DANIEL BUENOSome 38,000 U.S. researchers in the field of biomedicine have begun to follow stricter rules involving declaration of their financial interests. The new parameters were approved by the U.S. government for researchers sponsored by public institutions such as the National Institutes of Health (NIH), the world’s largest source of medical research financing. The rules put an end to the ambiguities found in earlier rules, which had been in effect since 1995, and are intended to ensure that the private interests of researchers do not influence the design, conduct, or publication of their work.
Now, all researchers must inform their institutions of any “significant financial interests” related to them or to members of their families that could have some impact on their professional activities that involve teaching, research, or service on ethics committees. The earlier rule was less comprehensive and required only that a researcher declare interests that were specifically related to the research project in question. The change seeks to prevent situations such as that of Charles Nemeroff, a professor of psychiatry at Emory University in Atlanta. He received more than US$ 800,000 from pharmaceutical multinational GlaxoSmithKline between 2000 and 2006 for giving more than 250 lectures to psychiatrists, but did not disclose those earnings to the university. When discovered and questioned by the university, he argued that the rules were ambiguous and that information about his paid work was not relevant to the institution, since it involved only his experience as a clinician.
Under the new rules, there is no doubt that such financial connections must be declared. The change makes universities responsible for determining whether private financial earnings by their researchers could influence government-financed research projects. There are other changes, too: the value of a source of income that is considered significant (and must therefore be reported) has been reduced from US$10,000 to US$5,000. According to an editorial in the magazine Nature, the U.S. government has reconsidered at least one aspect. According to the original proposal submitted by the NIH, every institution would have to publish on the Internet the information about potential conflicts of interests affecting its researchers, and update the data annually. The version ultimately approved made declaration on the Internet optional; moreover, an institution, if challenged, can defend itself in writing.
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