Chaos, vulnerability and control: parental beliefs about neonatal clinical trials.
OBJECTIVE
This study examined parental beliefs about participating in clinical trials involving greater than minimal risk to their neonate, and explored their views of their experiences.


METHODS
In this qualitative descriptive study, parents in the neonatal intensive care unit (NICU) who had been approached for permission for their neonates to be enrolled in research were asked to describe their decisions about their consent for or disagreement to their neonate's research participation. A total of 27 parents from three different hospital NICUs in the Mid-Atlantic region of the United States participated. Transcribed interviews were analyzed using qualitative content analysis.


RESULTS
Participant decisions developed through a dynamic process of meaning-making based on their beliefs about themselves and their neonates. The processes involved making sense of the chaos that they perceived in the environment and their own vulnerability, through taking control of their situation.
Ward
F R
FR
School of Nursing, University of Medicine and Dentistry of New Jersey, Newark, NJ 07101-1709, USA. wardf1@umdnj.edu
D035843:Biomedical Research; D003469:Culture; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D009359:Neonatology / Q000941:ethics*; D033282:Parental Consent / Q000941:ethics / Q000523:psychology*; D010290:Parents / Q000523:psychology*; D036302:Therapeutic Human Experimentation / Q000941:ethics