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- William W Parmley, MD, MACC
At the recent American College of Cardiology (ACC) meeting in Orlando, I participated in one of the Controversies in Cardiology sessions, regarding conflicts of interest for clinical researchers. As I prepared my remarks, it became apparent that some important changes, which I would like to highlight in this Editor’s Page, are evolving in the guidelines for such individuals.
Previously, I wrote an Editor’s Page entitled “Full Disclosure, the Antidote to Conflict of Interest” (1). I still believe that a full disclosure of all conflicts of interest relating to industry in the first slide of any talk goes a long way toward defusing or identifying bias that may creep into one’s remarks. Until this becomes the norm, however, the listener remains unsure about the speaker’s potential conflicts of interest, especially when he/she is particularly laudatory of a given product.
A recent national survey of policies on disclosure of conflicts of interest in biomedical research (2)reviewed the current guidelines in 127 medical schools and 170 research institutions that receive more than $5 million from the National Institute of Health (NIH) or the National Science Foundation (NSF). Forty-eight journals and 17 federal agencies were also surveyed. The results were quite interesting. Five medical schools and 10 research institutions had no policy on conflict of interest. Ninety-one percent of the institutions that had policies adhered to the federal threshold for disclosure ($10,000 in annual income or equity, or 5% ownership). Eight percent had policies requiring disclosure to funding agencies; 7% had policies requiring disclosure to journals; and four federal agencies had no policies on conflicts of interest. Only 43% of the journals surveyed had policies for disclosure of conflict of interest. Twenty-one percent required disclosure of income and equity interests, and only 2% required that conflicts of interest be reported.
The authors of this article made several recommendations based on the above data. There needed to be greater uniformity among institutional policies. All federal agencies should adopt a common conflict-of-interest rule. Research institutions should report to federal agencies the substance of conflicts and strategies for managing them. Journals should require disclosure of substantive conflicts of interest from all authors and should publish this information routinely. Both institutional review boards (IRBs) and research subjects should routinely be informed about conflicts of interest.
Another recent article (3)summarized the conflict-of-interest policies for investigators in clinical trials from the 10 medical schools in the U.S. that receive the most NIH funding. These included (in alphabetical order) Baylor, Columbia, Harvard, Johns Hopkins, University of Pennsylvania, UCLA, UCSF, University of Washington, Washington University of St. Louis, and Yale. All 10 required faculty members to disclose financial interests to university officials. Only four required disclosure by all members of the research staff. Five required disclosure of all financial interests. Six required disclosure to an IRB and a committee on conflicts of interest. Four had requirements that were stricter than federal regulations for investigators conducting clinical trials. One prohibited investigators from having stock, stock options, consulting agreements, or decision-making positions involving a company sponsoring the research. One prohibited researchers from trading stock or stock options in a company that sponsored the research or sold the product or device under study. Two did not allow faculty members to participate in clinical research if they had a significant financial interest in the company owning the product or device being studied.
Based on this data, the authors recommended that university-based investigators be prohibited from holding stock, stock options, or decision-making positions in a company affected by the results of their clinical research. They noted that of the 10 medical schools surveyed, only one had a policy that was close to this standard.
Based on this kind of information, Dean Joseph B. Martin of Harvard Medical School convened a group of individuals from eight of the above medical schools, plus another group of distinguished academics, to make recommendations to the Association of American Medical Colleges (AAMC) regarding conflict-of-interest policies for investigators in medical schools. One of those recommendations was that individuals directly involved in conducting, designing, or reporting research involving human subjects should have, at most, a minimal personal financial interest in a company that sponsors the research or owns the technology being studied. Thus, it will not be enough simply to declare a conflict of interest, but certain investigators will be prohibited from doing key clinical studies if they have more than a minimal financial interest in the drug or device.
The HEART Group (Heart Editors Action Round Table) has also been wrestling with this issue as it pertains to journals. At the recent American Heart Association and ACC meetings, a joint statement that will appear in each of the journals (including JACC) in the near future was adopted, regarding conflict-of-interest statements from authors. It is clear to me that these developments may change the face of clinical research greatly, mostly for the better. It is unfortunate that financial conflicts of interest play such a potent role in the current climate of clinical research, but recognition of this fact will help all of us to interpret the results of scientific trials appropriately.
- American College of Cardiology