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

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