Inclusion of Women in Medical Research

More research is needed to understand women's unique health needs, and it is crucial that women who do participate in research studies are informed volunteers. The Society’s campaign, Some Things Only a Woman Can Do provides women with accurate information about volunteering for medical research.

Frequently Asked Questions about Medical Research

• What is medical research?
• Why are women needed for medical research studies?
• Who may participate in medical research?
• What will I be told about the study?
• Why won't they tell me what I am taking?
• What are the risks?
• How will the research study benefit me?
• What might keep me from wanting to be in the study?
• Will I be paid for the study?
• Who will answer my questions?

Milestones in the Inclusion of Women in Research 

• 1977- The Food and Drug Administration (FDA) bars women of child bearing potential from participating in most early phase clinical research.

• 1985- A United States Public Health Service task force concludes that exclusion of women from clinical research was detrimental to women's health.

• 1986- The National Institutes of Health (NIH) adopts guidelines urging the inclusion of women in NIH-sponsored clinical research.

• 1990- The Society for Women's Health Research is founded and asks the General Accounting Office (GAO) to examine whether NIH is following its 1986 guideline.

• 1990- A GAO report reveals that the NIH guidelines are not being followed. The Physician's Health or "aspirin" study, designed to examine the impact of taking aspirin on cardiovascular disease, is one of many large studies not included women highlighted by the report.

• 1993- The NIH Revitalization Act of 1993 mandates that the NIH must ensure that women and members of minorities and their subpopulations are included in all human subject research.

• 1993- The FDA rescinds earlier guidelines barring the participation of women with child-bearing potential from most early phase research.

• 2000- The GAO concludes that although women are now included in clinical research proportionate to their representation in the population, analysis by sex of subjects is rare.

• 2001- The GAO concludes FDA not effectively monitoring research data to determine how sex differences affect drug safety and effectiveness.