Ittenbach Richard F, Corsmo Jeremy J, Miller Robert V, Korbee Leslie L
a Division of Biostatistics and Epidemiology (MLC 5041), Cincinnati Children's Hospital Medical Center , Cincinnati , Ohio , USA.
b Cincinnati Children's Hospital, Office of Research Compliance and Regulatory Affairs (MLC 7040) , Cincinnati , Ohio , USA.
AJOB Empir Bioeth. 2019 Jul-Sep;10(3):173-181. doi: 10.1080/23294515.2019.1577313. Epub 2019 Apr 19.
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. 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. 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. 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.
当今临床研究中使用的同意程序明显低于近30年前设想的理想程序。批评者认为，知情同意程序变得具有挑战性、形式化，研究人员和参与者对此都没有完全理解。因此，这项试点研究的目的是确定并描述青少年认为会影响他们对参与基因检测研究风险理解的知情同意程序的重要方面。通过焦点小组访谈，征求了15名青少年关于同意/赞成以及参与基因检测研究的个人研究经历。所有参与者在过去两年中至少参加了一项涉及基因检测的研究。所有小组均由同一位经验丰富的焦点小组主持人主持。使用传统的定性内容分析法确定、总结并解释主题和子主题。访谈中出现了三个总体主题：对可能发生之事的恐惧、对风险的更多信息需求，以及在整个同意过程中对自主权和决策控制权的需求。这项试点研究的结果提供了初步证据，表明青少年在涉及参与研究风险的知情同意/赞成过程中能够识别并描述关键问题。这些发现与其他关于青少年对基因检测研究的看法和建议的研究一致。
