Such investigations may include development of new therapeutic interventions, their evaluation, and subsequent application.
Interaction includes communication or interpersonal contact between investigator and subject.
In some cases it may refer to the first use of a new intervention in humans without any control treatment. In other cases it may refer to a rigorously designed and executed experiment involving a test and control intervention and randomization. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.