Medical Conflicts of Interest Committee May 10, 2004

1
Medical Conflicts of Interest CommitteeMay 10,
2004

• Agenda
• Vanderbilt University/Medical Center Policies and
  Procedures
• Issue to consider in reviewing conflict
  situations.
• Review of conflict situations.

2
Vanderbilt University Categories of Individual
Conflicts of Interest

• I. Activities that are routinely acceptable
  without disclosure.
• II. Activities that may be acceptable with
  advance disclosure and review, and, where
  appropriate, the adoption of a plan for
  management of potential conflicts of interest.
• III. Conflicts involving the University as a
  party, including subdivisions and departments and
  senior officials.

3
Category II.
Activities that may be acceptable with advance
disclosure and review, and, where appropriate,
the adoption of a plan for management of
potential conflicts of interest.

• IIA. Conflicts involving human subjects and
  individual faculty or staff members.
• IIB. Conflicts involving faculty or staff that do
  not involve human subjects.

4

Procedural Guidelines.IIA. Conflicts involving
human subjects and individual faculty or staff
members.

• Review by Human Subjects subcommittee of Medical
  Center C.I.O. Committee.
• Endorsement by 2/3 vote full Medical Center
  C.I.O. Committee, including a vote by at least
  one of the three external members of the
  committee.
• Endorsement by Chair of University Conflicts
  Committee.
• In-person meeting (rather than business by
  e-mail) can be called by request of two or more
  members.

5
Procedural Guidelines. IIB. Conflicts involving
faculty or staff that do not involve human
subjects.

• Chair of the Medical Center C.O.I. Committee
  approves, rejects, or develops appropriate
  management plans, with advice of appropriate
  subcommittee as necessary.
• Report to Chair of the University Conflict
  Committee.

6
Category III. Conflicts involving the University
as a party, including subdivisions and
departments and senior officials.

• Chair of Medical Center C.O.I. Committee makes a
  presentation and recommendation to the University
  Conflict Committee with access to all information
  and advise as considered necessary from the
  Medical Center C.O.I. Committee or its
  subcommittees.
• Decision is made by University Conflicts
  Committee.

7
Faculty Conflict of Interest Disclosures
Annual DisclosureForm
Office of Research
I.R.B.
Faculty Member
Tech Transfer/ Legal
Source of Disclosure
Triage by Associate Dean (Tom Hazinski)

• C.O.I. Subcommittees
• Human Investigation
• Basic Research/Technology
• Consulting/Business

Seek more information
Approval
University Conflicts Committee
Medical Ctr. C.O.I. Committee
8
Faculty Conflict of Interest Disclosures
Annual DisclosureForm
Office of Research
I.R.B.
Faculty Member
Tech Transfer/ Legal
Source of Disclosure
Triage by Associate Dean (Tom Hazinski)

• C.O.I. Subcommittees
• Human Investigation
• Basic Research/Technology
• Consulting/Business

Seek more information
Approval
9
Annual Disclosure Forms

• Web-based form 2003-2004
• Screening Form - Conflicts of Interest or
  Commitment or Debarment
• Simple and Brief
• Linkages to Obtain Supplemental Information
  (Yes Response)
• Comprehensive
• Specific
• Educational Pop-Ups

10
Responsibilities for Annual Disclosure Form
Process

• Process is coordinated by Deans Office.
• Department chairs are responsible for completion
  of Disclosure Forms by departmental faculty.
• Department chairs are responsible for initial
  assessment and providing recommendations.
• Chair of Committee (Associate Dean for Faculty
  Affairs) is responsible for initial review and
  triage.

11
Faculty Conflict of Interest Disclosures
Separate Disclosure Form
Annual DisclosureForm
Office of Research
I.R.B.
Faculty Member
Tech Transfer/ Legal
Source of Disclosure
Triage by Associate Dean (Tom Hazinski)

• C.O.I. Subcommittees
• Human Investigation
• Basic Research/Technology
• Consulting/Business

Seek more information
Approval
12
Relationship of I.R.B. to C.O.I. Committee

• I.R.B. is responsible for assuring that
  patients/subjects are appropriately aware of
  conflict of interest situations.
• The Medical Center Conflict of Interest
  Committee, and where appropriate the Chair of the
  University Conflicts Committee or the University
  Conflicts Committee itself, are responsible for
  assuring that conflict of interest situations are
  managed so as to avoid or minimize influence on
  research effort.
• No research program involving human subjects can
  be initiated until approvals from both the I.R.B.
  and the appropriate conflict committee(s) are
  received and reconciled.

13
Faculty Conflict of Interest Disclosures
Annual DisclosureForm
Office of Research
I.R.B.
Faculty Member
Tech Transfer/ Legal
Source of Disclosure
Triage by Associate Dean (Tom Hazinski)

• C.O.I. Subcommittees
• Human Investigation
• Basic Research/Technology
• Consulting/Business

Seek more information
Approval
14
Office of Research

• Grants to U.S.P.H.S. and N.S.F.
• Separate disclosure form for information about
  P.I. and other persons responsible for the
  design, conduct, or reporting of the research.
• Significant financial interest (10,000 annually,
  the equity interest exceeds five percent
  ownership or a value of 10,000 at fair market
  value, or royalty payments exceed 10,000
  annually).

