What are the different regulatory classifications under which research activities may fall?
The IRB is the only authority that can determine under which regulatory category your research project falls. Submitted activities may fall under one of the following four regulatory classifications:
- 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. Review the IRB Office’s “WORKSHEET: Human Research Determination (HRP-310)” for reference. Contact the IRB Office in cases where it is unclear whether an activity is Human Research.
- Exempt: Certain categories of Human Research may be exempt from some of the regulations but are still human subject research and, therefore, subject to IRB review under the ethical principles of Belmont. Projects which are determined to be exempt will not require annual review by the IRB. It is the responsibility of the IRB Office, not the investigator, to determine whether Human Research meets the criteria for an exempt determination. See the IRB Office’s “WORKSHEET: Exemption Determination (HRP-312)” and the IRB website to reference the categories of research that may be exempt. Once your project receives an exempt determination from the IRB Office, you do not need to submit anything additional to the IRB unless there are changes to research procedures, changes that may alter risk to participants, or changes to the scope of the project from that which was originally approved. If risk or scope/procedures change, a new project should be submitted to the IRB for review before implementation, as a new initial submission in eIRB+.
- Expedited: Certain categories of non-exempt Human Research may qualify for review using the expedited procedure, meaning that a single designated IRB reviewer, rather than the convened board, may approve the project. Review the IRB Office’s “WORKSHEET: Expedited Review (HRP-313)” and the IRB website to reference the categories of research that the IRB may review using the expedited procedure.
- Review by the Convened IRB: Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.