| SEC
Investigations and Clinical Trials
To
the Faculty:
Dear
Colleagues:
In
a June issue of JAMA, Eric Topol and David Blumenthal published
an editorial in which they described growing consulting relationships
between some clinical investigators and investments firms (matchmakers,
hedge funds, investment bankers, venture capital firms, brokerage
houses, etc.). In particular, they called attention to some clinical
investigators who have been paid to consult and disclose confidential
information about the conduct, status, and preliminary results
of ongoing clinical trials. Investment companies then use this
information to invest or advise clients on how to invest, based
on information that is not available to other investors.
The
JAMA editorial was followed in August by investigative reports
and editorials in The Seattle Times , and The New York Times.
, Senator Charles Grassley has asked the Securities and Exchange
Commission (SEC) to investigate these reports.
Clinical
trial agreements with the University nearly always contain confidentiality
agreements about the data and results, though they do appropriately
allow faculty to publish their results after a reasonable period
of time once the trials are completed. Directly or indirectly
disclosing material, confidential information from a trial to
individuals or companies that trade stock based on the information
is unethical. Further, disclosure of this confidential information
may be considered a violation of insider trading laws and a breach
of the clinical trial contract. The considerations are even more
serious if the faculty physician invests in the investment fund
or the company related to the information that has been exchanged.
These
articles indicate that amazingly subtle tactics are employed for
getting faculty who are investigators on clinical trials or who
serve on data safety monitoring boards to inadvertently divulge
confidential information. Further, some of our university colleagues
describe emails and phone calls to their clinical investigators
from these matchmaker companies. Because of these two facts, we
are providing the following information as help and guidance to
you, in the event you are approached to engage in one of these
consulting relationships.
First, it goes without saying that it is implicit in our Emory
University and School of Medicine policies that apply to conflict
of interest and the ethical conduct of research that providing
confidential information on the results of ongoing clinical trials
to anyone other than to those allowed by the clinical trial agreement
prior to publication is prohibited.
Second,
please let us remind you that all consulting relationships and
agreements are to be reviewed and approved by the departmental
chair and the Dean=s Office before faculty members may sign them
and begin the relationship. Please see School of Medicine Policies
on Commitment, Private Consulting, and Other Extraordinary Contributions
<http://www.med.emory.edu/database/dean/>. The agreements
(written or verbal) are reviewed for compliance with University
and School policy, for whether the relationship is beneficial
for the academic career of the faculty member and for the medical
school, and for commitment of effort. Agreements and explanations,
once approved by the departmental chair, should be sent to Assistant
Dean Brenda Seiton <bseiton@emory.edu>
for review.
Other
policies related to conflict of interest and commitment in the
School of Medicine are listed and linked below.
Thank
you so much for your attention to this important matter.
Sincerely,
Thomas
J. Lawley, M.D.
Dean
Claudia
R. Adkison, J.D., Ph.D.
Executive Associate Dean
Administration & Faculty Affairs
|
Administrative
& Faculty Affairs
Administrative Offices
| Organizational
Chart | Faculty Affairs |
Administrative
Affairs
