By Steve Usdin
Contributing Editor

WASHINGTON - The FDA has published proposed conflict-of-interest rules mandating financial disclosures by clinical investIgators.

The proposed regulations require that the sponsor of any drug, biological product, or device submit information concerning the compensation to, and financial interests of, any investigator conducting clinical studies to support a marketing application to the agency.

This requirement will apply to most clinical studies involving human subjects, as well as any study to establish bioavailability or bioequivalence.

The agency also proposes to require that sponsors certify the absence of certain financial interests of clinical investigators or disclose those interests when clinical studies are submitted to FDA in support of product approval.

Under the regulations, if a sponsor failed to include one of the submissions, the agency would refuse to file the application.

Full-time employees

Extensive financial disclosure is not required for full-time employees of the sponsor, as FDA assumes their interest in the outcome of trials is obvious.