Zink Sheldon, Kimberly Laura, Wertlieb Stacey
Department of Medical Ethics, University of Pennsylvania, Philadelphia, PA, USA.
Prog Transplant. 2005 Sep;15(3):291-5. doi: 10.1177/152692480501500315.
It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.
任何参与涉及人类受试者研究的人员都必须熟悉机构审查委员会的目的和作用。机构审查委员会的首要目的是通过监督联邦政府关于保护人类受试者法规的实施情况,来保护人类研究受试者。联邦政府要求,任何接受联邦资金的人类受试者研究都必须获得机构审查委员会的批准,而且许多学术期刊在发表研究成果之前,都要求提供机构审查委员会批准该研究的证明。在本文中,关于机构审查委员会作用的10个常见问题的答案凸显了机构审查委员会对开展符合伦理的研究所做出的重要贡献。目的是让每一位考虑从事人类研究受试者工作的研究人员都能掌握机构审查委员会职能的实用知识。这是探讨研究伦理常见问题的三篇系列文章中的第一篇。