Implementing two-stage consent pathway in neonatal trials.
Arch Dis Child Fetal Neonatal Ed
; 108(1): 79-82, 2023 Jan.
Article
en En
| MEDLINE
| ID: mdl-34949637
ABSTRACT
Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number ISRCTN89654042.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Padres
/
Consentimiento Informado
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Newborn
/
Pregnancy
Idioma:
En
Revista:
Arch Dis Child Fetal Neonatal Ed
Asunto de la revista:
PEDIATRIA
/
PERINATOLOGIA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Reino Unido