Article Text

Download PDFPDF
Parental experiences of being approached to join multiple neonatal clinical trials: qualitative study (PARENT)
  1. Judy Richards1,
  2. Judith Rankin1,
  3. Ed Juszczak2,
  4. Jon Dorling3,
  5. William McGuire4,
  6. Nicholas D Embleton1,5
  1. 1Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom
  2. 2National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK
  3. 3Division of Neonatal-Perinatal Medicine, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
  4. 4Centre for Reviews and Dissemination, University of York, York, UK
  5. 5Newcastle Neonatal Service, Newcastle Hospitals NHS Trust, Newcastle upon Tyne, United Kingdom
  1. Correspondence to Dr Nicholas D Embleton, Newcastle University, Newcastle upon Tyne NE1 7RU, UK; nicholas.embleton{at}ncl.ac.uk

Abstract

Objective To explore parents’ perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study.

Design A qualitative study involving 17 in-depth semistructured interviews, with parents who had been approached for multiple studies and who subsequently consented for their infant(s) to join at least one. Parents who declined all studies were not approached.

Setting and participants Parents of preterm infants receiving care at one of three neonatal intensive care units in the north of England.

Findings Most parents did not view concurrent participation in multiple trials or studies as a significant issue within the wider context of their infant’s care. Most parents did not feel pressured into enrolling their infant into more than one study, but some suggested that participation in several provided justification for the subsequent refusal to join others, articulating feeling of guilt at saying ‘no’, and others appeared fatigued by multiple approaches. Parents focused on the perceived risks and benefits of each individual study and, while acknowledging that making a fully informed decision was not possible, largely agreed due to their belief in the benefits of research, trust in the health professionals caring for their baby and a range of complex personal motivations.

Conclusions Parents valued the autonomy to make decisions about participation and felt, with hindsight, that their decisions were right. Research teams could be more aware of parental feelings of guilt or gratitude that may motivate them to give consent. Similarly, the capacity of parents to fully remember details of multiple studies when they are stressed, and their infant is sick, should be taken into consideration, and continued efforts should be made to ensure ongoing consent to participation.

  • qualitative research
  • neonatology
  • ethics
View Full Text

Statistics from Altmetric.com

Footnotes

  • Twitter @NeoResearch_Net

  • Contributors All authors contributed to the design of the study, drafting and revision of the manuscript for relevant intellectual content, and approval of the final version for publication, and agreed to be accountable for all aspects of the work.

  • Funding The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Funded by the Health Technology Assessment Programme of the National Institute for Health Research, UK.

  • Disclaimer Sponsors and funders had no role in study design or analysis.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the Office for Research Ethics Committees Northern Ireland (ref 15/NI/0021, 02/02/2015) and reporting followed Standards for reporting qualitative research guidelines.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. Relevant data are included in the article, but there may be additional data, themes and/or quotes present within the original transcripts.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.