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

By Nuria Homedes, Antonio Ugalde

The outsourcing of scientific trials to Latin the US by means of the transnational cutting edge pharmaceutical all started approximately two decades in the past. utilizing archival info 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 scientific trials within the sector ensue in those nations, and the eu drugs service provider has outlined them as precedence nations in Latin the US. The authors bring up 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 offered during this quantity, the 1st in-depth research of scientific trials within the area. ​

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10, Vol. 2, pp. 181–182. Washington, DC: U. S. Government Printing Office, 1949. html) Directives for Human Experimentation 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

At the other extreme are those who consider that ethical principles depend on the environment (Christakis et al. 1991). Their viewpoint is that studies with placebo control in low- and middle-income countries are justified, because none of the study participants would receive treatment if they were not enrolled in the clinical trial. Another contemporary viewpoint is that northern countries, especially the USA, should not try to impose their ethical values on the rest of the world (Macklin 2001; Tealdi 2006; Garrafa and Lorenzo 2008).

The National Bioethics Advisory Committee (2001) and the Nuffield (2002) reports support the exportation of the ethical review model to low- and middle-income countries and promote the development of resources in countries where research is conducted. Some authors see this as moral imperialism (Tealdi 2006; Garrafa and Lorenzo 2008; Lescano et al. 2008; McIntosh et al. 2008). One initiative has been to establish agreements between universities in high income countries and those in low- and middle-income countries to improve the skills needed to conduct clinical trials (Sidle et al.

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