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Asian Journal of Ethics in Health and Medicine

2025 Volume 5

Coordinating Multicenter Research during a Pandemic: Ethical and Operational Lessons from the German NAPKON Initiative


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  1. Department I of Internal Medicine, Center for Integrated Oncology, Faculty of Medicine, University of Cologne, University Hospital Cologne, Cologne, Germany.
  2. German Center for Infection Research (DZIF), Partner-Site Cologne-Bonn, Cologne, Germany.
  3. Department of Internal Medicine, Hematology/Oncology, Goethe University Frankfurt, Frankfurt am Main, Germany.
  4. Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  5. Department I for Internal Medicine, Faculty of Medicine, University Hospital of Cologne, University of Cologne, Cologne, Germany.
  6. Helmholtz Center Munich, Institute of Epidemiology, Research Unit Molecular Epidemiology, Munich, Germany.
  7. German Center for Cardiovascular Research (DZHK), Partner Site Munich, Munich, Germany.
  8. German Centre for Infection Research (DZIF), Partner Site Munich, Munich, Germany.
  9. Deutsches Herzzentrum der Charité, Medical Heart Center of Charité and German Heart Institute Berlin, Institute of Computer-Assisted Cardiovascular Medicine, Berlin, Germany.
  10. Department of Radiology, University Hospital LMU Munich, Munich, Germany.
  11. Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
  12. German Center for Lung Research (DZL), Berlin, Germany.
  13. Max Von Pettenkofer Institute & GeneCenter, Virology, Faculty of Medicine, Ludwig-Maximilians University, Munich, Germany.
  14. Institute of Clinical Epidemiology and Biometry, University of Würzburg, Julius Maximilian University of Würzburg, Würzburg, Germany.
  15. Institute for Medical Data Science (ImDS), University Hospital Würzburg, Würzburg, Germany.
  16. Hannover Unified Biobank, Hannover Medical School, Hannover, Germany.
  17. Department of Medical Informatics, University Medical Center Göttingen, Göttingen, Germany.
  18. Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald, Germany.
  19. Division of Infectious Diseases, Department of Medicine II, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  20. Department of Cardiology and Internal Intensive Care Medicine, Klinikum Bielefeld, Bielefeld University, Bielefeld, Germany.
  21. Trusted Third Party of the University Medicine Greifswald, Greifswald, Germany.
  22. School of Medicine, Institute of Clinical Chemistry and Pathobiochemistry, Technical University of Munich, Munich, Germany.
  23. TranslaTUM, Center for Translational Cancer Research, Technical University of Munich, Munich, Germany.
Abstract

With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), scientists worldwide encountered substantial obstacles. The German National Pandemic Cohort Network (NAPKON) was established in the fall of 2020 to make optimal use of available resources and coordinate research initiatives to address the coronavirus disease 2019 (COVID-19) pandemic. We evaluated the initial setup phase of NAPKON as a representative case for multicenter research efforts in Germany, with particular attention to the difficulties encountered and areas for potential improvement when linking 59 university and non-university study sites. We reviewed the ethics application procedures involving 121 ethics submissions, analyzing processing times, reviewer comments, and final decisions. Activation of study sites and patient enrollment activities were examined in relation to SARS-CoV-2 infection incidence rates. Across all initial ethics applications, the median time to a favorable ethics vote was under 2 weeks, and 30 of the study sites (65%) successfully integrated into NAPKON within 3 weeks per site. The use of electronic submission methods instead of traditional postal delivery (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), P-value = 0.01), along with acceptance of the lead ethics vote, markedly shortened the overall ethics review timeline. On average, each participating center recruited 37 patients over the 14-month monitoring period, although enrollment volumes varied widely across health care sectors. A clear positive association was identified between enrollment success and both COVID-19 incidence and hospitalization rates. The findings illustrate both the limitations and the advantages of Germany’s decentralized federal research framework. Implementing digital ethics submission platforms, recognizing a primary ethics decision, and establishing uniform procedural standards can promote greater consistency and accelerate the launch of studies in emergency pandemic situations.


How to cite this article
Vancouver
Tilch K, Pütz SM, Mitrov L, Stecher M, Appel K, Pilgram L, et al. Coordinating Multicenter Research during a Pandemic: Ethical and Operational Lessons from the German NAPKON Initiative. Asian J Ethics Health Med. 2025;5:312-29. https://doi.org/10.51847/8QHNcSoFQH
APA
Tilch, K., Pütz, S. M., Mitrov, L., Stecher, M., Appel, K., Pilgram, L., Geisler, R., Scherer, M., Vehreschild, J. J., Kraus, M., et al. (2025). Coordinating Multicenter Research during a Pandemic: Ethical and Operational Lessons from the German NAPKON Initiative. Asian Journal of Ethics in Health and Medicine, 5, 312-329. https://doi.org/10.51847/8QHNcSoFQH
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