US drug agency is slow to exclude doctors who commit research crimes from further trialsBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4518 (Published 02 November 2009) Cite this as: BMJ 2009;339:b4518
- Janice Hopkins Tanne
- 1New York
The US Food and Drug Administration has taken up to 11 years to debar doctors who engage in misconduct or crimes from participating in research involving new drugs, biologics, and medical devices, shows a report from the US Government Accountability Office.
Among the types of “alleged misconduct” cited by the FDA in its disqualification proceedings are submitting false information to the sponsor or to the FDA; failing to comply with requirements for obtaining informed consent from trial participants; failing to obtain approval from institutional review boards; failing to comply with the clinical trial’s research plan; failing to keep records about the use and disposal of investigational drugs, biologics, or devices; and failing …