Informed Consent Form

The form should be approved by an IRB/IEC and includes:

• That the trial involved research
• Purpose and duration of participation
• Approximate number of subjects involved in the trial
• Trial procedures and treatments
• Potential risks and discomforts
• Feasible alternative procedures or treatments
• Possible benefits to the subject
• Measures to preserve the confidentiality of records
• Information regarding compensation for injuries
• Point of contact to answer questions the subject or family may have and to report any injuries
• Volunteer’s rights regarding withdrawal from the clinical trial, without losing treatment benefits
• Subject’s diagnosis, probability of success if known, and prognosis