Review Timelines & Processes
Most human subjects research conducted on USU’s campus does not require Convened IRB (Full Board) Review. Only 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; or
- Contains a controverted or complex issue that cannot be resolved via other review processes.
For those protocols needing Convened IRB Review, complete applications must be received by the deadlines specified in the table on the right. During that time, you will work with the Human Research Protections Office to resolve any minor issues regarding the protocol, and it will then be assigned to the IRB no later than one week prior to the next scheduled meeting. If you submit after the stated deadline for the upcoming meeting, we will make every attempt to have the protocol reviewed at the next meeting but please note that agendas for meetings often fill quickly and in advance. Space on the agenda is first-come, first-served, and it is possible (though unlikely) that on-time submissions may not make it on to the next upcoming agenda, depending on the volume of submissions.
Expedited Protocol Reviews
Approximately 30% of all protocol submissions at USU are reviewed via the Expedited Review Process. Expedited reviews are completed on a rolling basis: there is no deadline for submission. They are typically completed in 3-6 weeks, depending on the level of complexity of the underlying project. Upon submission, the IRB Office completes a brief pre-review (within the first three days). Next, it will be assigned to a reviewer with overlapping scientific expertise. Once that reviewer completes their review, it will be reviewed for ethical, technical, legal, and regulatory requirements by a member of the IRB Office, who will compile all review comments and work with the research team through the process of approval.
Requests for Exemption comprise 65% of all protocol submissions at USU. Requests for Exemption are also reviewed on a rolling basis, i.e. there is no deadline for submission. 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 are usually reviewed on the same business day in which they are received, but we ask that you plan for ten days for processing. Some amendments require consultation with a scientific reviewer, the IBC, the Conflict of Interest office, etc. so while we generally process them in one day, others may take longer.
Determinations of Non Human Subjects Research (NHSR)
If you are uncertain whether your project requires IRB oversight, please submit a NHSR request. This is the only way the IRB can tell you whether a project requires a 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.
Fall 2020 Convened IRB Meeting Info
|Meeting Date||Submission Deadline|
|Aug. 11||N/A (Agenda is full)|
|Aug. 25||Jul. 15|
|Sept. 8||Aug. 11|
|Sept. 22||Sept. 1|
|Oct. 13||Sept. 15|
|Oct. 27||Oct. 13|
The convened IRB meets during the summer semester on an as-needed basis, and as permitted by our members’ availability. Remaining Fall 2020 dates will be provided in September.