What is “informed consent”?
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include: • Why the research is being done. • What the researchers want to accomplish. • What will be done during the trial and for how long. • What risks are involved in the trial. • What benefits can be expected from the trial. • What other treatments are available. • The fact that you have the right to leave the trial at any time.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an “informed consent” form before joining the study, indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent helps ensure that a prospective clinical trial participant understands what’s involved in the trial.
Informed consent is a process in which a patient learns all the key facts about the clinical trial before deciding whether to take part. A doctor or research nurse may explain all that is involved. In addition, these facts will be given to you in a written consent form that you may take home to read and discuss. The consent form will included details about: • The study approach • The possible risks and benefits • The tests and procedures you will have if you take part Patients interested in taking part are encouraged to ask questions until they have all the information needed. Informed consent continues as long as you are in the study. You may change your mind at any time and leave the study whenever you want. Should you wish to stop participating in the study, standard therapy will remain available to you.
Informed consent is a process by which the trial participant voluntarily confirms his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that relate to their participation. Doctors and nurses involved in the trial will explain the details of the clinical trial, outlining the potential benefits and the risks associated with the trial, the duration of the trial, tests and procedures that may be required, follow-up and confidentiality aspects. Potential participants should ask questions and be given time to consider their participation. Informed consent is documented by means of a written, signed and dated consent form. The participant has the right to withdraw consent at any time.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. To help someone decide whether or not to participate, the research team will review and discuss the informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. After we discuss the informed consent, you will be given an opportunity to ask any questions you may have. You can then decide whether or not to sign the document. Informed consent is not a contract, and you may withdraw from the trial at any time.
