See the main index of Decision Trees or the NIAID Human Subjects Application and Grant Handbook.
Step 1. Are human subjects involved? (even if exempted under 45 CFR Part 46)?
Step 2. Does the study claim an exemption to regulations?
Step 3. Does the study fit an allowed exemption?
Step 4. Are these issues adequately and appropriately addressed? Risk to subjects, adequacy of protection against risks, potential benefits of the research to subjects and others, importance of knowledge to be gained
Last Updated April 19, 2016
Last Reviewed April 19, 2016