Conflict of Interest

1
Conflict of Interest Informed Consentfor
Department of Pediatrics Fellows

• Presented by University of Pittsburghs COI
  Office
• David T. Wehrle, CPA, CIA, CFE/Director
• Khrys X. Myrddin/Associate Director
• July 3, 2008

2
What is a Conflict of Interest?

• A potential Conflict of Interest (COI) may exist
  if an individuals outside interests (especially
  financial) may affect, or perceive to affect,
  his/her research, teaching, or administrative
  activities at the University.

3
Example of Potential Conflict of Interest

• Dr. Karola Kinderschuh developed an orthopedic
  device for pediatric patients
• The technology is owned by Strait Narrow, Inc.,
  in which Dr. Kinderschuh has an ownership
  interest
• Dr. Kinderschuh is conducting federally sponsored
  research to further evaluate the device.

4
Why should you care about COI?

• Your COIs can affect
• Your role in studies
• Your potential research subjects willingness to
  participate in the research
• How your research is viewed by the academic
  community and the public.

5
Importance of COI Management

• If COI is not managed
• protection of human subjects may be compromised
• integrity of research may be at risk
• the public may lose trust in the University and
  its research findings
• the investigator/faculty member may lose the
  respect of the academic community

6
Importance of COI Management contd

• violation of scientific norms may result
• University may lose public support and funding
  for academic science
• may violate terms of research grants and
  contracts (including failure to disclose COI) and
  federal regulations.
• research results may be excessively delayed or
  not published

7
Importance of COI Management contd

• there may be a negative impact on students
• University resources may be improperly used
• increased government regulations may result
• scandals or negative media attention may occur.

8
COICs Standard COI Management Plan for Human
Subject Research

• University of Pittsburghs primary management
  tool is the Conflict of Interest Committees
  Standard COI Management Plan for Human Subject
  Research (SMP).

9
COICs Standard COI Management Plan for Human
Subject Research Details

• I will not serve as Principal Investigator (PI)
  on this protocol, although I may serve as a
  co-investigator.
• I will not be involved in the recruitment of
  volunteer subjects, nor will I administer the
  informed consent.
• I will not engage in the recording of research
  data.
• I will not be involved in clinical assessments of
  study eligibility criteria and intervention
  outcomes.

10
COICs Standard COI Management Plan for Human
Subject Research Details contd

• I will not participate in data and safety
  monitoring activities.
• I will not solely be involved in the
  interpretation of study results, although I may
  be involved as part of a committee that evaluates
  study results. Final decisions about the
  appropriate interpretation and presentation of
  research results shall be the responsibility of
  the PI.
• The existence of my Significant Financial
  Interest will be disclosed in the informed
  consent form.

11
COICs Standard COI Management Plan for Human
Subject Research Details contd

• If other individuals (such as students, staff, or
  other faculty members) will be involved in
  research under this protocol, I will notify them
  of the existence of my Significant Financial
  Interest through the use of a standard
  notification form. Students will be engaged in
  the protocol only with the approval of their
  department chair or dean.

12
COICs Standard COI Management Plan for Human
Subject Research Details contd

• I will disclose the existence of my Significant
  Financial Interest in any abstracts,
  presentations, press releases, or publications
  and in any proposals or applications for research
  funding related to the nature of that interest.
• I will notify the chair of the Conflict of
  Interest Committee (Dr. Jerome Rosenberg
  jrosenb_at_pitt.edu) of the titles and numbers of
  any present or future federal research grants
  supporting this protocol.

13
Aspects of Informed Consent Requirements

• Clinical aspects of Informed Consent it is a
  matter of both ethics and federal regulation that
  research subjects
• enter a study voluntarily
• be informed about risks and benefits
• understand the difference between experiment and
  treatment
• understand the information provided.
• COI aspects of Informed Consent consistent with
  recommendations of professional organizations and
  federal guidance, University policy requires
  disclosure of financial COIs as part of the
  Standard Management Plan.
• Cf. Bramstedt, KA A guide to informed consent
  for clinician-investigators Cleveland Clinic
  Journal of Medicine 20047111.
  http//www.ccjm.org/PDFFILES/Bramstedt11_04.pdf

14
Text of Informed Consent in SMP (Example)

• One or more of the investigators conducting this
  research has a financial interest in or a patent
  for the development of this pediatric heart
  valve. This means that it is possible that the
  results of this study could lead to personal
  profit for the individual investigator(s) and/or
  the University of Pittsburgh. This project has
  been carefully reviewed to ensure that your
  well-being holds more importance than any study
  results. Any questions you might have about this
  will be answered fully by Dr. Getrude Kleinherz,
  412-123-4567, or by the Human Subject Protection
  Advocate of the University of Pittsburgh
  (866-212-2668).

15
Discussion

• Putting yourself in the place of a potential
  research subject, what are your thoughts on the
  financial disclosure in the Informed Consent
  document in terms of
• Necessity to disclose
• Your ability to understand it
• The amount of information provided
• Your willingness to be a participant
• ?

