Informed Consent for a Neonatal Clinical Trial: Parental Experiences and Perspectives
OBJECTIVE: There is a variability regarding timing of consent and personnel used in patient recruitment for neonatal research. We explored the associations between the study personnel and timing of consent with parents' decisional conflict and ultimately their decision to enroll. STUDY DESIGN: This was a multi-site, cross-sectional survey conducted between August 2015 and October 2017. Participants were parents approached to enroll their 24-28-week infant in a clinical trial. Parents completed an interviewer-administered 61-item questionnaire. RESULTS: Overall, 163 surveys were completed; 105 by parents of enrolled infants and 58 by parents of non-enrolled infants (54.5% participation rate). Neither the individual requesting nor timing of consent was associated with parents' knowledge score, decisional conflict, or decision to enroll. Parents preferred to be approached prenatally and by their infant's doctor. CONCLUSION: Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.
Shah, A., Wilfond, B., Silvia, A., Hancuch, K., Woodrum, D., Heagerty, P., & PENUT Neonatal Informed Consent Working Group. (2018). Informed Consent for a Neonatal Clinical Trial: Parental Experiences and Perspectives. Journal of Perinatology, 38 (7), 865-872. https://doi.org/10.1038/s41372-018-0119-6