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[Clinical trials in "developing" countries: is there a special "Third World" ethic?].

David J Rothman1

  • 1Center for the Study of Society and Medicine, Columbia University, New York, USA. Djr5@columbia.edu

Zeitschrift Fur Arztliche Fortbildung Und Qualitatssicherung
|March 5, 2004
PubMed
Summary

Clinical trials in developing nations, particularly for AIDS treatments, have raised ethical concerns due to lower standards than international guidelines. This highlights issues with informed consent in diverse cultural settings.

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Area of Science:

  • Medical ethics
  • Global health research
  • Clinical trial conduct

Background:

  • Increasing frequency of clinical trials conducted in developing countries.
  • Concerns regarding ethical standards in international AIDS therapy and vaccine research.
  • Involvement of American researchers and institutions in studies with potentially lower ethical oversight.

Purpose of the Study:

  • To analyze ethical "double standards" in international clinical research.
  • To examine controversies arising from studies with compromised ethical practices.
  • To investigate challenges in implementing informed consent across different cultural contexts.

Main Methods:

  • Reconstruction of controversies surrounding specific clinical studies.
  • Analysis of the conditions enabling research ethics "double standards".

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  • Focus on the concept and practical application of informed consent.

    • Main Results:

    • Identified lower ethical standards in some international AIDS research compared to Declaration of Helsinki.
    • Highlighted controversies and ethical debates following study publications.
    • Underscored difficulties in achieving truly informed consent in diverse cultural settings.

    Conclusions:

    • The practice of conducting clinical trials in developing countries necessitates stringent ethical oversight.
    • Addressing cultural nuances is crucial for the ethical implementation of informed consent.
    • International collaboration in research must uphold universally accepted ethical principles.