Regulating clinical research: informed consent, privacy, and IRBs.

S. Hoffman
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引用次数: 2

Abstract

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task. Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical research, however, an increasing number of critics are voicing serious concerns about inadequate enforcement of the regulations and unacceptable research risks. In recent years, several subjects have died as a result of treatment received in clinical trials and several well-publicized lawsuits have been filed against researchers, research institutions, and Institutional Review Boards (IRBs). Intensifying concerns about both human subject welfare and potential liability are stimulating urgent calls for regulatory reforms. This symposium issue article provides a brief historical overview of Twentieth Century research abuses and the development of regulatory oversight in the United States. It discusses informed consent, IRBs, and the regulations that govern them. Finally, it analyzes contemporary deficiencies in the regulatory system and offers recommendations for reform.
规范临床研究:知情同意、隐私和irb。
在过去的二十年里,美国在生物医学研究领域取得了巨大的发展。预算的扩大、计算机能力的增强以及人类基因组计划都大大提高了研究能力。因此,在这个国家进行的研究项目数量不断增加,招募足够数量的人类受试者正成为一项越来越具有挑战性的任务。涉及人类参与者的临床研究受卫生和人类服务部(DHHS)和食品和药物管理局(FDA)颁布的联邦法规管辖。然而,鉴于医学研究的扩散,越来越多的批评者对条例执行不力和不可接受的研究风险表示严重关切。近年来,几名受试者因临床试验中接受的治疗而死亡,并且针对研究人员、研究机构和机构审查委员会(irb)提起了几起广为人知的诉讼。对人类主体福利和潜在责任的担忧日益加剧,促使人们迫切要求进行监管改革。这篇专题讨论会的文章提供了20世纪美国研究滥用和监管监督发展的简要历史概述。它讨论了知情同意、irb和管理它们的法规。最后,分析了当前监管制度的不足,并提出了改革建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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