Discussion of “inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993 — The perspective of NIH clinical trialists”

Woolson, Robert F.; Jones, Martha F.; Clarke, William R.; Torner, James C.

doi:10.1016/0197-2456(95)00124-7

Cited by 6 publications

(2 citation statements)

References 2 publications

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“…Some argued that the underlying premise that women had been systematically excluded from trial participation was false (Piantadosi,1995; and later Meinert, Gilpin, Ünalp, & Dawson, 2000). Others argued that the requirement for the “appropriate representation” minority groups in study populations was both vague and impractical and such a goal supported the false premise that only research that included specified proportions of minority group members would be generalizable to the population (Buist & Greenlick, 1995; Meinert, 1995; Piantadosi, 1995; Woolson et al, 1995). Still others noted that efforts to increase the number of minority group members in clinical research supported the notion that race was a biologic rather than social construct (Brawley, 1995).…”

Section: Introductionmentioning

confidence: 99%

Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators

Taylor

2009

Journal of Empirical Research on Human Research Ethics

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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. KeywordsNational Institutes of Health; Research Ethics Board administrators; inclusion policy; justice ACCORDING TO THE NIH INCLUSION guidelines, principal investigators (PI) are to propose their plans for the inclusion of women, minorities, and children in their research proposals or justify their exclusion (National Institutes of Health, 1997; National Institutes of Health, 1998; National Institutes of Health, 2001). The NIH inclusion guidelines were adopted to increase the representation of women, minorities, and children in clinical research in order to address potential harms (real and perceived) created by their exclusion or omission. For example, female and pediatric patients can be harmed as a result of the exclusion of women and children from research when their physician is forced to prescribe to them a drug that has been tested only in male subjects. Members of minority groups can be harmed if enrollment in research is perceived as a benefit and members of minority groups are routinely excluded from access to this benefit.It is the responsibility of Research Ethics Boards (REBs), scientific review groups (SRGs), and NIH program staff to evaluate whether the PI has adequately addressed the inclusion of women, minorities, and children and/or the adequacy of their justification for the exclusion of any or all of these populations

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Section: Introductionmentioning

confidence: 99%

Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators

Taylor

2009

Journal of Empirical Research on Human Research Ethics

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“…[23,24] Others argued that the requirement for the "appropriate representation" minority groups in study populations was both vague and impractical and such a goal supported the false premise that only research that included specified proportions of minority group members would be generalizable to the population. [23,[25][26][27] Still others noted that efforts to increase number of minority group members in clinical research supported the notion that race was a biologic rather than social construct. [28] It is not clear whether these scientific arguments and others were discounted or disregarded, but the implementation of the guidelines is at least evidence that the ethical argument in favor of inclusion had more influence with policy makers at the time.…”

Section: Introductionmentioning

confidence: 99%

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

Taylor

2008

Clinical Trials

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In March of 1994, the National Institutes of Health (NIH) released guidelines mandating the inclusion of women and minorities in clinical research. Four years later, the NIH released similar guidelines mandating the inclusion of children. These "inclusion guidelines" were created to increase the representation of women, minorities and children in clinical research to address potential harms (real and perceived) created by their exclusion or omission. As designated in the guidelines, Institutional Review Board (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 assess the experience with and attitudes of NIH Scientific Review Group (SRG) members with the implementation of these justice-based policy recommendations.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. 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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