The influence of relationships on children's and adolescents' participation in research

Abstract

Background: Since the 1950s, children and adolescents have been defined as a vulnerable group for research participation. In 1998, federal mandates were issued to include children in clinical research.

Objectives: The purpose of this qualitative study was to describe children and adolescents' understanding of research and the sociocultural factors that influenced them to become involved and continue participation in clinical research. The specific objective of the study findings reported here was to describe how relationships with adults (e.g., parents and investigators) influenced children and adolescent involvement in clinical research.

Method: This study employed qualitative methods, using semistructured interviews and narrative analytic techniques. There were 34 children and adolescent participants, (8-22 years of age) who had a diagnosis of either diabetes or a hematological malignancy. Participants were interviewed to obtain an understanding of their experience with the assent/consent process for a research study. All interviews were transcribed verbatim from the audiotapes.

Results: Three themes discussed in this article were related to the child/adolescent's relationships with powerful adults: (a) faith in their parent(s), (b) relationships with members of the research/medical team, and (c) the child's perception of what happens when a child/adolescent and his/her parent disagree about research participation.

Discussion: Chronically ill children are willing to dialog about their involvement in research trials, and describe how relationships with their parents and clinician/investigators influence them. They can articulate their ability and right to make the decisions about involvement in research, along with their parent(s).