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Ethical issues in clinical trials in developing countries.

Baruch A Brody1

  • 1Center for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Houston, Texas 77030, USA. bbrody@bcm.tmc.edu

Statistics in Medicine
|September 27, 2002
PubMed
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Ethical issues in international health research, including placebo use and exploitation, are examined. New standards for placebo control groups are proposed, and concerns about coercive offers are addressed.

Area of Science:

  • Global Health
  • Medical Ethics
  • Clinical Trials

Background:

  • Vertical transmission trials in developing countries raise significant ethical concerns.
  • Key issues include placebo control groups, coercive participation offers, and exploitation of host nations.

Purpose of the Study:

  • To examine critical ethical issues in international vertical transmission trials.
  • To propose a new standard for the acceptable use of placebo control groups.
  • To address concerns regarding coercive offers and exploitation in global health research.

Main Methods:

  • Ethical analysis of vertical transmission trials.
  • Development of a new ethical standard for placebo control groups.
  • Examination of coercion and exploitation in international research contexts.
Keywords:
Biomedical and Behavioral Research

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Main Results:

  • The use of placebo control groups in certain contexts is deemed ethically problematic.
  • Concerns about the coerciveness of participation offers are found to be largely unfounded.
  • Exploitation concerns are better mitigated by focusing on post-trial subject care.

Conclusions:

  • A new ethical framework is proposed for the use of placebo controls in developing countries.
  • The ethical validity of coercive participation offers requires re-evaluation.
  • Ensuring long-term subject welfare is paramount in addressing exploitation concerns in global health research.