15
Office of Research (continued)

• Reviewed when notice of funding received.
• Any conflicts of interest issues must be resolved
  before funding is released.
• Further information available from Office of
  Research website
• http//medschool.mc.vanderbilt.edu/oor/gm/
  index.php?GM5

16
Faculty Conflict of Interest Disclosures
Annual DisclosureForm
Office of Research
I.R.B.
Faculty Member
Tech Transfer/ Legal
Source of Disclosure
Involvement of Associate Dean (Tom Hazinski)

• C.O.I. Subcommittees
• Human Investigation
• Basic Research/Technology
• Consulting/Business

University Conflicts Committee
17
Medical Center Conflict of Interest Committee
Tom Hazinski, Chair Sherrie Leach,
Staff (Gerald Gotterer)
Clinical Investigation Italo Biaggioni Tom
Graham John Murray Alastair Wood Basic Research/
Technology Richard Caprioli Peng Liang Donald
Rubin Consultations/Business Lonnie
Burnett Rolanda Johnson
At-Large Richard Chappell Stuart Finder Fred
Goad, Jr.

• Ex Officio
• Diana Marver (Research Training)
• Leona Marx (General Counsel)
• Chris McKinney (Tech Transfer)

18
Conflicts of Interest
Conflicts of interest are ubiquitous and
inevitable in academic life, indeed, in all
professional life. The challenge for academic
medicine is not to eradicate them, which is
fanciful and would be inimical to public policy
goals, but to recognize and manage them sensibly
and effectively. David Korn JAMA 284,
2234-2236, 2000
19
Conflicts of Interest in Academic Medicine

• Non-Financial Pressures
• Desire for faculty advancement
• Compete for sponsored research
• Receive accolades from peers
• Receive prestigious prizes
• Alleviate pain and suffering

20
Existence of Conflict of Interest

• Describes a situation
• Not a judgement on appropriateness of behavior

21
http//frwebgate2.access.gpo.gov/cgi-bin/waisgate.
cgi?WAISdocID263613481400100WAISactionretrie
ve
22
Underlying Principles

• The regulations protecting human research
  subjects are based on the ethical principles
  described in the Belmont Report respect for
  persons, beneficence, and justice. Financial
  relationships in human research should not
  compromise these principles. Openness and honesty
  are indicators of respect for persons,
  characteristics that promote ethical research and
  can only strengthen the research process.

23
Points for Consideration

• Does the research involve financial relationships
  that could create conflicts of interest?
• How is the research supported or financed?
• Where and by whom was the study designed?
• Where and by whom will the resulting data be
  analyzed?

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Points for Consideration (2)

• What interests are created by the financial
  relationships involved in the situation?
• Do individuals or institutions receive any
  compensation that may be affected by the study
  outcome?
• Do individuals or institutions involved in the
  research
• Have proprietary interests in the product?
• Have equity interest in the research sponsor and
  is it a publicly or non-publicly held company?
• Receive payments of other sorts?

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Points for Consideration (3)

• Given the financial relationships involved, is
  the institution an appropriate site for the
  research?
• How should the financial relationships that
  create a conflict of interest be managed?

26
Points for Consideration (4)

• Management options
• reduction of financial interest
• disclosure of financial interests to prospective
  subjects
• additional oversight or monitoring of the
  research
• independent data and safety monitoring committee
• modification of role of particular staff
• elimination of the financial interest

27
Points for Consideration (5)Institutional Issues

• Separate responsibilities for financial decisions
  and research decisions.
• Extend the responsibility of COI Committees to
  address institutional financial interests in
  research
• Establish criteria to determine what constitutes
  an institutional conflicts, including those of
  leadership

28
Points for Consideration (6)Institutional Issues

• Establish clear channels of communication between
  COI Committees and IRBs.
• Establish procedures for disclosure of
  institutional financial relationships to COI
  Committees.
• Include individuals from outside the institution
  in the review and oversight of financial
  interests in research.

29
AAMC Policy on Human Subject Research (December,
2001)
Rebuttable Presumption that Financially Interest
Individuals May Not Conduct Human Subjects
Research. The policy should state that, in the
absence of compelling circumstances, a
financially interested individual may not conduct
human subject research. p.18
30
AAMC Policy on Human Subject Research (December,
2001) (2)
When the financial interest is directly related
to the research and may be substantially affected
by it, the risk is greatest and the bar must be
high however, even direct and potentially
lucrative financial interests may be justified in
some circumstances. For example, when the
individual holding such interests is uniquely
qualified by virtue of expertise and experience
and the research could not otherwise be conducted
as safely or effectively without that individual,
her or she should be permitted the opportunity to
rebut the presumption against financial interests
by demonstrating these facts to the satisfaction
of an institutions COI committee. p.7
31
Issues in Assessing COI Involving Human
Investigation

• Financial Consulting fees, stock equity, stock
  options
• Patient/Subject risk
• Study design
• Phase I Phase III trial
• Multi-center trial Single-center
  trial
• Double blind Open label study
• Presence of Absence of
• independent safety monitoring
  board
• Independent analysis Involvement of
  investigator
• in the analysis of
  data