The biomedical research community is reacting with concern to a proposal from the National Institutes of Health (NIH) to clamp down on financial conflicts of interest in research. In a flood of comments, many groups and some individual scientists say NIH is asking investigators to report irrelevant information. Although they agree reform is needed, many urge NIH to narrow the proposal. They also think the government should create a central database for disclosing conflicts to the public.
In May, NIH proposed several changes to a 1995 Public Health Service (PHS) conflicts of interest regulation. They included lowering the threshold for reporting industry income (from $10,000 to $5000 annually) and requiring investigators to report to their institutions all financial interests related to their job. Institutional officials would then scan these reports for conflicts with an NIH-funded project and, when appropriate, disclose the conflicts publicly on their Web sites. NIH wants investigators to report not only industry payments, but also income from non-profit organizations (except universities).
NIH received more than 170 comments by yesterday's deadline, the bulk from academic institutions, societies, and individual scientists. Many concerns are summed up in an 11-page letter from the Association of American Medical Colleges (AAMC), the Association of American Universities (AAU), and two other university organizations. The groups worry about "onerous regulations" that "create a glut of policies that increase activity without adding protections" and "erode ... trust."
The AAMC/AAU letter urges NIH to require that only income related to research be reportable, so that, say, royalties from writing a textbook would not need to be reported. It also says NIH should exempt payments from academic hospitals and nonprofits that fund research. The Federation of American Societies for Experimental Biology argues for exempting activities for scientific societies such as reviewing grants that are "an essential part of scientific life." Many commenters also urge NIH to exempt travel reimbursement, retirement and mutual funds, and patents that haven't been licensed.
Universities dislike NIH's plan to have institutions each post conflicts online; this will be confusing to the public and costly, they say. A better solution is to create a central federal database with the information, they suggest. It should be coordinated with the September 2013 launch of a federal database in which drug companies will report payments to physicians.
NIH got mixed advice on a relatively new concern: that because a researcher who breaks the rules is usually sanctioned by his or her institution, not NIH, a violator can escape punishment by moving to another university. The AAMC/AAU letter claims the new institution should not be required to consider the previous institution's sanctions, but instead "should have the freedom" to decide if the information is relevant. But others disagree. The American Association for the Advancement of Science (which publishes Science) says sanctions should move with an individual, as they now do for research misconduct. And Harvard University Vice Provost for Research David Korn suggests that PHS create a "registry ... of offenders" who have been barred by their institutions from receiving grants.
NIH has not yet posted all the comments online; agency spokesperson Don Ralbovsky said they should be up sometime next week. He said NIH is reviewing the comments and will have a timetable for issuing the final rule "once the analysis is further along."