You are asked to participate
You are being asked to participate in a clinical research study by your treating physician or another member of the research team. Your physician will discuss the study with you. You will receive the information also in written, so you can read it at home. In addition, your physician will explain all your rights and responsibilities. You will get sufficient time before you decide if you would like to participate or not. Read all information carefully and consider all procedures, benefits and risks, discomforts and precautions. Ask as many questions as needed. If you are willing to participate, you will be asked to sign the consent form. You may withdraw from the study at any time.
Your rights and responsibilities
Guidelines have been developed to protect subjects participating in a research study. There are strict rules for research physicians conducting clinical research. The most important rights for subjects are summarized hereafter.
Right to decide about participation (voluntary participation)
It is up to you to decide whether or not to take part in a clinical research study. It will always be your decision.
Right to receive information and ask questions
Your physician will inform you about the clinical research study, verbally and in written. Not only prior to study start, but also during the course of the study you have the right to receive information. Your physician should provide you with the information.
Right to withdraw from the clinical trial
Even if you have consented, you can withdraw your consent at any time. Also if the study has already started, you always have the right to withdraw from the study.
During the course of the study the investigators collect data. The collected data will be handled confidentially and the data will be assigned a code number. Your data will also get a code number and your name will be removed. If the results of the study are published, your identity will remain confidential.
What will I be responsible for if I participate in a clinical research study?
You also have responsibilities as a subject. In some research studies you have to stay sober or bring all remaining medication with you to a visit. If you are not willing to follow the instructions of the physician carefully, the research cannot be conducted the right way and the collected data is not reliable. If this happens your physician may end your participation and discuss further treatment with you.
Investigators try to prevent that something goes wrong during the course of a clinical trial. Also the ethics committee will look on measurements taken to prevent any damage. Nevertheless unforseeable injuries may occur. The pharmaceutical company or hospital conducting the research has taken out an insurance for the study. This insurance will compensate you for any possible damage as a result of your participation.