1. Small Facility Research: How does this work? Paul Bockelman, FACHE Director VA Medical Center, Sioux Falls Robert Hierholzer, MD ACOS for Research & Education VA Central California HCS, Fresno 2009 ORD Local Accountability for Research Meeting Baltimore, MD January 13-14, 2009

2. 2 Goals Identify and discuss a variety of issues encountered by facilities with small Research Programs. Share ideas about how to meet challenges unique to small Research Programs.

3. 3 Perspective of presenters VAMC, Sioux Falls GM&S Level 2 facility with 800 employees ~$900,000 in Research money/~dozen protocols Medical Center Director in the role for 1 year Quad – at least one change every year - forever! A Coordinator/R&D who is also the Research Integrity Officer, Conflict of Interest Officer and an Investigator An Administrative Assistant who was also the Research Compliance Officer University IRB Research Building (30 years old, no office space) Non Profit Corporation - $100K/year budget

4. 4 Perspective of presenters VA Central California HCS (Fresno) Level 2 facility with 900 employees About 20 active protocols: VA funded and unfunded ACOS/R&D also the ACOS/E and also an investigator, clinician and teacher Deputy ACOS with mostly non-research duties Limited space: research lab and staff offices External VA IRB Moribund Non Profit Corporation Academic affiliation with UCSF: 46 resident/dental positions & 6 new medicine fellowship positions

5. 5 Topics Accountability issues Research staffing Can research lead to recruitment? Committee expectations What is a Non-profit Corporation? Are we prepared as leaders? Capital Requirements Who pays for Research? Can you afford Research?

6. 6 Accountability: Why should I care? Low impact on total organization High risk if problems Human protection Animal protection Hazardous materials Risk potential Few staff Prepared staff (training, turnover, quality) “Secondary” research facilities (infrastructure)

7. 7 Accountability: Why should I care? Risk potential continued… Typically minimal budgets could lead to cutting corners Small system without robust processes could lead to risk for financial diversion Small town media One small step from Research to the Director’s Office

8. 8 Accountability: Why should I care? The case for Research Resident Review Committee (RRC) requirements for academic activity for faculty RRC requirements for academic activity for residents and fellows Access to clinical trials for veterans Impact on overall quality of care? Potential recruitment inducement

9. 9 Research Staffing Research Coordinator or ACOS/R: Required but not enough demand for full time Tough to find someone willing to take part-time role Tough to find someone who already has the skill set – OJT with a risky program! Demand may be low in terms size of program, but demands intense in terms of depth of the need Split assignments tough: multiple sets of regulations, committees etc. Lack of synergy

10. 10 Research Staffing Research A/O – not full time Need a quality person – grade is a limiter Again, OJT Orientation and mentoring program needed!

11. 11 Can Research lead to Recruitment and Retention? Small facilities are going to be reluctant to give up staff time for research due to working without excess capacity Research requires synergy – is it available at a small facility or in a smaller town? Research facilities must be in place if research is to assist in recruitment Support staff not available

12. 12 Can Research lead to Recruitment and Retention? New oncologist with research experience wants us to become an National Cancer Institute Independent Clinical Research Site. We have requisite patients, Principal Investigator has research experience, but lacks “support staff.” New physiatrist has funding from pharmaceutical company; study requires space….but there is none

13. 13 Committee Expectations Research committees (IRB, IACUC, Safety, Biosafety, facility R&D) Requirement for researcher participation Requirement for at least halftime VA employee Risk for lack of knowledge in area Lack of volume to participate – the committees consist of the same scientific staff – surely not desirable as a researcher!

14. 14 Committee Expectations Non-scientific members How to recruit – desirable to have staff that are interested and experienced Low staff turnover, therefore reluctant to help – what’s in it for me? Performance pay? Lack of diversity of experiences OJT Less knowledgeable members have an equal vote which could lead to less informed decisions or persuasion

15. 15 Committee Expectations Leadership members (Quad) Lack of experience - OJT – lack of technical training in ECF development program Expectation of committees: informed leadership Importance of attending every meeting Lack of experience at IRB – poor reflection on the facility by affiliate IRB and potential researchers?

16. 16 Committee Expectations What is the role of the R&D Committee? Relationship with external subcommittees Role in the overall Human Research Protection Program “Grow” research or “regulate” research? Finding, educating and keeping interested individuals to serve

17. 17 What is a Non-Profit Corporation? What advantage does this bring the facility? The director is responsible even if there is a committee leadership model Not big enough to afford an Executive Director Is it appropriate to fund foundation management out of healthcare dollars?

18. 18 Non-Profit Corporation Where does the money come from? What are the limitations on the funds? Who monitors the expenditures? Relationship between NPC and affiliate – indirect funding of educators? Where is the “Book of all Knowledge” for a new director? HIGH RISK

19. 19 Non-Profit Corporation Increasing expectations in terms of oversight and accountability Finding Board members Sufficient cash flow to make it “work” Difficulties with “use” of an “external” NPC Dilution of Board by requirements for statutory membership

20. 20 Are we prepared as leaders – do we know enough? IRB IACUC AALAC ORO VA Handbook on research “Expedited vs Exempt” Reviews Institution Official Research Compliance Non-Profit Corporations

21. 21 Capital Requirements Anyone have extra construction funds? Need resources to attract researchers Need researchers to attract resources In the bigger scheme at a hospital, research is going to be a lower priority Space crunch makes research “inviting” (as in taking the space for patient care requirements) What are the capital funding streams for space and equipment?

22. 22 Who pays for Research? VERA research support funds Local funding at small sites ORD CC101 Funds Actual $$ for research – what are the sources for small sites? Joint efforts with community/affiliate partners Affiliate funding Specific product research Mental Health funds?? DoD, NIH, NSF? How to attract pharmaceutical opportunities?

23. 23 Can you afford Research? Fixed costs are high – how do you know if you can afford research? What is the financial breakeven point? When does it become a marketing cost? When does it become an affiliation cost? THE PROGRAM MUST GROW TO DECREASE THE UNIT COST! Variable costs are external (mostly)

24. 24 Additional Issues “One size fits all ‘solutions’ “ from Washington: Full-time RCO Recruitment of patients by larger VAs Lack of knowledge of involvement at smaller facility Becoming a field ripe for harvest by larger facilities Hard to support all kinds of research: “one of everything” is very demanding Unfunded mandates

25. 25 Potential Solutions/Responses Mentoring/orientation for new Directors, ACOS/Coordinator, AOs Partnering (formal or informal) with larger facilities Limiting types of research or eliminating at smaller facilities. If research is a VHA mission, is this an option? Changes in statutory membership requirements for NPCs “Tailoring” mandates (e.g.: RCO mandates) Regional R&D Committees Regional Non-Profit Corporations

26. 26 This is a mission of the VA – but does it make sense at your facility?