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

By Nuria Homedes, Antonio Ugalde

The outsourcing of medical trials to Latin the United States by means of the transnational leading edge pharmaceutical all started approximately two decades in the past. utilizing archival details and box paintings in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors talk about the regulatory contexts and the moral dimensions of human experimentation within the quarter. greater than eighty% of all medical trials within the zone ensue in those nations, and the eu medications service provider has outlined them as precedence nations in Latin the United States. The authors bring up questions about the standard of knowledge acquired from the pains and the violation of human rights in the course of their implementation. Their findings are awarded during this quantity, the 1st in-depth research of medical trials within the sector. ​

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Extra info for Clinical Trials in Latin America: Where Ethics and Business Clash

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In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship. For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden.

Appropriate caution must be exercised in the conduct of medical research that may harm the environment. 14. The design and performance of each research study involving human subjects must be clearly described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

Good Clinical Practice (ICH GCP4) In a comparison between the Declaration of Helsinki, 2008, and Good Clinical Practice (GCP), it was found that the following items are not included in the GCP: • Requirement for researchers to give information about study financing, sponsors, and conflicts of interest to ethics committee members and to the study participants (continued) 4 ICH GCP: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Good Clinical Practice.

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