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Clin Trials. 2008;5(2):140-6. doi: 10.1177/1740774508089457.

Implementation of NIH inclusion guidelines: survey of NIH study section members.

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Department of Health Policy and Management, Bloomberg School of Public Health, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD 21205, USA.



Current National Institutes of Health (NIH) policy mandates the inclusion of women, minorities and children in clinical research. Institutional Review Boards (IRB), NIH Scientific Review Groups (SRG) and NIH program staff all have responsibility for the evaluation of Principal Investigator (PI) adherence to the inclusion guidelines.


The purpose of this survey was to describe the experience with and attitudes of SRG members toward the inclusion guidelines and to identify characteristics of respondents that predict their attitudes towards the policy.


A survey was sent to 746 SRG members. 425 SRG members responded and univariate and bivariate statistical analysis conducted.


The results of the survey identify one clear measure of success regarding the implementation of the NIH guidelines; SRG members indicate the guidelines are in part responsible for their attention to the inclusion of women, minorities and children in clinical research. In addition, SRG members believe that gender and race are important factors when assessing the diversity of study samples and that the current NIH guidelines are adequate for encouraging their inclusion. As a proxy measure of success, SRG members believe that PIs responsible for protocols reviewed by their study group are generally compliant with the inclusion guidelines.


At least one potential limitation of this study is that while an effort was made to assure confidentiality, because the project was funded by the NIH, respondents may have been less critical of the guidelines than they would have been if the study was funded by non-NIH funds.


Future research ought to explore whether IRB members and NIH program officers find PIs to be compliant as their projects get underway. In addition, more research ought to be conducted to assess the downstream effects of this important social policy.

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