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Informed consent for neonatal trials: practical points to consider and a check list

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...

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Autores principales: Aurich, Beate, Vermeulen, Eric, Elie, Valéry, Driessens, Mariette H E, Kubiak, Christine, Bonifazi, Donato, Jacqz-Aigrain, Evelyne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7778778/
https://www.ncbi.nlm.nih.gov/pubmed/33437878
http://dx.doi.org/10.1136/bmjpo-2020-000847
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author Aurich, Beate
Vermeulen, Eric
Elie, Valéry
Driessens, Mariette H E
Kubiak, Christine
Bonifazi, Donato
Jacqz-Aigrain, Evelyne
author_facet Aurich, Beate
Vermeulen, Eric
Elie, Valéry
Driessens, Mariette H E
Kubiak, Christine
Bonifazi, Donato
Jacqz-Aigrain, Evelyne
author_sort Aurich, Beate
collection PubMed
description 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.
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spelling pubmed-77787782021-01-11 Informed consent for neonatal trials: practical points to consider and a check list Aurich, Beate Vermeulen, Eric Elie, Valéry Driessens, Mariette H E Kubiak, Christine Bonifazi, Donato Jacqz-Aigrain, Evelyne BMJ Paediatr Open Review 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. BMJ Publishing Group 2020-12-29 /pmc/articles/PMC7778778/ /pubmed/33437878 http://dx.doi.org/10.1136/bmjpo-2020-000847 Text en © 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. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Review
Aurich, Beate
Vermeulen, Eric
Elie, Valéry
Driessens, Mariette H E
Kubiak, Christine
Bonifazi, Donato
Jacqz-Aigrain, Evelyne
Informed consent for neonatal trials: practical points to consider and a check list
title Informed consent for neonatal trials: practical points to consider and a check list
title_full Informed consent for neonatal trials: practical points to consider and a check list
title_fullStr Informed consent for neonatal trials: practical points to consider and a check list
title_full_unstemmed Informed consent for neonatal trials: practical points to consider and a check list
title_short Informed consent for neonatal trials: practical points to consider and a check list
title_sort informed consent for neonatal trials: practical points to consider and a check list
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7778778/
https://www.ncbi.nlm.nih.gov/pubmed/33437878
http://dx.doi.org/10.1136/bmjpo-2020-000847
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