Discontinuation of Human Subject Participation in Research.
On December 1, 2008, the HHS Office for Human Research Protections (OHRP), Office of Public Health and Science, announced it is requesting public comments on a draft guidance document entitled “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” The draft document is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS. OHRP will accept comments on the draft until January 30, 2009. In a related development, the FDA released guidance on “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” which clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. This Level 1 guidance is being issued for immediate implementation to prevent the potential loss of important clinical trial data.; if comments are received, the agency will review the comments and revise the guidance if appropriate.
