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30 November 2000

Strengthen Conflict 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 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 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.

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 $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 trainees.
  • 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, non renewal 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, 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 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 than 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.

Link:

New England Journal of Medicine



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