Informed Consent in Clinical and Research Settings: What Do Patients and Families Need to Make Informed Decisions?

Abstract

Informed consent requires that patients in clinical settings and participants in research voluntarily agree to a proposed plan based on their understanding of a clear and thorough explanation of purpose, risks, benefits, and alternatives. Although the need to obtain informed consent is well understood in clinical and research environments, the evidence suggests that patients, family members, and participants in research are often unclear about options, risks, and benefits even after providing “informed” consent. Individuals with communication or cognitive disorders are at particular risk for a suboptimal outcome of the informed consent process. There are many barriers to achieving true informed consent, but the use of appropriate strategies can minimize the impact of these barriers and allow clinicians and researchers to improve the process of achieving true informed consent.