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 USA via the transnational cutting edge pharmaceutical begun approximately 20 years 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 sector. greater than eighty% of all scientific trials within the zone occur in those nations, and the eu medications employer has outlined them as precedence nations in Latin the USA. The authors elevate questions about the standard of information 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 scientific trials within the sector. ​

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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.

CIOMS clarifies that informed consent is a process, and that patients should have time to study the information provided by the researchers and to question anything before they grant their consent to participate in the study. 2. Guideline 8 discusses the risks and benefits that may be considered acceptable, and Guideline 9, how to protect vulnerable populations, including people living in low socio-economic conditions, those with low educational levels, employees, the disabled, people with chronic or debilitating illnesses, indigent groups, residents in homes for aged persons, pregnant women, prisoners, university students, and inmates in state facilities (Macrae 2007).

2007; Rid and Schmidt 2010; Gunson 2009). All have been compiled in response to ethical violations taking place during research with human subjects up to the present day. Some are very general, and can be interpreted in many ways; the most specific cannot be adopted by consensus, because they represent the opinions of the groups which were able to dominate the discussions at that time, as has occurred with the recent versions of the Declaration of Helsinki (Benatar 2005; Rid and Schmidt 2010). Ethical problems during clinical trials are present in all parts of the world,5 but tend to be greater in low- and middle-income countries where the regulatory agencies are weaker, where there is less ability to conduct a scientific-ethical evaluation of research projects, where there are fewer opportunities to carry out research independently from pharmaceutical industry financing, and where there are fewer groups able to monitor the implementation of clinical trials.

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