NIH Strengthens Conflict Rules

The National Institutes of Health is proposing to cut in half the threshold for reporting financial ties to industry by extramural researchers. The agency has been under pressure from Congress and the Inspector General of the Department of Health & Human Services to strengthen such financial conflict-of-interest rules for many years.

The changes, which were published in the May 21 Federal Register, lower the threshold for disclosure of financial interests from $10,000 to $5,000 and require institutions to make public such disclosures when a conflict exists. As a result, 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.

NIH considered lowering the threshold even further, but “we were extraordinarily concerned about the administrative costs associated with the disclosure of a negligible financial interest,” NIH’s Acting Deputy Director for Extramural Research Sally J. Rockey noted during a May 20 press conference. “We determined that the cost would probably outweigh the intended benefit.”

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

The proposed rules “may provide some burden to the investigator and to the institutions in terms of additional reporting requirements,” NIH Director Francis S. Collins acknowledged. But they are essential for “obtaining and maintaining the public trust in the integrity of the scientific enterprise,” he said.

Sen. Chuck Grassley (R-Iowa), who wants medical researchers to disclose payments from drug companies, called the proposal “a step in the right direction.” Likewise, the Association of American Medical Colleges, which represents accredited medical schools, said the changes are a “significant milestone” on the path to “preserving the public’s trust and the integrity of research.”

NIH is accepting public comments on the proposed changes until July 20 and expects to release its final rule this summer.