Transcript Why Should you Care? - Conflict of Interest Office

University of Pittsburgh
Conflict of Interest Committee & Office
Partners in Promoting Integrity in Research, Teaching, and
Administration
Financial Conflicts of Interest:
Why Should You Care?
Presentation for the Pitt Research Network
March 17, 2009, noon – 1:00 p.m.
BST Room S-120
Jerome L. Rosenberg, PhD
(Chair/COI Committee & Research Integrity Officer)
David T. Wehrle, CPA, CIA, CFE
(Director/COI Office)
What is a Conflict of Interest?
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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.
Examples of Potential Conflicts
 Professor
Maureen Belstein,
faculty member/researcher
 Consultant for Diagnostic Systems, Inc.
(earned $35,000 last year)
 DSI wants to sponsor university research to
evaluate new cancer screening technologies
 Professor Belstein wants to be PI on the
study
Examples of Potential Conflicts
(cont’d)
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Dr. Maryann Ruecken developed a back brace
which was patented by the University; she
receives royalties for the device through Pitt
The technology is licensed to Strait & Narrow,
Inc., a non-publicly held company
She holds equity in the company
Dr. Ruecken is conducting federally sponsored
research to further evaluate the technology.
Importance of COI Management
Why is it important to identify and manage
conflicts of interests?
Importance of COI Management
If COI is not managed…
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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;
violation of scientific norms may result;
may violate terms of research grants and
contracts (including failure to disclose COI) and federal
regulations.
Importance of COI Management
(cont’d)
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University may lose public support and funding for
academic science;
research results may be excessively delayed or not
published;
students may be negatively impacted: inability to pursue
their research interests;
University resources may be improperly used;
increased government regulations may result;
scandals or negative media attention may occur.
Importance of COI Management
(cont’d)

For FDA-covered clinical studies, FDA
may:
initiate agency audits of data
 request additional analyses of data
 request additional independent studies to confirm
results of questioned study
 refuse to treat covered clinical study as providing
data as basis for an agency action
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ATLANTA JOURNAL CONSTITUTION
Depression expert at Emory pulls out of
research projects
NIH freezes grant money; Emory to begin monitoring
potential conflicts of interest
Gayle White, Craig Schneider  Tuesday, October 14, 2008
Emory psychiatry professor D. Charles B. Nemeroff is stepping down from
university research projects funded by the National Institutes of Health,
as the federal agency cracks down on the school’s handling of potential
conflicts of interest, university officials said.
The NIH has frozen funds for a $9.3 million project on depression led by
Nemeroff, acknowledged Ron Sauder, a university vice president. The
project had been under way for two of its proposed five years.
NEW YORK TIMES
Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY June 8, 2008
A world-renowned Harvard child psychiatrist whose work has
helped fuel an explosion in the use of powerful antipsychotic
medicines in children earned at least $1.6 million in consulting
fees from drug makers from 2000 to 2007 but for years did not
report much of this income to university officials, according to
information given Congressional investigators.
By failing to report income, the psychiatrist, Dr. Joseph Biederman,
and a colleague in the psychiatry department at Harvard
Medical School, Dr. Timothy E. Wilens, may have violated
federal and university research rules designed to police potential
conflicts of interest, according to Senator Charles E. Grassley,
Republican of Iowa. Some of their research is financed by
government grants.
THE CHRONICLE OF HIGHER
EDUCATION
Senator Grassley Pressures Universities on
Conflicts of Interest
By JEFFREY BRAINARD August 8, 2008
University scientists should have their grants
yanked by the National Institutes of Health if
they fail to report financial conflicts of interest,
said U.S. Sen. Charles E. Grassley.
Research Coordinators
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Play a key role in
 Assisting
investigators in complying with
University and federal COI policies and
regulations
 Facilitating implementation of management
plans
 Ensuring expeditious approval process
How the University Addresses
COIs
Disclosure
 Review
 Management
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How the University Addresses
COIs (cont’d)
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Disclosure on Faculty/Researcher Form
 Policy
11-01-03 requires disclosure of the outside
interests of faculty, investigators, and research
administrators (i. e., any staff members who direct or
can materially influence research, or who are
responsible for the design, conduct, and reporting of
research) …
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upon appointment
by April 15 of each year
whenever new outside interests are accrued
using the Superform system https://coi.hs.pitt.edu
How the University Addresses
COIs (cont’d)
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Disclosure also must be made/kept current (i.e.,
whenever new outside interests are accrued) in protocol
applications to
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Institutional Review Board (IRB)
Institutional Animal Care and Use Committee (IACUC)
Committee for Oversight of Research Involving the Dead
(CORID)
Institutional Biosafety/rDNA (Recombinant DNA) Committee
hSCRO (Human Stem Cell Research Oversight Committee)
How the University Addresses
COIs (cont’d)
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A process should be in place to ensure
that all research personnel—i.e., PIs, coinvestigators, and research coordinators—
respond to COI questions appearing in
protocol applications.
