Certain studies may have the characteristics of human subjects research but may not meet the regulatory definition. Studies which meet the definition require IRB review. There are three categories to be considered:
- studies that are human subjects research
- studies that may be considered human subjects research (gray area)
- studies that do not qualify as human subjects research
Any investigator who is unsure of whether his/her proposal constitutes “human subjects research” should contact the IRB office or submit an online “Human Subjects Research Determination” through HawkIRB. https://hawkirb.research.uiowa.edu/hawkirb
The IRB Chair and/or their designee will determine if the study meets the definition of human subjects research. Federal regulations do not allow investigators to make this determination themselves. If a study does not qualify as human subjects research, HawkIRB will issue a memo stating that the project does not require IRB review or approval. When a “Human Subjects Research Determination” is submitted through HawkIRB, a determination memo will be sent to the investigator via email. NOTE: Grant offices, faculty advisors, or publications may require a formal determination from the IRB/designee.