Informed consent is a legally-defined process of a person being told about key facts involved in a clinical trial before deciding whether to participate. A potential study subject is entitled to ask questions, consult with their doctor/oncologist, family and friends regarding the clinical trial. The informed consent document includes details of the clinical trial procedure, risks, possible benefits, purpose, duration and key contact information. After enrollment in a study, the volunteer is required to be provided with any additional information that becomes known which may affect the willingness of the subject to continue in the trial. A volunteer is allowed to withdraw consent at anytime and for any reason.





