Recruitment for clinical research in the neonatal intensive care unit (NICU) is difficult, which may lead to low enrollment rates, systematically skewed samples, and nongeneralizable results. Research without prior consent (RWPC), defined as obtaining consent only after infants have been randomized to a treatment arm, may improve enrollment but raises ethical challenges. There is a need to better understand how parents with lived experience of having an infant in the NICU consider RWPC’s impact on critical ethical values related to informed consent, including decision-making, respect, and trust. This mixed-methods study aimed to describe parental perceptions of the acceptability and ethical implications of RWPC for neonatal clinical research. Interviews were conducted with parents of infants recently admitted to the NICU across 6 US locations. Parents were asked a series of Likert-scale questions followed by open-ended questions with interactive probes about the acceptability of hypothetical study vignettes using either prospective informed consent or RWPC. Likert-scale responses were analyzed using mixed-effects linear regression models. Open-ended responses were inductively coded and thematically analyzed through a constructivist lens. Parents (n = 38) scored the acceptability of RWPC vignettes lower than prospective informed consent vignettes on mean adjusted total score and items about perceived control, values-aligned decision-making, and respect for babies and families. Four themes were identified as impacting parents’ views on acceptability of RWPC: (1) equipoise as the foundation for acceptability of consent approaches, (2) informational preferences for consent approaches, (3) complex interplay between consent approaches and research relationships, and (4) consent approaches as shaping perceived control. Parents’ perspectives illustrate key considerations for the potential use of RWPC as well as broader reflections on engagement about clinical research in the NICU setting. Situational factors in the NICU raise barriers to consent, and RWPC may be differentially acceptable depending on study specifics. Thoughtful communication about equipoise and attention to trust are essential when considering alternative methods of consent. Future research should further examine ethical trade-offs involved in RWPC and varied perceptions across study features.
Kraft et al. (Fri,) studied this question.