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关于人类受试者研究规划与实施的伦理考量

Ethical considerations in planning and conducting research on human subjects.

作者信息

Sieber J E

机构信息

Department of Psychology, California State University, Hayward 94542.

出版信息

Acad Med. 1993 Sep;68(9 Suppl):S9-13. doi: 10.1097/00001888-199309000-00027.

Abstract

The ethical conduct of research on humans requires more than a caring researcher and a legalistic adherence to federal regulations. It requires good planning and managing of issues accruing from the research relationship--communication, risk and perception of risk, and benefits--to all who have a stake in the relationship and outcome. In 1978 the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research identified ethical principles that should govern research on humans. Institutional review boards (IRBs) now exist in every organization that receives federal funding for human-subjects research. Researchers have an obligation to study the requirements of their IRB when they plan their research. Further, they must establish appropriate procedures for obtaining informed consent and assessing risk, risk perception, and ways to increase the benefits of research.

摘要

对人类进行研究的道德行为,需要的不仅仅是一位富有同情心的研究者以及对联邦法规的严格遵守。它需要对研究关系中出现的问题——沟通、风险及风险认知、益处——进行妥善规划和管理,涉及所有与该关系及结果有利害关系的人。1978年,保护生物医学和行为研究中人类受试者国家委员会确定了应指导人类研究的伦理原则。如今,每个接受联邦资金用于人类受试者研究的组织都设有机构审查委员会(IRB)。研究人员在规划研究时,有义务了解其IRB的要求。此外,他们必须建立适当程序以获得知情同意,并评估风险、风险认知以及增加研究益处的方法。

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