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Hidden risks associated with clinical trials in developing countries
  1. Cláudio Lorenzo1,
  2. Volnei Garrafa2,
  3. Jan Helge Solbakk3,4,
  4. Susana Vidal5
  1. 1Department of Public Health, University of Brasília, Brazil Post-Graduation Program of Bioethics, Brasília, Brazil
  2. 2UNESCO Chair of Bioethics, Post-Graduation Program of Bioethics, University of Brasília, Brasília, Brazil
  3. 3Section for Medical Ethics, Department of General Practice and Community Medicine, University of Oslo, Oslo, Norway
  4. 4Centre for International Health, University of Bergen, Bergen, Norway
  5. 5UNESCO Regional Programme of Bioethics and Ethics of Science, SHS Sector, UNESCO Regional Office for Science, Montevideo, Uruguay
  1. Correspondence to Professor Cláudio Lorenzo, Núcleo de Estudos e Pesquisas em Bioética, NEPeB, Campus Universitário Darcy Ribeiro, Faculdade de Ciências da Saúde, Brasília, DF – Brasil Caixa Postal 04451, CEP 70.904-970, Brazil; claudiolorenzo{at}


The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems.

  • bioethics
  • clinical trials
  • drugs and drug industry
  • ethics committees
  • history of health ethics
  • poor and low-income countries
  • research ethics
  • risk assessment
  • social control of human experimentation

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  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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