1. Research Administrative Review Robert Petzel, MD Network Director, VISN 23 Jack Hetrick, MEd Network Director, VISN 10 January 13, 2009

2. Research Administrative Review Initiated by ORD Goal is to develop recommendations to Respond to the challenge of effective management Strengthen research activities occurring at local VA facilities

3. General Areas of Focus Governance Reducing inefficiencies by changing Organizational structures Position descriptions Handbook requirements While strengthening local VA facilities’ research Productivity Accountability

4. General Areas of Focus Human Capital How key research leadership positions can be strengthened by Enhanced recruitment Changes to Minimize administrative burdens Maximize the ability to support productive research

5. Methods In person meeting June 2008 Information gathering by conference calls Survey to gather data on recruitment & retention of ACOS/R&D & AO/R&D

6. Research Administrative Review Report 1: Findings & Recommendations* Focus on 3 high priority areas: Medical Center research reporting relationships Clarifications of position descriptions for research leadership positions Changes in R&D Committee handbook *Published 12/15/08

7. Research Administrative Review Steering Committee Chair: Joel Kupersmith (CRADO) Ralph Gigliotti (Durham, Medical Center Director) Betty Goolsby (Durham, Asst. Director, Office of the Director) Jack Hetrick (VISN 10, Network Director) Odette Levesque (VACO 10NC, Clinician/QA liaison) Randy Petzel (VISN 23, Network Director) Tom Puglisi (ORO, Chief Officer) Jim Roseborough (VISN 12, Network Director) John Stuart (Memphis, ACOS/R&D)

8. Governance Working Group Chair: Randy Petzel (VISN 23, Network Director) Anna Alt-White, RN (VACO, Office of Nursing Services) Paul Bockelman (Director, Sioux Falls VA Medical Center) Thomas Capello (North Florida/South Georgia Health Care System, Med. Center Dir.) Lynn Cates (ORD, Director PRIDE) Michael Davey (ACOS/R&D Portland, OR VISN 20) Joe Francis (Deputy Chief Quality & Performance Officer) John Hudson (Research Compliance Officer, VISN 12) David Johnson (Baltimore, ACOS/R&D)

9. Governance Working Group Chair: Randy Petzel (VISN 23, Network Director) Marie Johnson (AO/R&D Gainesville, FL) Odette Levesque (VACO 10NC, Clinician/QA liaison) Skye McDougall (Chief Medical Officer, VISN 22) Brian Mittman (Sepulveda, Health Services Research) Lynn Pulliam (ACOS/R&D San Francisco, CA) Jim Roseborough (VISN 12, Network Director) Gordon A. Starkebaum (Seattle, COS) John Stuart (Memphis, ACOS/R&D)

10. Human Capital Working Group Organization of Research Subgroup Chair: Jack Hetrick (VISN 10, Network Director) Lead: Peggy Hannon (AO/R&D, Indianapolis) Jerry Beccia (CO, West Haven) Patsy Cipolloni (ACOS/R&D, Boston) Betty Goolsby (Durham Asst. to the Director) Susan Harper (ORO) Jeannette Post (VISN Director (retired), Boston)

11. Human Capital Working Group Protected Research Time Subgroup Chair: Jack Hetrick (VISN 10, Network Director) Lead: Ali Sonel, MD (ACOS/R&D, Pittsburgh) Ralph Gigliotti (Medical Center Director, Durham) Martin Hayworth (COS) Laurence Meyer (ACOS/R&D, Salt Lake City) Dean Norman (COS, Los Angeles) Bruce Sangeorzan, MD (Orthopedic Surgeon, Seattle)

12. Human Capital Working Group Recruitment & Retention Subgroup Chair: Jack Hetrick (VISN 10, Network Director) Lead: John Vara (COS, Miami) Phil Cook (AO/R&D, Milwaukee) Lynette Roff (Medical Center Director, Eastern CO) Gary Rosenthal, MD (ACOS/R&D, Iowa City) Don Rubin (ACOS/R&D, Tennessee Valley) Edgar Tucker (Medical Center Director, Houston)

13. Specific Findings 1.Information Systems 2.R&D Committee Handbook Revisions 3.Respective Responsibilities for Research 4.Resources for Research Compliance 5.Reporting Relationships 6.Performance Measures 7.Mentoring & Research Office Leadership 8.Training Resources 9.Protected Time

14. Specific Findings 1. Information Systems Support information tools to allow field offices to manage space, finances, personnel, etc. Define business requirements Obtain widespread input from field Develop consensus Target date January 2010 for Unified business operations model IT functional requirements document

15. Specific Findings 2. R&D Committee Handbook Revisions The R&D Committee should be refocused on governance & oversight of the local research program Oversight of individual protocols should be carried out by appropriate R&D Committee subcommittees Purely administrative functions have been re-assigned to the ACOS/R&D

16. Specific Findings 2. R&D Committee Handbook Revisions Refocus the R&D Committee on broader issues including: Ensuring the effective operation of the research program Establishing the strategic direction of the research program Establishing policy to ensure appropriate review for research involving human subjects, animals & biohazards Reviewing the quality & performance of the local review process Reviewing quality assurance activities, & programs designed to enhance the safety of personnel & the security of VA data & laboratories

17. Specific Findings 2. R&D Committee Handbook Revisions Recommendations for change: Approval of research by appropriate R&D Committee subcommittees Then the R&D committee will approve the minutes of the subcommittees Finally, when all appropriate approvals have been obtained, the ACOS/R&D will inform the investigator that the research may be initiated Continuing reviews will also be conducted by the appropriate R&D Committee subcommittees, as opposed to the full R&D Committee

