CHRU departments
Numerous international and South African regulatory authorities and clinical research bodies govern clinical trials and protect the rights and safety of clinical trial participants.
The following regulatory bodies approve clinical research before a trial at CHRU commences:
The University of the Witwatersrand’s Human Ethics Committee (WHREC) reviews and approves all protocols undertaken by CHRU. This committee is independent of the study sponsor and clinical investigators.
South African Health Products Regulatory Authority (SAHPRA) is an entity of the South African National Department of Health that ensures the health and wellbeing of participants.
Other regulatory permissions are required from the South African National Department of Health, relevant provincial Departments of Health, health districts (district clinics) and the hospital involved in a trial.
CHRU is involved in many international multi-centre studies. All studies conducted are compliant with:
The International Council on Harmonisation Good Clinical Practice (ICH GCP) and Human Subjects Protections (HSP).
Additional measures for participant protection
Independent data safety monitoring boards monitor trial results and side effects and will pause or halt a trial if they have concerns regarding patient safety.
Clinicians, mostly local doctors, are part of local communities and prioritise the interests of trial participants.
The South African law, through the Protection of Personal Information Act (POPI Act), regulates and protects the use of personal information.
No research procedures are conducted without prior informed consent from a participant. Participation in a trial is completely voluntary and participants are free to withdraw from a trial at any time.
CHRU Departments
