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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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-02-01
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| Series: | BMJ Paediatrics Open |
| Online Access: | https://bmjpaedsopen.bmj.com/content/4/1/e000847.full |
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| author | Donato Bonifazi Evelyne Jacqz-Aigrain Christine Kubiak Mariette H E Driessens Beate Aurich Eric Vermeulen Valéry Elie |
| author_facet | Donato Bonifazi Evelyne Jacqz-Aigrain Christine Kubiak Mariette H E Driessens Beate Aurich Eric Vermeulen Valéry Elie |
| author_sort | Donato Bonifazi |
| collection | DOAJ |
| 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. |
| format | Article |
| id | doaj-art-d02803dc163a480592694dd5c0a134fa |
| institution | Kabale University |
| issn | 2399-9772 |
| language | English |
| publishDate | 2020-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Paediatrics Open |
| spelling | doaj-art-d02803dc163a480592694dd5c0a134fa2024-12-01T06:10:09ZengBMJ Publishing GroupBMJ Paediatrics Open2399-97722020-02-014110.1136/bmjpo-2020-000847Informed consent for neonatal trials: practical points to consider and a check listDonato Bonifazi0Evelyne Jacqz-Aigrain1Christine Kubiak2Mariette H E Driessens3Beate Aurich4Eric Vermeulen5Valéry Elie6TEDDY European Network of Excellence for Paediatric Research, Via Luigi Porta 14, Pavia, ItalyParis University, Paris, FranceThe European Clinical Research Infrastructure Network (ECRIN), 5-7 Rue Watt, Paris, FranceDutch patient association for rare and genetic diseases (VSOP), Soest, The Netherlandsconsultant in drug safetyDutch patient association for rare and genetic diseases (VSOP), Soest, The NetherlandsDepartment of Paediatric Clinical Pharmacology and Pharmacogenetics, Robert Debré Hospital, 48 Boulevard Sérurier, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, FranceObtaining 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.https://bmjpaedsopen.bmj.com/content/4/1/e000847.full |
| spellingShingle | Donato Bonifazi Evelyne Jacqz-Aigrain Christine Kubiak Mariette H E Driessens Beate Aurich Eric Vermeulen Valéry Elie Informed consent for neonatal trials: practical points to consider and a check list BMJ Paediatrics Open |
| 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 |
| url | https://bmjpaedsopen.bmj.com/content/4/1/e000847.full |
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