The CHRU Community Advisory Board

Your Protection

Ensuring the protection of clinical trial participants

Numerous international, South African and clinical research bodies govern clinical trials and protect the rights and safety of clinical trial participants. We are committed to our participants: you and your safety always comes first.

In South Africa

The following regulatory bodies must approve the clinical research before any trial can commence:

  • Research ethics committee – TheUniversity of the Witwatersrand’s Ethics Committee reviews and approves all protocols undertaken by CHRU. This committee is independent of the study sponsor and the clinical investigators.
  • South African Health Products Regulatory Authority (SAHPRA) – This is an entity of the National Department of Health, created to ensure that health and well-being is prioritised. SAHPRA is tasked with regulating all health products. This includes clinical trials, complementary medicines and medical devices.

Other regulatory approvals are also required, for example from the Department of Health and the hospital or clinic involved in the trial.

Internationally

Internationally, there are research networks that provide oversight to trials taking place all over the world and these networks ensure that all clinical trials comply with the World Medical Association Declaration of Helsinki Ethical Principles for Medical Research involving human subjects.

Additional measures

  • Independent data safety monitoring boards monitor trial results and side-effects throughout the process and will pause or halt the trial if they have any concerns regarding patient safety.
  • The clinicians who may participate in and run the trial also put the interests of the participants first. They work independently and are not dictated to by the sponsors of the trial. As local doctors who are part of the local communities, they have participants’ best interests as their primary focus.
  • All trial participants complete an informed consent form, which details exactly what the trial involves and any potential risks. The trial is explained to you and all your questions are answered before and during the process.
  • You are free to withdraw from a trial at any time.