Current through Reg. 49, No. 38; September 20, 2024
(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.
