History of Women’s Participation in Clinical Research

Policies that encourage the inclusion of women in research originated during the women’s health movement, which emerged as part of the women’s movement. During the 1970s, few women worked in either medicine or science, and many women believed that women’s health needs were a low priority in the scientific and medical fields.

Caution About Allowing Women to Participate in Drug Trials

In 1977, a Food and Drug Administration policy (link is to an external PDF) (PDF, 1.4MB) recommended excluding women of childbearing potential from Phase I and early Phase II drug trials.7 The policy was broad and recommended excluding even women who used contraception, who were single, or whose husbands were vasectomized.8 This cautious approach resulted from drug-related incidents, particularly the tragedy that occurred from the use of the drug thalidomide. Thalidomide was a sedative that was never approved for use in the United States.9 However, the drug was used widely throughout Europe and Canada. Thousands of women who took the drug while pregnant gave birth to babies with horrible limb deformities. This horrific event caused researchers to adopt a cautious approach to female participation in clinical trials.10

Protests, Then Policies to Include Women

Excluding women from early stages of drug trials led to a shortage of data on how drugs affect women. Many people believed that individual women should be allowed to choose whether to take the risk of participating in research.11 For example, activists protested the exclusion of women from trials of HIV drugs.12 The 1985 report of the Public Health Service Task Force on Women’s Health Issues recommended long-term research on how behavior, biology, and social factors affect women’s health.13

In 1986, NIH established a policy that encouraged researchers to include women in studies. This policy was first published in the NIH Guide for Grants and Contracts in 1987. In July 1989, NIH announced through a Memorandum on Inclusion that research solicitations should encourage the inclusion of women and minorities. In fact, if women and minorities were excluded, scientists should include a rationale.

GAO Report and the Founding of ORWH

In 1990, the Congressional Caucus for Women’s Issues asked the General Accounting Office (GAO), now known as the Government Accountability Office, to conduct an investigation into NIH’s implementation of the guidelines for the inclusion of women. GAO reported that the policy had been poorly communicated and inconsistently applied and that it only pertained to extramural research.14 GAO also found that NIH had done little to encourage researchers to analyze study results by gender.15

Two months later, NIH established ORWH.16 In 1991, Dr. Bernadine Healy became the first female NIH Director and launched the Women’s Health Initiative,17 a set of clinical trials and an observational study that together enrolled more than 150,000 postmenopausal women over a period of 15 years. The trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.18

Inclusion Becomes Law

Between 1989 and 1993, inclusion of women in clinical research was NIH policy, but it was not law. In 1993, Congress wrote the NIH inclusion policy into Federal law through a section in the NIH Revitalization Act of 1993 (Public Law 103-43) titled Women and Minorities as Subjects in Clinical Research.19

The law includes various requirements for NIH-funded research, including the following:

  • NIH ensures that women and minorities are included in all clinical research.
  • In trials including women and minorities, the trial should be designed and carried out so that it is possible to analyze whether the variables being studied affect women and minorities differently than other participants.
  • Cost is not an acceptable reason for excluding women and minorities.
  • NIH initiates programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as volunteers in clinical studies.

ORWH Monitors Inclusion

In March 1994, NIH published revised guidelines based on Public Law 103-43 that took effect in September of that year. From that point on, NIH would not fund any grant, cooperative agreement, or contract or support any intramural project unless it complied with this policy. The policy was amended to its current form in 2001.

ORWH has led efforts to monitor adherence to the policy since its inception. Every year, grantees must report on the sex, race, and ethnicity of the people who are enrolled in all clinical trials covered by the policy. Since 1994, NIH has published reports about the activities, including results and accomplishments, of NIH-supported research.

  1. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM131196.pdf (link is to an external PDF) (PDF, 1.4MB)(p. 10 of policy; p. 13 of pdf)
  2. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM131196.pdf (link is to an external PDF) (PDF, 1.4 MB)(p. 10 of policy; p. 13 of pdf)
  3. http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/
  4. Presentation by Susan Wood, Ph.D., to Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) scholars on November 5, 2014.
  5. Presentation by Susan Wood, Ph.D., to BIRCWH scholars on November 5, 2014.
  6. Presentation by Susan Wood, Ph.D., to BIRCWH scholars on November 5, 2014.
  7. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1424718/?page=4
  8. Extramural research is NIH-funded research by way of awards, grants, and contracts to outside institutions to help them pay for research projects and resources. This funding includes the salaries of the investigators they employ, proportional to the percentage of their time on the particular research project. See http://www.niaid.nih.gov/researchfunding/qa/pages/extraintra.aspx#difference
  9. http://www.gao.gov/products/GAO/T-HRD-90-50
  10. http://orwh.od.nih.gov/about/mission.asp
  11. https://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_145.html
  12. https://www.nhlbi.nih.gov/whi/
  13. http://history.nih.gov/research/downloads/PL103-43.pdf (link is to an external PDF) (PDF, 2.3MB)