Sec. 5. (a) Written informed consent as required under section 4(4) of this chapter must include the following: (1) An explanation of the currently approved products and treatments for the individual's disease or condition. (2) An attestation by the individual of the individual's debilitating condition and that the individual concurs with the individual's physician that all currently approved treatments are unlikely to prolong the individual's life or improve the individual's debilitating condition. (3) A clear identification of the specific individualized investigational treatment proposed to be used to treat the individual. (4) A description of the best and worst outcomes, including the most likely outcome, resulting from use of the individualized investigational treatment of the individual's life threatening or severely debilitating illness. (5) A statement acknowledging that new, unanticipated, different, or worse symptoms or death may result from the proposed treatment. (6) A statement that the individual's health insurance may not be obligated to pay for any care or treatment and that the patient may be liable for all expenses of the treatment unless specifically required to do so by contract or law. (7) A statement that eligibility for hospice care may be withdrawn if the individual begins individualized investigational treatment and does not meet hospice care eligibility requirements. (8) A statement that the individual or the individual's legal guardian consents to the individualized investigational treatment for the life threatening or severely debilitating illness. (b) The description of outcomes described in subsection (a)(4) must be based on the treating physician's knowledge of both the individualized investigational treatment and the individual's life threatening or severely debilitating disease.
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