Evidence map›Paper›PMID 41963975›Full record

ArticleBMC medical ethics2026

Parent perspectives on neonatal research without prior consent: a mixed-methods interview study.

Stephanie A Kraft, Abigail Brickler, Abril Beretta, Rishabh Jain, Andrea Kelsh, Kaashif A Ahmad, Justin T Clapp, Neal W Dickert, Rebecca A Dorner, Katherine F Guttmann and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

15 authors.

Stephanie A KraftDepartment of Bioethics and Decision Sciences, Geisinger College of Health Sciences, Danville, PA, USA. skraft1@geisinger.edu.
Abigail BricklerDepartment of Bioethics and Decision Sciences, Geisinger College of Health Sciences, Danville, PA, USA.
Abril BerettaTreuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA.
Rishabh JainDepartment of Pediatrics, University of Washington, Seattle, WA, USA.
Andrea KelshTreuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA.
Kaashif A AhmadPediatrix Neonatology of San Antonio, San Antonio, TX, USA.
Justin T ClappDepartment of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Neal W DickertDepartment of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Rebecca A DornerNeonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
Katherine F GuttmannDepartment of Pediatrics, Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Anup C KatheriaNeonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA.
Stephanie K KukoraBioethics Center and Division of Neonatology, Department of Pediatrics, Children's Mercy Kansas City, Kansas City, MO, USA.
Benjamin A MoosoOffice of IRB Administration, UC San Diego Health Sciences, San Diego, CA, USA.
Elliott Mark WeissTreuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA.
FAM-CONNECT Collaborative

Funding

Seattle Children's Research Institute Pediatric Pilot Funds (MPIs Weiss/Kraft)
6 · The paper itself

Abstract

backgroundRecruitment for clinical research in the neonatal intensive care unit (NICU) is difficult, which may lead to low enrollment rates, systematically skewed samples, and nongeneralizable results. Research without prior consent (RWPC), defined as obtaining consent only after infants have been randomized to a treatment arm, may improve enrollment but raises ethical challenges. There is a need to better understand how parents with lived experience of having an infant in the NICU consider RWPC’s impact on critical ethical values related to informed consent, including decision-making, respect, and trust. This mixed-methods study aimed to describe parental perceptions of the acceptability and ethical implications of RWPC for neonatal clinical research.

methodsInterviews were conducted with parents of infants recently admitted to the NICU across 6 US locations. Parents were asked a series of Likert-scale questions followed by open-ended questions with interactive probes about the acceptability of hypothetical study vignettes using either prospective informed consent or RWPC. Likert-scale responses were analyzed using mixed-effects linear regression models. Open-ended responses were inductively coded and thematically analyzed through a constructivist lens.

resultsParents (n = 38) scored the acceptability of RWPC vignettes lower than prospective informed consent vignettes on mean adjusted total score and items about perceived control, values-aligned decision-making, and respect for babies and families. Four themes were identified as impacting parents’ views on acceptability of RWPC: (1) equipoise as the foundation for acceptability of consent approaches, (2) informational preferences for consent approaches, (3) complex interplay between consent approaches and research relationships, and (4) consent approaches as shaping perceived control.

conclusionsParents’ perspectives illustrate key considerations for the potential use of RWPC as well as broader reflections on engagement about clinical research in the NICU setting. Situational factors in the NICU raise barriers to consent, and RWPC may be differentially acceptable depending on study specifics. Thoughtful communication about equipoise and attention to trust are essential when considering alternative methods of consent. Future research should further examine ethical trade-offs involved in RWPC and varied perceptions across study features.

Indexed as

Biomedical ResearchInformed ConsentIntensive Care Units, NeonatalParentsPatient SelectionAdultDecision MakingFemaleHumansInfant, NewbornInterviews as TopicMaleQualitative ResearchTrustUnited StatesClinical trialsDeferred consentInformed consentInterviewsNeonatalNICUWaiver

Identifiers

PMID41963975
PMCPMC13270558

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.