Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
BMC Med Ethics. 2021 Jul 31;22(1):108. doi: 10.1186/s12910-021-00675-7.
BACKGROUND: The landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC. METHODS: Semi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method. RESULTS: Interviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States. CONCLUSIONS: Interviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.
背景:在过去的十年中,临床研究领域发生了变化。随着技术的进步,出现了使用电子知情同意书(eIC)的实践。然而,一些挑战阻碍了 eIC 在临床研究中的成功和广泛部署。因此,我们旨在调查各利益相关者对 eIC 的潜在优势和挑战的看法。
方法:对来自 11 个欧洲国家的 5 个利益相关者组的 39 名参与者进行了半结构化访谈。利益相关者组包括医生、患者组织代表、监管代表、伦理委员会成员和制药行业代表,他们都参与了临床研究。使用框架方法对访谈进行了分析。
结果:受访者认为,eIC 的一个强大功能是其个性化方法,因为它可以增强参与者的授权。然而,他们也确定了一些伦理和实际挑战,例如确保研究参与者不会被信息淹没,并为那些希望使用纸质知情同意书而不是 eIC 的研究参与者提供相同的选择。根据受访者的说法,eIC 有可能在研究参与者和研究团队之间建立高效的长期互动,以便在研究期间和之后为参与者提供信息。受访者强调,与研究团队的个人互动至关重要,这是电子平台无法替代的。此外,各利益相关者组的受访者都支持在欧洲成员国之间采用统一的 eIC 方法的想法。
结论:受访者报告了一系列设计和实施挑战,需要克服这些挑战才能促进创新,以便以电子方式告知研究参与者并获得他们的同意。重要的是,eIC 的实施应与研究参与者和研究团队之间的面对面接触并行进行。此外,受访者希望 eIC 能够提供个性化方法的机会,并随着时间的推移加强持续沟通。如果成功实施,eIC 可能有助于使研究参与者参与临床研究。
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