This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future.

本文探讨了 GATEKEEPER 项目期间遇到的道德和法律挑战，以及这些挑战如何为未来大规模试点 (LSP) 项目的综合框架的开发提供信息。 GATEKEEPER 是一个 LSP 项目，有 48 个合作伙伴在欧洲开展 30 项实施研究，将 50,000 名目标参与者分为 9 个参考用例。该项目强调了在法规和程序各异的各个司法管辖区获得道德批准的复杂性。通过对所面临的问题和应对这些挑战所采用的策略的详细分析，本研究提出了一个道德和法律框架。该框架源自对伦理申请表和法规的比较分析，旨在简化未来 LSP 研究项目的伦理审批流程。通过解决 GATEKEEPER 中遇到的障碍，拟议的框架为更高效和有效的项目管理提供了路线图，确保未来类似项目的顺利实施。