Parents' Views of Involvement in Concurrent Research with Their Neonates

Abstract

It would be useful to researchers and bioethicists to know more about parents’ decision processes and emotional state during the time they are deciding whether to enroll their infant in a clinical trial. The aim of this research study was to discover whether parents who had been previously asked to enroll their neonates in clinical trials would have found concurrent research about their decision-making overly burdensome. Twenty-seven parents of critically ill neonates who had been approached for their child’s research participation in a clinical trial were asked what they believed about the potential burden or value of being interviewed during the time of research decision-making about their infant’s participation. For this qualitative descriptive study, interviews were audio-recorded, transcribed, and analyzed using content analysis techniques. Participants considered concurrent research acceptable for them but potentially problematic for others. Theories of risk preferences and social comparison might explain these findings.

Parents report positive experiences about enrolling babies in a cord‐related clinical trial before birth

“…of the perspectives of parents during their actual experience, as their accounts may be influenced by time and the health outcomes of their baby (34). The women were approached for informed consent of the original RCT shortly before giving birth to a preterm infant and sometimes when they were already in labour.…”

Ethical considerations in longitudinal studies of human infants

“…Do caregivers have their children participate for their own personal reasons, or to benefit their children (Warin, 2011)? A great deal of research that covers this issue is relevant largely to clinical populations (e.g., Ward, 2010), such that the caregivers' motivation to participate is largely driven by a possible medical benefit to their child. In some clinical research, caregivers indicated that they participated because they wanted better healthcare options for their child and they wanted to help other children (e.g., Fisher, McKevitt, & Boaz, 2011).…”

“…In some clinical research, caregivers indicated that they participated because they wanted better healthcare options for their child and they wanted to help other children (e.g., Fisher, McKevitt, & Boaz, 2011). Caregivers of terminally ill infants who chose to include their children in clinical research indicated that they actually gained better understanding of their experiences and obtained more information as a result of their participation (Ward, 2010). Additionally, some caregivers were altruistic in their motivations to participate in research, and just wanted to aid in research findings (e.g., Hayman et al, 2001).…”

“…These studies focus on factors associated with non-normative development, such as terminal illness (e.g., Ward, 2010), contemporary research like genomics and personalized medicine (e.g., Dove, Avard, Black, & Knoppers, 2013), and sudden infant death syndrome (e.g., Hayman, Taylor, Peart, Galland, & Sayers, 2001). While this research provides great insight into improving outcomes for medical and clinical research, applying this research to ethical assessments of research with typically-developing infants becomes a challenge.…”

“…For example, caregivers' decision making process about whether their neonate should be included in a clinical trial could be very different from the decision process to be involved in a naturalistic home observation of play in typically developing infants. For medical and clinical research, involvement may be more risky, the stakes may be higher, and emotional states are more burdened (e.g., Ward, 2010). Furthermore, much of the literature considering ethics of research with minors has dealt strictly with older children and adolescents (e.g., Swartling, Hansson, Ludvigsson, & Nordgren, 2011;Thompson, 1990;Warin, 2011).…”