摘要
伦理委员会与知情同意书是保障受试者权益的主要措施。因此,伦理审查工作需要加大对知情同意的审查力度,注重研究受益和风险的平衡,维护受试者权益和安全。知情同意是人体生物医学研究的主要伦理要求之一。知情同意的伦理审查一般要考虑以下要点:信息的完整、充分性;知情同意书签署过程;用语的规范性;知情同意书风险处置等。
Ethics committee and informed consent are the main measures to safeguard the rights and interests of the subjects.Therefore, it needs to increase the ethical review intensity on informed consent , pay attention to the balance of benefit and risk , to maintain the subjects＇rights and interests and security .Informed consent is one of the main ethical requirements for human body research .The following key points should be considered during the ethical review on informed consent：the completeness and sufficiency of the information;signed process;standardi-zation of the language;risk disposal, etc.
出处
《中国医学伦理学》
2014年第2期180-182,共3页
Chinese Medical Ethics
关键词
医学研究
伦理审查
知情同意
风险
信息
Medical Research
Ethical Review
Informed Consent
Risk
Information
