What do I check for human subjects if my application describes research that meets the criteria for an exemption?
Research described by the six exemption categories in section 46.101(b) of 45 CFR 46 is considered human subjects research but is exempt from the requirement for IRB oversight of the research as described in 45 CFR 46. If you believe that the research described in your application is exempt, you should indicate “Yes” in Item 4, and include a Human Subjects section in your application as per the supplemental instructions for preparing the human subjects section of the research plan, describing the involvement of human subjects in the research and why you believe the research meets the criteria for an exemption.
Related Questions
- What do I check for human subjects if my application describes many subprojects but not all of the subprojects include human subjects research?
- What do I check in Item 4 if my application describes many subprojects but not all of the subprojects include human subjects research?
- What do I check for human subjects if my application describes research that meets the criteria for an exemption?
