Researchers are aware of a consent’s importance, because informed consents are THE basis for study participation in research projects, if not otherwise regulated by law. Any incorrectly filled-in consent is invalid and inevitably leads to the participant’s exclusion from the study and loss of data for the research.
The article highlights paper-based consent forms, their electronic equivalents in gICS, and their quality. Based on the quality criteria and quality assurance measures described in the article, the frequency of quality issues and the resulting threat of data loss was reduced from more than 8% of participants to less than 1% in the example project BFCC. A win for research!
This publication was published Open Access in January 2023 and can be cited as follows:
Rau H*, Stahl D, Reichel A, Bialke M, Bahls T, Hoffmann W, We Know What You Agreed To, Don’t We?—Evaluating the Quality of Paper-Based Consents Forms and Their Digitalized Equivalent Using the Example of the Baltic Fracture Competence Centre Project. METHODS OF INFORMATION IN MEDICINE. (open access) 2023. https://doi.org/10.1055/s-0042-1760249
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