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6ER-030 Evaluation of a group-based online informed consent conversation (eConsent) in participants from a vaccination clinical trial: a mixed method study
  1. N Tan1,
  2. M Lafeber2,
  3. R Sablerolles1,
  4. L Visser3,
  5. D Postma4,
  6. A Goorhuis5,
  7. H Van Der Kuy1
  1. 1Erasmus Mc, Hospital Pharmacy, Rotterdam, The Netherlands
  2. 2Erasmus Mc, Internal Medicine, Rotterdam, The Netherlands
  3. 3Leiden Umc, Infectious Diseases, Leiden, The Netherlands
  4. 4Umc Groningen, Internal Medicine and Infectious Diseases, Groningen, The Netherlands
  5. 5Amsterdam Umc, Infectious Diseases, Amsterdam, The Netherlands


Background and Importance Use of digital consent (eConsent) has expanded in the last few years in Europe especially during the pandemic. Slow recruitment rate and limitation in reaching out to participants from different backgrounds are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in study recruitment for the SWITCH-ON trial.

Aim and Objectives We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use.

Material and Methods SWITCH-ON study aims to analyse the immunogenicity of healthy population following bivalent COVID-19 booster vaccination. 434 healthcare workers aged between 18 and 65 were successfully recruited and were sent a questionnaire about their experience with group eConsent after their informed consent session. Out of 399 completed questionnaires received (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively.

Results Participants found group eConsent efficient, useful to hear questions from others and being in a group created a sense of togetherness. However, limited privacy, barriers to ask questions in a group and peer pressure can limit the use of group eConsent. 165 (46%) participants thought that group eConsent was also suitable to recruit participants with disease or conditions while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population and one-to-one conversation should always be available. Participants who had experience both one-to-one and group eConsent shared different preferred consent formats for future studies.

Conclusion and Relevance Group eConsent can be an effective tool for research recruitment with further optimisations to overcome the limitations raised by participants. Using webinars to providegeneral information about the study, followed by an individual session for each participant will retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting will address the privacy questions and makes group eConsent easier to be implemented in many study populations.

Conflict of Interest No conflict of interest.

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