How the University Addresses
COIs (cont’d)
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Review and management process
 Deans
and department chairs review disclosures to
identify and manage potential conflicts;
 Certain conflicts must be addressed by the Conflict of
Interest Committee (COIC) or by its standing
subcommittee, the Entrepreneurial Oversight
Committee.
Conflict of Interest Policy
Conflict of Interest Committee’s Human
Subject Research Working COI Policy:
http://www.coi.pitt.edu/Policies/IRBCOIPolicy.htm
 Individuals are generally prohibited from serving
as principal investigators (PI) of a human subject
research study if they have a significant financial
interest (SFI) that may be affected, or perceived
to be affected, by the outcome of the research
study. …
Conflict of Interest Policy (cont’d)
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Such individuals may be permitted to
serve as co-investigators with the
implementation of the Standard Conflict of
Interest Management Plan for Human
Subject Research. …
Standard COI Management Plan
(Text )
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In view of my Significant Financial Interest (SFI)
in ____________________________ (specify
name of company and/or technology being
evaluated), I agree to the following components
of a plan to manage my conflict of interest with
respect to Institutional Review Board (IRB)
Protocol #________________.
Standard COI Management Plan
(cont’d)
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I will not serve as Principal Investigator
(PI) on this protocol, although I may serve
as a co-investigator. The PI selected
must be approved by the IRB. As a coinvestigator, I will be responsible for:
________________________________.
Standard COI Management Plan
(cont’d)
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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
(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.
Standard COI Management Plan
(cont’d)
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The existence of my Significant Financial
Interest will be disclosed in the informed
consent form using the following language:
Standard COI Management Plan
(cont’d)
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One or more of the investigators conducting this
research has a financial interest in or a patent for the
development of this (add study specific information). 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. (Enter the name and telephone
number of the PI of the research study) or by the Human
Subject Protection Advocate of the University of
Pittsburgh (866-212-2668).
Standard COI Management Plan
(cont’d)
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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
(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.
Standard COI Management Plan
(cont’d)
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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.
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COI Management Strategies
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PI exclusion rule: an alternate PI must be selected who
can exercise complete scientific independence from the
conflicted investigator
Characteristics of a suitable alternate PI:
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does not have a COI
has supervisory approval as alternate PI
is scientifically qualified
is a tenured faculty member
has no reporting relationship to conflicted investigator
has independent funding
is not a mentee of the conflicted investigator on a training grant
has own lab space
COI Management Strategies (cont’d)
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Request for exception to PI exclusion rule
 May
be granted if compelling circumstances exist
 For research overseen by the IRB, IACUC, or
hSCRO, a written request must be submitted through
COI Committee to authorized institutional official (vice
chancellor for research conduct and compliance)
 For research overseen by the CORID, the COIC and
investigator’s dean and department chair must
approve request
 If granted, would require implementation of a
management plan, including the possible
establishment of a data stewardship committee
Conflict of Interest Policy (cont’d)
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All other exceptions to the standard COI
management plan (e.g., adding/removing
elements to/from the standard plan) must be
approved by a subcommittee of the COI
Committee.
These requests for exceptions should be
communicated to the director of the COI Office.
A response to the request will be provided within
two weeks of receiving the request.
Questions?
Contacts
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Jerome L. Rosenberg, PhD
Chair, COI Committee
412-624-3007 [email protected]
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David T. Wehrle, CPA, CIA, CFE
Director, COI Office
412-383-1774 [email protected]
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Khrys X. Myrddin
Associate Director, COI Office
412-383-2828 [email protected]
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Hannelore Rogers, MA
Coordinator, COI Office
412-383-1968 [email protected]
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COI Web site: www.coi.pitt.edu