临床试验知情同意书的设计规程及范例

临床试验知情同意书分“知情告知”与“同意签字”两部分, 其设计应符合完全告知、充分理解、自主选择的原则, 必要时还应设计帮助受试者理解研究目的、程序、风险与受益的视听资料。临床试验前需作筛选检查, 收集生物标本, 必须得到两种知情同意, 一种用于生物标本的收集和分析, 另一种用于得出满意实验室结果并符合纳入标准后参加试验。本文介绍了知情同意书的设计规程, 包括设计依据、设计原则、格式、内容与印刷的规定, 以及知情同意书的范例。

Design discipline and example of informed consent form for clinical trial

Informed consent form is composed of two parts-informing understanding and consent signature.The design of an informed consent form should comply with regulations of full disclosure, adequate comprehension and voluntary choice.And sometimes audiovisual aids which were used for helping subjects to understand the purpose, process, risks and benefits of research were needed.For clinical study of screening collection of biological specimens, two separate informed consents were needed for the subjects, one is consent for collection and analysis of biological specimens, the other is consent for taking part in trial after satisfied results was obtained and according with inclusion criteria.This article introduces the regulations of designing an informed consent form which included basis of design, principles of design, format, content, provision of print, and example of an informed consent form.