Informed consent is an ongoing process in which a (prospective) participant is informed about the facts of a specific clinical trial so that he/she can decide whether or not to participate or continue to participate in a specific clinical trial.
Informed consent involves signing a written consent form, which forms the basis of the person’s willingness to participate in a trial. The informed consent form is not a contract, but it is signed to ensure that a person takes part in a trial out of his/her own free will.
As a potential research participant or participant in a clinical trial, you must know that:
- Your informed consent is a necessary requirement for ethical and scientific research. This means that your right, dignity and well-being as a research participant must be protected, respected and promoted at all times before, during and after the research study ;
- You have the right to be provided with all the necessary information before you make any decision to participate;
- Information must be given in a simple and clear style via the use of your home language (mother tongue). This is done to ensure that you understand and are able ask questions;
- Your decision to participate must be free of coercion, undue influence or incentives. You will not be penalised if you refuse to participate;
- Your informed consent must be both written and verbal;
- Your informed consent must be given, in writing, for access to your medical records for trial related activities and audits, ethics committee review and regulatory inspection;
- You are free to withdraw from participating in a clinical trial at any time;
- If you withdraw from the clinical trial, this will not affect the standard of care you receive.