Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives

• Published in: South African Journal of Science 2022-05, Vol.118 (5-6), p.33-38
• Main Authors: Nair, Gonasagrie, Kabanda, Siti M., Jacobs-Alfred, Meagan M.M., Obasa, Adetayo E.A., McCaul, M., Moodley, Keymanthri
• Format: Article
• Language: English
• Subjects: Acceptability; Clinical trials; Coronaviruses; COVID-19; COVID-19 vaccine access; COVID-19 vaccines; Data analysis; electronic consent; Electronic devices; Electronic equipment; FDA approval; Health care; Health sciences; healthcare professionals; Hospitals; Informed consent; Medical research; Motivation; Pandemics; Participation; Preferences; Professional ethics; Professionals; Public health; Questions; Safety measures; Surveys; Vaccines; voluntariness of consent
• ISSN: 0038-2353; 1996-7489
• DOI: 10.17159/sajs.2022/13048

The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information - an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study par ticipation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and adver tisement, to par ticipate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of par ticipants (38.6%) were not able to discuss the study with research staff. While the majority of par ticipants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that repor ting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the repor ting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most impor tant motivation for par ticipation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to par ticipate.