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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

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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 JOURNAL OF MEDICAL INTERNET RESEARCH Zola Matuvanga et al Original Paper 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 Trésor Zola Matuvanga1,2,3, MD; Ginger Johnson4, PhD; Ynke Larivière2,3, MPH; Emmanuel Esanga Longomo5, MD; Junior Matangila1, PhD; Vivi Maketa1, PhD; Bruno Lapika6, PhD; Patrick Mitashi1, PhD; Paula Mc Kenna7, MSc; Jessie De Bie2,3, PhD; Jean-Pierre Van Geertruyden2, PhD; Pierre Van Damme3, PhD; Hypolite Muhindo Mavoko1, PhD 1Department of Tropical Medicine, University of Kinshasa, Kinshasa, the Democratic Republic of the Congo 2Global Health Institute, University of Antwerp, Antwerp, Belgium 3Centre for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium 4Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium 5Division Provinciale de la Santé de la Province de la Tshuapa, Boende, the Democratic Republic of the Congo 6Department of Anthropology, University of Kinshasa, Kinshasa, the Democratic Republic of the Congo 7Janssen Pharmaceutica NV, Beerse, Belgium Corresponding Author: Trésor Zola Matuvanga, MD Department of Tropical Medicine University of Kinshasa Avenue Université numéro 1, Commune de Lemba Kinshasa the Democratic Republic of the Congo Phone: 243 810046306 Email: [email protected] 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. https://www.jmir.org/2021/8/e28573 J Med Internet Res 2021 | vol. 23 | iss. 8 | e28573 | p. 1 (page number not for citation purposes) XSL·FO RenderX JOURNAL OF MEDICAL INTERNET RESEARCH Zola Matuvanga et al 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 (J Med Internet Res 2021;23(8):e28573) doi: 10.2196/28573 KEYWORDS biometric identification; iris recognition; vaccine trial; participants© visits; acceptability; feasibility; Democratic Republic of the Congo; mixed methods; Ebola fingerprint structureÐthe most widespread biometric method Introduction of identificationÐthat varies during childhood and only becomes Identification and recognition of study participants in a clinical stable after many years [5,9]. Fingerprinting also carries trialÐduring the process of recruitment and during follow-up additional risks such as spreading some infectious diseases, visitsÐis a growing issue [1]. Conventional methods for the since it requires the participant (and, sometimes, the operator) recognition of participants in health facilities may include patient to come in physical contact with the fingerprint device. Identical name, date of birth, government identity card with photo, and (ie, monozygotic) twins were found to have higher similarities phone number [2-5]. However, these methods are not always of fingerprint patterns compared with nonidentical twins [4,5]. reliable or accurate [5]. For example, identity cards can be stolen Iris scanning is feasible under most circumstances, as it can be or forgotten, and there is a risk of assigning a participant©s ID carried out from anywhere between 10 cm to several meters (intentionally or unintentionally) to another participant during away from the eye, and results are generally available within a study visit. Some participants may share their ID card number 30 seconds [7,12]. Even genetically similar people have entirely with a family member with a similar physical resemblance, if independent irises; thus, iris scanning recognition avoids they are unable or unwilling to keep to their appointment time. misidentification of identical twins [3-5]. However, iris In clinical trials, efficacy and safety data such as (serious) recognition may be challenging for people who suffer from adverse events, are repeatedly assessed through anamneses, diabetes or any other iris disease [4,5]. Moreover, the accuracy physical examinations, and biological samples during different of the scanning devices can be affected by unusual light effects, visits, possibly, over a long period of time. Thus, participant in comparison with fingerprinting [2,5]. enrollment and identification are essential steps to ensure that Iris scans may offer one of the most secure strategies of all data collected are unique and that neither the participant nor authentication and recognition in clinical trials [7]. Iris-based the visit has been misidentified [1,2]. A biometric identification biometric systems have demonstrated a promising performance method coupled with a unique participant ID number could during the process of recognition, with an average time (during mitigate the occurrence of mistakes made using conventional initial clinical trial enrollment) of less than 2 minutes and a methods during initial and follow-up clinical trial visits [3]. sensitivity rate of at least 86% [8,11,12]. In Kenya, an iris scan Biometric technology confirms the physical presence of the sensitivity or accuracy rate of 95% was found in HIV and person by assessing unique physical or behavioral characteristics tuberculosis patients during routine hospital consultations [8]. that cannot be borrowed, stolen, or forgotten. Such technology This was better than fingerprint biometric recognition found in uses matching algorithms or artificial intelligence for identifying Ghana (68.7%) or in Uganda (75.5%) [11,12]. Thus, use of iris the particular feature [3,6,7]. A number of biometric identifiers, scan technology can substantially reduce the possibility for including physical traits (eg, fingerprint; face; palm; cornea; fraud and abuse within a clinical trial [3,9,10]. Lastly, it has a iris; thermogram of the body, face or ear; and DNA) or high acceptance rate, with very low false-match and rejection behavioral traits (eg, signature, voice, typing dynamic, smell, rates [1,2]. and walk pattern) have demonstrated technical feasibility in Despite its attractive design features, there is little information various studies [6-10]. Biometric identification systems have available about the acceptability of iris scan technology for the many advantages over more conventional methods of general public, especially, information on how it varies across identification, such as easier fraud detection and more accuracy and within countries. Acceptability within a population may for face recognition than photographs. Therefore, biometric depend on many factors such as positive perception, confidence, identification is increasingly used worldwide in various fields and constraints presented against the use of iris scans. For to recognize individuals and secure their data (eg, during example, in one of the few studies available, a survey was elections, at airports, or for criminal detection) [6]. conducted in Australia on the willingness of the general Irises are an ideal part of the body for biometric identification. population to use biometric security technologies; it found that The iris is flat and has a fine texture and geometric configuration 61% of the population would accept fingerprints, whereas only determined randomly upon embryogenesis [3,10,11]. It is a 41%
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