Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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8 Implementation
8 Implementation
Pages 203-212
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From page 203... ...
The present emphasis placed by NIH on the recruitment of diverse population groups into clinical research is a strong initial step in the pursuit of equity in clinical studies. Where earlier versions of the current NIH policy on inclusion of women in clinical studies simply encouraged investigators to include women in study populations, more recent policy statements require that 'iclear and compelling" rationales be given for the exclusion of women from proposed studies.
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From page 204... ...
, the ultimate burden for achieving justice falls on the national research agenda as a whole and cannot be implemented by a mechanical approach to the selection of subjects on a study-by-study basis. The preceding chapters have laid out the rationale and guiding principles for including greater numbers of women in clinical studies; they also identified the considerations ethical, scientific, social, and legal that might impede the achievement of this goal.
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From page 205... ...
, the implementation of the overall research agenda by the NIH advisory councils, and finally to the overall assurance of accomplishing the research mission by NIH. The ultimate criteria for judging the success of a public policy to achieve justice and promote inclusion will be changes in research policy and clinical practice, and ultimately improvements in health status indicators, particularly in areas where unjustifiable disparities currently exist.
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From page 206... ...
The Investigator Immediate Actions The committee believes that tracking both the composition of study populations and topics of funded studies, and providing this information on a regular basis to all those involved in the research process, will, in and of itself, raise the level of awareness and activity concerning the issues of both study composition and attention to women's health concerns. NIH already requires investigators to report the composition of study populations, which
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From page 207... ...
Investigators clearly need broad-based support from the other actors within the research process in order to carry out their part of a comprehensive agenda.The committee recommends that IRBs, IRGs, TEGs, scientific advisory councils, and NIH management become more directly involved with investigators in activities that promote development of more inclusive study designs. Measures recommended by the committee, such as IRB review of protocols for study population composition and NIH provision of opportunities for investigator training and access to needed databases, facilitate investigator efforts to realize the goal of greater inclusion.
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From page 208... ...
The committee believes that providing feedback to IRBs concerning the characteristics of the study populations and research topics it has approved will serve to raise the level of awareness of IRBs to issues of justice and inclusion. The NIH Office of Protection from Research Risks (OPRR)
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From page 209... ...
Because clinical research carries both benefits and burdens, justice requires that no one group-gender, racial, ethnic or socioeconomic receive disproportionate benefits or bear disproportionate burdens of research. For the overall biomedical research agenda to comply with the requirements of justice, studies must not only include women as well as men, but also women and men from different age cohorts and different racial and ethnic groups.
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From page 210... ...
Investigators would be able to consult this database in developing strategies to identify and detect gender, racial, and ethnic differences. NIH should require that proposals for clinical studies include in their literature reviews the following: the extent to which an evidentiary base exists for suspecting gender or other subgroup differences relevant to the proposed research; the demographic characteristics of subjects in past similar research; groups for which the proposed study might have special relevance; how the preceding information justifies the population selected for the proposed study; and how that choice will address gaps identified in the literature.
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From page 211... ...
Reporting requirements for all studies should be comprehensive and uniform and at a minimum include: the research questions addressed and the gender, race, ethnicity, socioeconomic status, age and hormonal status (i.e., pregnancy, stage of menstrual cycle) of the study population.
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