Stakeholders’ experiences in the use of electronic informed consent of research participants at the Makerere University College of Health Sciences

Abstract

Informed consent is an important aspect of research, but obtaining it can be challenging, and as such, researchers have tried to make the process more engaging and informative. As a result of the COVID-19 pandemic, electronic informed consent (EIC) has become more popular, and it has been found to increase inclusion and diversity by providing tailored information to participants. However, it has not been globally adopted due to concerns around privacy, confidentiality, and determining the voluntariness of the participants. Despite its acknowledgement as the future for clinical research, there is low adoption of EIC in Uganda. Limited studies have explored the perspectives of researchers and research ethics committees, particularly in developed countries, however, the opinions and experiences of research participants and researchers have not been thoroughly investigated in Sub-Saharan Africa, specifically Uganda. A qualitative study was conducted to explore the experiences and views of researchers and their research team members(medical officers, study coordinators and research assistants) to develop strategies to effectively implement EIC in Uganda. Objectives This study aimed to explore the experiences and ethical challenges of stakeholders at the Makerere University College of Health Sciences regarding the use of electronic informed consent so as to improve its processes. This was a descriptive phenomenology cross-sectional study at the Makerere University College of Health Sciences, and qualitative methods were adopted. Twenty in-depth interviews were conducted with research teams, including principal investigators and their team members, and were carried out using qualitative research methods. The qualitative data was analyzed using thematic analysis to highlight the experiences of the participants. Each interview was audio recorded and transcribed verbatim and then arranged and coded using NVivo software. Four main themes emerged from this study. They include stakeholders’ perceptions about the use of electronic informed consent, experiences with the use of electronic informed consent, ethical challenges of using e-consent, and recommendations for the use of e-consent. Respondents viewed electronic informed consent as a promising approach for the inclusion of individuals despite their geographical location. However, limited access and high costs of digital platforms, lack of formal guidance and training and low digital literacy levels hindered the adoption of electronic informed consent. Other ethical issues highlighted included participants struggling to fully comprehend the consent process due to the lack of formal guidance and training from research ethics committees. Despite these challenges, EIC was seen as a promising method for consenting participants in the near future, especially for geographically dispersed study populations, provided improvements, accessibility, and guidance by the ethical committees are in place.