Review Timelines & Processes

Convened IRB (Full Board) Reviews

Most human subjects research conducted on USU’s campus does not require Convened IRB (Full Board) Review. Fewer than 5% of protocol submissions come before the Convened IRB at USU. Which protocols must come to the Convened IRB? Any research which:

• Involves greater than minimal risk procedures;
• Does not fall fully within the Expedited Review categories defined by the Office of Human Research Protections;
• Involves prisoners or wards of the state;
• Has a conflict of interest that impacts the risk determination of the protocol; or
• Contains a controverted or complex issue that cannot be resolved via other review processes.

Protocols are reviewed by the Convened IRB in the order in which they are received. New protocols requiring this level of review must be in no later than 14 days prior to the meeting date, though this does not guarantee review at the next upcoming meeting. Researchers can track meeting assignments using the Activity Log in their protocols. While the IRB does not hold scheduled meetings during the summer, it meets to review items as needed at the Board’s earliest possible opportunity. For the most expeditious review timeframe, it is strongly recommended that you submit these protocols during the academic year; otherwise, please plan an an extended review timeframe. Full board protocols that receive review and approval over the summer will be given, at most, a Spring semester continuation review date so as to maximize the efficiency of the IRB. 

The Convened IRB also reviews major modifications, revisions to initial reviews, and continuation reviews during its meetings. The deadline for submission of those items is 3:00 p.m. the Tuesday prior to the meeting date. Any questions regarding review by the Convened IRB should be sent to irb@usu.edu.

Expedited Protocol Reviews

Approximately 30% of all protocol submissions at USU are reviewed via the Expedited Review Process. The categories of procedures available for Expedited Review are available from the Office for Human Research Protections (HHS). Expedited reviews are completed on a rolling basis: there is no deadline for submission, and they are reviewed all 12 months of the year (though applications are reviewed more quickly during the academic year, when our faculty reviewers are on contract time). Expedited reviews are typically completed in 3-7 weeks, depending on the level of complexity of the underlying project.

Upon submission, the Human Research Protections Office completes a brief pre-review (within the first three days). Next, it will be assigned to a reviewer with overlapping or closely related scientific expertise. Once that reviewer completes their review, it will be reviewed for ethical, technical, legal, and regulatory requirements by a member of the HRP Office, who will compile all review comments and work with the research team through the process of approval. Protocols cannot be denied using the Expedited Review process; only the Convened IRB may deny a full protocol.

Exempt Reviews

Requests for Exemption comprise 65% of all protocol submissions at USU. Explanations of the categories of exemption are available on our Getting Started page. Requests for Exemption are reviewed on a rolling basis, i.e. there is no deadline for submission, and they are reviewed all 12 months of the year. Exemption determinations are typically rendered within 10 calendar days of submission. Please note, however, that while Exemption #4’s HIPAA carve-out does permit an exempt review, HIPAA itself demands an Expedited review of the use of Protected Health Information. Thus, protocols submitted under the HIPAA exemption tend to follow the Expedited Review timeline more closely than the exemption determination timeline.

Amendments

Amendments are usually reviewed on the same business day in which they are received, but we ask that you plan for ten business days for processing. Amendments which are minor modifications may require consultation with a scientific reviewer, the IBC, Radiation Safety, the Conflict of Interest office, etc. More than minor modifications (to Expedited and Full Board protocols) are reviewed by the Convened IRB, and will take the full ten business days for review depending on the date of submission (more in the summer). More than minor modifications to Exempt protocols require a new protocol submission.

Determinations of Non Human Subjects Research (NHSR)

If you are uncertain whether your project requires IRB oversight, filing a Determination of Non Human Subjects Research (NHSR) is the only way the IRB can advise you whether ot not a substantive protocol is necessary. You can find more information about that process on our NHSR site. This is the only way the IRB can tell you whether a project requires an exempt, expedited, or full board protocol. Trained IRB members will examine whether the project meets the definition of “research” involving “human subjects.” If it does, you will be directed to file an appropriate protocol. If it does not, you will be given documentation supporting the determination. No determinations can be made over the phone, via email, or otherwise, though from time to time, staff might be willing to share informal advice.

Spring 2024 Convened IRB Meeting Information