Indiana § 16-42-26.5-5 Written informed consent

Indiana Statutes

§ 16-42-26.5-5 — Written informed consent

Indiana § 16-42-26.5-5

Title 16HEALTH

Art. 42REGULATION OF FOOD, DRUGS, AND

Ch. 26.5Individualized Investigational Treatment

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Bluebook

Ind. Code § 16-42-26.5-5 (2026).

Text

(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 li

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(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(7) A statement that eligibility for hospice care may be withdrawn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.