18. Specific Findings 2. R&D Committee Handbook Revisions New R&D Committee Responsibilities Developing broad objectives for the local research program so that it supports VA’s mission Determining the extent to which the research program has met its objectives Overseeing all research program activities for each VA facility for which it serves as the R&D Committee of record Reviewing all research program-related written agreements

19. Specific Findings 3. Respective Responsibilities for Research Sample position descriptions (PDs) for ACOS/R&D & AO/R&D* were solicited & they revealed Substantial variability in qualifications & responsibilities Some variability is needed based on the size of the local research program *ORO already has developed a PD for Research Compliance Officers

20. Specific Findings 3. Respective Responsibilities for Research Network Director Responsibilities Fostering an institutional culture that supports the ethical conduct of research throughout the network Ensuring adequate support for local research programs including, but not limited to, providing adequate resources, staff, equipment, & infrastructure Ensuring local facilities’ compliance with all VA & other federal requirements for the conduct of research

21. Specific Findings 3. Respective Responsibilities for Research Medical Center Director Responsibilities Fostering a culture that supports the ethical conduct of research Fostering a culture of high-quality research Ensuring adequate support for local research programs Serving as the Institutional Official (IO) responsible for all aspects of the research program As IO, ensuring the facility’s compliance with all VA & other Federal research requirements Serving as a non-voting, ex officio member of the R&D Committee

22. Specific Findings 3. Respective Responsibilities for Research Medical Center Director Responsibilities Reporting to & corresponding with oversight offices & accreditation organizations Providing sufficient resources for research oversight programs Certifying that research personnel have appropriate credentials, privileges, & scope-of-practice requirements Ensuring the research compliance program has sufficient resources & that Research Compliance Office reports directly to Medical Center Director Completing & fulfilling the Office of Research Oversight (ORO) Medical Center Director Certification

23. Specific Findings 3. Respective Responsibilities for Research ACOS/R&D Responsibilities Fostering a culture that supports the ethical conduct of research Fostering a culture of high-quality research Managing the ongoing operation of Research & Development program activities Promoting the growth & development of Research & Development opportunities for new & experienced investigators through training & assistance with the VA grant applications process Providing support to the Research & Development Committee Functioning as Executive Secretary of the R&D Committee

24. Specific Findings 3. Respective Responsibilities for Research AO/R&D Responsibilities Fostering a culture that supports the ethical conduct of research Fostering a culture of high-quality research Preparing & submitting communications, reports & correspondence Developing, implementing & maintaining an effective means of research program review Coordinating with VACO, VISN, other VA facilities Managing of research program budget Working with investigators, affiliates, granting agencies, etc. to ensure completion of applications, reports, etc.

25. Specific Findings 3. Respective Responsibilities for Research Investigator Responsibilities Fostering a culture that supports the ethical conduct of research Fostering a culture of high-quality research Having the required & appropriate expertise, training, credentials & privileges to conduct research Complying with all applicable personnel & research requirements Obtaining the appropriate approvals prior to initiating research activities Developing research plans that are scientifically valid & that minimize risk to human subjects & animals used in research, & personnel

26. Specific Findings 4. Resources for Research Compliance Ensure VA research has adequate resources to meet compliance milestones & achieve scientific goals Ensure Medical Center Directors are addressing these issues & making efforts to improve the VA research enterprise Depending on the size & need of the research program, increase support staff (e.g., deputy ACOS/R&D or associate AO/R&D) Support should come from VERA dollars, but new methods of support should be explored

27. Specific Findings 5. Reporting Relationships The ACOS/R&D reports to the Medical Center Director through the Chief of Staff There was consensus that the ACOS/R&D should have a mechanism to regularly engage with the Executive Leadership Board Some felt that for certain issues the ACOS/R&D should report directly to the Medical Center Director The ACOS/R&D should have a role in staff hires to help identify promising candidates & potential research involvement

28. Organization Chart Director Clinical Science R&D, ORD Cooperative Studies Research Centers

29. Specific Findings 6. Performance Measures Research performance measures should be in contracts for VISN & local leadership For FY 2009 each VA facility performing research must have a Research Compliance Officer (RCO) In the future, other measures should be considered

30. Specific Findings 7. Mentoring & Research Office Leadership Sponsor a periodic web conference for leaders to share experiences in successfully recruiting & retaining ACOS/R&D, AO/R&D & RCO Support mentoring programs to prepare future ACOS/R&D, AO/R&D & RCO Develop cross-site mentoring programs to allow new hires to spend time training in another facility Create opportunities for local facilities to share what they have learned with other facilities

31. Specific Findings 8. Training Resources Develop online “how to” manuals on the responsibilities of ACOS/R&D & AO/R&D (& for VISN & Medical Center Directors) Meet the new requirement to develop an ongoing local awareness/training program at each facility (your Working Group at this meeting will address this issue)

32. 9. Protected Time for Research Challenges No current guidance on protected time Dual roles of many investigators >70% are also clinicians Complicated, inconsistent, non- transparent formulas are used for determining how investigators are paid to do research

33. 9. Protected Time for Research Potential Solutions Transparency of research VERA funds VERA calculations recalculated Monitoring protected time Protected time as a performance measure Guidance on protected time for research

34. Research Administrative Review Next Steps Protected time for research Recruitment & retention of ACOS/R&D & AO/R&D Mentoring & succession planning ACOS/R&D & AO/R&D responsibilities Affiliate relationships