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Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals' and

Angret de Boer1,2, André Krom3, Rania Kalaai2

  • 1Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.

Pediatric Research
|April 16, 2025
PubMed

Insights

Ethical and legal issues must be resolved for the Artificial Amnion and Placenta Technology (AAPT) trials. Addressing these complexities ensures a responsible informed consent process for parents and healthcare professionals.

Area of Science:

  • Medical Ethics
  • Reproductive Technology
  • Clinical Trial Design

Background:

  • The Artificial Amnion and Placenta Technology (AAPT) aims to improve outcomes for extremely premature infants.
  • First-in-human trials are anticipated, necessitating empirical research with stakeholders.
  • This study addresses crucial legal and ethical considerations for AAPT trial counselling and informed consent.

Purpose of the Study:

  • To explore stakeholder perspectives on counselling and informed consent for AAPT trials.
  • To identify key ethical and legal issues influencing the informed consent process.
  • To inform the responsible design of future AAPT clinical trials.

Main Methods:

  • A qualitative study design was employed.
  • Individual and focus group interviews were conducted with healthcare professionals (HCPs) and parents.
  • Thematic analysis was used to analyze interview data.

Main Results:

  • Fifteen parents and 46 HCPs participated.
  • Key themes emerged regarding the moral/legal status of participants, the pregnant person's role, and technology terminology.
  • Interconnected factors influencing counselling and informed consent, including parental hope, were identified.

Conclusions:

  • Resolving ethical and legal issues is vital for establishing parental rights and a sound informed consent process.
  • Navigating complexities like participant moral status and rights is essential before trial progression.
  • Establishing consensus and open dialogue among stakeholders is crucial for a robust ethical framework.
Abstract

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