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