28-465. Medical Cannabidiol Pilot Study; created; physician or pharmacist; duties; risks and benefits form; use; participant; document; contents.

(1) The University of Nebraska Medical Center shall create the Medical Cannabidiol Pilot Study. The pilot study shall designate at least two medical providers to conduct research on the safety and preliminary effectiveness of cannabidiol to treat patients with intractable seizures and treatment resistant seizures. The medical providers shall be physicians licensed to practice medicine and surgery in Nebraska, and at least one shall be a pediatric neurologist. The medical providers shall adhere to the policies and procedures established by the University of Nebraska Medical Center for the pilot study.

(2) A physician designated as a medical provider or a licensed pharmacist participating in the Medical Cannabidiol Pilot Study shall not be subject to arrest or prosecution, penalized or disciplined in any manner, or denied any right or privilege for approving or recommending the use of cannabidiol under the pilot study.

(3)(a) A physician designated as a medical provider conducting research under the Medical Cannabidiol Pilot Study shall:

(i) Determine eligibility for participation in the pilot study;

(ii) Keep a record of the evaluation and observation of a patient under the physician's care, including the patient's response to cannabidiol treatment; and

(iii) Transmit the record described in subdivision (a)(ii) of this subsection to the department upon request.

(b) All medical records received or maintained by the department pursuant to this section are confidential and may not be disclosed to the public.

(4) The University of Nebraska Medical Center shall create a risks and benefits form to be signed by the medical provider conducting the cannabidiol trial and by the patient who is to be administered cannabidiol or a parent or legal guardian of the patient if the patient is under nineteen years of age. The risks and benefits form shall document their discussion of the risks and benefits of invasive therapies, including, but not limited to, neurostimulation such as vagus nerve stimulation and responsive neurostimulation and epilepsy surgery, including corpus callosotomy, if indicated. This form shall be completed and on file with the University of Nebraska Medical Center before the patient begins the cannabidiol trial.

(5) The University of Nebraska Medical Center shall provide a document to patients who are to be administered cannabidiol or a parent or legal guardian of such patients confirming participation in the Medical Cannabidiol Pilot Study. The document shall include, at a minimum, the patient's name, date of birth, and address, as well as the name and contact information of the patient's medical provider. If the patient is under nineteen years of age, the document shall also include the name, date of birth, and address of the parent or legal guardian of the patient. The document may be provided by the patient to law enforcement agencies in order to verify participation in the pilot study.

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