NIH Proposes Update Of Conflict-Of-Interest Rules

The National Institutes of Health is proposing changes that would tighten financial conflict-of-interest rules for extramural researchers. The agency has been under pressure from Congress and the Inspector General of the Department of Health & Human Services to strengthen such rules for many years.

One of the key changes, published in today's Federal Register, is lowering the threshold for disclosure from $10,000 to $5,000. NIH grantees who receive more than $5,000 in a one-year period from industry payments or equity interests would be required to disclose that financial information to their institutions.

Another change is requiring each institution to determine when a financial conflict exists and to disclose the financial conflicts of its faculty in a public website. Under existing regulations, researchers determine when they have a financial conflict and institutions are not required to publicly reveal when faculty have such conflicts.

The changes "may provide some burden to the investigator and to the institutions, in terms of additional reporting requirements," NIH director Francis S. Collins noted during a press conference yesterday. But they are essential for "obtaining and maintaining the public trust in the integrity of the scientific enterprise," he said.

The proposed revisions would update existing regulations, which were put into place in 1995. NIH is accepting public comments on the proposed changes for 60 days and expects to release its final rule this summer.