What is “informed consent”?
Informed Consent is the process by which a physician helps a patient arrive at an informed decision regarding treatment options. Sometimes this is very simple and straightforward, such as the decision to apply a cast for a broken bone. Other times it can be extraordinarily difficult, like choosing among various ways of treating cancer. The physician must help the patient understand the disease he/she faces and the risks and benefits of the various modalities. The patient’s hopes and fears must be addressed as well as psychological factors and family expectations. The patient must be aided in coming to an understanding of what this disease means in his/her life at this time. The physician should proactively call on other sources of support and expertise and the patient should be encouraged to seek other opinions and points of view as well. The physician should help the patient realize that there is often no “right” answer, but only multiple trade-offs and then help negotiate these compl
“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.
Although the specific definition of informed consent varies state to state, it generally means that a physician must inform a patient of all 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 before proceeding.
Federal and state rules mandate that study participant informed consent be obtained and properly documented before a participant is enrolled in a study. In most cases the participant must sign and date a detailed informed consent form. Informed consent forms are written in understandable language. Sansum Clinic is committed to making sure that every research participant has a good understanding of their study.
