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Small Facility Research: How does this work?

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

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Small Facility Research: How does this work?

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  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. 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. 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. 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. 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. 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. 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. Accountability: Why should I care?The case forResearch • 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. 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. Research Staffing • Research A/O – not full time • Need a quality person – grade is a limiter • Again, OJT • Orientation and mentoring program needed!

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

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