Development, implementation, and evaluation of a registry for the documentation and analysis of assisted suicide in Germany (RegAS) - study protocol.

BACKGROUND: In 2020, the German Federal Constitutional Court declared the criminal prohibition of assisted suicide as unconstitutional, thereby abolishing previous restrictions. Since then, requests and cases have increased steadily. To ensure transparency and traceability of national assisted suicide practices, systematic and reliable data are required. However, no comprehensive registry currently exists to document and analyze assisted suicide cases in Germany, resulting in a significant data gap for epidemiology, health reporting, and healthcare development. The development, implementation, and evaluation of such a registry is essential to better understand current practices, identify challenges, and improve prevention and support strategies. METHODS: Iterative, mixed-methods, design-based implementation study with five work packages: 1. conceptual, ethical, and legal development of registry content through a scoping review and a group Delphi process; 2. establishment of the legal, ethical, and technical framework of the registry using an iterative, design-based approach; 3. evaluating and refining the registry through a formative mixed-methods design combining quantitative user surveys and web analytics with qualitative think-aloud and retrospective interviews; 4. exploring barriers to the adoption, continuation, and use of the registry through quantitative surveys and in-depth qualitative interviews with potential users; 5. strategic development, dissemination, and integration of the registry within existing healthcare and suicide prevention structures. The study involves expert consultations and stakeholder engagement and is conducted by a multidisciplinary consortium of palliative care and suicide prevention experts in Germany. DISCUSSION: The establishment of a permanent registry for assisted suicide could substantially improve transparency and empirical knowledge in a highly sensitive and ethically complex field. Systematic documentation may help identify needs, vulnerabilities, and structural challenges faced by individuals considering assisted suicide. In the long term, the findings derived from the registry are expected to contribute to the development of targeted support services in Germany. The study results may also provide valuable insights for other countries facing comparable ethical, legal, and regulatory challenges. TRIAL REGISTRATION: Registered on 25 October 2025 in the BQS (Institute for Quality and Patient Safety) registry, No. 2020467 and on 29 April 2026 in the German Clinical Trials Register (DRKS), No. DRKS00040174.