(a) The administration or provision of an investigational drug, biological product, or device constitutes the practice of medicine and, therefore, must be performed under the direction of a licensed physician who is responsible for compliance with the Medical Practice Act, Texas Occupations Code, Title 3, Subtitle B and applicable Board Rules. Physicians administering or providing an investigational drug, biological product, or device are obligated to maintain their ethical and professional responsibilities. This includes maintaining a distinction between their roles as physician-investigators and their roles as treating physicians, as required by applicable federal law.
(b) Prior to the administration or provision of an investigational drug, biological product or device, physicians must have their proposed use either included in an FDA/NIH approved protocol/study or approved by an IRB. The IRB must:
  (1) be affiliated with an academic setting or a Texas licensed hospital;
  (2) be accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP);
  (3) be registered by the U.S. Department of Health and Human Services Office for Human Research Protection, pursuant to 21 CFR Part 56; or
  (4) have received national accreditation by an organization acceptable to the TMB.
(c) Physicians who fall under subsection (a) of this section must obtain written assurances from the individual or facility from which they obtained the investigational drug, biological product or device that the investigational drug, biological product or device was manufactured, labeled, and distributed in a manner consistent with the Texas Food, Drug, and Cosmetic Act and the federal Food, Drug, and Cosmetic Act.
(d) Physicians who fall under subsection (a) of this section shall be expected to conform to the following standards:
  (1) The administration or provision of an investigational drug, biological product, or device should be part of a systematic program competently designed, under accepted standards of scientific research, to evaluate the efficacy and safety of the investigational drug, biological product, or device, which shall include:
    (A) oversight by a principal investigator whose specific responsibility is to ensure that subjects are enrolled through appropriate inclusion and exclusion criteria;
    (B) written documentation regarding the objectives of the study that is made available to subjects, including information regarding the distinction between the goals of the clinical research study and the goals, risks and benefits of treatment; and
    (C) written disclosure to patients if the clinical research study involves the use of placebos, including an explanation of the placebos.
  (2) It is the physician's responsibility to ensure that the name and complete contact information of the individuals to whom an investigational drug, biological product, or device are administered or provided as well as data regarding efficacy and safety of the investigational drug, biological product, or device is available for review by TMB within 14 days of request by the TMB and to ensure that subjects are aware of the TMB's ability to obtain such information.
  (3) In accordance with the Declaration of Helsinki, the Belmont Report, and CFR Part 46, physicians who engage in the administration or provision of an investigational drug, biological product, or device should demonstrate the highest concern and caution for the welfare, safety, and comfort of the patient to whom an investigational drug, biological product, or device is administered or provided.
  (4) Physicians who fall under subsection (a) of this section, must have patients sign informed consent forms that are compliant with applicable regulations, and which indicate that an investigational drug, biological product, or device is or may be administered or provided to these patients. These consent forms shall:
    (A) be approved by the IRB; and
    (B) when applicable, state whether drugs, biological products, or devices are not commercially available and investigational and subject to clinical investigation standards as discussed in §200.3(7) of this title (relating to Practice Guidelines for the Provision of Complementary and Alternative Medicine).
(e) The TMB will use the guidelines as provided herein to determine whether a physician's conduct violates the Medical Practice Act, §§164.051 - 164.053 in regard to administering or providing an investigational drug, biological product, or device.
  (1) Patient Assessment. Prior to the enrollment of patients into a clinical research study that involves the administration of an investigational drug, biological product, or device, the attending physician or the physician enrolling the patient in the research study shall undertake an assessment of the patient. Such assessment shall be documented in the patient's medical record and the clinical research study record and be based on performance and review of an appropriate medical history and physical examination of the patient;
  (2) Treatment Plan. A treatment plan tailored for the individual needs of the patient shall be compiled by the attending physician and should include criteria by which treatment progress or success can be evaluated with stated objectives. Such a documented treatment plan shall consider pertinent medical history, previous medical records and physical examination, as well as the need for further diagnostic further testing, consultations, referrals, or the use of other treatment modalities.
  (3) Adequate Medical Records. A physician using an investigational drug, biological product or device shall keep accurate and complete medical records to include:
    (A) any diagnostic, therapeutic and laboratory results;
    (B) the results of evaluations, consultations and referrals;
    (C) treatments employed and their progress toward the stated objectives, expected outcomes, and goals of the treatment and clinical research study;
    (D) the date, type, dosage, and quantity prescribed of any drug, supplement, or remedy used in the treatment plan;
    (E) all patient instructions and agreements regarding the investigational agents and the clinical research study;
    (F) periodic reviews of the condition of the patient;
    (G) documentation of any communications with the patient's concurrent healthcare providers informing them of treatment plans; and
    (H) a copy of the executed consent form.
(f) A licensed physician shall not be found guilty of unprofessional conduct or be found to have committed professional failure to practice medicine in an acceptable manner solely on the basis of administering or providing an investigational drug, biological product, or device, unless it can be demonstrated that such use does not comply with this section.

Source Note: The provisions of this §198.3 adopted to be effective July 8, 2012, 37 TexReg 4929; amended to be effective March 15, 2016, 41 TexReg 1840; amended to be effective July 19, 2018, 43 TexReg 4754