III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies
Título del documento: III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies
Revista: Revista de investigación clínica
Base de datos: PERIÓDICA
Número de sistema: 000454136
ISSN: 0034-8376
Autores: 1
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2
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Instituciones: 1Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México. México
2Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Comité de Etica, Ciudad de México. México
Año:
Periodo: Sep-Oct
Volumen: 71
Número: 5
Paginación: 297-305
País: México
Idioma: Inglés
Tipo de documento: Artículo
Enfoque: Analítico, crítico
Resumen en inglés Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies
Disciplinas: Medicina,
Ciencia y tecnología
Palabras clave: Investigación médica,
Patrocinadores,
Industria farmacéutica,
Comités de ética
Keyword: Medical research,
Sponsors,
Pharmaceutical industry,
Ethics committees
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