Learning Objective #1: Describe the significance of addressing parental beliefs about neonatal clinical trials

Learning Objective #2: Explain the investigator's proposed study for learning about parental beliefs about neonatal clinical trials

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The purpose of the proposed qualitative descriptive study is to examine parental beliefs about neonatal research involving greater than minimal risk with the potential for direct benefit to the premature neonate. A small number of studies have examined parents' beliefs about neonatal research, and most existing studies were conducted in countries other than the United States. Limitations of previous studies of parents of neonates enrolled in clinical trials, including survey designs and demographically-limited samples from countries other than the United States, will be attenuated by the design of the proposed study.

The aims of the proposed qualitative descriptive study are to identify and describe parental beliefs about: 1) Participating or not participating in clinical trials involving greater than minimal risk to their premature neonate; 2) Their experiences with their neonate's participation in a clinical trial; 3) The risks and/or benefits of their own research participation concurrent with research in which their premature neonate participates.

The specific methodology used in the proposed study will be focus group interviews. The investigator will moderate an estimated number of at least 4 focus groups of 6 individuals each. These focus groups will consist of mothers who enrolled their premature neonates in clinical trials, mothers who declined to enroll their neonates, fathers who enrolled their neonates, and fathers who declined to enroll their neonates. The settings for the study, all participating in clinical trials with premature neonates, are The Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children's Hospital of Philadelphia. Qualitative analysis will occur concurrently with data collection following constant comparison assumptions.