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Older Teens’ Understanding and Perceptions of Risks in Studies With Genetic Testing: A Pilot Study

Abstract Background: The consent process used in clinical research today falls markedly short of the ideal process envisioned nearly 30 years ago. Critics have suggested that the informed consent process has become challenging, formalistic, and incompletely understood by researchers and participants alike. Hence, the purpose of this pilot study was to identify and characterize important aspects of the informed consent process that teens believe impact their understanding of risks of participation in studies with genetic testing. Methods: The personal research experiences of 15 teens regarding consent/assent and research participation in studies with genetic testing were solicited through focus-group interviews. All participants had enrolled in at least one research study involving genetic testing in the prior 2 years. All groups were facilitated by the same experienced focus-group moderator. Themes and subthemes were identified, summarized, and interpreted using conventional qualitative content analysis. Results: Three overarching themes emerged from the interviews: fear of what could happen, need for additional information regarding risks, and need for autonomy and decision-making control throughout the consent process. Conclusion: Results of this pilot study provide preliminary evidence that teens can identify and characterize key issues in the informed consent/assent process when it comes to the risks of research participation. These findings are consistent with other research regarding teens’ perceptions and recommendations for genetic testing research.