Informed Consent

Informed consent is the practice of giving one's agreement to participate in an activity after being advised about the possible risks that may be incurred. Every day in the United States people are asked to provide consent in a number of different health situations, such as prior to undergoing surgery, before taking part in a research intervention, and in order to release test results. There are a number of standard protocols that characterize the informed consent process, which have developed under U.S. law to protect the rights of patients and research participants. Research is ongoing as stakeholders identify best practices for effectively communicating the essential features of disclosure and consent materials.

The elements of valid informed consent are typically understood as follows: First, patients/participants must receive ...