Identifying and Managing Conflict of Interest and Conflict of Commitment

1
Identifying and Managing Conflict of Interest
and Conflict of Commitment

• Tom Hazinski, MDProfessor and Associate
  DeanCo-Chair, Medical Center Conflict of
  Interest Committee

2
Conflict of Interest and Commitment

• Background and Principles
• Key Issues at Vanderbilt
• Significant Financial Interest of faculty and
  institution
• Human Subjects Research
• Conflicts of Commitment
• COI processes
• Case Studies

3
Conflict of Commitment

• Can arise when faculty engage in activities that
  are in addition to a members primary University
  appointment.and that may have adverse effects on
  the performance of University obligations.
• Activities that are usually permitted Service on
  scientific boards, study section, expert panels,
  external consultations, CME, foundation and
  organizational leadership, editorial boards, etc.
  Full-time faculty appointment implies a full-time
  professional obligation to University.
• External and non-job related internal commitments
  cannot exceed 50 days per year without approval.

http//www.vanderbilt.edu/compliance/html/conflict
_of_interest_policy.pdf
4
COI - The Quick Version

• Real Estate Location, location, location
• COI Disclosure, disclosure, disclosure
• COI/COC test
• Would public discovery of the activity or
  situation adversely affect (or appear to affect)
  patient safety, my medical judgment, the
  scientific integrity of my research, embarrass
  the University, or violate a standard of conduct?

5
Conflicts of Interest in Academic Medicine

• -Non-Financial
• Desire for faculty advancement
• Compete for sponsored research
• Receive accolades from peers
• Receive prestigious prizes
• Alleviate pain and suffering
• -Financial gain by physician or investigator
• Society and regulators have focused on
  financial conflicts of interest.

6
COI - Definition

• A situation in which an individuals financial,
  professional or personal considerations may
  directly or indirectly affect, or have the
  appearance of affecting, an individuals
  professional judgment in exercising any
  University duty or responsibility, including
  research.
• Faculty should evaluate and arrange their
  activities to avoid compromising their ability to
  carry out their primary obligations to the
  University.

http//www.vanderbilt.edu/compliance/html/conflict
_of_interest_policy.pdf
7
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
8
Belmont Report 1979http//www.hhs.gov/ohrp/huma
nsubjects/guidance/belmont.htm

• Set boundaries between practice and research.
• Emphasized basic ethical principles
• Respect for persons
• Beneficence
• Justice
• Set human subject protection policies
• Informed consent IRBs established.
• Assessment of risks and benefits
• Selection of subjects

9
Bayh-Dole Act of 1980

• Designed to promote use, development and
  promotion of technology invented with federal
  funding.
• Recipients of federal funding have the right to
  retain ownership to inventions developed with
  federal funding.
• Recipient must share royalties, or other income,
  derived from the invention with the inventor(s).
• Result Investigators and institutions sought
  commercial opportunities.

10
Patents to Universities1986-1999
Source Association of University Technology
Managers
11
U.S. University Hospital Royalties(millions
of dollars)
12
Existence of Potential Conflict of Interest

• Describes a situation
• Not a judgement on appropriateness of behavior or
  personal integrity.
• Faculty members must disclose potential COIs.

13
Situations That Should be DisclosedSome Examples

• A significant financial interest in a company
  that does business with Vanderbilt.
• Income from a drug or device company that exceeds
  reporting thresholds.
• Acceptance of a gift 300 from a single entity.
• Financial relationship with a sponsor of your
  research.
• Use of trainees in industry-sponsored research.
• University investment in your research.
• Supervision of a family member employed at
  Vanderbilt.
• External commitments that exceed 50 days per year.

14
A.A.M.C. Policy GuidelinesDecember, 2001

• Protection of students and trainees
• Legal obligations
• Sanctions
• IRB will not approve research until COI situation
  is clarified.
• Office of Research will not release grant funds
  until COI is assessed.
• Office of Tech Transfer cannot execute a final
  contract until COI situation is clarified.
• Department Chair or COI Committee may prohibit or
  modify the disclosed activity.

15
Faculty Conflict of Interest Disclosures Are
Reviewed by the Medical Center Conflict of
Interest Office (MCCOIC)
16
Medical Center Conflict of Interest Committee -
2005
Tom Hazinski (Gerald Gotterer), Chair
Sherrie Leach, Staff
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)
17
Faculty Conflict of Interest Disclosures
18
Annual COI Faculty Disclosure Form

• Web-based form for 2003-2004 academic year for
  SOM faculty.
• 99.3 compliance rate
• New Vanderbilt University policies in place for
  2005.
• Online form sent to faculty April, 05
• ALL FACULTY MUST COMPLETE THIS ANNUAL REQUIREMENT.

19
(No Transcript)
20
Faculty Conflict of Interest Disclosures
21
Faculty Conflict of Interest Disclosures
22
Vanderbilt University IRBApplication for Human
Research
23
Faculty Conflict of Interest Disclosures
24
Office of Research

• COI disclosure form required for all federal
  grants and contracts.
• Separate disclosure form for information about
  P.I. and all participants.
• Significant financial interest
• 10,000 annual income from one entity.
• the equity interest exceeds 5 ownership.
• Equity interest is 10,000 at fair market
  value.
• Royalty payments exceed 10,000 annually.

25
Office of Research (continued)

• Situation 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/

26
FORM USED AT VANDERBILT TO GATHER COI DETAILS
27
Growth of Industry-sponsored clinical research
and University investments prompts increased
federal scrutiny
28
Points for Consideration (1)

• Financial Details
• Does the research involve financial relationships
  that could create conflicts of interest?
• How is the research supported or financed?
• Is individual or institutional compensation
  influenced positively by 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?
• How should the financial relationships that
  create a conflict of interest be managed?

