The federal government today proposed an overhaul of regulations covering financial conflicts of interest in biomedical research. The widely
anticipated rules would expand the amount of information that researchers must report to their institutions, make some of it public, and require that
more details than in the past be submitted privately to the National Institutes of Health (NIH).
NIH Director Francis Collins described the rules as "a substantial change." While that's true, the proposal falls short of what some in the academic
community have called for.
NIH is responding to growing public concerns that drug company money is biasing research, including a probe by Senator Charles Grassley (R–IA) of several psychiatrists with NIH
funding who allegedly failed to disclose hundreds of millions of dollars in consulting income. The proposed regulation revises a 15-year-old Public
Health Service rule that largely leaves it up to institutions to decide whether there's a conflict and how to handle it.
NIH wants to lower the definition of "significant" financial interest from $10,000 to $5000, or any equity in a nonpublicly-traded company (the
previous cutoff was 5%). Researchers would have to tell their institutions about all interests over this threshold that "reasonably appear to be
related to the Investigator's institutional responsibilities"—leaving administrators, not the investigator, to decide which are related to a
specific NIH-funded project.
If institutional officials find a significant conflict involving an NIH grant, they would have to send NIH a detailed report on the amount of money
involved and how the conflict is being managed. And the institutions would have to disclose publicly all of these conflicts on a Web site.
Although these are big changes, they fall short of advice from an Institute of Medicine panel and the Association of American Medical Colleges (AAMC). Both think that
researchers should report all potential financial conflicts to their institutions, with no minimum dollar threshold.
There are also differences between what would be reported to NIH and to the public. For example, in making conflicts public, institutions may report
amounts in increments, the highest level of disclosure being an open-ended "above $250,000." That means the public won't know if the amount is
$260,000 or $2 million. Asked on a press call why public information should be less accurate than the data researchers disclose, NIH official Sally
Rockey referred reporters to the proposed rule's preamble. It discusses privacy, but this reporter could not find a specific explanation for the
AAMC Chief Scientific Officer Ann Bonham says NIH, "on balance, took into account our recommendations" and that the proposal "is a significant step
forward in maintaining the public trust." Grassley issued a similar statement calling the changes "an important step in the right direction." The
notice appears in the Federal Register tomorrow. NIH will then take comments for the next 60 days before issuing a final regulation.
This article was corrected on 6/9/2010.