Orzechowski Marcin, Schochow Maximilian, Kühl Michael, Steger Florian
Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Ulm, Germany.
Institute of Biochemistry and Molecular Biology, Ulm University, Ulm, Germany.
Front Cell Dev Biol. 2021 Apr 28;9:627816. doi: 10.3389/fcell.2021.627816. eCollection 2021.
Research with induced pluripotent stem cells (iPSCs) involves specific ethical challenges, which should be addressed in the informed consent process. Up to now, little concern has been paid to the practice of information in iPSC-clinical studies. In order to fill this research gap, we have searched the documentation of the Research Ethics Committee at Ulm University from the years 2007 to 2019. In our previous research, we have identified 11 items for evaluation of the process of information in iPSC research. We used these items to analyze content and form of information provided for participants in the iPSC studies conducted at Ulm University and Ulm University Hospital in Germany. All analyzed studies provide general information regarding the study's aim, method, and collection of donor's personal data and specimen. The information for participants in these studies adheres to general guidelines for research involving human subjects; however, in several areas fails to take into account the specific nature of research with iPSCs. The majority of analyzed studies fail to provide information about possible individual consequences connected with genetic research, such as the possibility of re-identification of the donor or incidental findings acquired during research. Missing is also information about the possibility of future studies involving reproductive research or transplantation of cells and organs. The donor information process in all analyzed studies is conducted in form of the information sheet and oral information. The results of our research show that the process of informed consent in iPSC research should be updated as new developments emerge in this area. However, comprehension of information should not be jeopardized through information overload. Effective communication of essential information requires improved information methods tailored to the needs of participants, such as video animations, interactive consent modules or social media instruments.
对诱导多能干细胞（iPSC）的研究涉及特定的伦理挑战，这些挑战应在知情同意过程中加以解决。到目前为止，iPSC临床研究中的信息告知实践很少受到关注。为了填补这一研究空白，我们查阅了乌尔姆大学研究伦理委员会2007年至2019年的文档。在我们之前的研究中，我们确定了11项用于评估iPSC研究中信息告知过程的项目。我们使用这些项目来分析德国乌尔姆大学和乌尔姆大学医院进行的iPSC研究向参与者提供的信息内容和形式。所有分析的研究都提供了关于研究目的、方法以及捐赠者个人数据和样本收集的一般信息。这些研究中向参与者提供的信息符合涉及人类受试者研究的一般准则；然而，在几个方面没有考虑到iPSC研究的特殊性。大多数分析的研究没有提供与基因研究相关的可能的个体后果的信息，例如捐赠者重新识别的可能性或研究过程中获得的偶然发现。关于未来涉及生殖研究或细胞及器官移植研究可能性的信息也缺失。所有分析研究中的捐赠者信息告知过程都是以信息表和口头告知的形式进行的。我们的研究结果表明，随着该领域新进展的出现，iPSC研究中的知情同意过程应予以更新。然而，不应因信息过载而危及对信息的理解。有效传达基本信息需要改进符合参与者需求的信息告知方法，如视频动画、交互式同意模块或社交媒体工具。
