Managing withdrawals and exclusions of study participants in COVID-19-research by NUKLEUS

Managing withdrawals and exclusions of study participants in COVID-19-research by NUKLEUS

Abstract Background This article describes how withdrawals and exclusions of study participants can be managed in COVID-19-cohort studies by NUKLEUS (German: NUM Klinische Epidemiologie- und Studienplattform), using NAPKON (German: Nationales Pandemie Kohorten Netz). The aim of this manuscript was t...

Full description

Saved in:
Bibliographic Details
Main Authors: Heike Valentin, Henriette Rau, Lizon Fiedler-Lacombe, Arne Blumentritt, Ekaterina Heim, Alexander Rudolph, Katrin Leyh, Monika Kraus, Bettina Lorenz-Depiereux, Irina Chaplinskaya, Christian Schäfer, Jens Schaller, Joerg Janne Vehreschild, Melanie Stecher, Margarete Scherer, Martin Witzenrath, Beate Balzuweit, Stefan Schreiber, Thomas Bahmer, Wolfgang Lieb, Steffen Cordes, Wolfgang Hoffmann, Sabine Hanß, Dana Stahl
Format: Article
Language:English
Published: BMC 2025-05-01
Series:BMC Medical Research Methodology
Subjects:
COVID-19
GDPR
Informed consent
Informational right to self-determination
NAPKON
SARS-CoV-2
Online Access:https://doi.org/10.1186/s12874-025-02526-0
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Background This article describes how withdrawals and exclusions of study participants can be managed in COVID-19-cohort studies by NUKLEUS (German: NUM Klinische Epidemiologie- und Studienplattform), using NAPKON (German: Nationales Pandemie Kohorten Netz). The aim of this manuscript was to describe, how partial withdrawals can be performed so that most of the data and bio-samples can be kept for research purposes. Methods The study has taken all signed informed consents (ICs) of study participants into account in order to develop a method how partial withdrawals can be developed and installed. The informed consents, which comprise of mandatory and optional modules were investigated to find out which optional modules can be withdrawn from without withdrawing consent from the whole study. Results Withdrawals refer to signed ICs including mandatory and optional modules. Withdrawals can be submitted verbally or in writing, and regarding the IC, as a whole, or only partially. Consequently, implemented withdrawals for NAPKON cohorts comprise partial withdrawals with partial or no data deletion or complete withdrawals with data deletion. Thus, more data is still available for research purpose, which would have been lost without the possibility of partial withdrawals. In NAPKON, a total of 3,97% of the participants have submitted a withdrawal or have been excluded from the study if the inclusion criteria were no longer met. Conclusions This manuscript is to the author’s knowledge one of the first article related to withdrawals within COVID-19-studies (NAPKON). The processes serve as ‘best practice’ examples for planning and establishing withdrawal processes in medical research.
ISSN:1471-2288

Similar Items