Barbour G L, Blumenkrantz M J
JAMA. 1978 Dec 15;240(25):2741-2.
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.
在人体实验中，获取临床研究的知情同意是一个主要的法律、伦理和道德考量。向患者提供信息的方式差异很大，而且通常没有系统来确认患者记住的信息量。一项始于1975年的退伍军人管理局合作研究，除了标准的书面同意书外，还使用了录像带信息包以确保一致性。每次展示后都会进行问卷调查，以评估在尝试随机分组之前学到的材料量。偶尔需要重复播放，且这并不影响随机分组的比例。录像带展示，尤其是在合作研究中，可确保一致性，考虑到患者不同的教育水平，并提供知情同意程度的文件记录。
