Informed Consent

A process by which a potential participant is told about all aspects of the research study that are relevant to the subject’s decision to participate, including possible physical or psychological harms that may result from his or her participation. After being informed of these aspects, the potential participant either agrees or refuses to participate in the research study.

Informed consent is documented by means of a written, signed, and dated consent form. The form may not contain any language in which the participant appears to have waived legal rights or to have released the researchers and their institution from liability due to negligence.

(see deception)