What is “informed consent”?
“Informed consent” is an ongoing process, and it starts well before any consent forms are signed and continues until the subject’s participation is completed. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation, providing an opportunity for the individual to ask questions and receive answers, and allowing individuals to decide whether to participate. If consent is to be informed, the subjects must genuinely understand the study.The informed consent process is different from the consent form. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed.
Informed consent, a key part of a good trial, is required in studies that are federally regulated or funded as well as being subject to 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 who are conducting the trial. You are given an informed consent form to read and consider carefully. The informed consent document can be unsettling. It is important to realize that this consent procedure is done to protect you, not to frighten you. You should fully understand both the benefits and the risks involved in a particular trial so that you can make your own informed decision about whether you wish to participate. Ask any questions you may have. Then, if you agree to take part, you can sign the form. Of course, you may also refuse. The informed consent pro
Study procedures, risks, and benefits are explained to volunteers during the informed consent process. During the informed consent, volunteers are given the information needed to make an “informed” decision about participating in a clinical study. All volunteers are given the opportunity to ask questions and exchange information freely with the clinical study physician during informed consent.
