Expedited Review & EXEMPT RESEARCH
IRB regulations provide a streamlined review process for research that falls into categories specified as “Exempt” or “Expedited.” The streamlined review process means that the research can be reviewed by one member of the IRB committee, which allows approval to be granted more quickly.
The IRB Chair (or the Chair’s designee) must confirm that research eligible for approval using expedited procedures meets the same ethical standards as research requiring full-board approval. Investigators may not solicit subject participation or begin data collection until they have received approval from the IRB to begin the research. Categories of research eligible for expedited review are listed by the Office for Human Research Protections within the U.S. Department of Health and Human Services.
The IRB Chair (or the Chair’s designee) must confirm that research falls into one of the exemption categories. Investigators may not make their own determination of exemption. A determination that research is exempt does not absolve the investigators from ensuring that the welfare of human subjects participating in research activities is protected, and that methods used and information provided to gain subject consent are appropriate to the activity. Investigators may not solicit subject participation or begin data collection until they have received approval from the IRB to begin the research. Categories of exempt research are described in section 46.101 of 45 CFR 46.