Ethical Considerations in Implementing a Biometric Co-Enrolment Prevention System in Clinical Trials in South Africa

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

Ensuring the security and privacy of information in mobile health-care communication systems

The sensitivity of health-care information and its accessibility via the Internet and mobile technology systems is a cause for concern in these modern times. The privacy; integrity and confidentiality of a patient's data are key factors to be considered in the transmission of medical information for use by authorised health-care personnel. Mobile communication has enabled medical consultancy; treatment; drug administration and the provision of laboratory results to take place outside the hospital. With the implementation of electronic patient records and the Internet and Intranets; medical information sharing amongst relevant health-care providers was made possible. But the vital issue in this method of information sharing is security: the patient's privacy; as well as the confidentiality and integrity of the health-care information system; should not be compromised. We examine various ways of ensuring the security and privacy of a patient's electronic medical information in order to ensure the integrity and confidentiality of the information