Bill of Rights
Before you decide whether you want to participate in an investigational trial, you have the right to:
- Be informed of the nature and purpose of the investigation.
- Be given an explanation of the procedure to be followed in the medical investigation and any drug or device to be utilized.
- Be given a description of any attendant discomfort and risks reasonably to be expected from your participation in the investigation.
- Be given an explanation of any benefits reasonably to be expected from your participation in the Investigation.
- Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to you, and their relative risks and benefits.
- Be informed of the avenues of medical treatment, if any, available to you after the investigational procedure if complications should arise.
- Be given an opportunity to ask any questions concerning the medical investigation of the procedure involved.
- Be instructed that consent to participate in the investigational procedure may be withdrawn at any time and that you may discontinue participation in the medical investigation without prejudice.
- Be given a copy of this form and the signed and dated written consent form.
- Be given the opportunity to decide to consent or not to consent to the medical investigation without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on your decision.