According to federal regulations, the expedited review process may be used when the study procedures pose no more than minimal risk to participants and the research activities fall within specific regulatory categories identified as eligible for expedited review. This means the research must involve no greater risk than that encountered in daily life or routine physical or psychological examinations, and must fit within categories established by federal authorities such as the Department of Health and Human Services (DHHS) or the Food and Drug Administration (FDA). The expedited review allows for review by the IRB chairperson or designated experienced reviewers instead of the full IRB committee, but does not allow them to disapprove the research—only the full IRB can do that. Key points include:

• The research involves no more than minimal risk.
• The procedures and activities fall within federally designated categories approved for expedited review.
• The expedited reviewers ensure the research meets federal requirements, including informed consent standards.
• The process excludes research that could place participants at more than minimal risk, including risks to privacy or stigmatization without adequate protections.
• It is not used for classified research.
• Minor changes to previously approved research may also be reviewed through this process.

This is based on the regulations at 45 CFR 46.110 and 21 CFR 56.110, which define the categories and criteria for expedited review.