Expedited Category Review | What is Expedited Review | What are the Criteria | What is the definition of minimal risk | Who decides whether or not a project has “minimal risk” | What Research Categories fall under Expedited Category Review | What is the application process | How will I know that a Protocol has been approved | Who receives these IRB Action Notices | What happens if my Expedited Review does not qualify
The regulatory definition of “minimal” risk is:
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
45 CFR 46. 102 (i)