{"data":{"id":"us-ky/krs-217.5404","jurisdiction":"us-ky","citation":"KRS 217.5404","heading":"Written informed consent required for treatment with investigational","body":"drug, biological product, or device.\n(1) A patient or a patient's legal guardian shall provide written informed consent for\ntreatment with an investigational drug, biological product, or device.\n(2) At a minimum, the written informed consent shall include:\n(a) An explanation of the currently approved products and treatments for the\ndisease or condition from which the patient suffers;\n(b) An attestation that the patient concurs w ith the treating health care provider's\nbelief that all currently approved and conventionally recognized treatments are\nunlikely to prolong the patient's life;\n(c) Clear identification of the specific investigational drug, biological product, or\ndevice that the patient is seeking to use;\n(d) A description of the potentially best and worst outcomes of using the\ninvestigational drug, biological product, or device and a realistic description\nof the most likely outcome;\n(e) A statement that the patient's health  plan or third -party administrator and\nprovider shall not be obligated to pay for any care or treatments consequent to\nthe use of the investigational drug, biological product, or device unless they\nare specifically required to do so by law or contract; and\n(f) A statement that the patient understands that the patient shall be liable for all\nexpenses related to the use of the investigational drug, biological product, or\ndevice and that the liability for expenses extends to the patient's estate, unless\na cont ract between the patient and the manufacturer of the investigational\ndrug, biological product, or device states otherwise.\n(3) The description of potential outcomes required under subsection (2)(d) of this\nsection shall:\n(a) Include the possibility that ne w, unanticipated, different, or worse symptoms\nmay result and that the proposed treatment may hasten death; and\n(b) Be based on the treating health care provider's knowledge of the proposed\ntreatment in conjunction with an awareness of the patient's condition.\n(4) The written informed consent shall be:\n(a) Signed by:\n1. The patient;\n2. A parent or legal guardian, if the patient is a minor; or\n3. A legal guardian, if a guardian has been appointed for the patient; and\n(b) Attested to by the patient's treating health care provider and a witness.","path":["KRS Chapter 217"],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=46074","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:52:26Z","sha256":"197ea9f7baf9c35c64281e5ff9a41814edeefef1bc90cdfad251cdcc656d8ce9","source_id":"us-ky","stale":false,"prev":"us-ky/krs-217.5403","next":"us-ky/krs-217.5405"},"notice":"GroundRules: Original legal text. Not legal advice."}