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J Empir Res Hum Res Ethics. 2009 Jun;4(2):65-73. doi: 10.1525/jer.2009.4.2.65.

Inclusion of women, minorities, and children in clinical trials: opinions of research ethics board administrators.

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School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.


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.

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