方法证据记录
Types of Ethics Committees in Research
Research ethics committees are independent governance bodies established to review and oversee human subjects research. In the United States, these are called Institutional Review Boards (IRBs); in the United Kingdom and Commonwealth nations, Research Ethics Committees (RECs); and in European Union and other jurisdictions, they are termed Ethics Committees. These bodies operate under national regulations—45 CFR 46 in the U.S., the Medicines for Human Use (Clinical Trials) Regulations in the UK, and the EU Clinical Trials Regulation in Europe—to ensure research protects participant rights, safety, and welfare.
源记录
引文逐字复制自方法源记录。这些引文不代表任何层级的验证。
Classification and Structure of Research Ethics Review Bodies
分类方法记录 · process-pipeline / research-ethics
- U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46. · URL
- U.S. Food and Drug Administration. (2013). Institutional Review Boards: Frequently Asked Questions. Center for Drug Evaluation and Research. · URL
- International Council for Harmonisation. (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1). Good Clinical Practice E6(R2). · URL
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