of Interest Rules for Clinical Trials, Study Urges
A growing potential for conflicts of interest has
prompted university-based medical research centers to take important steps to require
researchers to disclose financial interests in companies that sponsor studies and to
manage potential conflicts.
A new UCSF study of the nations leading
research centers calls on the institutions to strengthen these rules particularly
in regard to clinical trials.
UCSF researchers analyzed policies governing
conflicts of interest at the 10 medical schools that receive the most research funding
from the National Institutes of Health. Their study is published in today's edition
(November 30) of the New England Journal of Medicine.
All of the universities included in the study
required faculty members to disclose financial interests to university officials, but the
study found numerous "loopholes" in the way in which information is reported and
potential conflicts are managed, said lead author Bernard Lo, MD, UCSF professor of
medicine and a nationally recognized medical ethicist.
"Patients and the public may not be able
to trust that clinical trials are being conducted in an unbiased manner," said Lo.
"It is vital to the mission of the universities to put policies in place that will
gain their trust."
The study concludes with a suggestion that
universities prohibit investigators, staff, and immediate family members from holding
stock, stock options, or decision-making positions in a company that may be affected by
the outcome of the trial. Of the 10 medical schools studied, only one had a policy that
was close to this standard, the report notes.
"Rather than trying to manage or reduce
these conflicts of interest, we suggest prohibiting them," the authors state.
Their analysis found important variations
among the policies. These included:
- As required by federal regulations, all 10
universities required disclosure of financial interests, including stock and stock options
and income from salary, honorariums, and consulting fees. About half of the institutions
did not require disclosure of equity or income below a certain threshold, usually $10,000.
- All 10 university policies applied to
full-time and part-time faculty, but reporting requirements for research staff members and
trainees varied considerably. Four policies applied to all research staff, and three
others applied to selected research staff, generally those with "responsibility for
the design, conduct and reporting of research." Only four policies applied to
- All of the institutions required disclosure of
financial interests held by spouses and dependent children of investigators. One
university extended disclosure to "de facto" spouses, parents, siblings, and
adult children. Two universities also required disclosure of any "trust, organization
or enterprise" over which the faculty member "exercises a controlling
- Four universities had additional requirements
involving prohibition of certain financial arrangements. One prohibited faculty from
having any financial interests, including stock options, consulting agreements, and
decision-making positions, that involved a company sponsoring the study. Three others had
less restrictive prohibitions.
Universities included in the study were
Baylor College of Medicine, Columbia University College of Physicians and Surgeons,
Harvard Medical School, Johns Hopkins University School of Medicine, University of
Pennsylvania Medical School, UCLA School of Medicine, UCSF School of Medicine, University
of Washington School of Medicine, Washington University School of Medicine, and Yale
University School of Medicine. The report addresses the overall need for strengthening
conflict of interest policies and does not identify specific policies by the
The steps already taken to reduce and manage
conflicts of interest demonstrate the ability of the nations research institutions
to ensure that clinical investigators act impartially and with integrity, Lo said. They
must act together to develop a consistent and uniform set of guidelines, he said.
"It can easily be accomplished
school by school," Lo said.
Public concern about the safety and
regulation of clinical trials makes it particularly important to address the issue, Lo
said. In clinical trials, investigators make many judgments that may affect the safety of
the subjects and the results of the trial, including who may participate and how an
adverse reaction should be assessed and managed, the study notes.
"Other scientists and the public must
trust that the investigators make such decisions solely on the basis of their professional
judgment, without regard for personal gain," the study states. " Financial
conflicts of interest may undermine that trust."
The authors note that officials at five of
the universities reported they were in the process of revising their policies and as a
result may resolve some of the concerns noted in the study. Conflict of interest policies
for federally sponsored researchers also are being reconsidered, the study notes.
"Universities have a special social role
in training young scientists, providing care to patients recruited for clinical trials,
making unbiased clinical recommendations, and developing social norms and professional
values," the authors state. "Thus, we believe that university scientists who
conduct clinical research should be held to a higher standard than researchers employed by
Co-authors of the study were Leslie E. Wolf,
JD, MPH, UCSF assistant adjunct professor of medicine and Abiona Berkeley, JD, a UCSF