This section of the Investigator Manual covers regulatory classifications for human participant research, approval criteria, review decisions, and IRB records and rosters.
Regulatory Classifications for Human Participant Research
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.
IRB Approval Criteria
The criteria for IRB approval can be found in HRP-312 – WORKSHEET – Exemption and Limited IRB Review for exempt Human Research and HRP-314 – WORKSHEET – Criteria for Approval for non-exempt Human Research. The latter worksheet references other checklists that might be relevant to your study.
All checklists and worksheets can be found on the IRB web site. These checklists are used for initial review, continuing review, and review of changes to previously approved human research. You are encouraged to use the checklists to write your protocol or application in a way that addresses the criteria for approval.
Accessing IRB Records and Rosters
Investigators are responsible for maintaining complete study files. All IRB related study documents are located in ARROW, and if needed, can be requested. Information from the IRB Roster, HRP-601, is available upon request.