Introduction

Exempt research is no greater than minimal risk and fits within an exemption category. Exemption determinations are made by a designated IRB reviewer. In limited circumstances, investigators may obtain an exemption determination using a guided application process in the Electronic Research Integrity and Compliance Administration system (ERICA).

Guided exemptions are only offered for eligible projects based on answers in the new study application and cannot be requested by investigators. Investigators have the option to request that an IRB reviewer make the exemption determination rather than relying on the guided application process. Guided exemptions are only allowed for certain projects such as surveys, questionnaires, and interviews with adult participants under Exempt Category 2(i), Exempt Category 2(ii), or certain secondary data analysis projects under Exempt Category 4(iii). However, not all projects within these categories will qualify for a guided exemption.

Guidance

Based on your responses in the ERICA application, your study may qualify for a guided exemption. This means your research is considered lower risk and may not require full IRB review.

If your study appears to qualify, you will be prompted to complete additional pages in ERICA. These pages help determine whether your study meets the criteria for a guided exemption. Please note that completing the additional pages does not guarantee a guided exemption. An ERCIA algorithm will evaluate your responses to make the final determination. If your study does not qualify, it will proceed to standard IRB review.

Materials to Include with your Application

• Consent: Attach the consent script or consent document, if consent will be obtained. Even if your study will not require a signature, a consent script or consent cover letter must still be included.
• Study Tools: Attach all surveys, questionnaires, and/or interview guides, if applicable.

Additional Requirements

• Training: You and your study team members must have current human subjects research training.
• Conflict of Interest: You and your study team members must submit Business Relationship Reporting financial disclosures.

If training confirmation or conflict of interest disclosures are incomplete at the time of submission, ERICA will send you a reminder. You will have two weeks to complete the required items. If the outstanding items are not completed within that timeframe, the application will be forwarded to an IRB staff member for review. At that point, the study will no longer be eligible for a guided exemption.

Investigator Responsibilities for Guided Exemptions

• If a guided exemption is issued, the study will not be reviewed by an IRB reviewer. You are responsible for confirming the adequacy, consistency, and accuracy of your responses.
• You will receive a guided exemption determination letter from ERICA to use as documentation for your records. You must not proceed with your research until you receive this letter.
• Continuing review is not required. However, an annual HRPP Progress Update must be submitted to keep the study open and active with the University of Utah IRB and HRPP.
• Substantive changes to the study require an amendment application to secure approval or confirm the exempt determination.
• Studies granted a guided exemption must adhere to the University of Utah IRB reporting requirements for unanticipated problems and deviations.
• Studies granted a guided exemption must be closed with the IRB once all research activities are complete. A final project report should be submitted to close the study.

Documents and References

University of Utah IRB Guidance, Exempt Research

SOP 401b: Research Activities Exempt from IRB Review

Points to Consider