Enhancement of informed consent in dental clinical trial

Forsyth Institute, Cambridge MA

Investigators

Abstract

A supplementary educational system for clinical research subjects in dental research studies is proposed that involves creating a menu-driven audiovisual program that can be recorded on a DVD. This program will contain descriptive information for all commonly administered dental treatments that are currently undergoing clinical research, describe all measurement and sampling procedures and describe the rights and support systems available to individuals who agree to participate as research subjects. Several publications have suggested that approximately 40% of clinical research subjects are unable to recall essential elements of informed consent. It is the objective of this project to increase the awareness of clinical research subjects through visual reinforcement. The proposed DVD system will be made available to the subject in the waiting room at computer kiosks and/or a small viewing room. The DVD system will be made available to researchers throughout the United States. Because of the relative inexpensive nature of DVD media, a version will be produced that can be dispensed for playing on home entertainment systems. It is hoped that the result of this project will enhance and facilitate the decision-making process for subjects enrolled in dental research clinical trials by reinforcing the instructions and explanations given by clinicians.