Montana Code 50-12-105. Written informed consent required
50-12-105. Written informed consent required. (1) A patient or a patient’s legal guardian must provide written informed consent for treatment with an investigational drug, biological product, or device.
Terms Used In Montana Code 50-12-105
- Contract: A legal written agreement that becomes binding when signed.
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- Health care provider: means any of the following individuals licensed pursuant to Title 37:
(a)a physician;
(b)an advanced practice registered nurse authorized by the board of nursing to prescribe medicine; and
(c)a physician assistant. See Montana Code 50-12-102
- Written informed consent: means a written document that meets the requirements of 50-12-105. See Montana Code 50-12-102
(2)At a minimum, the written informed consent must include:
(a)an explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;
(b)an attestation that the patient concurs with the treating health care provider in believing that all currently approved and conventionally recognized treatments are unlikely to improve the patient’s condition;
(c)clear identification of the specific investigational drug, biological product, or device that the patient is seeking to use;
(d)a description of the potentially best and worst outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome;
(e)a statement that the patient’s health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device unless they are specifically required to do so by law or contract;
(f)a statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that hospice care may be reinstated if the treatment ends and the patient meets hospice eligibility requirements; and
(g)a statement that the patient understands that the patient is liable for all expenses related to the use of the investigational drug, biological product, or device and that the liability for expenses extends to the patient’s estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.
(3)The description of potential outcomes required under subsection (2)(d) must:
(a)include the possibility that new, unanticipated, different, or worse symptoms might result; and
(b)be based on the treating health care provider’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition.
(4)The written informed consent must be:
(a)signed by:
(i)the patient;
(ii)a parent or legal guardian, if the patient is a minor; or
(iii)a legal guardian, if a guardian has been appointed pursuant to Title 72, chapter 5; and
(b)attested to by the patient’s treating health care provider and a witness.