>
>Topics of the day:
>
> 1. IRB and Clinical Trials (2)
>
>My question is related to the conduct and business of clinical trials and
the management of IRB's. I had an investigator ask an intriguing question
and want to hear from you all. This investigator has made reference to
conflict of interest and ethics. I would appreciate any and all responses
whether to this listserv or directly to me.
>
>Question: In a centralized research administration office, do you think
there is a conflict of interest or any ethical problems if the person
responsible for the management of the IRB also be involved in the pursuit
of clinical trial business?
>
>Thank you.
>
>
>Thane J. Peterson
>Director of Research
>Iowa Health System
>1215 Pleasant, Suite 305
>Des Moines, Iowa 50309
>
>515-241-5725
>515-241-4185 FAX
Dear Thane:
Here are some different articles and quotes I have put together regarding
Conflicts of Interests. I have included some cites on this as well if you
want to read further
Institutions need to minimize the impact of conflicts of interests on their
institutions, and be aware that regulatory oversight will probably become
more stringent in this area.
A conflict of interest is a set of conditions in which professional
judgment concerning a primary interest (such as a patient's welfare or the
validity of research) tends to be unduly influenced by a secondary interest
(such as financial gain). In general, the primary interest of a physician,
scholar, or other worker is determined by his or her professional duties,
such as the health of patients or the integrity of research. "The
secondary interest is usually not illegitimate in itself, and indeed it may
even be a necessary and desirable part of professional practice. Only its
relative weight in professional decisions is problematic. A conflict of
interest differs from scientific misconduct, fraud, or plagiarism.
For instance there is great potential for conflicts of interests for IRB
members because many are researchers themselves and may be more interested
in new scientific discoveries than protecting human research subjects. In
addition, many institutions rely on the results of their clinical research
for revenue, and a successful clinical trial is often critical to achieving
large profits. An institution may exert pressure on IRB members so they
can reap these rewards. (See David S. Shimm & Roy G. Spence, Jr., Conflict
of Interest and Informed Consent in Industry-Sponsored Clinical Trials, 12
J. LEGAL MED. 477, 507 (1991); see, e.g., William Booth, Conflict of
Interest Eyed at Harvard, 242 SCIENCE 1497, 1497.)
Prudent stewardship of public funds that support research programs requires
that appropriate steps be taken to ensure high quality results. Therefore,
recipient organizations must establish safeguards to prevent employees,
consultants, or members of governing bodies from using their positions for
purposes that are, or give the appearance of being, motivated by a desire
for private financial gain for themselves or others such as those with whom
they have family, business, or other ties. Therefore, each institution
receiving PHS funds must have written policy guidelines on conflict of
interest and avoidance thereof. These guidelines should reflect state and
local laws and must cover financial interests, gifts, gratuities and
favors, nepotism, and other areas such as political participation and
bribery. These rules must also indicate how outside activities,
relationships, and financial interests are reviewed by the responsible and
objective institution official(s). In addition, the institution has the
responsibility for maintaining objectivity in research by ensuring that the
design, conduct, or reporting of research will not be biased by any
conflicting financial interest of investigators responsible for the
research in accord with the provisions of PHS regulations 42 CFR Part 50,
Subpart F, and 45 CFR Part 94. If this cannot be handled at the
institutional level, the funding agency should be notified. (PHS Grants
Policy Statement, Revised April 1, 1994, p. 8-18).
Conflict of interest problems are further exacerbated by the reduced amount
of governmental funding available for research. Since the 1970s, the NIH
has been forced to dramatically reduce the amount of money available for
research, even though the cost of scientific study has continued to
increase. The shortage of government funding has caused many medical
school faculty members to turn to industry to fund their research. To
receive NIH or NSF funding all key personnel on NIH or NSF grant proposals
must sign a Conflict of Interest form declaring they have no conflict of
interest regarding the research they are proposing, or if they do they must
fully disclose it.
Institutions need to be aware of, and balance, the market pressures being
born by the FDA and pharmaceutical companies to bring new drugs
expeditiously to market, as well as, the institutions desire to obtain
revenue for conducting these trials against the best interests of their
patients, and their interest in limiting liability that could stem from
conducting and or/participation in clinical trials.
Regards,
Deborah
Research Administrator
Cell & Molecular Biology
Northwestern University Medical School
303 East Chicago Avenue
Chicago, IL 60611
Phone: 312-503-4334
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