OPRS SOP 402: Research Activities Exempt From IRB Review
Approved Date
Revised Date
Full Details
POLICY
Research activities that meet all applicable criteria set forth by the federal regulations (45 CFR 46.104) and involve no greater than “minimal risk” may qualify for exemption from IRB review. An exemption must be determined by OPRS, not an individual investigator. The exemption categories are posted on the OPRS web site. UIUC IRB may rule a proposal is exempt if it fits into one of the exemption categories and is no greater than minimal risk. However, the UIUC IRB may determine that there are studies that may pose ethical concerns and are reviewed as with any other new study application.
The staff reviewer is an IRB member designated by the IRB Chair to review all requests for exemption and make a final determination. Such claims of exemption are recorded and stored in the same way as all other projects.
All exempt reviews conducted by UIUC IRB designated members meet the requirements of a limited IRB review by ensuring that when appropriate, the research plan includes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
The University of Illinois Urbana-Champaign retains the authority to suspend or terminate IRB approval of research approved with a limited review.
University of Illinois Urbana-Champaign IRB does not utilize broad consent. Exemption categories intended for research using broad consent are not applied at the University of Illinois Urbana-Champaign. See the OPRS Website for detailed descriptions of the exemption categories (RGD: Exempt Research).
Continuing review is not required for studies determined to be exempt.
PROCEDURES
1. Exempt Research Activities
1.1. The investigator submits a new study application via email to irb@illinois.edu.
1.2. The OPRS staff reviewer conducts a review of the research proposal using the IRB internal checklist (Determining if Human Research is Exempt from IRB review). When one or more of the exemption categories are applicable to the research, the OPRS staff reviewer documents the applicable category(ies) using the internal checklist and makes the final exemption determination.
1.3. All exemption determinations are communicated to the investigator via email and includes the applicable category(ies) justifying the exemption determination.
If the OPRS staff reviewer determines the proposal is not eligible for an exempt determination, including limited review, the OPRS staff reviewer will move the application to an expedited or convened board review. The research may only be tabled or dis