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

Streszczenie

The Office for Protection from Research Risks (OPRR), in consultation with the Food and Drug Administration (FDA), is requesting written comments relating to the proposed republication of the list that identifies certain research involving human subjects which may be reviewed by the Institutional Review Board (IRB) through the expedited review procedure authorized in Sec. 46.110 of 45 CFR Part 46. This list was originally published in 1981 and subsequently referenced in the Federal Policy (Common Rule) for the Protection of Human Subjects (56 FR 28003). Pursuant to Sec. 46.110(a), the Secretary, HHS, has the authority to amend and republish the list. In the 16 years 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 procedures or categories of research. OPRR seeks information and suggestions from the research community and public on possible revisions to the expedited review list.