van Rijssel Tessa I, van Thiel Ghislaine J M W, van Delden Johannes J M
Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Health Care Anal. 2025 Jun;33(2):139-150. doi: 10.1007/s10728-024-00483-1. Epub 2024 May 19.
Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.
去中心化临床试验（DCTs）有推进临床试验开展的潜力，但也引发了若干伦理问题，包括获得有效的知情同意。关于数字化带来的伦理问题的辩论主要集中在例如数据保护、安全和数据质量等直接风险上。然而，我们认为，需要从更广泛的视角审视DCTs的伦理层面，以应对DCT实践带来的新挑战。数字化通过塑造行为、体验、社会关系和价值观，产生的影响超出了其直接目的。我们在考虑技术的这些软性影响的同时，研究了受DCTs影响的知情同意程序的四个要素：（i）告知参与者并测试其理解程度，（ii）与责任和负担相关的自由，（iii）对参与者与研究者关系的信任，以及（iv）对隐私概念的影响。我们的分析表明，广阔的视野是DCTs最佳开展的关键。此外，它还深入探讨了DCTs对知情同意的伦理影响。诸如DCTs之类的技术可能产生深远影响，现有监管框架并未立即涉及这些影响，但认识到这些影响仍然很重要。这些发现可以指导DCTs未来的实践，以在这种开展临床试验的新方法中促进临床研究的重要价值。
