Informed consent for neonatal trials: practical points to consider and a check list.
ethics
neonatology
Journal
BMJ paediatrics open
ISSN: 2399-9772
Titre abrégé: BMJ Paediatr Open
Pays: England
ID NLM: 101715309
Informations de publication
Date de publication:
2020
2020
Historique:
received:
20
08
2020
revised:
23
11
2020
accepted:
29
11
2020
entrez:
13
1
2021
pubmed:
14
1
2021
medline:
14
1
2021
Statut:
epublish
Résumé
Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision-making process is influenced by the severity of the child's condition, the benefit-risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both. Misconceptions about the absence of risks or unrealistic expectations about benefits should be openly addressed to avoid misunderstandings which may harm the relationship with the clinical team. Continuous consent can be sought where it is unclear whether the free choice of parental consent has been compromised. Obtaining informed consent is a dynamic process building on trusting relationships. It should include open and honest discussions about benefits and risks. Investigators may benefit from training in effective communication. Finally, involving parents in neonatal research including the development of the informed consent form and the process of obtaining consent should be considered standard practice.
Identifiants
pubmed: 33437878
doi: 10.1136/bmjpo-2020-000847
pii: bmjpo-2020-000847
pmc: PMC7778778
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
e000847Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: BA has worked for GlaxoSmithKline between October 2006 and September 2009 and holds company shares. Between October 2009 and May 2015, she has worked for Novartis.
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