16
The COINS Study

• Purpose of study analyze aspects of financial
  disclosure to potential research participants
  provide data and recommendations for the
  development of best practices surrounding such
  disclosures.
• 3-year study
• 5 million of funding
• NIH-sponsored
• Parents of pediatric patients are included in
  this study
• Conflict of Interest Notification Survey

17
COINS Study Views of investigators, et.al.

• Purpose of study to understand the attitudes,
  beliefs, and practices of IRB chairs, COIC
  chairs, and investigators regarding disclosure of
  financial interests to potential research
  participants.
• The participants included 10 academic medical
  centers, 10 independent hospitals, and 10
  unaffiliated research entities from which
  respondents were recruited.
• Weinfurt, KP, Friedman JY, et. al Disclosing
  Conflicts of Interest in Clinical Research Views
  of Institutional Review Boards, Conflict of
  Interest Committees, and Investigators Journal
  of Law, Medicine Ethics 2006 34 (3) 581-591.
  http//www.pubmedcentral.nih.gov/articlerender.fcg
  i?artid1850937

18
COINS Study Views of investigators, et.al.
Results

• Most respondents suggested that disclosure should
  occur under all circumstances in which a
  financial interest exists.
• Justifications for such disclosure included
• A participants right to know
• Enabling potential research participants to make
  better informed decisions
• Engendering participants trust in investigators
  and the research institutions
• Some respondents underscored the need for
  disclosure to prevent a later reaction of
  distrust if research participants learned about a
  previously undisclosed COI

19
COINS Study Views of investigators, et.al.
Results contd

• Some concerns about making disclosures
• Inability of research participants to understand
  disclosure
• Violation of the investigators privacy
• Possibility that disclosure would affect
  potential research participants willingness to
  enroll
• Possible undermining of the participants trust
  in the investigator
• Increased length of the Informed Consent document.

20
COINS Study Views of investigators, et.al.
Results contd

• Much disagreement about whether the amount of the
  financial interest should be disclosed.
• None of the investigators thought such detailed
  information should be disclosed.
• Most respondents seemed to agree that the nature
  of the relationship was important to disclose,
  but that such disclosures should be kept simple.

21
COINS Study Views of Potential Research
Participants

• Purpose of study determine what participants
  wanted to know about financial interests, their
  capacity to understand the disclosure, and their
  reaction to proposed disclosure statement.
• Participants 16 focus groups healthy adults,
  adults with mild chronic illness, healthy
  children, parents of children with leukemia or
  brain tumor, adults with heart failure, adults
  with cancer.
• Weinfurt KP, Friedman JY et al Views of
  Potential Research Participants on Conflicts of
  Interest Journal of General Internal Medicine
  2006 901-906.

22
COINS Study Views of Potential Research
Participants Results

• Many participants reported that they did not know
  about or hadnt thought about investigators
  financial interests in research before
  participating in the study.
• Participants wanted to know about financial
  interest, whether or not those interests would
  affect their participation.
• Parent of sick child It seems to me, with
  this kind of thing, there ought to be disclosure.
  Ive never even thought of these kinds of
  scenarios until you brought them up hereand its
  opened my eyes to the possibilities of things
  that can be going on that we have not idea of.
  Weve got little folks with lives on the line,
  and I think we deserve and ought to know.

23
COINS Study Views of Potential Research
Participants Results contd

• Some participants indicated that the COI
  disclosure would affect their decision about
  participating in research.
• Participants felt that disclosure was more
  important for riskier studies than for less risky
  ones when participants health was at stake,
  they suggested that they might be less able to
  evaluate the risk posed by a financial
  disclosure, even though they generally believe
  that such risks are important to consider.
• There was variation in subjects ability to
  understand the nature implications of financial
  interests.

24
COINS Study Views of Potential Research
Participants Results contd

• Participants expressed the view that disclosure
  of financial interests was important in
  preserving trust in doctors/researchers.
• Some participants felt the amount of money
  received by investigators would be important to
  know, whereas other felt they would not want to
  know the amount.

25
FDA Halts Gene Experiments at University of
Pennsylvania By Rick Weiss and Deborah
NelsonWashington Post Staff WritersSaturday,
January 22, 2000 Page A1 The federal
government yesterday halted all human gene
therapy experiments involving a prominent
researcher at the University of Pennsylvania,
saying an investigation into the September death
of a teenager there found the school's
prestigious program in serious disarray.
26
Case of Inadequate COI Disclosure

• Jesse Gelsinger was not informed that several
  monkeys injected with the vector had died.
• The informed consent document approved by the FDA
  was allegedly altered to exclude this
  information.
• Jesse was also not informed that other humans who
  had previously participated in the trial suffered
  serious adverse effects.

27
Case of Inadequate COI Disclosure contd

• The extent of the PIs and the University of
  Pennsylvanias financial COI was not adequately
  disclosed to Jesse.
• Jesses entry into the trial was deemed reckless,
  because his blood ammonia level on the day before
  he received the gene transfer exceeded the limit
  set forth in the FDA protocol.

28
Contact

• Jerome L. Rosenberg, PhD/Chair, COI Committee
• 412-624-3007 jrosenb_at_pitt.edu
• David T. Wehrle, CPA, CIA, CFE/Director, COI
  Office
• 412-383-1774 wehrledt_at_upmc.edu
• Khrys X. Myrddin/Associate Director, COI Office
• 412-383-2828 myrddink_at_upmc.edu
• Hannelore Rogers, MA/Coordinator, COI Office
• 412-383-1968 rogershn_at_upmc.edu
• COI Web site www.coi.pitt.edu