Exploring the Difference Between Exempt Human Subjects Research and Expedited IRB Review

We've heard that there is some confusion about exempt human subjects research and expedited IRB review. Expedited review is not the same as exempt research. Here are a few points to provide clarity.

For human subjects research, certain types may qualify for an exemption from the regulatory requirements in the Common Rule (45 CFR 46). This is commonly referred to as exempt research. Exempt research generally does not need to be reviewed by an Institutional Review Board (IRB). You can review details about the exemption types on our Definition of Human Subjects Research website or the Office for Human Research Protection's Exemptions website. There are eight categories of exemptions.

Separately, research that is non-exempt human subjects research (i.e., research subject to the HHS regulations at 45 CFR 46) and meets certain conditions may be reviewed by an IRB through an expedited review procedure. Therse conditions are listed in the OHRP guidance: Expedited Review Categories (1998). There are nine categories of research for expedited review.

You can learn more about the NIH requirements for human subjects research on the NIH Human Subjects Research website. Remember, most human subjects research (everything that meets the definition of clinical research) also requires inclusion monitoring. You can find out more on the inclusion policy webpages.

Have questions? Reach out to your program officer. You can also send human subjects research questions to [email protected] and inclusion-related questions to [email protected].