Evidence map›Paper›PMID 41949671›Full record

ArticleEuropean journal of pediatrics2026

Facilitators and barriers in obtaining informed consent for neonatal research: a scoping review.

Kelly K Storm, Veroni Stolk, Wes Onland, Sylvia A Obermann-Borst, Anne Smits, Irwin K M Reiss, Anton H van Kaam, Sinno H P Simons, G Jeroen Hutten

Abstract readScoping Review
In one paragraph

Article in European journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Kelly K StormDepartment of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands. k.storm@erasmusmc.nl.
Veroni StolkDepartment of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.
Wes OnlandDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, The Netherlands.
Sylvia A Obermann-BorstCare4Neo, Neonatal Patient and Parent Advocacy Organization, Rotterdam, The Netherlands.
Anne SmitsNeonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.
Irwin K M ReissDepartment of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.
Anton H van KaamDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, The Netherlands.
Sinno H P SimonsDepartment of Neonatal and Pediatric Intensive Care, Division of Neonatology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.
G Jeroen HuttenDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Obtaining informed consent is crucial in clinical research. This process is particularly challenging in a Neonatal Intensive Care Unit. Parents of critically ill neonates already experience high emotional distress, and soliciting consent for research may exacerbate this burden. As evidence-based medicine is essential to improve neonatal care, clinical trials in neonates require adequate and non-selective enrollment. This study aims to find facilitators and barriers influencing the consent process in neonatal research. A scoping review was conducted using PubMed, Embase, Web of Science, Cochrane CENTRAL, CINAHL, and Google Scholar to identify peer-reviewed articles published in English, focusing on factors influencing parental decisions regarding their child's enrollment in neonatal research. Identified factors were thematically categorized and labeled based on the level of evidence and direction of influence. From the 2108 retrieved articles, 20 were included for analysis. Common facilitators of research participation were perceived benefits for the child, altruistic motives to benefit or help other children, and the wish to contribute to knowledge and science. Notably, a higher severity of illness facilitated consent. Important barriers to participation were parental stress and fear, concerns about risks for the child, and the logistical burden of participation.

conclusionObtaining consent in neonatal research is a complex process influenced by a nuanced balance between facilitators and barriers. The findings highlight the importance of providing adequate support to reduce the burden of participation. Through trust and clear communication, parents can feel empowered to make well-informed decisions, even in the most challenging situations. WHAT IS KNOWN: • Obtaining informed consent for research in the NICU is challenging due to the critical illness of the neonates, parental stress, and time constraints, often resulting in low and selective enrollment. WHAT IS NEW: • Parents are often motivated by perceived benefits, altruism, and the wish to contribute to knowledge and science, while parental fear, perceived risks, and burden of participation are barriers to research participation.

Indexed as

Biomedical ResearchInformed ConsentParental ConsentParentsDecision MakingHumansInfant, NewbornIntensive Care Units, NeonatalClinical researchInformed consentNeonatologyParental decision-making

Identifiers

PMID41949671
PMCPMC13061776

What Socratic holds

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LicenceCC BY
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Registered trials

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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 Socratic graph.