565 - Parental views on the acceptability of waiver of consent in neonatal clinical trials: the FAM-CONNECT study
Sunday, April 27, 2025
8:30am – 10:45am HST
Publication Number: 565.5694
Elliott M. Weiss, University of Washington, Seattle, WA, United States; Abril Beretta, Seattle Children's, seattle, WA, United States; Andrea Kelsh, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, United States; Sandhya Subramanian, NA, Seattle, WA, United States; Simran Sekhon, NA, KENT, WA, United States; Laura Heck, Seattle Children's, Covington, WA, United States; Ben A. Mooso, University of California, San Diego School of Medicine, La Jolla, CA, United States; Justin Clapp, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States; Neal W. Dickert, Emory University School of Medicine, Atlanta, GA, United States; Anup Katheria, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, United States; Katherine Guttmann, Icahn School of Medicine at Mount Sinai, New York, NY, United States; Stephanie K.. Kukora, Children's Research Institute, Children's Mercy Hospital, Children's Mercy, Kansas City, MO, United States; Diana Montoya-Williams, Children’s Hospital of Philadelphia, Philadelphia, PA, United States; Kaashif A. Ahmad, Pediatrix Medical Group, Houston, TX, United States; Rebecca A. Dorner, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, United States; Muntasir Natour, Children's Hospital Los Angeles, Los Angeles, CA, United States; Stephanie A. Kraft, Geisinger, Danville, PA, United States
Associate Professor University of Washington Seattle, Washington, United States
Background: Clinical trial recruitment is challenging in neonatology due to clinical acuity, recovering parents, heightened emotional states, and compressed timelines for enrollment decisions. Alternative methods of consent such as waiver of consent may increase enrollment and, critically, decrease bias in the research sample, but have been used for few US neonatal trials. There are potential ethical concerns with the use of these alternative methods, warranting exploration of parental views before more broad utilization. Objective: To explore parental views of alternative methods of consent for participation in neonatal clinical trials. Design/Methods: Six recruitment sites were selected to include a geographically and demographically diverse sample. We presented each participant with one of three study vignettes using either full consent or alternative consent approach, then asked a series of Likert-scale and open-ended questions derived from bioethical frameworks. Participants were then presented with a second vignette using the other consent approach. Vignettes described three neonatal comparative effectiveness research studies representing a range of trials: (1) target oxygen level, (2) invasive procedure, and (3) drug choice. Participants were assigned to vignette pairs by stratified randomization. Interview guide and case vignettes were refined through cognitive interviews and our team including NICU parent advisors. A codebook was iteratively created using inductive and deductive review of a subset of transcripts. Interviews were audio-recorded, transcribed, translated (if performed in Spanish), deidentified, and coded by two independent coders with discrepancies addressed with a third team member. Our quantitative analysis used Likert-scale scores to assess differences by consent method. Results: We conducted N=37 interviews (Table 1). Responses suggested higher acceptability in the standard consent scenarios, except for “would you participate?” for which responses were similar (Table 2). Qualitative responses clustered around four major themes: enrollment decision-making, standard of care and clinical equipoise, specific considerations for each consent methods, and general attitudes about consent (Table 3).
Conclusion(s): Parents hold critical perspectives about the acceptability of alternative methods of consent in NICU research. These findings may help share future US neonatal research and regulatory practices. Future research should assess differences in parent experience within neonatal clinical trials testing varied models of consent.
Demographics of parent participants FAM-CONNECT PAS Table 1 11.04.24.pdf*Participants could select multiple Race options. Parents were invited to participate if they had an invite admitted to one of six US NICUs: Kansas City (Mercy Children’s Hospital); Philadelphia (University of Pennsylvania Medical Center); New York City (Kravis Children’s Hospital at Mount Sinai Hospital); San Antonio (Methodist Children’s Hospital); San Diego (Sharp Mary Birch Hospital for Women and Newborns); Seattle (University of Washington Medical Center)
Parental views of research teams differentiated by method of consent FAM-CONNECT PAS Table 2 11.04.24.pdfFor each question, we present the mean score using Likert responses on a 1-5 scale (strongly disagree to strongly agree). The different clinical trial vignettes were combined such that “standard consent” includes the three cases (target oxygen level, invasive procedure, and drug choice) presented to the participant with standard consent methods while the “alternative consent” includes the same three cases presented to the participant with alternative consent methods. All questions were positively worded so that “strongly agree” (5) suggests a positive response and “strongly disagree” (1) suggests a concerning response related to the approach of consent.
