different ACOS responsible for: –Day to day management & operations of research program R&D Committee responsible for: –Broad oversight of research program –Rigorous review of research projects

5. 5 Scope of R&D Committee Responsible through the COS to the Medical Center Director, for oversight of the research program Responsible for maintaining high standards throughout the R&D program Assuring scientific & ethical quality of research ACOS/R&D & AO/R&D assist the Committee with its duties

6. 6 Scope (Cont.) R&D Committee approval must be obtained prior to initiating any research Applicable “subcommittee” approvals must be obtained prior to final R&D Committee approval A R&D Committee may serve as the R&D Committee of record for another VA only –MOU required –Local accountability is a key point

7. 7 Specific Areas Plan & develop broad objectives Determine extent to which R&D committee has met its objectives Review budgetary & other resource needs Oversee all R&D activities: 2new areas –Security of VA Protected Information –Credentialing, privileges, scope of practice Review certain written agreements Review & evaluate all “subcommittees”

8. 8 Institutional Official (IO) Medical Center Director (MCD) is the IO MCD responsible for all aspects of the R&D program MCD is responsible for ensuring adequate resources & administrative support. Examples: –Personnel –Space –Equipment –Education & training opportunities –Etc.

9. 9 R&D Committee Membership Draft policies do change! –Unlikely at this point Changes made since last Local Accountability presentation Based on OGC’s opinion and FACA requirements

10. 10 Committee Membership Members’ expertise reflect the types of research being conducted At least 5 voting members –All voting members must be full time or permanent part time Federal employees At least 2 VA staff members with clinical or administrative duties At least 2 investigators that are actively engaged in research If affiliated with a university, 1 member who holds an academic appointment & is a Federal employee

11. 11 Committee Membership (Cont.) If conducting research involving investigational drugs, consider including 1 person from research pharmacy or Pharmacy service (voting or non-voting member) If serve as R&D Committee of another facility, consider having 1 member from that facility Other voting or non-voting members as required by research program

12. 12 Committee Membership (Cont.) Voting members may fill more than one criterion for required membership Ad hoc non-voting members may be used –If non-Federal employee: provide individual advise or exchange facts & information only Ex-officio, non-voting members include: –ACOS, COS, MCD, compliance officer, AO

13. 13 Committee Membership (Cont.) Alternate members may be used If facility has centers, including Centers of Excellence, consider a member from the center Members & Conflict of Interest: members may not participate in discussion or vote if in conflict

14. 14 “Subcommittees” Required “subcommittees”: –IRB –IACUC –Biosafety Option for other “subcommittees” –Scientific review –Continuing review –Others as needed

15. 15 Responsibilities Related to the Facility’s Research Program Have oversight responsibilities, not responsibilities for day to day management Need to receive sufficient information (annual, quarterly reports or other information) to fulfill areas of responsibility Information on compliance, QA, requests for WOC appointments, & special programs such as Biosafety, Animal Welfare, & HRPP

16. 16 Review of Research Initial review of research: –Final approval only after receive approval from applicable “subcommittees” Continuing review to occur each year Review during a convened meeting Quorum required to approve research: –Majority of voting members present for discussion & vote

17. 17 Review of Research (Cont.) Review includes: –Budget, supplies & equipment needs –VAPI (data) use, storage & security –Scientific merit –Relevance to VA –PI’s qualifications –Conflicts of Interest –Personnel including responsibilities & working within privileges & scope of practice

18. 18 “Just-In-Time” Concurrence from R&D Committee to submit after a preliminary review –Appropriateness of scientific methodology –Relevance of the research to VA’s mission –Investigator’s qualification –Adequacy of resources Review by full board or expedited procedure

19. 19 “Just-In-Time” Continued Develop SOPs on how to conduct preliminary review Concurrence ≠ approval to initiate research –Prior to initiating research PI must: Submit to required subcommittees (IRB, IACUC etc,) Submit to R&D Committee Obtain approvals from all

20. 20 R&D Committee Operations SOPs for all recurring activities Record keeping: –Maintain records of all activities & applicable communications –Minutes kept for committee & subcommittees Record keeping may be by committee itself or others in research office Annually review operations/function of the committee

21. 21 The Committee’s Life Expectancy Not even computers will replace committees, because committees buy computers. Edward Shepherd Mead

22. 22 Remember M-3, Part 1, Chapter 2 & 3 is still policy until USH signs the new Handbook into policy. Draft HB: consider as guidance ORD will send e-mail out when it is official policy Compliance with all requirements within 6 months

23. 23 The important thing is not to stop questioning. Albert Einstein

24. 24