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Pregnancy and informed consent to research.

L H Glantz1

  • 1Boston University School of Public Health, USA.

Journal of the American Medical Women'S Association (1972)
|November 9, 2000
PubMed
Summary

Federal regulations since 1975 have limited pregnant women's research participation rights by requiring paternal consent. Proposed 1998 amendments to recognize women as sole decision-makers remain unadopted, despite increased legal recognition of women's autonomy.

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Area of Science:

  • Bioethics
  • Public Health Law
  • Women's Health Research

Background:

  • Federal regulations have historically restricted pregnant women's autonomy in research participation.
  • Since 1975, regulations mandated paternal consent for fetal participation in research.
  • This requirement has been challenged by evolving legal recognition of pregnant women's rights and bodily autonomy.

Purpose of the Study:

  • To analyze the historical context and evolution of federal regulations concerning pregnant women's consent in human subjects research.
  • To examine proposed regulatory changes aimed at empowering pregnant women as sole decision-makers.
  • To assess the current status of these proposed amendments and their impact on research ethics.

Main Methods:

  • Review of federal regulations and historical documents pertaining to human subjects research.
  • Analysis of legal precedents and scholarly discourse on pregnant women's rights in research.
  • Examination of proposed amendments by the Department of Health and Human Services in 1998.

Main Results:

  • Federal regulations from 1975 imposed limitations on pregnant women's research consent authority by requiring father's consent.
  • Legal advancements have increasingly affirmed pregnant women's right to make autonomous decisions, including research participation.
  • Despite proposed 1998 amendments to eliminate paternal consent requirements and recognize women as sole decision-makers, these changes have not been implemented.

Conclusions:

  • Current federal regulations continue to impede pregnant women's decision-making authority in research.
  • The proposed amendments represent a significant step towards aligning research ethics with established legal principles of autonomy.
  • The non-adoption of these amendments highlights ongoing challenges in translating legal recognition of women's rights into regulatory practice for human subjects research.

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