Team Research Using Qualitative Methods: Investigating Children’s Involvement in Clinical Research

Abstract

With changes in U.S. federal guidelines mandating inclusion of children in clinical research, more and more children are being sought as subjects in clinical trials. As research participants, children are more vulnerable than adults because of cognitive and emotional development, legal capacity, level of autonomy, and dependence on family influence. The purpose of this article is to describe the methods and process of a family-focused qualitative study of the clinical research experiences of ill children and their mothers, fathers, and siblings. This research, undertaken by a team of investigators, was designed to result in understanding family members’ perspectives on research involving children and recommendations for optimal ways to obtain informed consent and conduct clinical research on children.