What is “patient informed consent”?
Before enrolment in a clinical trial a patient or his legal guardian has to give informed consent. By participating in a clinical trial the patient has to confirm, that he has understood the potential risks and benefits of the trial and that he knows his rights and responsibilities being included in the trial. This is indispensable to run a clinical trial. The patient informed consent includes all issues dealing with his disease and the treatment given by the trial. Other treatment options and the outcome in respect to different therapies have to be explained in a way the patient understands. The patient has the right to backtrack his consent at any time without reasoning. Informed consent deals also with data security and handling of personal data. The content of informed consents is part of the evaluation process of a trial done by ethical committees or the institutional Review Boards.
