Department of Health and Human Services December 1, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials.'' This guidance 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trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. The guidance will be of interest especially to sponsors, clinical investigators, and members of investigational review boards (IRBs).

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/requests/, 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 the Department of Health and Human Services (HHS). OHRP will consider comments received before issuing the final guidance document.