Submitted activities may fall under one of the following four regulatory classifications:
Non-Committee Review Processes
Three categories of research do not require review by the convened IRB:
- 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 ARROW 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 and Limited IRB Review for guidance on the categories of research that may be exempt. See also the Exemption Categories Tool.
- 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
Human Research that does not qualify for review using one of the three non-committee procedures must be reviewed by the convened IRB.
IRB meeting dates are available here.