What is “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.
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.
Informed consent is the process of learning the key facts about the clinical trial before a person decides 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 • That the participant has the right to leave the trial at any time.
Informed Consent is an ongoing process to keep you informed about the particular study you are interested in. It ensures that after being informed of all the risks of the study and your responsibilities you agree to enroll. In the process, you will be asked to sign a consent form. Be sure that you understand and agree with everything about the study before you sign this form. We’ll give you a copy to keep. Joining a vaccine study means that you agree to meet the schedule and requirements of the study. If you don’t feel comfortable with this, or if you can’t make all the appointments, talk to the people running the trial. Perhaps they can be flexible, or together you may decide that you cannot participate in the study. You may discontinue your participation in the study at any time. It is important to understand that the researchers plan their trials around the participants; test results can lose their meaning when volunteers drop out. If you think you might drop out for any reason, it
Informed consent, a key part of a good trial, is required in studies that are federally regulated or funded as well as by many state laws. Informed consent means that as a patient, you are given information so you can understand what is involved in a trial, including its potential benefits and risks, and then decide freely to take part in it or not. The nature of the treatment is explained by the doctors and nurses in the trial. You are given an informed consent form to read and consider carefully. Ask any questions you may have. Then, if you agree to take part, you can sign the form. Of course, you can also refuse. The informed consent process is an ongoing process. If you enter a trial, you will continue to receive any new information about your treatment that may affect you willingness to stay in the trial. Signing a consent form does not bind you to the study. You can still choose to leave the study at any time.
