The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial

The Need for an Evolving Informed Consent Process in a Fetal Therapy Trial
Case Commentaries
Meredith A. Atkinson, Erika Ezumba, Jena L. Miller
The American Journal of Bioethics, 16 September 2024
Excerpt
… In the face of uncertainty about the longer-term burden of morbidity and mortality in surviving neonates, the study team had to consider what level of detail regarding neonatal outcomes observed in infants born to trial participants to share with potential participants during the study screening process, while the study continued active recruitment. In addition, they had to determine if and how such information should be modified over the course of the trial as additional neonates were born to trial participants, and an increasing amount of data on the clinical course and outcomes of the neonates became available. Given the high potential burden in neonatal survivors and their families, including the need for intensive caregiver-provided, at-home care for infants who survive to hospital discharge and a need for life-long renal replacement therapy, the consent discussion takes place over days and in collaboration with multiple specialists… More

information is required to deeply characterize long-term outcomes among survivors and the psychosocial impact on the family, whether the amnioinfusion intervention is offered through a research protocol or as clinical care. This will require systematic collection of prospective data beyond the primary outcome defined in the RAFT trial, including observational data from institutions where the intervention is offered as clinical care.