Closing the evidence gap in infectious disease: point-of-care randomization and informed consent.
Clin Microbiol Infect
; 23(2): 73-77, 2017 Feb.
Article
en En
| MEDLINE
| ID: mdl-27497812
ABSTRACT
The informed consent document is intended to provide basic rights to patients but often fails to do so. Patients' autonomy may be diminished by virtue of their illness; evidence shows that even patients who appear to be ideal candidates for understanding and granting informed consent rarely are, particularly those with acute infections. We argue that for low-risk trials whose purpose is to evaluate nonexperimental therapies or other measures towards which the medical community is in a state of equipoise, ethics committees should play a more active role in a more standardized fashion. Patients in the clinic are continually subject to spontaneous 'pseudo-randomizations' based on local dogma and the anecdotal experience of their physicians. Stronger ethics oversight would allow point-of-care trials to structure these spontaneous randomizations, using widely available informatics tools, in combination with opt-out informed consent where deemed appropriate.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Distribución Aleatoria
/
Enfermedades Transmisibles
/
Sistemas de Atención de Punto
/
Consentimiento Informado
Tipo de estudio:
Clinical_trials
Aspecto:
Ethics
Límite:
Humans
Idioma:
En
Revista:
Clin Microbiol Infect
Asunto de la revista:
DOENCAS TRANSMISSIVEIS
/
MICROBIOLOGIA
Año:
2017
Tipo del documento:
Article