I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies
Rev. invest. clín
; Rev. invest. clín;71(3): 149-156, May.-Jun. 2019. tab, graf
Article
en En
| LILACS
| ID: biblio-1289682
Biblioteca responsable:
BR1.1
ABSTRACT
Abstract 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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
LILACS
Asunto principal:
Proyectos de Investigación
/
Comités de Ética en Investigación
/
Estudios Observacionales como Asunto
Tipo de estudio:
Guideline
/
Observational_studies
/
Qualitative_research
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Rev. invest. clín
Asunto de la revista:
MEDICINA
Año:
2019
Tipo del documento:
Article
País de afiliación:
México