The long-term objective of this application is to improve the outcome of the informed consent process, specifically, a subject's knowledge of the purpose of the research, the expected duration of the subject's participation, the research procedures, the experimental nature of the research, its risks and discomforts, compensation in case of injury, expected benefits, alternatives, costs, confidentiality, voluntariness of participation, provision of new findings that may relate to the subjects' willingness to continue, and whom to contact for answers to questions.
The specific aims of this study are to: 1) Compare understanding of a given informed consent in diverse protocol types among groups of patients who receive information by one of four methods: - an information booklet developed for each protocol; - a videotaped program produced for each protocol; - a computer-assisted instruction program developed for each protocol; - the protocol's current written consent form; 2) Identify patient (e.g., age, education, health status) and protocol (e.g., type, complexity) characteristics that influence patients' understanding of clinical trails. Data will be analyzed using a four-group (consent form versions) one-way multivariate analysis of variance (MANOVA). The results of this research will help to determine if particular methods work better in particular populations or study types.
