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.
This panel presents a unique opportunity to consider this complex issue from multiple perspectives. We will hear from clinician researchers about their experience with different consent processes in clinical trials, from a bioethicist about the ethical trade-offs involved, and the views of a parent with lived experience who is involved in PLATIPUS. The audience will benefit from the range of perspectives of the panel regarding when alternative modes or processes for consent might be acceptable, with sufficient time for questions and audience discussion.