Misrepresenting "Usual Care" in Research: An Ethical and Scientific Error.
Am J Bioeth
; 20(1): 31-39, 2020 01.
Article
en En
| MEDLINE
| ID: mdl-31896328
ABSTRACT
Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
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Ensayos Clínicos como Asunto
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Revisión Ética
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Nivel de Atención
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Error Científico Experimental
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Protocolos de Ensayos Clínicos como Asunto
Tipo de estudio:
Guideline
Límite:
Humans
Idioma:
En
Revista:
Am J Bioeth
Asunto de la revista:
ETICA
Año:
2020
Tipo del documento:
Article