In the past, women were not included in most clinical research. This was often based on two notions: (1) that women are more biologically complicated than men; and (2) as primary caregivers of young children, a woman had too many competing time demands to participate in research studies.187 More than two decades ago, NIH established the Office of Research on Women's Health, in recognition that excluding specific subgroups from research produces knowledge that only helps a portion of the public. In 1991, the U.S. Department of Health and Human Services established the Office on Women's Health to ensure that broader public health issues related to sex and gender were addressed. Since these offices were established, significant progress has been made in several major areas:
- Policies have been implemented ensuring that women and minorities are included in NIH-funded clinical research
- Research on women’s health and sex differences has expanded.
- Career development and mentoring programs have increased the numbers of women’s health researchers.
- Research results have been translated into health benefits for women.188
- There has been greater communication to a variety of public audiences about sex and gender differences in basic and behavioral science, as well as in public health.
"Remember the famous study, take an aspirin a day to keep the heart attack away? That study was done on 10,000 men. Not one woman was included. In a study of the aging process, they told me women weren’t included because there wasn’t a ladies room available for study participants. Yet the results of these studies were being applied to men and women. I vowed to fix that."
Although significant strides have been made to include women in clinical research, most animal-based research still tends to over-rely on males. Because these studies are important in guiding clinical studies, NIH announced a new policy in 2014 requiring that both sexes be represented in NIH-funded research involving animal and cell models.12
Since its inception, NIDA has sponsored research on issues related to women and substance use. Beginning with an early focus on the effects of drug use on pregnant women and the children they carry, NIDA then expanded its interest to sponsor research into women's specific substance use disorder risk factors and treatment needs. When the HIV/AIDS epidemic emerged in the 1980s, NIDA responded with funding for projects on gender-specific risk factors for infection and on the impact of drug use on HIV transmission between mother and newborn and the subsequent health of both. In 1995, NIDA formally established the Women and Sex/Gender Differences Research Program to understand the underlying causes of substance use disorders and the best ways to prevent and treat them in both men and women.189