Written informed consent shall, at a minimum, include the following:
(1)A description of the currently approved products and treatments for the terminal illness from which the patient suffers;
(2)An attestation that the patient concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; and the known risks of the investigational drug, biological product, or device are not greater than the probable outcome of the patient's terminal illness;
(3)Clear identification of the specific proposed investigational drug, biological product, or device that the patient is seeking to use;
(4)A description of the potential best and worst outcomes of using the investigational drug, biological product, or
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Written informed consent shall, at a minimum, include the following: (1) A description of the currently approved products and treatments for the terminal illness from which the patient suffers; (2) An attestation that the patient concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; and the known risks of the investigational drug, biological product, or device are not greater than the probable outcome of the patient's terminal illness; (3) Clear identification of the specific proposed investigational drug, biological product, or device that the patient is seeking to use; (4) A description of the potential best and worst outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition; (5) A statement that the patient understands that his or her health benefit plan is not obligated to pay for the investigational drug, biological product, or device, or any care or treatment consequent to the use of such drug, product, or device, unless such health benefit plan is specifically required to do so by law or contract; (6) A statement that the patient understands that his or her eligibility for hospice care may be withdrawn if he or she begins treatment with the investigational drug, biological product, or device but that such hospice care may be reinstated if such treatment ends and he or she meets hospice eligibility requirements; and (7) A statement that the patient understands that he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that such liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the investigational drug, biological product, or device states otherwise.