| 论医学研究知情同意的伦理审查 |
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| 引用本文： | 胡晋红. 论医学研究知情同意的伦理审查[J]. 中国医学伦理学, 2014, 0(2): 180-182 |
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| 作者姓名： | 胡晋红 |
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| 作者单位： | 第二军医大学长海医院药学部,上海200433 |
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| 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。
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| 关 键 词： | 医学研究 伦理审查 知情同意 风险 信息 |
Ethical Review on Informed Consent in Medical Research |
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| HU Jin-hong. Ethical Review on Informed Consent in Medical Research[J]. Chinese Medical Ethics, 2014, 0(2): 180-182 |
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| Authors: | HU Jin-hong |
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| Affiliation: | HU Jin-hong ( Pharmacy Department of Changhai Hospital, Second Military Medical University, Shanghai 200433, China) |
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| Abstract: | 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. |
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| Keywords: | Medical Research Ethical Review Informed Consent Risk Information |
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