For Immediate ReleaseContact: Don L. Gibbons, Harvard Medical School, 617-432-0442 [email protected]
Leading NIH-funded Medical Schools Agree on Guidelines that Would Strengthen Conflict of Interest Policies of Virtually All Schools, Hospitals, and Research Institutes
Proposal Submitted To National Medical College Association This Week
Boston -- February 8, 2001--Agreeing that the protection of research subjects is paramount, the leaders of eight of the nation's top-10 NIH-funded medical schools and another six nationally prominent leaders in academic medicine have drafted a set of guidelines that would clarify, strengthen, and add structure to most research institutions' policies for dealing with financial conflicts of interest that can arise from collaborations between faculty and industry.
"While academic-industry collaborations are essential if patients are to benefit from the current biomedical revolution, the integrity of those relationships must be monitored by policies that are clearer and more stringent than is the norm today," said Harvard Medical School dean Joseph B. Martin, who convened the group.
The group's recommendations address inconsistencies and gaps in policies described in a series of four articles in the November 1 JAMA and the November 30 New England Journal of Medicine that the group reviewed when they met in Washington, D.C. on November 27 and 28. In the weeks since, the group has refined the draft proposals developed at the meeting and is submitting them this week to the Association of American Medical Colleges, which has formed a committee to review financial conflicts-of-interest policies for medical schools and teaching hospitals nationally.
The proposals are designed to guide individual institutions as they review their own conflict-of-interest policies and were drafted with an eye to refining some of the weaknesses and gaps cited in the November journal articles. In particular, the proposals recommend that institutions consider the following actions:
o Require disclosure of financial interests to the institutional review boards that approve clinical research trials, something only around one percent of institutions do now.*
o Apply required disclosure of financial ties to anyone involved in research--faculty, students, and staff--and that disclosure should be both on a set periodic basis as well as in real time if their situation changes.
o Asks institutions to consider a higher standard for clinical research than for basic laboratory research. "Individuals directly involved in the conduct, design, or reporting of research involving human subjects should not have more than a clearly defined minimal personal financial interest in a company that sponsors the research or owns the technology being studied."
o Defines financial interests that should be disclosed to include any fees, honoraria, or gifts associated with consulting or lectures, equity including stock options, and payments for directorships or executive roles.
o Suggests key terms, such as "family" be clearly defined.
o Seeks clear delineation of any allowable financial interest, such as mutual funds.
o Require disclosure to journals considering publishing related research, something only seven percent of institutions do now.*
o Encourages all biomedical science journals to require and publish disclosure of financial interests, something only 43 percent do now.*
"The consensus document developed under the leadership of Dean Martin is a thoughtful addition to the ongoing dialogue regarding conflict of interest policies in medical research. The proposals put forth will provide an excellent starting point as the AAMC's task force on conflicts of interest begins its own deliberations in the near future, " said AAMC President Jordan J. Cohen, M.D. The AAMC task force is being chaired by William Danforth, M.D., chancellor emeritus of Washington University.
The November meeting was planned over the summer following much national debate on the topic after Harvard Medical School announced its intention to retain its strict conflict policies in May. Dr. Martin was urged by many national leaders to create a venue to continue the dialogue, and this forum was the result.
The journal articles showed that nearly all institutions have established policies for monitoring potential conflicts but that there is currently considerable variation in the way medical schools and teaching hospitals manage conflicts. Many rely on a case-by-case method with few clearly delineated guidelines.
Cohen announced the AAMC intent to form a committee to study the issue in October. The effort is being chaired by William Danforth, chancellor emeritus of Washington University.
* Data from S. Van McCrary, et al., NEJM, 11/29/00, page 1621.
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