Gerardo Gonzalez

The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies, and that medical care of industry-sponsored research trials is better than their usual medical care. The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study. The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation. Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Este primer ensayo esta organizado en tres partes. En la primera desarrolla una amplia argumentación teórica que le permite definir y sustentar las herramientas fundamentales con las que se trabaja en el instituto, tales como los conceptos de ecosistema, cultura, ambiente y desarrollo. A partir de esta reflexión, el autor plantea la necesidad de construir estrategias para materializase la idea de desarrollo sostenible y como ejemplo presenta la creación del IDEADE. Finalmente, en el ensayo se intenta demostrar la validez y eficacia de la conceptualización básica de la que se parte, examinando resultados de sus operacionalización en dos de los proyectos realizados por el IDEADE.