Protection of Human Subjects: Suggested Revisions to the Institutional Review Board (IRB) Expedited Review List; Request for Comments

摘要

The Food and Drug Administration (FDA), in consultation with the Office for Protection from Research Risks (OPRR), is requesting written comments relating to the proposed republication of the Expedited Review List that identifies certain research involving human subjects that may be reviewed by the Institutional Review Board (IRB) through the expedited review procedures authorized in FDA's regulations. Since the list was created, significant advances have been made in medicine and biological technology such that it is appropriate to consider revising this list to include additional categories of research. FDA seeks information and suggestions from the research community and the public on possible revisions to the Expedited Review List. The proposed list included in this notice is for discussion purposes only. FDA and OPRR will consider the comments received in deciding whether to revise the list.