Am I protected in a clinical trial?
In any kind of research involving humans (such as clinical trials) the health and rights of participants is of primary consideration. To help protect participants from the possible risks involved in clinical trials there are stringent scientific, medical and ethical principles that researchers must adhere to.
These principles form part of an important scientific document referred to as a protocol. Every clinical trial must develop a protocol and this must be approved by a Human Research Ethics Committee (HREC). The committee ensures that participants' rights are maintained throughout the study and that the protocol is being followed.
Participants' rights are extremely important in a clinical trial and researchers are required to obtain informed consent from individuals prior to them becoming involved in the trial. The informed consent process requires that researchers inform patients about the key facts of the study, including the type of treatments, other treatment options, how many tests and what sort of tests are required, possible benefits of the study, possible risks and the known side-effects of therapy. All of this information must be provided before a patient decides whether or not to participate in a study. Signed informed consent must be given by every patient prior to commencing a clinical trial, and the rights of the patient continue for the duration of the study.
As a participant you have the right to change your mind and leave the study at any time. Signing a consent form does not mean you must stay in the study. You are free to stop participation at any point during the study, before the study has begun, once you have started or even during the follow-up period.
