the voluntary decision by an individual to grant or withhold permission for an action or procedure affecting them, based on a clear and complete understanding of all relevant information. This includes the purpose of the activity, potential benefits and risks, available alternatives, and the individual’s rights. In research involving human participants, informed consent means that participants agree freely to take part after receiving plain-language information that enables them to make an informed choice. Researchers have an ongoing ethical obligation to provide updates and ensure participants continue to understand what their participation involves.
Synonyms: Voluntary Consent
Example
Before enrolling in a clinical trial for a new arthritis medication, participants are provided with a written Informed Consent Form explaining the study’s purpose, procedures, potential benefits, and risks. They are given time to ask questions and may withdraw at any point. Only after reading and understanding the information do they sign the form, demonstrating their informed consent to participate.