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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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5 Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials
Pages 29-34

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From page 29...
... The extension of protectionism from pregnant women to all women of reproductive potential was, I believe, the result of intellectual lassitude, defensive legalism, and a misplaced sense of obligation.2 While it might be argued that the prospect of increased research costs has also been a factor, I do not believe thM such estimates were attempted until quite recently, when the prospect of a policy change became serious. There are a number of considerations that support the reform of current policy toward a presumption of inclusion of women of reproductive potential as research subjects.
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From page 30...
... Consonant with policies concerning children as subjects, when research involving pregnant women has been permitted, potential parents have been regarded as the appropriate decision makers concerning the acceptability of fetal risk, except when a risk-benefit analysis applied to the woman fetus pair is patently unfavorable. Future generations will include women as well as children.
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From page 31...
... Therefore, exclusionaryresearchpolicies applied under currently prevailing conditions not only fail to provide some degree of benefit to women of reproductive potential, they are also a source of risk to women. These considerations establish a prima facie case in favor of participation in clinical trials, especially in light of the failure of opposing arguments.
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From page 32...
... I have argued that studies that pose a patently unfavorable balance of risks and benefits should not be offered to women of reproductive age, as they would not be offered to any human subjects; studies Tut pose no foreseeable risk to the reproductive system should routinely include both male and female subjects. In all other cases, respect for persons implies that individual women of reproductive potential should be the ultimate decision makers with respect to the question whether the risks of participation are acceptable or not.
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From page 33...
... 3. ~ all other cases the informed consent process should enable the woman to be the ultimate decision maker concerning He acceptability of nsks.9 An important by-product of these considerations could be a more cautious approach to He investigation end use of drugs in mares of reproductive potential.
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From page 34...
... Bonnie Goldmann (Senior Director, Regulatory Affairs, Merck Research Laboratories) , Food and Drug Law Institute Conference on Clinical Trials, Washington, D.C., October 5, 1992.
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Key Terms

  • reproductive potential
  • research involving
  • pregnant women
  • human subjects
  • foreseeable benefits

  • clinical trial
  • biologically mediated
  • policies concerning
  • mediated risks
  • legal issues

  • reproductive age
  • ethical principles
  • fetal protection
  • patently unfavorable
  • ultimate decision

  • consent process
  • research subjects
  • male subjects
  • future generations
  • misplaced sense

  • bonnie goldmann
  • research subject
  • pharmaceutical sources
  • various substances
  • affecting women

  • trials create
  • future human
  • specific subgroup
  • foreseeable risk
  • principles mentioned


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