For example, some demonstration and service programs may include research activities. It does not include research activities which are incidentally regulated by a Federal Department or Agency solely as part of the Department's or Agency's broader responsibility to regulate certain types of activities whether research or non-research in nature.
Interaction includes communication or interpersonal contact between investigator and subject.
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.