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Nuria Homedes, MD, DrPH
associate professor of management, policy and community health, School of Public Health
 
Dr. Homedes

Creating a Network to Conduct Research on Ethics and Clinical Trials in Latin America

 

More and more pharmaceutical companies are beginning to outsource clinical trials to third world countries such as, Brazil, Chile, Mexico, Argentina, Guatemala, Colombia, Peru, and Costa Rica.  These countries are limited in their experience to conduct clinical research trials and regulatory agencies are weak and unable to handle current influxes in business.  Violations of ethical principals are frequent and there is little communication among countries, which leads to duplication of work, and countries have not been able to benefit from what others have learned. 

Nuria Homedes, MD, DrPH, associate professor of management, policy and community health at The University Texas School of Public Health at Houston, and editor of Boletin Farmacos, a free access electronic bulletin board, heard about this injustice when she found an article written by a Costa Rican journalist.  A clinical trial studying the effectiveness of a vaccine against the papilloma virus, 15,000 participants strong, began without obtaining informed consent forms from guardians. Later, she found psychiatric patients had never filled out consent forms in another research project based in Argentina.  Even more frightening is that the FDA has been using some false reports to approve drugs that are sold in the United States.  After comparing notes with representatives from other Latin American countries, Homedes learned from Colombian experts that participants in clinical trials did not understand the process or reason for informed consent forms.  

Homedes feels that she can make a difference and is creating a network to conduct research on ethics and clinical trials in Latin America.  She has a unique platform, being editor of an online message board, so her plan is to first, foster the creation of a research network to document how clinical trials are being conducted in Latin America and propose improvements.  Her second goal is to create channels of communication, so if an ethical violation occurs in one country it can be corrected before it happens in a neighboring nation.  Finally, Homedes will promote the development of a research agenda, including multicentric studies and the preparation of research projects that could be submitted to foundations or agencies interested in funding proper bioethical research in Latin America.

As an International Programs Award recipient, Homedes can take steps closer to reaching her goal of meeting with key Latin American bio-ethicists with interest in pharmaceuticals.  Her entire budget will be used to finance a two-day meeting, held in Argentina in May 2008, for key Latin American researchers who are interested in pursuing research on the ethical dimensions of clinical trials and other pharmaceutical-related issues. 

 
March 6

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Last updated March 3, 2008
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