What is “informed consent”?
• Informed consent is a document used to “inform” the participating patients to various aspect of a study. The document will explain the purpose of the study, the drugs being studied, and visits required of the patients. It will also describe the potential risks or side effects as well as the potential benefits of participating in the study. Most clinical trials involve participants with competent mental ability that can understand the document. It is the first step to any clinical trial and is signed by the investigator (doctor), the patient, and a witness.
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. If you are considering participating in a study, the research staff will give you informed consent documents that contain details about the study. This information should be written so that you can understand it. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study or your participation before you make a decision. You may also want to discuss participation with another doctor, a family member or friend. If you decide to participate in a trial, you must sign the informed consent form, showing that you have been given this information and that you understand it. The informed consent form is NOT a contract and you can leave the study at any time, without penalty, for any reason.
Informed consent means is an FDA requirement that says you must be given complete information about the study before you agree to take part. The FDA requires that you receive and understand the following information: • The study involves research of an unproven drug or device • The purpose of the research • How long the study will take • What will happen in the study and which parts of the study are experimental • Possible risks or discomforts • Possible benefits • Other procedures or treatments that you might want to consider instead of the treatment being studied • The FDA may look at study records, but the records will be kept secret • Whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment • The person to contact with questions about the study, your rights, or if you get hurt • You can quit at any time Make sure you understand all of the information before you agree to be in the study.
In many situations where medical care or treatment is provided to an individual, medical professionals are required to obtain the patient’s “informed consent.” Although the specific definition of informed consent may vary from state to state, it means essentially that a physician (or other medical provider) must tell a patient all of the potential benefits, risks and alternatives involved in any surgical procedure, medical procedure or other course of treatment, and must obtain the patient’s written consent to proceed. If this duty is breached and injuries result, the patient may have a legal claim for damages.
