Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial

Tan, N.H.; Lafeber, M.; Sablerolles, R.S.G.; Roders, I.V.; Hoef, A. van de; Grafhorst, K. van; Visser, L.G.; Postma, D.F.; Goorhuis, A.; Rietdijk, W.J.R.; Kuy, P.H.M. van der

doi:doi:10.1186/s13063-024-08367-4

Background Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefts of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use. Methods SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID19 booster vaccination. Four hundred thirty-four healthcare workers aged 18–65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the fnal analysis....Show moreBackground Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefts of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use. Methods SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID19 booster vaccination. Four hundred thirty-four healthcare workers aged 18–65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the fnal analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively. Results Participants found that group eConsent was an efcient method that it allowed them to hear each other’s questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-fve (46%) participants thought that group eConsent was suitable to recruit participants with diseases 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 experienced both one-to-one and group eConsent shared diferent preferred consent formats for future studies. Conclusion Group eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefts of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement.
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Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial