Transcript Conflicts of Interest Who they impact and why? Prepared by The Office of Research Training & Compliance (ORT&C) March 27, 2008 Director, Jackie Bendall.

Conflicts of Interest
Who they impact and why?
Prepared by
The Office of Research Training & Compliance (ORT&C)
March 27, 2008
Director, Jackie Bendall
Just In: Washington Post article
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Tobacco Cash in Lung Study
Lung scans were proved effective
Funds provided for research came from ACS,
DHHS
3.6 Million came from a parent company of
cigarette maker Liggett Group, Inc.
Foundation was formed
Washington Post, cont.
Cornell Foundation
What is a COI?
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A COI can occur when there is an actual
or perceived divergence between a
faculty member’s private interests and
professional service to the University.
Conflicts Occur When a Faculty
Member/PI
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Deprives GW of appropriate (compensated) time
and effort (conflict of commitment) due to other
competing demands;
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Makes substantial use of GW human or material
resources for non-University purposes;
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Has financial involvements that appear to affect
his/her academic responsibilities (e.g., invention
royalties outside of the University)
Examples of Actual COIs within Academia:
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A Department Chair purchases a computer from company run
by his son;
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A research scientists gives a friend use of a GW lab and
doesn’t disclose to anyone;
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A GW researcher invents a new device using GW resources
and fails to disclose to University;
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A faculty member acts as the thesis or dissertation advisor to
a graduate student for a research project, suggested by the
faculty member, w/ expectation to enhance the value of the
company in which the faculty has a significant interest;
Examples of Actual COIs within
Academia:(Cont.)
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A faculty member goes against the university policy
and accepts the sponsor’s request to suppress
publication due to undesirable results that could
significantly affect the sponsor’s financial interests;
Submits proposals in which researcher has financial
interest in the proposed sponsor, subcontractor,
vendor, or collaborator;
A faculty member/clinician accepts a fee/vacation
for the sake of influencing the financial status of
company and himself/herself (e.g., writing
prescriptions for a drug).
What does Perceived mean in this
case?
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Exist when an investigator’s significant financial
interest could lead an independent observer to
reasonably question whether the design, conduct, or
reporting of research might be influenced by the
possibility of personal gain.
- PI conducts federally or foundation sponsored nonclinical research on a product developed by a company for
which he is a consultant;
- A PI who participates on a scientific advisory board
conducts non-clinical research sponsored by company
How is significant defined?
GW policy defines Significant financial interest" as:
Stock or ownership interest of the lesser of $10,000 or 5% ownership
in the outside entity (excludes mutual funds);
Receipt, right or expectation of income in any form (e.g., consulting),
salary, allowance, forbearance, forgiveness, interest in real or
personal property, dividend, royalty derived from the licensing of
technology or other processes or products, rent, capital gain, real or
personal property, or any other form of compensation or > $10,000
per 12 month period;
Serving as PI for or having a management position in the outside
entity;
Corrupted Science:
Corporations view science not as a generator of truth but as one
among many inputs into production
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Drug Companies carefully choose and pay exorbitant fees to
influence what is presented;
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Ghost Writing (fees paid to Doctors who can be cited in
journal articles, articles written by ghost writers);
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Companies pay scientists fees to submit articles to open and
peer reviewed journals so that their unbiased science could be
cited in appeals;
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Companies seek to repress publication that affect their bottom
line and those of their shareholders;
Senator Grassley’s Common Themes
with the FDA
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Suppression of Scientific Dissent
Cozy Relationship with Industry
Pressure to Alter or Exclude Information
Pressure to Approve Products
Atmosphere of Fear of Retaliation
Organizational Challenges
Lack of Leadership
Patient Safety and Efficacy of Drugs
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Teaching how to practice has been handed to
the Pharma companies;
Dangerous side effects are rarely on the
curriculum;
Half of all continuing medical education
courses are paid for by drug companies (up
1/3 from a decade ago). Promotion of
sponsor’s product?
Proposed Legislation – Senator
Grassley – Senate Finance Committee
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Requires drug makers to disclose payments
that they make to prescribers for services
provided, including consulting, giving
presentations, or attendance at seminars.
Create a federal registry of such payments
similar to those registries in Maine, Vermont,
and Minnesota.
Continuing education provided by Pharma
Industry should not be accredited.
Conflicts in Research cannot be
avoided in many cases
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The mere existence of a conflict does not necessarily
imply wrongdoing on anyone’s part;
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Gov’t encourages collaboration, therefore start-ups
are created; (STTRs, SBIRs);
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The University encourages engagement and
collaboration with the outside world;
Prevention Techniques
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Refer to your employer’s policy regarding
COI;
Be wary of publication restrictions and the
loss of control to publish;
Be wary of gifts, typically there are strings
attached;
Always, Always, Always, read the fine print;
Always Disclose your relationship;
Reporting of COI
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Report your concerns even if you are not completely
sure there is a problem;
Speak to your supervisor first;
Provide as many facts as possible;
If you are uncomfortable contacting someone
directly, contact the University’s Regulatory
Compliance Help and Referral Line at 1-888-5085275;
Reports will be handled in strict confidence to the
extent possible or permitted by law.
THE END, THANK YOU FOR
LISTENING!
Questions?