| (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.
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