title: Streamlining ethical review.
abstract: The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize-and may improve-protections for research participants. The authors discuss underutilized options, including research that need not be classified as human subjects research, categories of studies that can be exempt from ethical review, studies that need only undergo expedited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter research by using the IRB of 1 institution. The authors speculate on multiple reasons for the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process.
authors.affiliation: Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. millumj@cc.nih.gov
authors.forename: Joseph
authors.initials: J
authors.lastname: Millum
authors.forename: Jerry
authors.initials: J
authors.lastname: Menikoff
mesh_terms: D026724:Ethical Review / Q000145:classification; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics