Gabriela Minaya- National Institute of Health of Peru
Gabriela Minaya
- National Institute of Health of Peru
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19
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Publications (19)
The varied, abrupt and amazing geography of the land of Peru is home of one of the major concentrations of indigenous peoples in the world. The asymmetry of power, however, in their relationship with the rest of society and the State is still very evident in their social exclusion, their gap in social and economic development, barriers in their acc...
In 1981 the President of Peru issued a decree to regulate pharmaceutical research in the country but the Ministry of Health did not register any clinical trial involving humans until 1995. The rapid growth in the number of clinical trials and trial participants that occurred during the following years led the Ministry of Health to revise the entire...
la investigación experimental con personas debe ceñirse a la legislación especial sobre la materia y a los postulados éticos contenidos en la Declaración de Helsinki y sucesivas declaraciones que actualicen los referidos postulados
El artículo hace una revisión histórica del proceso regulatorio de ensayos clínicos hasta llegar a la publicación del Reglamento de ensayos clínicos en el Perú, mediante Decreto Supremo 017-2006-SA. En menos de un año se modificó parte del Reglamento, teniendo muchas críticas entre ellas las de la Defensoría del Pueblo. Por otra parte, se hace un r...
El desarrollo de investigación científica en salud requiere de un sistema de investigación sostenido, articulado y coherente con las prioridades de investigación; este sistema de investigación implica la existencia de financiamiento tanto interno como externo, y de disponer recursos humanos competentes. El canon minero es un derecho constitucional,...
Objetivos. Describir las principales características de los ensayos clínicos (EC) autorizados en el Perú desde 1995 a agosto de 2012. Materiales y métodos. Se realizó un estudio transversal, en el que se revisaron todos los expedientes de protocolos de EC presentados para su evaluación y posible aprobación al INS, cuyos datos forman parte del Regis...
Objective:
To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012.
Material and methods:
Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials...
This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory auth...
The development of scientific health research requires a sustained and articulated research system that is consistent with the research priorities, as well as both internal and external funding, and availability of competent human resources. The Mining Canon, a constitutional right, has been partly used to foster applied scientific research in publ...
Objective. To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012. Material and methods. Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. W...
The development of scientific health research requires a sustained and articulated research system that is consistent with the research priorities, as well as both internal and external funding, and availability of competent human resources. The Mining Canon, a constitutional right, has been partly used to foster applied scientific research in publ...
This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory auth...
Peru has made great strides in clinical trials (CTs) regulation in recent years. However, by 2008, Peru did not have guidance on how to review the ethical and scientific aspects of clinical trials for use by research ethics committees (RECs). In 2009, REC inspections by the Peruvian National Institute of Health (NIH) indicated that there were serio...
Se realizó una revisión de los procesos de constitución y funciones de instancias nacionales de la ética de la investigación en salud en países de Latinoamérica y Europa, que se caracterizan por su relación con la legislación y estructuras gubernamentales del ámbito de la salud, pero, sobre todo, por estar vinculados en casi la totalidad de casos c...
We performed a review of the constitution processes and functions of national commissions on health research ethics in Latin America and Europe countries, which are characterized by its relation with the legislation and governmental structures in health sector, but, especially, in almost totality of cases for being linked by the functioning of the...
We performed a review of the constitution processes and functions of national commissions on health research ethics in Latin America and Europe countries, which are characterized by its relation with the legislation and governmental structures in health sector, but, especially, in almost totality of cases for being linked by the functioning of the...
