Enhancement of informed consent in dental clinical trial

提出了一种用于牙科研究的临床研究对象的补充教育系统，该系统包括创建可记录在DVD上的菜单驱动的视听节目。该计划将包含目前正在进行临床研究的所有常用牙科治疗的描述性信息，描述所有测量和采样程序，并描述同意作为研究对象参与的个人可获得的权利和支持系统。一些出版物表明，大约40%的临床研究对象无法回忆起 知情同意的基本要素。本项目的目标是通过视觉强化来提高临床研究对象的意识。拟议的DVD系统将在候车室、电脑亭和/或小观察室向受试者提供。DVD系统将向全美的研究人员提供。由于DVD媒体的相对便宜的性质，将生产一个版本，可以分发在家庭娱乐系统上播放。希望这一项目的结果将加强和促进主体的决策过程 通过加强临床医生的指导和解释，登记参加牙科研究临床试验。

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.