Electronic consenting in a randomised control trial of complex intervention for children with autism: Experiences from COMPASS trial, India

Abstract

Abstract Background: Technological advancements have facilitated increased use of virtual interactions in public health research between investigators and study participants. This includes electronic informed consent (eIC) as a feasible alternative to traditional paper based, in-person consenting processes. The COVID-19 pandemic impacted a large number of studies globally and processes like eIC enabled continued recruitment of participants into trials. Although current evidence on use of eIC are largely positive, further research is required from diverse contexts. This paper presents the processes of development and implementation of eIC in a large RCT on autism from India. Method: Cognitive interviews with 12 community members and 51 pilots were conducted to develop the eIC standard operating procedure for the RCT. The eIC implementation process included 5 steps and all interactions between participants and researchers were done over calls. This eIC procedure was used to recruit 220 participants to the trial between January 2021-December 2022. 14 researchers of the trial’s evaluation team used the eIC procedures and their feedback was routinely incorporated to the eIC implementation. All qualitative data was thematically analysed to identity strengths and limitations of the eIC procedure and descriptive analysis of quantitative data was done for population characteristics, eIC rates and duration of eIC. Results: 76.4% (n=220) of participants approached for eIC were found eligible for inclusion and gave consent for participation in the trial. The eIC calls took an average of 20 minutes (Range: 18-30 minutes) including the audio recording of participant responses to consenting statements read out by researchers. Key strengths of the eIC process as shared by researchers were time flexibility of conducting eIC calls and comprehension of trial information among participants. Major limitations were around establishing trust and rapport with participants during virtual interactions and appointment scheduling. Conclusion: The rate of consenting achieved in this trial using the eIC procedure and the feedback from researchers have provided further evidence supporting the use of eIC in complex trials in low- and middle-income countries. Trial registration: ISRCTN ID: 21454676; https://www.isrctn.com/ISRCTN21454676?q=21454676; Registration date: 22.06.2018