Institutional Responsibilities for Research

1. Institutional Responsibilities for Research K. Lynn Cates, MD Assistant Chief Research & Development Officer

2. Bottom Line • Each VA facility must assume responsibility for all its research • Medical Center Director and ACOS/R&D have ultimate responsibility for what happens • Research Office and R&D Committee have oversight responsibility for local VA research • VA has some requirements that are beyond those of other entities (e.g., affiliates)

4. If men were angels, no government would be necessary... A dependence on the people is, no doubt, the primary control on the government; but experience has taught mankind the necessity of auxiliary precautions.The Federalist No. 51

5. The Media’s Image of Investigators: “Rebellious and disobedient,” as he describes himself… has never fully lost his youthful disrespect for authority and establishments. New York Times, September 4, 2007

6. Role of VA Local Accountability • Maintain the public’s trust • Protect the Agency and Facility • Allow innovation within safe boundaries • Protects the Research Program & Investigators • Why documentation matters: • It shows the “dots” are connected • It’s what gets measured

7. 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.

8. What is “VA Research” • Research conducted by VA investigators • On VA time (including WOC, IPA) • Utilizing VA resources, including • VA Research funds • NPC funds • Title 38 salary support • CPRS • Equipment (e.g., computers) • On VA property (including space leased to VA) • Implies VA is accountable (e.g., for research-related injuries) • The R&D Committee is responsible for approval and oversight of all VA research

9. Scope of R&D Committee • Responsible through the COS to the Medical Center Director, for oversight of the research program • ACOS/R&D & AO/R&D assist the Committee with its duties

10. Scope of R&D Committee • Responsible for maintaining high standards throughout the R&D program including ensuring • Scientific & ethical quality of research • Protection of human subjects • Safety of personnel engaged in research • Welfare of laboratory animals • Security of VA data and VHA research laboratories

11. 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 • R&D Committee may serve as the R&D Committee of record for another VA • MOU required • Local accountability is key

12. Management & operations Doing things right Day-to-day details Tactical Monitors ongoing operations Broad oversight & review Doing the right things Long term picture Strategic Scans the broader environment for risks and opportunities Complementary Roles R&D Committee ACOS/Research Office

13. R&D Committee Membership • Members’ expertise reflects the types of research being conducted • At least 5 voting members • All voting members must be full time or permanent part time compensated Federal employees • At least 2 VA staff with clinical or administrative duties • At least 2 investigators active in research • If affiliated with a university, 1 member who holds an academic appointment & is a Federal employee

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

15. R&D Committee Membership • Voting members may fill more than one role • Ad hoc non-voting members may be used (OK if non-Federal if advice/facts only) • Ex-officio, non-voting members include: • ACOS • COS • MCD • Research Compliance officer • AO

16. R&D Committee Membership • 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 (leave the room!)

17. R&D CommitteeOverall R&D Program Oversight • Plan & develop broad objectives • Determine extent to which R&D program has met its objectives • Review budgetary & other resource needs • Oversee all R&D activities: 2 new areas • Security of VA Protected Information • Credentialing & privileging • Review certain written agreements • Review & evaluate all “subcommittees”

18. R&D CommitteeOverall R&D Program Oversight • Oversight is NOT the same as daily management • Staff should provide sufficient information to fulfill areas of responsibility, but not a deluge

20. Annual Reviews should be prepared by R&D staff for: • Publications • Research employees privileges & scopes of practice • WOCs • CRADAs and other agreements • Research Biosafety and Biosecurity • Privacy and Information Security • Animal Program • Human Research Protection Program

21. R&D CommitteeReview of Research • Initial review of research: • Final approval only after receives 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

22. R&D CommitteeReview of Research Includes • Budget, supplies & equipment needs • VAPI (data) use, storage & security • Scientific merit • Relevance to VA • PI’s qualifications • Conflicts of Interest • Personnel (incl. privileges & scope of practice) • Impact on facility (e.g., pharmacy, lab)

23. It is key to review and approve each protocol individually!

24. For each project, the R&D Committee should consider: • Risks • Rigor • High quality science • High standards of ethical conduct • Relevance • Will it benefit veterans? • Is it right for our facility? • Resources

25. “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

26. “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 in writing from all

27. What Makes a Committee Effective? • Thorough (assess the environment fully) • Imaginative (looks for creative solutions) • Deliberate (make decisions and carry them out) • Timely (responds promptly; proactive) • Efficient (don’t waste members time) From Griffith, “The Well-Managed Health Care Organization”

28. How to get there: • Prioritization • Clear mission • Use calendar and agenda appropriately • Preparation • Read ahead materials • Members who understand the environment • Focus • Address issues one-at-a-time to understand all angles • Avoid purely ritualistic reviews • Delegation (with accountability) • Designated reviewers • Subcommittees

29. 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

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

31. Tension: Accountability versus Redundancy

32. Tension: Accountability versus Redundancy • Don’t redo the work of subcommittees or Merit review, BUT… • Review should be sufficient for the committee to understand what the project entails in terms of • Risks • Rigor • Relevance • Resources

33. Checklists alone do not assure oversight! • Audits • Walk-arounds • Communicate up, down, and sideways: • Staff, investigators • Veterans • Senior management • Key services (pharmacy, privacy, IT) • Situational awareness

34. Affiliate Relationships • An area of ongoing scrutiny • Blue Ribbon Panel • IG • Congress • If using their IRB or IACUC: • Strong MOU • Must see the minutes • Must be apprised promptly of compliance issues • Must have appropriate and active VA representation • Using an affiliate’s subcommittee will add to the R&D Committee’s work

35. Gray Areas • Research that is conducted in space that VA leases to a non-VA entity • University research (e.g., NIH projects) involving an investigator with a dual appointment • Why worry? VA is responsible for all its research SOLD

36. Bottom Line • Each VA facility must assume responsibility for all its research • Medical Center Director and ACOS/R&D have ultimate responsibility for what happens • Research Office and R&D committee have oversight responsibility for local VA research • VA has some requirements that are beyond those of other entities (e.g., affiliates)