Can patients be involved in a clinical trial without their knowledge?
Patients may not be enrolled into a clinical trial without their knowledge and written consent. American citizens are now protected under strict federal regulations preventing the unauthorized use of investigational treatments. In the case of minors, a parent or legal guardian may provide consent for a child to participate in a clinical trial. Investigational treatments may, however, be administered to patients in life threatening situations who are unable to provide informed consent only if no other treatment options are available, and if there are no authorized persons or family members to sign the consent form on the patient’s behalf.
