Informed consent for enrolling minors in genetic susceptibility research: a qualitative study of at-risk children’s and parents’ views about children’s role in decision-making

To better understand the process by which families at increased risk of disease would decide in order to enroll their children in genetic susceptibility research to develop recommendations regarding the informed consent process by which at-risk children are enrolled in such research in the future. Parents and children (ages 10–17 years) from families at increased risk for heart disease ( n = 21 dyads) or breast cancer ( n = 16 dyads) participated in two face-to-face, audio-taped, semi-structured interviews: Initial interviews were conducted with parents and children separately, and follow-up family interviews were conducted 1 year later. Interview transcripts were coded based on common themes. Families vary in the stage at which, and degree to which, children would be involved in decision-making about research participation. In general, the older/more mature the child, the less risky the research and the more open the communication style, the greater the likelihood that decisions would be made jointly. Most children wanted some parental input, but still thought the final decision should be theirs. Most parents would want to make the initial decision about whether it would be reasonable to consider enrolling their child in the research being proposed, but none opposed the child having some time alone with the researcher. All parents and children in our study placed extreme importance on not forcing children to participate in nontherapeutic research if they do not want to. Decision-making about enrolling children in genetic susceptibility research should be based on an informed consent process that (a) gives parents and children sufficient opportunity to ask questions of the researcher(s) and to communicate with one another, and (b) gives children the opportunity to exercise their right to refuse participation without parental influence. This process should be tailored to the child’s maturity level and style of communication in the family.