I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies
Rev. invest. clín
;
71(3): 149-156, May.-Jun. 2019. tab, graf
Article
in English
| LILACS
| ID: biblio-1289682
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.
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Research Design
/
Ethics Committees, Research
/
Observational Studies as Topic
Type of study:
Practice guideline
/
Observational study
/
Qualitative research
/
Risk factors
Limits:
Humans
Language:
English
Journal:
Rev. invest. clín
Journal subject:
Medicine
Year:
2019
Type:
Article
Affiliation country:
Mexico
Institution/Affiliation country:
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán/MX
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