BioCentury
ARTICLE | Top Story

Clinical trial penalties

May 24, 2000 7:00 AM UTC

President Clinton and Health and Human Services Secretary Donna Shalala said they will propose that HHS be authorized to impose civil monetary penalties of up to $250,000 per individual investigator and $1 million per research institution for violations of clinical trial regulations. FDA currently issues warning letters or imposes regulatory sanctions, such as shutting down a trial or revoking an investigator's right to conduct trials, but it does not have the authority to impose monetary penalties for failure to comply with regulations. The White House proposal will require legislation by Congress.

The administration also said it will write new guidelines to clarify requirements that investigators obtain new informed consent from trial participants after any unexpected death or serious adverse event in a trial, and require that Institutional Review Boards (IRBs) conduct an annual audit of safety protocols to ensure that informed consent has been obtained and is being maintained appropriately. HHS also said it will evaluate the informed consent process to ensure that it safeguards the rights of trial participants. For "particularly risky or complex clinical trials," HHS said it may require third-party observation of the informed consent process. ...