Limited IRB Review

A “Limited IRB review” is required under the 2018 Revised Common Rule for certain Exempt human subjects research categories. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data (categories 2(iii) and 3(i)(C)).

The “Limited IRB reviewer” must determine that, per 45 CFR 46.111(a)(7), “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”