伦理审查委员会(IRB)是一个独立的机构,旨在保护人类研究参与者的权利和福利。根据《联邦法规》第45篇第46部分(45 CFR 46),任何由联邦政府资助的研究都必须经过IRB的审查和批准。 任何涉及美国食品和药物管理局(FDA)监管产品的临床研究也必须由IRB审查和批准(21 CFR 56)。个别机构或赞助者可能会要求所有的研究,无...
Synonyms Research ethics committee Definition Institutional Review Board (IRB) is a committee containing members of mixed backgrounds and including both scientist and nonscientist members whose task is to review and monitor biomedical and behavioral research involving human subjects. The World Medical ...
The term used in the United States to describe the standing committee in a medical school, hospital, or other health care facility that is charged with ensuring the safety and well-being of human subjects involved in research. The IRB is responsible for ethical review of research proposals. Man...
伦理审查委员会，简称IRB，是科学研究领域中一道至关重要的伦理防线，旨在确保所有人类研究参与者在受试过程中得到最大程度的尊重和保护（45 CFR 46）。联邦政府资助的研究项目，无论是药物还是医疗设备的临床试验，均需首先通过IRB的严格审核（21 CFR 56），即使是非政府资助的研究，某些机构或赞助者也...
药物临床试验独立伦理委员会(Independent Ethics Committee,IEC或者Institutional Review Board,IRB)是什么组织?相关知识点: 试题来源: 解析 由医学专业人员、法律专家及非医务人员组成的独立组织,其职责为核查临床试验方案及附件是否合乎道德,并为之提供公众保证,确保受试者的安全、健康和权益受到保护。参加新药临床试验的...
Institutional review board (IRB), in the United States, ethics committee that reviews proposed and ongoing research involving human subjects. The institutional review board (IRB) exists to protect the rights and safety of human subjects who participate i
Synonyms Research ethics committee Definition Institutional Review Board (IRB) is a committee containing members of mixed backgrounds and including both scientist and nonscientist members whose task is to review and monitor biomedical and behavioral research involving human subjects. The World Medical Associ...
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Learn about Institutional Review Boards (IRB). Understand what an IRB is, learn the purpose of IRBs, and read about their evaluation process for...
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