Evidence map›Paper›PMID 26537492›Full record

SynthesisTrials2015

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.

E Wilman, C Megone, S Oliver, L Duley, G Gyte, J M Wright

Registry-linked trialOpen access · goldAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07284329 (Examining the Efficacy of a Parent-targeted Co-designed Digital Media Intervention to Increase Recruitment Rates Across a Multi-site Randomized Clinical Trial in Canadian NICU's), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 11% of its field
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.

NCT07284329 narecruitingnot on this mapstarted 2025, after this paper: background citation

Examining the Efficacy of a Parent-targeted Co-designed Digital Media Intervention to Increase Recruitment Rates Across a Multi-site Randomized Clinical Trial in Canadian NICU's

TypeinterventionalSponsorIWK Health CentreRan2025 to 2026Enrolled787ConditionsConsent ProcessArmsIntervention (Video) Arm
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  18. Implementing two-stage consent pathway in neonatal trials.Archives of disease in childhood. Fetal and neonatal edition · 2023
    Article
  19. Article
  20. The culture of research communication in neonatal intensive care units: key stakeholder perspectives.Journal of perinatology : official journal of the California Perinatal Association · 2021
    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

6 authors at 4 institutions in 1 country.

E WilmanInter-Disciplinary Ethics Applied, University of Leeds, Leeds, UK. eleanor.wilman@gmail.com.
C MegoneInter-Disciplinary Ethics Applied, University of Leeds, Leeds, UK. c.b.megone@leeds.ac.uk.
S OliverSocial Science Research Unit and EPPI-Centre, Institute of Education, University of London, London, UK. S.oliver@ioe.ac.uk.
L DuleyNottingham Clinical Trials Unit, Nottingham Health Science Partners, University of Nottingham, Nottingham, UK. Lelia.Duley@nottingham.ac.uk.
G GyteNational Childbirth Trust, London, UK. gmlgyte@gmail.com.
J M WrightLeeds Institute of Health Sciences, University of Leeds, Leeds, UK. j.m.wright@leeds.ac.uk.
University of Leeds · GBNational Childbirth Trust · GBUniversity of London · GBUniversity of Nottingham · GB

Funding

Department of Health RP-PG-0609-10107
6 · The paper itself

Abstract

backgroundConducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials?

methodsA systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature.

resultsBetween them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent.

conclusionsDespite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.

Indexed as

Infant, PrematureResearch DesignAttitude of Health PersonnelClinical Trials as TopicEmergenciesEmotionsGestational AgeHealth Knowledge, Attitudes, PracticeHumansInfant, NewbornInfant, Newborn, DiseasesMotivationParental ConsentParentsRisk AssessmentVolition

Identifiers

PMID26537492
PMCPMC4634156
OpenAlexW2115324689

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.