Benefits of fully electronic consent management and consent collection via tablet PC in supporting time-critical pandemic research -the example of COVID-19-project NAPKON

Dana Stahl¹Henriette Rau^1*Arne Blumentritt¹Lizon Fiedler-Lacombe¹Ekaterina Heim¹Heike Valentin¹Martin Bialke²Monika Kraus³Wolfgang Hoffmann²

• ¹Trusted Third Party, University Medicine Greifswald, Greifswald, Germany
• ²Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany
• ³Institute of Epidemiology, Helmholtz Munich, Munich, Bavaria, Germany

A study participant's informed consent based on study information and expressed using a consent form (CF) is the ethical and legal basis for research with humans. Automatic access to consent states in a timely manner for all systems is crucial for knowing whether and which medical data, images and biological samples may be collected for research. To support time-critical (pandemic) research, this paper evaluates a fully electronic consent management, and a consent collection process via tablet PC in comparison to traditional paper-pencil-based approaches and assesses its impact on patient recruitment.The initial CF validity increased significantly from 67.38% in paper-pencil-based CFs to 99.46% in tablet-CFs. This quality increase also reduced the numbers of invalid CFs or CFs needing corrections, which would lead to study exclusion and, consequently, lower recruitment rates and data lost for research. Time lags between recruitment and availability of data decreased significantly using tablet-CFs, supporting time-critical research while protecting participants' privacy. Overall, participants' and study staff's feedback on tablet-CF collection was positive and highlighted the benefits of the tablet-CF collection in reducing documentational burden on study staff and enabling participants to adjust CF presentation, e.g. choose bigger font size.Although tablet-CF-collection has measurable positive effects, especially on patient recruitment rates due to an increase in initially valid CFs, the majority of NAPKON study sites still used solely paperpencil-based processes. Since feedback of study staff and participants was mainly positive, other barriers beyond technical availability and workflows likely exist, which need to be evaluated in further settings.Fully electronic informed consent collection can be seen as "best practice" approach to ensure valid CFs and increase patients' initial study inclusion rates. Due to the additional benefits regarding less time-to-research, electronic consent form collection should be integrated into pandemic response schemes and other time-critical research.