Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study

Abstract

Background A partnership between the University of Antwerp and the University of Kinshasa implemented the EBOVAC3 clinical trial with an Ebola vaccine regimen administered to health care provider participants in Tshuapa Province, Democratic Republic of the Congo. This randomized controlled trial was part of an Ebola outbreak preparedness initiative financed through Innovative Medicines Initiative-European Union. The EBOVAC3 clinical trial used iris scan technology to identify all health care provider participants enrolled in the vaccine trial, to ensure that the right participant received the right vaccine at the right visit. Objective We aimed to assess the acceptability, accuracy, and feasibility of iris scan technology as an identification method within a population of health care provider participants in a vaccine trial in a remote setting. Methods We used a mixed methods study. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and was assessed at enrollment. Feasibility and accuracy research was conducted using a longitudinal trial study design, where iris scanning was compared with the unique study ID card to identify health care provider participants at enrollment and at their follow-up visits. Results During the FGDs, health care provider participants were mainly concerned about the iris scan technology causing physical problems to their eyes or exposing them to spiritual problems through sorcery. However, 99% (85/86; 95% CI 97.1-100.0) of health care provider participants in the FGDs agreed to be identified by the iris scan. Also, at enrollment, 99.0% (692/699; 95% CI 98.2-99.7) of health care provider participants accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (636/683; 95% CI 91.2-95.0) of the participants returning for scheduled follow-up visits. The iris scanning operation lasted 2 minutes or less for 96.0% (656/683; 95% CI 94.6-97.5), and 1 attempt was enough to identify the majority of study participants (475/683, 69.5%; 95% CI 66.1-73.0). Conclusions Iris scans are highly acceptable as an identification tool in a clinical trial for health care provider participants in a remote setting. Its operationalization during the trial demonstrated a high level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but requires a trained operator to reduce the duration and the number of attempts to identify a participant. Trial Registration ClinicalTrials.gov NCT04186000; https://clinicaltrials.gov/ct2/show/NCT04186000

Acceptability and Applicability of Biometric Iris Scanning for the Identification and Follow Up of Highly Mobile Research Participants Living in Fishing Communities Along the Shores of Lake Victoria in Kenya, Tanzania, and Uganda

“…Similarly, the high acceptability rates for return visits aligns with findings in previous studies [22,23], and corroborates the self-reported satisfaction with the initial iris biometric scan in our study participants. Despite the high acceptability, it is noteworthy that the levels of awareness and prior use of biometric iris technologies in most populations remain low and participants express general safety concerns and anxiety about the physical effects biometric scanning could have on eyes [23]. Other reasons for hesitancy in accepting biometric iris identification include privacy and confidentiality concerns among patients and misconceptions about iris scanning [22,23].…”

“…These limitations include multiple registration, breach in confidentiality associated with use of names and inaccuracies or errors arising during documentation or verification of personal identifiers [9][10][11][12]14]. Similarly, the high acceptability rates for return visits aligns with findings in previous studies [22,23], and corroborates the self-reported satisfaction with the initial iris biometric scan in our study participants. Despite the high acceptability, it is noteworthy that the levels of awareness and prior use of biometric iris technologies in most populations remain low and participants express general safety concerns and anxiety about the physical effects biometric scanning could have on eyes [23].…”

“…Our study showed high (99%) acceptability for both initial iris scan and the repeat scan one month after enrolment among participants in fishing communities around Lake Victoria. High rates of biometric iris scan acceptability have been reported previously in different populations in low-and middle-income settings including health care providers enrolled in vaccine trials (99%), patients attending HIV care clinics (98%), and genetics studies (100%) [22,23,27]. Our findings confirm that acceptability of iris scanning for biometric identification remains high in the community in the research context where participation is voluntary and not linked to 22) 60( 20) 36( 12) 80( 27) 243 (20) HIV positive 9(3) 44( 15) 44( 15) 71( 24) 168 (14) either health services or other government services from which participants draw direct benefits.…”

“…Despite its reliability, the use of iris scanning in both research and routine health care services has sometimes raised worries and misconceptions among both patients and study participants including safety concerns and anxiety about the physical effects that intense light exposure during biometric scanning could have on eyes [22,23]. There is little information about the acceptability of iris scan technology among residents of fishing communities and similar key populations that have become a focus of HIV vaccination and other prevention research interventions.…”

Open-label, randomised, clinical trial to evaluate the immunogenicity and safety of a prophylactic vaccination of healthcare providers by administration of a heterologous vaccine regimen against Ebola in the Democratic Republic of the Congo: the study protocol

“…Furthermore, prior to the start of the clinical trial, a pilot study was performed whereby potential participants were interviewed on the feasibility and acceptability of the use of a biometric iris scanning tool for participant identification during the trial and the use of telephone messaging with visit reminders for participant adherence. 27…”