Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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1 Women's Participation in Clinical Research: From Protectionism to Access
1 Women's Participation in Clinical Research: From Protectionism to Access
Pages 1-10
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policies which discouraged the inclusion of women of"childbeanag potential" in early drug trials led to their widespread exclusion in later, Phase III testings That the article stirred so little response reflects the relative consensus at the time among researchers and federal policymakers vis a vis protectionist policies governing research on women. In contrast, the findings of the General Accounting Office (GAO3 in 1990 met with public outcry and congressional action in He form of the Women's Health Equity Act.2 This GAO report documented that the National ldstitutes of Health (NIH)
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offers "additional safeguards" for research involving fetuses, embryos, or pregnant women.l1 Thus, at one extreme, federal (NIH) policy makes no mention of fertility On July 22, 1993, the FDA issued a new guideline titled Guidelinefor the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs.
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The original Food and Drugs Act of 1906, for example, required no safety testing prior to marketing and instead monitored drugs' strength and purity.~4 Congress passed a revised Federal Food, Drug and Cosmetic Act in 1938 only after the Elixir Sulfanilamide tragedy,which resulted in 107 poisoning deaths. The strengthened law required industry sponsors to prove drug safety before market release.~5 Public concern and sensitivity to ethical issues in research were greatly strengthened by the Nuremberg war crime trials dunog the late 1940s, which revealed Nazi atrocities in human experimentation perpetrated on Jews and other "undesirables." As a result, the Nuremberg Code promulgated standards for the protection of human research subjects.
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well after treatment was widely available.22 Partly in response to Tuskegee, the 1974 National Research Act called for the establishment of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to "identify ethical principles" and to "develop guidelines" for research involving human subjects.23 Further impetus for creation of the National Commission was the raging political debate over abortion, artificial reproductive technologies, and fetal tissue research.24 In 1973, The Supreme Court case Roe v. Wade legalized abortion and galvanized He small but impassioned antiabortion movement in He United States.2S Abortion politics affected not only contraceptive and abortifacient (e.g., RU4863 research, but all research involving women of"childbeanng potential." Indeed, Fletcher and Ryan have remarked on the irony that 45 C.F.R.
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Dramatic increases in medical school enrollment among women during the 1970s3° provided a vocal minority of medical professionals in the subsequent decade who questioned current priorities and policies in women health research. Women observed that historically, medical and public health professionals have conflates women's health with reproductive and child health.
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In response to criticism, NIH officials buttressed traditional justifications for excluding women fetal protection and liability concerns with an argument of cost.37 The inclusion of women in clinical research means that researchers must consider hormonal cycling and deal with larger sample sizes and recruinnent "difficulties" all of which, they argued, increase study costs. These responses assume that the normal hormonal variations women experience throughout their menstrual cycles complicate research design by introducing an additional variable for which the researcher must control.
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Women, they assert, require "special arrangements" such as child care and transportation. However, women's health advocates are quick to respond that women demons greater health-seeking behavior than men and are generally more compliant patients and research participants.42 On balance, perks the observed behavioral differences between men and women merely point to the need for gender-specific strategies to recruit and retain both genders in clinical studies, rather the pose inherent obstacles to women's inclusion.
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1991. Forging a Wombats Health Research Agenda: Clinical Pharmacy Panel Report.
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16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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1992. Health Research that Excludes Women is Bad Science.
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