...changes to a previously approved research project. Minimal risk for the Common Rule is defined as: The probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests.10 Under expedited procedures that bypass the full IRB process, the IRB chair or one or more...

...Federal regulations define minimal risk as the risk for which "... the probability and magnitude of the harm or discomfort anticipated in the research are...routine physical or psychological examinations or tests."86 However, this seemingly straightforward concept implying a very low absolute risk has been...

...and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (k) Minimal risk meansthat the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests. (I) Legally authorized representative means an individual or judicial or other body authorized under...

...risk is met only when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than...routine physical or psychological examinations or tests. In an expedited review, one or more committee members assigned by the chair reviews the research proposal...