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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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3 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I)
Pages 18-22

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From page 18...
... THE PREGNANT WOMAN AS SUBJECT Both He National Commission and the federal regulations distinguish clinical research involving pregnant women on the basis of whether the woman or the fetus is the subject of He research. In each case they make a further distinction between research that is therapeutic-the purpose of the activity is to meet He "health needs of the mother" or "the health needs of the particular fetus" and research that is nontherapeutic.
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From page 19...
... If use of an experimental drug poses more than minimal risks to the fetus and offspring, a woman should have even less of a moral right to take such a drug to treat a cold, morning sickness, or any condition that is not life-threatening or very serious, where the primary purpose of the research is to meet her health needs. Thus a researcher, an IRB, or other review body should males a judgment about the degree of the benefits or burdens of taking or forgoing the experimental treatment relative to the harm to the fetus and offspnag if it is given.
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From page 20...
... No one, not even the pregnant woman, has a moral right to engage in experimental clinical research not necessary to meet her own substantial health needs when there will be a major impact on offspring. THE: [E:TUS AS SUBJI:Cr Clinical research involving pregnant women may also be directed at the fetus as the subject of the research.
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From page 21...
... On the other hand, parents should be free to have experimental in utero therapies used when they reasonably believe that the benefits of the procedure to offspring outweigh the risks. Nontherapeutic Fetal Research: Not to Meet the Fetus's Health Needs The federal regulations restrict research not directed to meet the health needs of the fetus to situations in which "the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means" (45 C.F.R.
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From page 22...
... Treating all fetuses the same overlooks the fact that nontherapeutic research on fetuses going to term could affect the interests of offspring, whereas research on fetuses to be aborted cannot hurt future offspring, much less previable fetuses, which are nonsentient and do not have interests. There is one possible risk with nontherapeutic research on fetuses going to be aborted that is of ethical concem.
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Key Terms

  • pregnant women
  • research involving
  • previable fetuses
  • future offspring
  • nontherapeutic research

  • involving pregnant
  • ethical concern
  • experimental procedures
  • experimental procedure
  • human subjects

  • expected offspring
  • minimal risk
  • national commission
  • nontherapeutic fetal
  • experimental drug

  • treat handicap
  • alternative treatment
  • research ethically
  • fetal research
  • fetus imposed

  • involving viable
  • bring previable
  • fetus include
  • sufficient opportunity
  • morning sickness

  • benefit offspring
  • women whenever
  • regulations permit
  • experimental clinical
  • interventions affecting


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