For Minimal Risk Activities
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Required for recruitment of subjects in verbal scripts/cover letters, and in consent letters (activities not exceeding minimal risk)
For Activities Exceeding Minimum Risk
Additional elements are required, as appropriate, if activities exceed minimal risk.
Additional protections are required for the following populations:.