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Neonatal research: the parental perspective.

B J Stenson1, J-C Becher, N McIntosh

  • 1Simpson Centre for Reproductive Health, Royal Infirmary, Little France, Edinburgh EH16 4SU, Scotland, UK. ben.stenson@luht.scot.nhs.uk

Archives of Disease in Childhood. Fetal and Neonatal Edition
|June 24, 2004
PubMed
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Many parents of infants in neonatal research trials do not recall giving consent, yet most value the consent process. Ensuring informed consent remains crucial for ethical research practices.

Area of Science:

  • Neonatal research ethics
  • Parental consent in clinical trials

Background:

  • Informed consent is a cornerstone of ethical research involving human subjects, particularly vulnerable populations like neonates.
  • Understanding parental recall and perspectives on consent is vital for maintaining trust and ethical standards in pediatric research.

Purpose of the Study:

  • To assess parental memory of the consent process for infant participation in neonatal research.
  • To evaluate parents' views on the necessity and importance of obtaining consent for such studies.

Main Methods:

  • A survey was administered to parents of 154 infants enrolled in a neonatal randomized trial, 18 months post-enrollment.
  • The survey assessed recall of the consent procedure and parental satisfaction with their decision to consent.
  • Response rate was 64%, with follow-up questionnaires for non-responders.
Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

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Main Results:

  • 18% of responding parents did not recall or were unsure about consenting to their infant's study participation.
  • The majority of parents (79%) were content with their decision to consent, with no reported feelings of undue pressure.
  • 83% of parents would oppose waiving the consent process for ethically approved trials.

Conclusions:

  • A notable percentage of parents lack recall of the consent process for neonatal research, highlighting potential memory gaps.
  • Parents value the informed consent procedure and would prefer it to be maintained even for studies with ethics committee approval.