What do I check in Item 4 if my application describes research that meets the criteria for an exemption in Item 4a?
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 check “Yes” in Item 4, and complete the Human Subjects section of your application as per the PHS 398 Instructions, describing the involvement of human subjects in the research and why you believe the research meets the criteria for an exemption.
Related Questions
- What is the process and criteria of evaluation that the Research Grant application goes through with the IAC and then with the Ethnic Studies Research Center?
- What do I check in Item 4 if my application describes research that meets the criteria for an exemption in Item 4a?
- What do I check for human subjects if my application describes research that meets the criteria for an exemption?
