关键词: 临床试验, 知情同意书, 设计规程, 范例

Abstract: 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.

Key words: clinical trial, informed consent form, regulations of design