29
Points for Consideration (2)

• Study Design Details
• Where and by whom was the study designed?
• What is the nature of the study?
• E.g., Mechanistic in vitro study vs a clinical
  study that will increase the value of the
  financial interest.
• Will investigators with financial interests
  obtain consent from patients?

30
Points for Consideration (3)

• Data Analysis Details
• Where and by whom will the resulting data be
  analyzed?
• Will investigators with financial interests or
  their subordinates be involved in primary data
  analysis?
• Is there an independent DSMB and patient safety
  monitoring plan?

31
Points for Consideration (4)

• Given these details
• Is Vanderbilt an appropriate site for the
  research?
• Can the faculty member perform the research at
  Vanderbilt?
• Rebuttable presumption of non-participation
  special expertise and patient safety issues can
  override financial considerations.

32
COI Management Options

• Disclosure of financial interests to prospective
  subjects and in publications/presentations.
• Reduction of financial interest to below
  threshold.
• Data analysis and safety monitoring by
  individuals unaffiliated with investigator or
  company.
• Additional oversight or monitoring of the
  research by external overseer.
• Modification of role of particular
  staff/trainees.
• Elimination of the financial interest.
• Perform research at non-Vanderbilt sites.

33
Consequences of Failure to Disclose COI

• Human subjects in research studies could question
  the motives of the faculty member and
  investigator equipoise.
• Loss of public support and confidence in academic
  health centers and in research.
• Institutional and Federal audit of Vanderbilt
  research programs.
• Public embarrassment of faculty member, Medical
  Center and School.
• Violation of faculty code of conduct could lead
  to disciplinary action.

34
Case Study 1

• Faculty member of a clinical department owns
  1,000 shares of a publicly traded pharmaceutical
  companies A. The value is in excess of 10,000.
• Company A sponsors a large multi-centered,
  double-blind study involving over 10,000 patients
  and 100 sites studying the effects of a new
  pharmaceutical. The faculty member is responsible
  for the Vanderbilt site, which has 40 patients
  enrolled. An independent DSMB monitors the
  trial.
• Data analysis is performed by a data coordinating
  center independent of the company.

35
Case Study 1 (continued)

• Both the IRB application and the patient consent
  forms indicate the existence of a potential
  conflict of interest.
• Faculty member discloses a financial interest in
  company A.
• There are no trainees involved with the study.
• There is no VU investment.
• The faculty member discloses his stock ownership
  in all relevant publications and presentations.

36
Case Study 1 (continued)

• Does the faculty member have a potential conflict
  of interest?
• If so, what management or oversight is necessary?

37
Case Study 2

• A faculty member discovers a potentially useful
  new application of an existing drug. Under
  Vanderbilts policies, Vanderbilt licenses the
  rights to the database concerning this new
  application to a private pharmaceutical company.
• The faculty member has a significant financial
  interest in this activity as the medical director
  of and with an ownership position in the private
  pharmaceutical company. He also is actively
  involved with the Vanderbilt I.R.B.

38
Case Study 2 (continued)

• It should be noted that successful development
  and marketing of this new application will
  financially benefit the faculty member, the
  company, and Vanderbilt University.
• The faculty member proposes that studies in human
  subjects relating to the efficacy of this new
  application be undertaken at Vanderbilt. Though
  he himself will not carry out the study, faculty
  members reporting to him will do so. The proposed
  Data Safety Monitoring Board contains a faculty
  member at another medical school, a Vanderbilt
  statistician, and physician in private practice
  a former fellow of the faculty member.

39
Case Study 2 (continued)

• Final Recommendation
• Special expertise of Vanderbilt faculty warranted
  study being carried out at Vanderbilt.
• Study reviewed by IRB of another medical school.
• Principal Investigator on the study is faculty
  member who does not report to the inventor and
  who has no financial interest in the outcome.
• Data Safety Monitoring Board should have no
  members with any relationship to inventor.

40
Case Study 2 (continued)

• The only person with access to blinding code is
  statistician who prepared randomization sequence.
• Statistical analysis of the data will be carried
  out by an independent company, with access to
  randomization codes only after the database is
  locked.
• If needed for patient safety, unblinded
  statistician will provide code only to the Data
  Safety Monitoring Board.
• Medical Director of pharmaceutical company (the
  inventor) is blinded to randomization code until
  final analysis is performed by independent CRO
  contractor.

41
Conflicts of Interest At Vanderbilt

• Additional information
• Your Chair or academic supervisor
• MCCOIC Office (320 Light Hall)
• University Conflicts Policies http//www.vanderbi
  lt.edu/compliance/html/conflict_of_interest_policy
  .pdf
• http//www.vanderbilt.edu/compliance/html/conf_co
  mm.pdf
• Office of Research website
• Faculty Manual
• Office of Compliance

42
COI in ResearchKey Points to Remember

• Conflicts of interest are part of academic life.
• They can usually be avoided and minimized by
  personal judgment, discretion and disclosure.
• Consult with your academic supervisor if you have
  questions.
• Some situations must be reconciled by peer
  review, management and additional oversight.
• Level of management and oversight is highly
  situation-dependent and respectful of faculty
  members academic freedom.
• Faculty members must disclose potential COIs to
  MCCOIC annually and when new situations occur.
• Research situations that require review involve
  industry sponsorship, clinical research, use of
  trainees, University financial investment, and
  when PI has an SFI.