What is “informed consent”?
Informed consent gives volunteers information about a clinical research study so that they may make an informed decision to participate in a study. The informed consent process ensures that volunteers can get answers to questions about the study and be comfortable about the nature of the study in general. The study coordinator/nurse and physicians are responsible for making sure that each volunteer provides informed consent before participating in a study.
Informed consent means that you, the patient, has been presented with the options for treatment, the common and serious risks and expected benefits of each option and what the likely outcomes of the treatment (or of no treatment) are. In addition, you should be given a chance to ask questions. Informed consent is usually given in writing and requires a signature (exceptions are extreme emergencies).
Informed consent by a patient is required before participating in a clinical trial, according to the National Cancer Institute: “Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. In addition to talking about these facts with the research doctor or nurse, they will be included in a written consent form that you can take home to read and discuss. The consent form will include details about: • the study approach • the intervention given in the trial • the possible risks and benefits • the tests you may have Don’t hesitate to ask questions until you have all the information you need. While informed consent begins before you agree to participate in a trial, you should feel free to ask the healthcare team any questions you have at any point. Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want — before the study starts or at any time duri
