We'd appreciate your feedback. Send feedback Subscribe to our newsletters and alerts


Asian Journal of Ethics in Health and Medicine

2024 Volume 4

Navigating Ethical and Logistical Challenges in Establishing a Nationwide Cohort Study amid the COVID-19 Pandemic in Germany


, ,
  1. Department of Medical Ethics, Faculty of Medicine, Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam.
  2. Department of Health Law and Ethics, Faculty of Public Health, University of Medicine and Pharmacy at Hue, Hue, Vietnam.
Abstract

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) created unprecedented challenges for research worldwide. To coordinate efforts and optimize resources in response to the COVID-19 pandemic, Germany established the National Pandemic Cohort Network (NAPKON) in autumn 2020. This study evaluates the initial implementation of NAPKON as a model for multicenter research, focusing on the difficulties and opportunities involved in linking 59 university and non-university study sites. We reviewed 121 ethics submissions, analyzing their processing times, feedback, and outcomes. In addition, study site activation and patient recruitment were assessed in relation to regional SARS-CoV-2 infection rates. Initial ethics approvals were typically granted in under two weeks, and 65% of study sites (30 centers) became operational within three weeks. Using electronic submissions instead of postal applications (9.5 days [Q1: 5.75, Q3: 17] vs. 14 days [Q1: 11, Q3: 26], p = 0.01) and accepting a primary ethics vote significantly reduced approval timelines. Across the observation period of 14 months, each center enrolled a median of 37 patients, though rates varied considerably depending on the healthcare sector. Recruitment success was positively associated with both COVID-19 case numbers and hospitalization rates. Overall, the findings underscore both the challenges and advantages of Germany’s federated research system, suggesting that digital ethics tools, primary ethics vote adoption, and standardized procedures can facilitate faster and more uniform study initiation during a public health crisis.


How to cite this article
Vancouver
Mai NT, Anh TQ, Ha PT. Navigating Ethical and Logistical Challenges in Establishing a Nationwide Cohort Study amid the COVID-19 Pandemic in Germany. Asian J Ethics Health Med. 2024;4:152-69. https://doi.org/10.51847/uikLJkZC8a
APA
Mai, N. T., Anh, T. Q., & Ha, P. T. (2024). Navigating Ethical and Logistical Challenges in Establishing a Nationwide Cohort Study amid the COVID-19 Pandemic in Germany. Asian Journal of Ethics in Health and Medicine, 4, 152-169. https://doi.org/10.51847/uikLJkZC8a
Articles
Smart Home Health Technologies and Elder Care: Mapping Ethical Issues Through a Systematic Review
Asian Journal of Ethics in Health and Medicine
Vol 2 , 2022 | Ana Seselja Perisin
Human Rights and Bioethical Principles in Correctional Settings: A Systematic Review of the Evidence
Asian Journal of Ethics in Health and Medicine
Vol 4 , 2024 | Delyse Leadbeatter
Placebo Without Deception: Ethical Implications of Open-Label Treatments
Asian Journal of Ethics in Health and Medicine
Vol 1 , 2021 | Chen Yu
Guiding Ethical Review of AI Applications in Health Research: A Ugandan Perspective
Asian Journal of Ethics in Health and Medicine
Vol 1 , 2021 | Mei Ling Tan

About SMER

Find out more