Enhancement of informed consent in dental clinical trial

加强牙科临床试验中的知情同意

• 批准号: 6777723
• 负责人: Jo MAX GOODSON
• 金额: $ 10万
• 依托单位: ADA FORSYTH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777723
• 关键词: DVD /CD ROM; behavioral /social science research tag; computer assisted instruction; decision making; dental research; education evaluation /planning; educational resource design /development; health education; health science research support; human rights; informed consent; social support network; training aid

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.

提出了一种牙科研究中临床研究对象的补充教育系统，该系统涉及创建可以记录在DVD上的菜单驱动的视听程序。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受试者参与的个人的权利和支持系统。一些出版物表明，大约40%的临床研究受试者无法回忆 知情同意的基本要素。本项目的目的是通过视觉强化提高临床研究受试者的意识。受试者可在候诊室的电脑亭和/或小型阅览室使用拟议的DVD系统。DVD系统将提供给美国各地的研究人员。由于DVD媒体相对便宜的性质，将生产一个版本，可以分配给家庭娱乐系统播放。希望本项目的结果将加强和促进受试者的决策过程 通过强化临床医生给出的说明和解释，参加牙科研究临床试验。