Participant verification: Prevention of co-enrolment in clinical trials in South Africa

Abstract

Background. As KwaZulu-Natal Province is the epicentre of the HIV epidemic both in South Africa (SA) and globally, it is an ideal location to conduct HIV prevention and therapeutic trials. Numerous prevention trials are currently being conducted here; the potential for participant co-enrolment may compromise the validity of these studies and is therefore of great concern. Aim. To report the development and feasibility of a digital, fingerprint-based participant identification method to prevent co-enrolment at multiple clinical trial sites. Methods. The Medical Research Council (MRC) HIV Prevention Research Unit (HPRU) developed the Biometric Co-enrolment Prevention System (BCEPS), which uses fingerprint-based biometric technology to identify participants. A trial website was used to determine the robustness and usability of the system. After successful testing, the BCEPS was piloted in July 2010 across 7 HPRU clinical research sites. The BCEPS was pre-loaded with study names and clinical trial sites, with new participant information loaded at first visit to a trial site. Results. We successfully implemented the BCEPS at the 7 HPRU sites. Using the BCEPS, we performed real-time 'flagging' of women who were already enrolled in another study as they entered a trial at an HPRU site and, where necessary, excluded them from participation on site. Conclusion. This system has promise in reducing co-enrolment in clinical trials and represents a valuable tool for future implementation by all groups conducting trials. The MRC is currently co-ordinating this effort with clinical trial sites nationally.

Ethical considerations in implementing a biometric co-enrolment prevention system in clinical trials in South Africa

“…The biometrics co-enrolment prevention system (BCEPS) is a novel approach used to prevent co-enrolment of research parti cipants in multiple clinical trials in SA. [2] This system was developed and implemented by the HPRU in collaboration with the SAMRC Infor mation Technology (IT) Services Division and an external deve loper in 2010. [2] This is a webbased system, which uses biometric technology to capture participant's personal identification details in real time.…”

“…[2] This system was developed and implemented by the HPRU in collaboration with the SAMRC Infor mation Technology (IT) Services Division and an external deve loper in 2010. [2] This is a webbased system, which uses biometric technology to capture participant's personal identification details in real time. [2] In brief, this system is used to capture the participant's full name, SA identity number or passport number (if not South African) and fingerprints.…”

“…[3] In 2008, the HIV Prevention Research Unit (HPRU) of the South African Medical Research Council (SAMRC) identified several participants who co-enrolled in two HIV prevention clinical trials being conducted in close proximity. [2] These co-enrolments fortunately did not impact on participant safety and study outcomes. [4] This incident did, however, raise concerns among sponsors and researchers that co-enrolment in HIV prevention clinical trials is a reality that must be identified and prevented from occurring.…”

“…[1] Co-enrolment or concurrent enrolment of participants into multiple clinical trials testing therapeutic or prevention agents, is a potential risk in this setting. [2] Co-enrolment has the potential to affect the power of a study that determines the effect of an intervention, bias the study due to possible interactions between the interventions, increase the burden of clinic attendance and study procedures on participants and impact on the safety of the participant due to the possible unexpected interactions between interventions. [3] Reported reasons for coenrolment in this region include access to high quality healthcare at the clinical research site (CRS), study re-imbursements, altruism, access to investigational products such as study gels to enhance sexual pleasure, perceived low risk of being identified by researchers as being co-enrolled, and peer pressure by fellow co-enrollees.…”

“…This consideration is especially important when implementing trials in resource-poor settings where trial participants are more likely to attempt to co-enrol. [2]…”