Annie Janvier, MD, PhD (she/her/hers)
Profesor of Pediatrics and Clinical Ethics
University of Montreal
Montréal, Quebec, Canada
Clinical studies in the delivery room to evaluate emergency treatments are crucial to improve the care of babies. Meaningful informed consent from parents in these situations is ethically challenging. Antenatal consent may be impossible (perinatal asphyxia). When possible, it often leads to results that are not representative (to minority groups). Parents may be approached “too early” (the majority not delivering preterm) or “too late” (during labor) with an unacceptable emotional burden.
Alternative options for consent include waiver of consent and deferred consent, either consenting parents for their baby to remain in a study or to use their clinical information. Other studies have used blocked randomization for comparative effectiveness research. Deferred consent improves recruitment rates and the generalizability of results. In the few studies examining parental perspectives, they reported that this mode was acceptable. In this Bioethics Club a multidisciplinary panel will review the ethical challenges surrounding parental consent in these complex situations.
Annie Janvier (neonatologist, clinical ethicist): introduction, plan
Matthew Rysavy (neonatologist, researcher): The complexity of emergency research in neonatology: implications of different types of consent strategies on the interpretation of large neonatal studies.
Peter Davis (neonatologist, researcher): Parental perspectives regarding deferred consent for Neonatal research.
Annie Janvier: Interventions for Neonatal asphyxia and parental perspectives: the example of the Albino trial.
Rebecca Pearce (parent representative: member of research advisory boards, parent associations and support groups): Should there be consent forms to include a child’s clinical outcomes in follow-up and research databases, and what should they look like?
Annie Janvier: Conclusion
Speaker: Annie Janvier, MD, PhD – University of Montreal, CHU Sainte-Justine
Speaker: Annie Janvier, MD, PhD – University of Montreal, CHU Sainte-Justine
Speaker: Rebecca L. Pearce, BSc, MSc, BEd – Ste Justine Hospital, McGill University Faculty of Education
Speaker: Peter G. Davis, MBBS, MD – University of Melbourne
Speaker: Matthew A. Rysavy, MD, PhD – McGovern Medical School at the University of Texas Health Science Center at Houston