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

Abstract

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. Study Design 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.

Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study

“…Some of these articles could have been much more explicit about how triallists or recruiters could use their research, for example, those recruiting for trials could understand how to be more sensitive to the journey a parent is on. 89,92 This contrasted with McCann et al 91 who placed emphasis on the utility of their research by including a section in the discussion on implications for triallists.…”

“…They focused on sensitive trial recruitment practices, such as when parents were asked to put sick infants in a trial 89,92 and cancer trials that recruited 91 produced a sophisticated qualitative analysis based on observation and interview to develop the concept of 'conditional altruism' rather than simply list themes. Kohara and Inoue 90 also provided an in-depth analysis using a grounded theory approach.…”

Why do parents enrol their children in research: a narrative synthesis

“…Parents reported considering whether their child could cope with research participation,21 23 28 35 36 reflecting on the child's health and personality. Although some parents cited the child's ability to cope as reason to participate,35 this assessment was more commonly offered as reason not to participate 23 28 36…”

Asking For Parents' Permission to Enroll Their Child Into a Clinical Trial: Best Practices

“…Using words such a choice, repeating information, and using a calm, deliberate manner of speaking to avoid appearing rushed are also effective strategies. 14,19,20 Whereas parents' understanding of the information within the consent document influences their decision to provide permission, ensuring understanding can be challenging. Tait and colleagues 12 assessed parents' understanding of information presented during a consent discussion as perceived by both the parent and an independent assessor.…”

“…17,23,24 Families who did not provide permission report that they felt they were given too little information, the consent discussion was rushed, or that the clinical trial would affect their child's care or place more burden on the child. 13,16,19,23 Other factors resulting in unwillingness to provide permission included parental anxiety around making the decision, parental difficulty making the decision, parents with a higher educational level, and parents of children with a chronic disease. 11,13,17 This discussion highlights the many complex and interrelated components of the consent process when attempting to obtain parental permission for a child to participate in a clinical trial.…”