Evidence map›Paper›PMID 33437878›Full record

ReviewBMJ paediatrics open2020

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

Beate Aurich, Eric Vermeulen, Valéry Elie, Mariette H E Driessens, Christine Kubiak, Donato Bonifazi, Evelyne Jacqz-Aigrain

Abstract readReview
In one paragraph

Review in BMJ paediatrics open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Design and implementation of a Neonatal Family Research Advisory Council (NFRAC).Journal of perinatology : official journal of the California Perinatal Association · 2025
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Beate AurichDepartment of Paediatric Clinical Pharmacology and Pharmacogenetics, Robert Debré Hospital, 48 Boulevard Sérurier, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.ORCID 0000-0002-8830-023X
Eric VermeulenDutch patient association for rare and genetic diseases (VSOP), Soest, The Netherlands.
Valéry ElieDepartment of Paediatric Clinical Pharmacology and Pharmacogenetics, Robert Debré Hospital, 48 Boulevard Sérurier, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Mariette H E DriessensDutch patient association for rare and genetic diseases (VSOP), Soest, The Netherlands.
Christine KubiakThe European Clinical Research Infrastructure Network (ECRIN), 5-7 Rue Watt, Paris, France.
Donato BonifaziConsorzio per le Valutazioni Biologiche e Farmacologiche, Via Nicolo Putignani, Bari, Italy.
Evelyne Jacqz-AigrainDepartment of Paediatric Clinical Phramcology and Pharmacogenetics, Robert Debré Hospital, APHP, 48 Boulevard Sérurier, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

ethicsneonatology

Identifiers

PMID33437878
PMCPMC7778778

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.