The FDA's New Guidelines on Financial Disclosure by Clinical Investigators

There has been a growing number of claims in medical device and pharmaceutical product liability actions based on purported conflicts of interest of clinical investigators conducting medical device or pharmaceutical clinical studies. Financial interests of clinical investigators can be a potential source of bias in clinical study data used to support the application for FDA approval of a new drug or a new medical device. In particular, a clinical trial investigator may have a financial interest in the outcome of the study, due to payment arrangements or equity interests in the sponsors of clinical studies. While the FDA does not prohibit a clinical trial investigator from having a purported financial interest, it does regulate the disclosure of that information. The financial disclosure requirements of clinical investigators are governed by 21 Code of Federal Regulations Part 54, which came into effect in 1999. Generally, FDA regulations require that medical device and pharmaceutical manufacturers submit financial interest disclosures with their applications for a new drug or a new device. On March 20, 2001, the FDA issued its original Guidance on Financial Disclosure By Clinical Investigators to assist pharmaceutical and medical device companies, as well as clinical investigators in interpreting and complying with the federal regulations governing financial interest disclosures.