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Parental perspectives on a trial using waived informed consent at birth.
Katheria, Anup C; Schmölzer, Georg M; Law, Brenda; Yoder, Bradley A; Clark, Erin; El-Naggar, Walid; Morales, Ana; Dorner, Rebecca A; Mooso, Benjamin; Rich, Wade; Vora, Farha; Finer, Neil.
Afiliación
  • Katheria AC; Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA. anup.katheria@sharp.com.
  • Schmölzer GM; University of Alberta, Edmonton, AB, Canada.
  • Law B; University of Alberta, Edmonton, AB, Canada.
  • Yoder BA; University of Utah, Salt Lake City, UT, USA.
  • Clark E; University of Utah, Salt Lake City, UT, USA.
  • El-Naggar W; Dalhousie University, Nova Scotia, Canada.
  • Morales A; Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
  • Dorner RA; Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
  • Mooso B; University of California at San Diego, San Diego, CA, USA.
  • Rich W; Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
  • Vora F; Loma Linda University, Loma Linda, CA, USA.
  • Finer N; Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
J Perinatol ; 44(3): 415-418, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38129598
ABSTRACT

OBJECTIVES:

To determine parental perspectives in a trial with waived consent. STUDY

DESIGN:

Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge.

RESULTS:

121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study. 110 (91%) respondents reported that they both understood the information provided in the consent process and had enough time to consider participation. Four percent had a negative opinion on the study's effect on their child's health.

CONCLUSIONS:

Most responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Padres / Consentimiento Informado Límite: Child / Humans / Infant / Newborn Idioma: En Revista: J Perinatol Asunto de la revista: PERINATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Padres / Consentimiento Informado Límite: Child / Humans / Infant / Newborn Idioma: En Revista: J Perinatol Asunto de la revista: PERINATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos