UCSF analysis suggests strengthening conflict of interest policies governing clinical trials at nati

By Bill Gordon

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 University of California, San Francisco study of
the nation’s 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 the November 30 edition 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.

The study team obtained information about conflict of interest policies in
clinical research from the Internet web sites of the various medical schools,
the same place faculty members and staff are most likely to obtain the
information.  The researchers subsequently confirmed that the information was
complete and up to date through follow-up telephone calls and email queries.

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

* 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 interest.”

* 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.

* Policies of seven universities specifically addressed violations of the
conflict of interest policies.  Penalties included censure, suspension of
grants and approval of studies, nonrenewal of appointment, and dismissal.  The
study team did not collect information on actual penalties imposed.

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, University of California, Los Angeles School of Medicine, University of
California, San Francisco 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
institutions’ names.

The steps already taken to reduce and manage conflicts of interest demonstrate
the ability of the nation’s 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 that researchers employed
by commercial organizations.”

Co-authors of the study were Leslie E. Wolf, JD, MPH, UCSF assistant adjunct
professor of medicine and Abiona Berkeley, JD, a UCSF medical student.

The work was supported in part by grants from the Robert Wood Johnson
Foundation and the National Institutes of Mental Health and by a Jane Shohl
Colburn Student Research Fellowship.