TY  - JOUR
T1  - Coordinating Multicenter Research during a Pandemic: Ethical and Operational Lessons from the German NAPKON Initiative
A1  - Katharina Tilch
A1  - Sina M. Pütz
A1  - Lazar Mitrov
A1  - Melanie Stecher
A1  - Katharina Appel
A1  - Lisa Pilgram
A1  - Ramsia Geisler
A1  - Margarete Scherer
A1  - J. Janne Vehreschild
A1  - Monika Kraus
A1  - Bettina Lorenz-Depiereux
A1  - Gabi Anton
A1  - Roberto Lorbeer
A1  - Martin Witzenrath
A1  - Maximilian Muenchhoff
A1  - Sarah Berger
A1  - Christina Pley
A1  - Kirsten Haas
A1  - Jens-Peter Reese
A1  - Thomas Illig
A1  - Dagmar Krefting
A1  - Matthias Nauck
A1  - Siegbert Rieg
A1  - Christoph Stellbrink
A1  - Heike Valentin
A1  - Christof Winter
JF  - Asian Journal of Ethics in Health and Medicine
JO  - Asian J Ethics Health Med
SN  - 3108-5059
Y1  - 2025
VL  - 5
IS  - 1
DO  - 10.51847/8QHNcSoFQH
SP  - 312
EP  - 329
N2  - 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.
UR  - https://smerpub.com/article/coordinating-multicenter-research-during-a-pandemic-ethical-and-operational-lessons-from-the-german-hzvm1qxpronq8di
ER  -