Department of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.
J Med Internet Res. 2022 Apr 20;24(4):e33167. doi: 10.2196/33167.
Online communication with participants, including online recruitment, electronic informed consent, and data communication, is one of the fields to which information and communication technology (ICT) has been applied in medical research. Online communication provides various benefits, especially for genome research and rare disease research. However, ethical challenges that are derived from or exacerbated by online communication need to be addressed. Here, we present an overview of such ethical issues and provide practical guidance for the ethical implementation of ICT. We specify the ethical issues in the context of using online communication for medical research by an analysis based on the eight ethical principles for clinical research. Informed by this ethical context, we then develop a novel framework for the governance of medical research involving ICT, which consists of eight categories: five research processes (ie, design of research, recruitment, informed consent, data communication, and dissemination and return of results) and three overarching perspectives related to multiple processes of research (ie, access to research and online dialog, community involvement, and independent review). Finally, we present a practical guidance chart for researchers, patient partners, independent reviewers, and funding agencies. We believe that our study will contribute to the ethical implementation of online communication in medical research.
在线沟通（包括在线招募参与者、电子知情同意和数据沟通）是信息和通信技术（ICT）在医学研究中应用的领域之一。在线沟通提供了各种好处，特别是在基因组研究和罕见病研究方面。然而，在线沟通引发或加剧的伦理挑战需要得到解决。在这里，我们概述了这些伦理问题，并为 ICT 在医学研究中的伦理实施提供了实用指南。我们通过基于临床研究八项伦理原则的分析，在使用在线沟通进行医学研究的背景下具体阐述了伦理问题。在这一伦理背景下，我们制定了一个包含八项内容的新框架，用于管理涉及 ICT 的医学研究，其中包括五个研究流程（即研究设计、招募、知情同意、数据沟通以及研究结果的传播和反馈）和三个与研究的多个流程相关的总体视角（即研究的准入和在线对话、社区参与和独立审查）。最后，我们为研究人员、患者伙伴、独立审查人员和资助机构提供了一个实用指南图表。我们相信，我们的研究将有助于医学研究中在线沟通的伦理实施。
