The IRB office utilizes an initial pre-review screening process, during which a Protocol Analyst reviews each submission for completeness and compliance.
The analyst may ask the PI to make changes to the submission before it is reviewed by the IRB (pre-review). The IRB reviewer(s) may also ask for changes or clarifications, which the IRB Protocol Analyst will communicate to the research team after IRB review (post-review).
Regulatory Classifications for Human Participant Research
Submitted activities may fall under one of the following four regulatory classifications. Three categories of research do not require review by the convened IRB. Human Research that does not qualify for review using one of the three non-committee procedures must be reviewed by the convened IRB.
Non-Committee Review Processes
- Not “Human Research”: Activities must meet the institutional definition of “human research” to fall under IRB oversight. Activities that do not meet this definition are not subject to IRB oversight or review. Refer to the HRP-310 – WORKSHEET – Human Research Determination for guidance. If you are unsure whether your project meets the definition of human research, contact the IRB office for assistance before beginning work on your project. If you need a formal IRB determination of not research (e.g., if requested by publishers or sponsors), you can submit an eProtocol application to obtain this documentation.
- Exempt Research: Certain categories of human research may be exempt from certain regulations, but still require IRB review to confirm this. Per institutional policy, the IRB and not the investigator determines whether human research qualifies for exemption. Refer to HRP-312 – WORKSHEET – Exemption Determination for guidance on the categories of research that may be exempt.
- Research Qualifying for Review Using the Expedited Procedure: Certain categories of non-exempt Human Research may qualify for review using the expedited procedure, meaning that the project may be approved by a single designated IRB reviewer, rather than the convened board. Review HRP-313 – WORKSHEET – Expedited Review for reference on the categories of research that may be reviewed using the expedited procedure.
Review by the IRB Committee
- Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.
- The University of Alabama has two Institutional Review Boards: a Medical and Non-Medical IRB. IRB meeting dates and submission deadlines are available below: