71-9604.

Written informed consent; contents.

To be acceptable under the Investigational Drug Use Act, a written, informed consent shall consist of a signed writing executed by an eligible patient, or his or her parent or legal guardian if the eligible patient is a minor, and attested to by the eligible patient's treating physician, that:

(1) Explains the approved products and treatments available at that time for the disease or condition from which the patient suffers;

(2) Attests to the fact that the patient concurs with his or her treating physician that no treatment then approved by the United States Food and Drug Administration would likely prolong the patient’s life;

(3) Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use;

(4) Describes the potential outcomes, if known, of using the investigational drug, biological product, or device. The description shall include any possibility of worsening symptoms and death hastened by the treatment;

(5) Contains a statement that the patient's health insurance carrier is not obligated to pay for the investigational drug, biological product, or device; and

(6) Makes clear that the patient understands that he or she is liable for all expenses of the investigational drug, biological product, or device.