How Do Young People with Cystic Fibrosis Conceptualize the Distinction Between Research and Treatment? A Qualitative Interview Study

Abstract

Background: Recently, it has been argued that the distinction between medical research and medical care is not as clear-cut as is often implied in research ethics protocols. Young people with cystic fibrosis, a progressive genetic disorder requiring daily management, often grow up participating in biomedical research. Given debates about the importance of the treatment/research distinction, as well as recent challenges to maintaining this distinction, the purpose of this article is to provide empirical evidence about young people's understanding of their research experiences. Methods: Semistructured interviews were conducted with 19 young people (ages 8 to 18 years) with cystic fibrosis. Interviews focused on their experiences participating in research related to cystic fibrosis, their reasons for participating, and their understanding of the distinction between research and treatment. Qualitative methods were used to analyze patients’ perceived distinction between research and treatment. Results: Some participants clearly distinguished between research and clinical care, using signifiers including the type and nature of procedure, purpose, and voluntariness of the activity. Other participants described research and treatment as connected activities. In some cases they labeled research-related activities as treatment activities, and in other cases their descriptions highlighted the overlapping nature of research and treatment in sophisticated ways. Conclusions: The results of this study support suggestions that the distinction between research and care as upheld by research ethics is not meaningfully sustainable in all contexts. Sometimes participants see research and treatment as separate activities, but in other instances they understand that research and treatment may be closely connected. The results of this study may aid researchers and research ethics boards in helping potential participants to understand the possible impacts of research participation.

Keywords:

• Adolescent
• bioethics
• child
• cystic fibrosis
• interviews
• qualitative research

Notes

1. See Grant and Sugarman (2004) for a discussion of the use of incentives in research.