Expedited Category Review
What is the definition of minimal risk?
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)
Pages in Expedited Category Review
- Expedited Category Review
- What is Expedited Category Review?
- What are the Criteria for Expedited Category Review?
- You are here: What is the definition of minimal risk?
- Who decides whether or not a project has "minimal risk"?
- What research categories are eligible for an Expedited Category Review?
- What is the application process for submitting an Expedited Category Review research project?
- How (and When) Will I know that a Protocol has been Approved?
- Who receives these IRB Board Action Notices / Letters of Approval?
- What happens if my "Expedited Review" project turns out not to qualify for Expedited Review?