Transcript Document

Conflict of Interest &
Informed Consent
for Pediatrics Fellows &
Pediatric Neurology Residents
Presented by University of Pittsburgh’s COI Office
David T. Wehrle, CPA, CIA, CFE/Director
Khrys X. Myrddin/Associate Director
September 23, 2010
What is a Conflict of Interest?
A potential Conflict of Interest (COI) may
exist if an individual’s outside interests
(especially financial) may affect, or
perceive to affect, his/her research,
teaching, or administrative activities at the
University.
Example of Potential Conflict of Interest
Dr. Carol Kleinhertz developed a pediatric heart valve;
The technology is owned by Ebb & Flow, Inc., in
which Dr. Kleinhertz has an ownership interest;
Dr. Kleinhertz is conducting federally sponsored
research to further evaluate the device.
Why should you care about COI?
COIs can affect…
investigators’ role in studies;
potential research subjects’ willingness to participate
in the research;
how research is viewed by the academic community
and the public.
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;
Importance of COI Management
cont’d
 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;
Importance of COI Management
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cont’d
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.
Case of Failure to Disclose Consulting
Income
Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY
PUBLISHED: JUNE 8, 2008 in The New York Times
[Dr. Joseph Biederman], a Harvard child psychiatrist
whose work has helped fuel an explosion in the use of
antipsychotics in children earned at least $1.6 million in
consulting fees from drugmakers from 2000 to 2007 but
for years did not report much of the income to university
officials, according to information given Congressional
investigators, The New York Times reports.
Federal Regulations
PHS—42 CFR Part 50 Subpart F for
Grants
PHS—45 CFR Part 94 for Contracts
FDA—21 CFR Part 54
NSF Grants Policy Manual – Investigator
Financial Disclosure Policy
University of Pittsburgh’s new COI Policy
Conflict of Interest Policy (11-01-03) for
Faculty, Scholars, Researchers, Research
Staff/Coordinators
COI Questions on IRB Protocols
 Section 7 - Qualifications of Investigators and Sources of
Research Study Funding
 7.3 Does any investigator* involved in this study:
a) possess an equity interest in the publicly-traded entity that either
sponsors this research or owns the technology being evaluated that
exceeds 5% ownership interest or a current value of $10,000?
b) possess any equity interest in the non-publicly-traded entity that
either sponsors this research or owns the technology being
evaluated?
* 'Investigator' means any member of the study team who participates in the design,
conduct, or reporting of this research, as well as his/her spouse, registered domestic
partner, dependents, or other members of his/her household.
COI Questions on IRB Protocols cont’d
c) receive salary, consulting fees, honoraria, royalties or other payments
from the entity that either sponsors this research or owns the technology
being evaluated that is expected to exceed $10,000 in any twelvemonth period?
d) have rights to the intellectual property (IP) being evaluated, as either the
inventor of the IP for which a patent has been issued, or as the inventor
of the IP that has been optioned or licensed to a company?
e) have a financial relationship with a Licensed Start-up Company (which
is being monitored by the COI Committee) that has an option or license
to utilize the technology being evaluated?
f) receive compensation of any amount when the value of the
compensation would be affected by the outcome of the research, such
as compensation that is explicitly greater for a favorable outcome than
for an unfavorable outcome or compensation in the form of an equity
interest in the entity that either sponsors this research or owns the
technology being evaluated.
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.
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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.
Standard COI Management Plan for
Human Subject Research Details cont’d
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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.
Standard COI Management Plan for
Human Subject Research Details cont’d

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.
Standard COI Management Plan for
Human Subject Research Details cont’d
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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; [email protected])
of the titles and numbers of any present or future
federal research grants supporting this protocol.
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 2004;71:11. http://www.ccjm.org/PDFFILES/Bramstedt11_04.pdf
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.
Hilary Heart, 412-123-4567, or by the Human Subject
Protection Advocate of the University of Pittsburgh, 866212-2668.
Discussion
Putting yourself in the place of both a
potential investigator and a research
subject, what are your thoughts about the
financial disclosure on the Informed
Consent Form (ICF) with respect to
the necessity to disclose;
your ability to understand it;
the amount of information provided;
your willingness to be a participant
…?
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.
$5 million NIH-sponsored study
Parents of pediatric patients are included in this
study
*Conflict of Interest Notification Survey
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.fcgi?artid=1850937
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 participant’s 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
COINS Study: Views of Investigators,
et.al.: Results
cont’d
 Some concerns about making disclosures
 Inability of research participants to understand disclosure;
 Violation of the investigator’s 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 Form.
COINS Study: Views of Investigators,
et.al.: Results
cont’d
 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.
COINS Study No. 1* : 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 of healthy adults, adults
with mild chronic illness, healthy children, parents of
children with leukemia or brain tumors, 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.
COINS Study No. 1: Views of Potential
Research Participants: Results
 Many participants reported that they did not know about,
or hadn’t thought about, investigators’ financial interests
in research before participating in the study.
 What participants wanted to know about financial
interest:
[Parent of sick child:] “It seems to me, with this kind of thing, there
ought to be disclosure. I’ve never even thought of these kinds of
scenarios until you brought them up here…and it’s opened my
eyes to the possibilities of things that can be going on that we
have no idea of. We’ve got little folks with lives on the line, and I
think we deserve and ought to know.”
COINS Study No. 1: Views of Potential
Research Participants: Results
cont’d
 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.
COINS Study No. 1: Views of Potential
Research Participants: Results
cont’d
 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
others felt they would not want to know the amount.
COINS Study No. 2*: Views of Potential
Research Participants: Results
When financial information was included in
the ICF
Research participants were less willing to
participate if investigator held equity:
 5.3% refusal vs. 1.4% if no COI
18.9% made negative comments
*Weinfurt K, Hall M, et al. Effects of disclosing financial interests on participation in medical research:
A randomized vignette trial. American Heart Journal, Vol 156, Number 4 (October 2008)
COINS Study: Authors’ Conclusions &
Recommendations*
Disclosure is not the remedy that many
seek; but it may have positive effects on
people’s satisfaction with and trust in
research process;
Those who oversee potential COIs in
research should be explicit about the goals
to be achieved and should design
disclosure statements to meet those goals;
* Weinfurt, KP, Hall, MA., et.al.: Disclosure of Financial Relationships to Participants in Clinical
Research. New England Journal of Medicine 2009, 361:9
COINS Study: Authors’ Conclusions &
Recommendations cont’d
Disclosure during consent process should
be brief, simple, and allow for participants’
questions;
Study personnel administering informed
consent should receive training to
effectively answer participants’ questions
about investigators’ or institution’s financial
relationships;
COINS Study: Authors’ Conclusions &
Recommendations cont’d
Study participants should not be the sole
decision makers with respect to
acceptable risks of investigators’ financial
relationships in clinical research;
Investigators’ equity interests should be
limited, if not avoided, rather than simply
disclosed.
Contacts/Assistance/Resources
 Jerome L. Rosenberg, PhD/Chair, COI Committee
412-624-3007 [email protected]
 David T. Wehrle, CPA, CIA, CFE/Director, COI Office
412-383-1774 [email protected]
 Khrys X. Myrddin/Associate Director, COI Office
412-383-2828 [email protected]
 Hannelore Rogers, MA/Coordinator, COI Office
412-383-1968 [email protected]
 COI Web site: www.coi.pitt.edu
 Superform Web site: https://coi.hs.pitt.edu