Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. Activities which meet this definition constitute research for purpose of this policy, whether or not they are conducted or support under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.