Consent is an ethical cornerstone of clinical research and healthcare in general. Although the ethical principles of consent - providing information, ensuring comprehension, and ensuring voluntariness - are well-defined, the technological infrastructure remains outdated. Clinicians are responsible for obtaining informed consent from research subjects or patients, and for managing it before, during, and after clinical trials or care, which is a burden for them. The voluntary nature of participating in clinical research or undergoing medical treatment implies the need for a participant-centric consent management system. However, this is not reflected in most established systems. Not only do most healthcare information systems not follow a user-centric model, but they also create data silos, which significantly reduce the mobility of patient data between different healthcare institutions and impact personalized medicine. Furthermore, consent management tools are outdated. We propose ClinConNet (Clinical Consent Network), a platform that connects researchers and participants based on clinical research projects. ClinConNet is powered by a dynamic consent model based on blockchain and take advantage of dynamic consent interfaces, as well as blockchain and Self-Sovereign Identity systems. ClinConNet is user-centric and provides important privacy features for patients, such as unlinkability, confidentiality, and ownership of identity data. It is also compatible with the right to be forgotten, as defined in many personal data protection regulations, such as the GDPR. We provide a detailed privacy and security analysis in an adversarial model, as well as a Proof of Concept implementation with detailed performance measures that demonstrate the feasibility of our blockchain-based consent management system with a median end-to-end consent establishment time of under 200ms and a throughput of 250TPS.

翻译：同意是临床研究乃至整个医疗保健领域的伦理基石。尽管同意的伦理原则——提供信息、确保理解和确保自愿性——已有明确定义，但技术基础设施仍显陈旧。临床医生负责从研究对象或患者处获取知情同意，并在临床试验或护理前、中、后期进行管理，这对他们而言是一项负担。参与临床研究或接受医疗的自愿性意味着需要一个以参与者为中心的同意管理系统。然而，这在大多数现有系统中并未得到体现。不仅多数医疗信息系统未遵循以用户为中心的模式，它们还造成了数据孤岛，严重降低了患者数据在不同医疗机构间的流动性，并影响了精准医疗的发展。此外，现有的同意管理工具也已过时。我们提出ClinConNet（临床同意网络），这是一个基于临床研究项目连接研究人员与参与者的平台。ClinConNet采用基于区块链的动态同意模型，并利用动态同意界面、区块链及自我主权身份系统。ClinConNet以用户为中心，为患者提供了重要的隐私保护功能，如身份数据的不可关联性、保密性和所有权。同时，它兼容如GDPR等众多个人数据保护法规中定义的“被遗忘权”。我们在对抗模型中提供了详细的隐私与安全分析，并通过概念验证实现及详细的性能指标证明了我们基于区块链的同意管理系统的可行性：其中位端到端同意建立时间低于200毫秒，吞吐量达到250TPS。