Ethical and coordinative challenges setting up a national cohort study during the COVID-19 pandemic in Germany
Year: 2023
Type: preprint
Abstract: With the outbreak of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the Coronavirus Disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example of multicenter studies in Germany, highlighting challenges and optimization potentials in connecting 59 university and non-university study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcome. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p-value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period – with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted challenges and chances of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic.
Source: Research Square
Authors: Katharina Tilch, Sina M. Hopff, Katharina Appel, Monika Kraus, Bettina Lorenz-Depiereux, Lisa Pilgram, Gabi Anton, Sarah Berger, Ramsia Geisler, Kirsten Haas, Thomas Illig, Dagmar Krefting, Roberto Lorbeer, Lazar Mitrov, Maximilian Muenchhoff, Matthias Nauck, Christina Pley, Jens-Peter Reese, Siegbert Rieg, Margarete Scherer, Melanie Stecher, Christoph Stellbrink, Heike Valentin, Christof Winter, Martin Witzenrath, J. Janne Vehreschild
Institutions: University of Cologne, University Hospital Cologne, Goethe University Frankfurt, German Centre for Cardiovascular Research, Helmholtz Munich, Charité - Universitätsmedizin Berlin, German Center for Infection Research, Humboldt-Universität zu Berlin, Freie Universität Berlin, University of Würzburg, Medizinische Hochschule Hannover, Universitätsmedizin Göttingen, University of Göttingen, Deutsches Herzzentrum der Charité, Max-von-Pettenkofer-Institut für Hygiene und Medizinische Mikrobiologie, Ludwig-Maximilians-Universität München, Universitätsmedizin Greifswald, Universität Greifswald, University of Freiburg, University Medical Center Freiburg, Bielefeld University, Klinikum Bielefeld, Technical University of Munich
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4380608373