There is an increasing concern among the members of the medical profession with legal rights, obligations and limitations affecting clinical investigation. This is understandable in light of the virtual explosion of clinical investigation within medical science. Clinical investigation is the systematic collection, evaluation and reporting, by or under the supervision of physicians, of data about other human beings for the purpose of advancing scientific medical knowledge. Thus it includes neither investigation relating to animals (even though such investigation may also advance scientific medical knowledge), nor investigation of human beings for purposes unrelated to medical science, nor the trial of unproven procedures in the treatment of patients unless this is also a part of a systematic program of clinical investigation. Nevertheless, clinical investigation need not occur within the physician-patient relationship, which arises when a person seeks and a physician undertakes to furnish medical diagnosis or treatment. For example, a person who volunteers as a subject of clinical investigation does not have a physician-patient relationship with a physician who does not undertake to furnish him any medical benefit.
Howard N. Morse,
Legal Implications of Clinical Investigation,
20 Vanderbilt Law Review
Available at: https://scholarship.law.vanderbilt.edu/vlr/vol20/iss4/1