A. A person shall be eligible for expanded access to investigational drugs, biological products, or devices if:
1. He has a terminal condition, attested to by his treating physician and confirmed by a second physician not previously involved in the treatment of the person who has conducted an independent examination of the person;
2. He has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for him to participate in an ongoing clinical trial for his terminal condition;
3. The potential benefits of use of the investigational drug, biological product, or device to treat his terminal condition are greater than the potential risks of the use of the investigational drug, biological product, or device to treat his terminal condition;
4. He has received a recommendation from his treating physician for use of an investigational drug, biological product, or device for treatment of his terminal condition; and
5. He or, if he is incapable of making an informed decision, his legally authorized representative has given written informed consent to use of the investigational drug, biological product, or device for treatment of his terminal condition or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian has given written informed consent to the use of the investigational drug, biological product, or device for treatment of his terminal condition. Documentation indicating that the person meets the criteria for eligibility for expanded access to investigational drugs, biological products, or devices shall be provided by the person’s treating physician and shall be included in the person’s medical record.
B. Written informed consent to use of an investigational drug, biological product, or device shall include:
1. An explanation of the currently approved products and treatments for the person’s terminal condition;
2. A statement that the person has, in consultation with his treating physician, considered all other treatment options currently approved by the U.S. Food and Drug Administration and the treating physician has determined that no reasonable opportunity exists for the person to participate in an ongoing clinical trial for his terminal condition;
3. An explanation of the specific investigational drug, biological product, or device proposed for treatment of the person’s terminal condition;
4. A description of possible outcomes resulting from use of the investigational drug, biological product, or device to treat the person’s terminal condition, including a statement that new, unanticipated, different, or worse symptoms might result from and death could be hastened by the proposed treatment, based on the treating physician’s knowledge of the proposed treatment in conjunction with an awareness of the person’s terminal condition;
5. A statement that the person may be required to pay any costs associated with use of the investigational drug, biological product, or device; and
6. A statement that the person or, if the person is a minor or lacks capacity to provide informed consent, his parent or legal guardian consents to the use of the investigational drug, biological product, or device for treatment of his terminal condition.