Parental beliefs about neonatal clinical trials: Chaos, vulnerability, and control

A paradigm shift from protecting children from possible research risks to ensuring they receive possible research benefits drives contemporary biomedical investigations. The principle of protective inclusion has effectively replaced that of protective exclusion of children from research. Although policies regarding ethical human subjects research have been made more explicit and detailed as perceived needs have arisen, knowledge about perceptions of research participants is less clear. Even more ambiguous is an understanding of the thought processes and emotions of parents who are asked to enroll their neonates in clinical trials. The aims of this qualitative descriptive study were to: (1) Identify and describe parental beliefs about participating or not participating in clinical trials involving greater than minimal risk to their neonate; (2) Identify and describe parental beliefs about their experiences with their neonate\u27s participation in a clinical trial; (3) Identify and describe parental beliefs about the value and feasibility of being involved in a research study about themselves concurrent with research in which their neonate participates. This research identified barriers and facilitators of research participation, and filled a gap in the literature by assessing parents\u27 perceptions of the value and feasibility of concurrent interviews with parents enrolling their neonates in research studies. This qualitative descriptive study obtained in-depth interview data from 27 parents recruited from 3 neonatal intensive care units who provided retrospective insights into their experiences as they were approached about enrolling their neonates into clinical trials of more than minimal risk. Data were analyzed using qualitative content analysis. Themes of chaos, vulnerability, and control characterized parents\u27 experiences of their children\u27s clinical research. Parents\u27 descriptions of enrolling their neonates in clinical research were consistent with the conceptual orientations for this research, symbolic interactionism and Naturalistic Decision Making. Their accounts developed through a dynamic process of meaning making based on their beliefs about themselves and their neonates. These processes involved making sense of the chaos that they perceived in the environment and their own vulnerability, through taking control of their situation