Panel Session Australasian Association of Bioethics and Health Law Conference

PLATIPUS pregnancy and neonatal clinical trials: when are alternative modes or processes of consent appropriate? (1963)

Amir Zayegh 1
  1. The Royal Women's Hospital Melbourne, Parkville, VICTORIA, Australia

This panel presents an opportunity to explore the ethical and practical implications and the acceptability of using alternative modes and processes for consent in pregnancy and neonatal trials. Clinical treatments given to pregnant women or premature infants to improve short- and long-term neonatal outcomes often lack quality evidence supporting efficacy and safety. When consent for treatment is required, parents are often in a vulnerable position. Perceptions of risk and potential for harm in these complex populations often lead to exclusion from the very research required to overcome the problem. Researchers are increasingly advocating for and utilising alternative modes of consent or consent waivers for trials involving urgent treatments, but their appropriate use remains controversial. The PLatform for Adaptive Trials In Perinatal UnitS (PLATIPUS) is the world’s first perinatal adaptive and platform trial aiming to improve research efficiency while improving consent processes and trust in research.

Presenters:

  • Researcher’s view: Amir Zayegh [Consultant Neonatologist, Royal Women's Hospital, and PhD Candidate, University of Melbourne, Melbourne, Australia]
  • Lived Experience/Consumer’s view: Emma Forrest [Lived Experience Committee, PLATIPUS]
  • Bioethicist’s view: Angela Ballantyne [Professor of Bioethics, University of Otago, Wellington, New Zealand]
  • Clinician’s view: Nicola Austin [Neonatal Paediatrician, Health New Zealand, Waitaha Canterbury, Christchurch New Zealand]