Videotape aids informed consent decision.

Abstract

Obtaining informed consent for clinical investigations represents a major legal, ethical, and moral consideration in human experimentation. Mechanisms for informing the patient vary widely, and usually no system exists to confirm the degree of information retained by the patient. A Veterans Administration Cooperative Study, begun in 1975, has used a videotape information package in addition to a standard written consent form to ensure uniformity. Each presentation was followed by a questionnaire to assess the amount of material learned before attempting randomization. Repeated showings were occasionally necessary and did not affect the rate of randomization. A videotape presentation, especially in cooperative studies, ensures uniformity, makes allowance for varying educational levels of patients, and provides documentation of the degree of informed consent.