- I am not sure if I need to submit a HawkIRB application. How can I find out if my project will need IRB approval?
- Can my research project be considered exempt?
I am not sure if I need to submit a HawkIRB application. How can I find out if my project will need IRB approval?
All human subjects research conducted at the University of Iowa or by UI students, faculty, or staff must have IRB approval. If you are unsure whether your proposal meets te definition of human subjects research, you can submit an online Human Subjects Research Determination (HSRD) form through HawkIRB. The IRB Chair and/or their designee will determine if your proposed project meets the definition of human subjects research.
- If the Chair/designee determines the project is not human subjects research, HawkIRB will generate a memo stating the project does not require IRB review or approval.
- If the Chair/designee determines the project meets the regulatory definition of human subjects research, you must receive IRB approval for the project before conducting it. the HawkIRB application will initiate a DRAFT New Project Application on your behalf, based on the responses you have provided in the HSRD form. It is your responsibility to complete this DRAFT New Project Application and submit it to the IRB for review. Research cannot begin until formal IRB approval is granted.
ADDITIONAL RESOURCES:
- UI Investigators Guide
- - Chapter 3. Scope and Purpose of Institutional Review Boards, Section B. What Needs Review by the IRB
- IRB Standard Operating Procedures
- - Chapter IV. The Authority of the IRB
- OHRP Guidance on Engagement of Institutions in Human Subjects Research
Can my research project be considered exempt?
Some research may qualify for exemption from certain federal regulations [45 CFR 46.104 (DHHS) and 21 CFR 56.104 (FDA)]. During the review process, the IRB chair will determine whether your research meets the exempt criteria.
Important: Research that meets the criteria for exemption is still considered human subjects research, and still needs IRB approval. If your study does qualify for exemption, you still need to submit an application in HawkIRB and receive approval before conducting the research. If your project is not considered human subjects research, it does not need IRB approval.
ADDITIONAL RESOURCES:
- IRB Standard Operating Procedures
- - Chapter IV. The Authority of the IRB, Section C. Exempt Human Subjects Research
