FDA issues draft guidelines urging caution in reporting adverse events

FDA issues draft guidelines urging caution in reporting adverse events

On Monday, April 9, the Food and Drug Administration published a new set of draft guidelines for reporting adverse event reporting related to clinical trials, with a 60-day period for public comment. The draft guidelines urge researchers to make sure that any health problem experienced by a volunteer during a clinical study is unusual or troubling before they report it to the institutional review board.

Institutional review boards (IRBs) are responsible for evaluating the risks and benefits of experiments involving human subjects. Researchers must send reports to the IRB detailing unexpected health problems, or "adverse events," experienced by the subjects of a study, so the IRB can continuously evaluate safety.

The FDA drafted the new guidelines in response to years of complaints from IRBs that they receive too many adverse-event reports that lack necessary context or explanation. The draft guidelines discourage researchers from submitting the reports when health problems are isolated and do not appear to represent a pattern of serious risk unexpected in the study.

The draft document is titled Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting—Improving Human Subject Protection. The document contains the address for submitting comments and contact information for questions.

Source: Chronicle of Higher Education news blog, April 11,2007