Enrolling pregnant women: issues in clinical research.

BACKGROUND: Despite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations. METHOD: In October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research. This report summarizes three areas that emerged from that meeting as important next steps to be taken to promote ethically responsible and scientifically sound research during pregnancy. FINDINGS: The three areas are: 1) Reclassify pregnant women from their current status in regulations as a "vulnerable" population to a scientifically "complex" population and change the presumption of exclusion to one of inclusion; 2) examine the institutional review boards' (IRB) gatekeeper role in interpreting regulations governing pregnancy research and identify steps to facilitate IRB approval of ethically informed pregnancy research; and 3) develop a pregnancy-focused research agenda that addresses pressing clinical needs, identifies opportunities to gather information from existing resources and studies, and encourages important new research areas. CONCLUSION: Research is needed to address the therapeutic needs of pregnant women and to study pregnancy as it may shed light on a pregnant woman's later health and the health of her child.

Women's mental health research: the emergence of a biomedical field.

This review surveys the field of women's mental health, with particular emphasis on its evolution into a distinct area of biomedical research. The field employs a biomedical disease model but it also emphasizes social and cultural influences on health outcomes. In recent years, its scope has expanded beyond studies of disorders occurring in women at times of reproductive transitions and it now encompasses a broader study of sex and gender differences. Historical and conceptual influences on the field are discussed. The review also surveys gender differences in the prevalence and clinical manifestations of mental disorders. Epidemiological findings have provided a rich resource for theory development, but without research tools to test theories adequately, findings of gender differences have begged the question of their biological, social, and cultural origins. Clinical depression is used to exemplify the usefulness of a sex/gender perspective in understanding mental illness; and major theories proposed to account for gender differences are critically evaluated. The National Institutes of Health (NIH) is the primary federal funding source for biomedical women's mental health research. The review surveys areas of emphasis in women's mental health research at the NIH as well as some collaborative activities that represent efforts to translate research findings into the public health and services arenas. As new analytic methods become available, it is anticipated that a more fundamental understanding of the biological and behavioral mechanisms underlying sex and gender differences in mental illness will emerge. Nonetheless, it is also likely that integration of findings predicated on different conceptual models of the nature and causes of mental illness will remain a challenge. These issues are discussed with reference to their impact on the field of women's mental health research.

Public health context of women's mental health research.

As more attention is directed to the mental health care of women, sex and gender differences in research design and in regulatory policies have interfaced with clinical care and public policy. An emphasis on women's mental health issues in the provision of treatment and care as well as the design of large-scale screening strategies to identify and treat women with mental disorders promises to be effective public health approaches to reducing the burden of mental illness in women. The past decade has seen increased emphasis on women's mental health and sex/gender differences in the federal sector and in the research community. Federal regulations (summarized in the NIH Outreach Notebook) call for the inclusion of women and minorities in NIH-funded clinical research. The regulations also place emphasis on gender analysis of the results of clinical trials, in particular phase III trials, the findings of which are likely to influence practice. There has been substantial progress toward the goal of including women in research, but more remains to be done. A 2000 GAO report titled "Women's Health: NIH Has Increased Its Efforts to Include Women in Research" commended NIH for tracking the number of women in clinical research but the report also noted that relatively few NIH-funded studies, including major clinical trials, had reported findings by gender of study participants. This was seen as an impediment to progress in developing gender-based effective treatments. In the past decade, the women's health field has moved beyond an exclusive emphasis on women's reproductive function to one that defines health as a scientific enterprise to identify clinically important sex and gender differences in prevalence, etiology, course, and treatment of illnesses affecting men and women in the population as well as conditions specific to women. Nonetheless, for mental disorders, women's reproductive function and its impact on mental health conditions is still understudied. Based on the epidemiology of mental disorders, the course of mental disorders in women in relation to reproductive transitions remains an important issue for the mental health field because the burden of mental disorders, such as depression and anxiety, fall disproportionately on women of childbearing and childrearing age. The public health emphasis on women's mental health does not lessen the basic scientific opportunities to be had by a focus on gender and sex differences. A 2001 report of the Institute of Medicine titled "Exploring the Biological Contributions to Health: Does Sex Matter?" underscores the benefit to health care of looking for sex differences at the biological level. Basic and clinical neuroscience research is rapidly accruing a knowledge base that will provide information at the level of genes and cells of the influences of biological sex on mental health outcomes in both women and men. A focus on women's mental health and gender/sex differences research promises to yield improvement in treatments and services and thereby to improve the public health as well as to increase fundamental knowledge about the etiology and neurophysiology of mental disorders.

Bridging the gap: recruitment of African-American women into mental health research studies.

OBJECTIVE: To develop a strategy for recruiting African-American women into a research study for pregnant women. METHODS: With few exceptions, NIH-funded investigators must include women and minorities in clinical research. The authors used the recommendations provided in the Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research as a guide to help them reach out to African-American women in the community. RESULTS AND CONCLUSIONS: The outreach experience led to a conference for African-American women about mental health. On the basis of this experience, the authors formulated a five-pronged approach for recruitment of African-American women into their study. The NIH guidelines were useful for this purpose.