临床试验中纳入女性、少数群体和儿童：研究伦理委员会管理人员的意见
Inclusion of women, minorities, and children in clinical trials: opinions of research ethics board administrators.
作者信息
Taylor Holly A
机构信息
School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
出版信息
J Empir Res Hum Res Ethics. 2009 Jun;4(2):65-73. doi: 10.1525/jer.2009.4.2.65.
Abstract
IN AN ATTEMPT TO ENCOURAGE INCLUSION of women, minorities, and children in clinical trials, the U.S. National Institutes of Health (NIH) requires investigators conducting NIH-sponsored research to adequately address NIH inclusion guidelines concerning recruitment of women, minorities, and children. A survey of U.S. Research Ethics Board (REB) administrators at institutions receiving NIH funding indicated awareness and implementation of the inclusion guidelines. According to the administrators, investigators and REBs address inclusion in more than half of the relevant protocols. About half of the REB administrators consider the guidelines partly responsible for increased attention to inclusion, but only about a quarter believe that there is greater inclusion as a result.
摘要
为鼓励将女性、少数族裔和儿童纳入临床试验，美国国立卫生研究院（NIH）要求开展由NIH资助研究的研究人员充分遵守NIH关于招募女性、少数族裔和儿童的纳入指南。一项针对接受NIH资助机构的美国研究伦理委员会（REB）管理人员的调查表明，他们知晓并执行了这些纳入指南。据管理人员称，研究人员和伦理委员会在超过一半的相关方案中考虑了纳入问题。约一半的伦理委员会管理人员认为这些指南在一定程度上促使人们对纳入问题给予了更多关注，但只有约四分之一的人认为纳入情况因此有了更大改善。
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