Clinical Trials in Latin America: Where Ethics and Business by Nuria Homedes, Antonio Ugalde

By Nuria Homedes, Antonio Ugalde

The outsourcing of medical trials to Latin the US by means of the transnational leading edge pharmaceutical begun approximately two decades in the past. utilizing archival details and box paintings in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors speak about the regulatory contexts and the moral dimensions of human experimentation within the quarter. greater than eighty% of all medical trials within the sector happen in those international locations, and the eu drugs organisation has outlined them as precedence international locations in Latin the United States. The authors increase questions on the standard of knowledge acquired from the pains and the violation of human rights in the course of their implementation. Their findings are provided during this quantity, the 1st in-depth research of medical trials within the area. ​

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8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

34 N. Homedes and A. Ugalde 29. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee.

2 Standard Treatment in Low- and Middle-Income Countries, and the Concept of Vulnerability In the world population, 13 % consume 87 % of medications, which, leads us to safely say that most residents of low- and middle-income countries lack access to needed medicines. Several ethicists have no objection to placebo controlled studies in these countries, because patients have no access to treatment anyway and the trials offer the possibility to advance science (Levine 1998, 1999). Others (Lurie and Wolfe 1997) argue that lack of access is an economic issue, which cannot justify studies in these populations that would not be permitted in industrialized countries.

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