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

Abstract

Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant’s identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names, SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs, the system flagged this as a potential coenrolment. By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data security and access, and data management and storage, we were able to successfully implement BCEPS within the clinical trials conducted at HPRU, while adhering to the principles of good clinical practice (GCP), including respect for persons, beneficence and justice.