| Revista: | Revista de investigación clínica |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000454194 |
| ISSN: | 0034-8376 |
| Autores: | González Duarte, Alejandra1 Kaufer Horwitz, Martha2 Zambrano, Elena1 Durand Carbajal, Marta2 Alberú Gómez, Josefina2 Galindo Fraga, Arturo1 Armenta Espinosa, Alejandra1 Loria Acereto, Alvar2 Rull Gabayet, Marina2 Medina Franco, Heriberto2 Sierra Salazar, Mauricio1 Hinojosa, Carlos A2 Oseguera Moguel, Jorge1 Aguayo González, Álvaro1 Domínguez Sánchez, Patricia1 Hernández Jiménez, Sergio1 Aguilar Salinas, Carlos A2 |
| Instituciones: | 1Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Comité de Etica, Ciudad de México. México 2Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Comité de Investigación, Ciudad de México. México |
| Año: | 2019 |
| Periodo: | May-Jun |
| Volumen: | 71 |
| Número: | 3 |
| Paginación: | 149-156 |
| País: | México |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Analítico, prospectivo |
| Resumen en inglés | It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study |
| Disciplinas: | Medicina |
| Palabras clave: | Investigación médica, Estudios observacionales, Registros médicos, Entrevista, Encuestas de salud, Reportes de caso, Estudios retrospectivos, Consentimiento informado, Comités de ética |
| Keyword: | Medical research, Observational studies, Medical records, Interview, Health surveys, Case reports, Retrospective studies, Informed consent, Ethics committees |
| Texto completo: | Texto completo (Ver HTML) Texto completo (Ver PDF) |
