Honesty, trust, and respect during consent discussions in neonatal clinical trials.

Abstract

“Participating in the study provided an avenue for a premature baby like mine to receive an outstanding level of care and extra support from the research nurse that may not otherwise be available outside research. It was also fulfilling knowing that from this research may come the help that others with this same condition may need. It played a significant role in our education about improving and maintaining his health. ”—Parents of a neonatal clinical trial participant Participation in neonatal clinical trials is often viewed as risky, ethically challenging, burdensome for parents, and a favor that altruistic families are performing for future generations of babies.1,2 Views such as “valid consent in the antenatal/perinatal population is difficult, if not impossible, to obtain” are common.3 However, neonatal research need not be viewed through such a negative lens. Parents who have participated in clinical trials may view their research involvement very differently, as an exciting opportunity rather than a burden.4 Participation can have benefits for the newborn child and the family, even if the infant is not assigned by chance to a therapy that proves to be superior after completion of the trial.5,6 Collectively, as a group of research nurses and clinical investigators, we have discussed research participation with >900 families. We have found that when done well, conversations about consent to research can empower and support families at a time of crisis and reassure them that health care professionals are … Address correspondence to Sara B. DeMauro, MD, MSCE, The Children’s Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Division of Neonatology, 2 Main, Philadelphia, PA 19104. E-mail: demauro{at}email.chop.edu