Entering a clinical trial may be a new venture for you and therefore a little unnerving. It should be comforting to know that it is not only your physical wellbeing that is protected in the proceedings around clinical trials but also your rights.
Any volunteer who gives his or her consent to participate in a clinical trial or who is asked to give his or her consent on behalf of another has the right to:
◾know the purpose of the clinical trial
◾understand all the risks, side effects or discomforts that might be reasonably expected
◾be aware of any benefits that can be reasonably expected
◾know what will happen in the study and whether any procedures, drugs or devices are different than those that are used as standard medical treatment
◾know what other alternative treatment is available and how those treatments may be better or worse than being in a clinical trial
◾be allowed to ask any questions about the trial before giving consent and at any time during the course of the clinical trial
◾be allowed ample time, without pressure, to decide whether to consent or not to consent to participate in the trial
◾refuse to participate, for any reason, before and after the trial has started
◾receive a signed and dated copy of the informed consent form
◾be told of any medical treatments available if complications occur during the trial.
◾know how participation in a trial will influence current medical treatment
◾know who will provide medical care after trial participation stops
◾have no personal expenses for participation in a clinical trial
If you have any questions please contact us at info@clinicalresearch.co.za.