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Research Administrative Review
Robert Petzel, MDNetwork Director, VISN 23
Jack Hetrick, MEdNetwork Director, VISN 10
January 13, 2009
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
General Areas of FocusGovernance
• Reducing inefficiencies by changing• Organizational structures
• Position descriptions
• Handbook requirements
• While strengthening local VA facilities’ research
• Productivity
• Accountability
General Areas of FocusHuman Capital
How key research leadership positions can be strengthened by
• Enhanced recruitment
• Changes to • Minimize administrative burdens
• Maximize the ability to support productive research
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
Research Administrative ReviewReport 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
Research Administrative ReviewSteering 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)
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)
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)
Human Capital Working GroupOrganization 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)
Human Capital Working GroupProtected 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)
Human Capital Working GroupRecruitment & 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)
Specific Findings
1. Information Systems2. R&D Committee Handbook Revisions3. Respective Responsibilities for Research4. Resources for Research Compliance5. Reporting Relationships6. Performance Measures7. Mentoring & Research Office Leadership8. Training Resources9. Protected Time
Specific Findings1. 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
Specific Findings2. 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
Specific Findings2. R&D Committee Handbook RevisionsRefocus 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
Specific Findings2. R&D Committee Handbook RevisionsRecommendations 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
Specific Findings2. R&D Committee Handbook RevisionsNew 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
Specific Findings3. Respective Responsibilities for ResearchSample 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
Specific Findings3. Respective Responsibilities for ResearchNetwork 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
Specific Findings3. Respective Responsibilities for ResearchMedical 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
Specific Findings3. Respective Responsibilities for ResearchMedical 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
Specific Findings3. Respective Responsibilities for ResearchACOS/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
Specific Findings3. Respective Responsibilities for ResearchAO/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.
Specific Findings3. Respective Responsibilities for ResearchInvestigator 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
Specific Findings4. 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
Specific Findings5. 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
Organization Chart
VISN Director
Medical Center Director
Research ComplianceOfficer
AO/R&D
Research CentersCoEs &REAPs
Chief of Staff R&D Committee
IACUC
IRB
Radiation Safety
Biosafety
Others, e.g.Research Equipment
ACOS/R&D
Director Clinical Science R&D, ORD
Cooperative Studies Research Centers
Specific Findings6. 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
Specific Findings7. 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
Specific Findings8. 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)
9. Protected Time for ResearchChallenges
• 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
9. Protected Time for ResearchPotential Solutions
• Transparency of research VERA funds
• VERA calculations recalculated
• Monitoring protected time
• Protected time as a performance measure
• Guidance on protected time for research
Research Administrative ReviewNext 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