New Hampshire § 126-Z-1 - Section 126-Z:1 Definitions.

§ 126-Z-1. Section 126-Z:1 Definitions.

In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protection of Human Subjects under 42 U.S.C. section 289(a) and 45 C.F.R. part 46. Any eligible facility is subject to the FWA laws, regulations, policies, and guidelines including renewals or updates. I-a. "Eligible patient" means a person to whom all of the following apply: (a) The person has been diagnosed with a terminal illness by the person's physician. (b) The person has already tried or is not a candidate for eligible United States Food and Drug Administration (FDA) approved treatment options for their disease or condition. (c) The person is unable to participate in a clinical trial involving the eligible investigational drug, biologic or device. (d) The person has given written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf. (e) The physician providing access to an investigational drug, biologic, or device will not be compensated directly by the manufacturer for providing access to this therapy. I-b. "Health care provider" means a physician licensed to practice medicine in the state of New Hampshire. I-c. "Individualized investigational treatment" means drugs, biologics, or devices unique to and produced exclusively for use for an individual patient, based on their own genetic profile, including but not limited to individualized gene therapy antisense oligonucleotides (ASO), individualized neoantigen vaccines, and any other individualized treatment. II. "Investigational drug, biologic, or device" means a drug, biologic, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains under investigation in a clinical trial. II-a. "Other protected access" includes: (a) "Expanded access" whereby the treating physician requests access to an investigational drug, biologic, or device from the FDA and is subject to oversight from an Institutional Review Board; and (b) "Off-label use" means prescribing an FDA approved drug, biologic, or device for a use not approved for that specific indication consistent with RSA 329:17, VI-b. III. "Physician" means the licensed allopathic or osteopathic physician who is providing medical care or treatment to the eligible patient for the terminal illness. IV. "Remote signing" means the signing of any form, witnessed by a notary public or a licensed health care provider, providing written informed consent for a person diagnosed by a physician with a terminal illness to participate in a clinical trial or receive a drug, biologic, or device, by the patient or, if the patient is a minor or lacks the mental capacity to provide consent, by a parent or legal guardian on the patient's behalf. V. "Telehealth prescreening" means any remote, real-time discussion intended, in part, to determine whether a person with a terminal illness may be: (a) Ineligible for or not selected to participate in a clinical trial; or (b) Ineligible to receive or not be offered a drug, biologic, or device. VI. "Terminal illness" means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of a clinical trial analysis is survival, which is the definition of "life threatening" under 21 C.F.R. section 312.81.