Texas Register

RULE §198.3Practice Guidelines for the Use of Investigational Agents
ISSUE 09/30/2011
ACTION Proposed
Rule Withdrawn: 11/14/2011
Preamble Texas Admin Code Rule

(a)Using investigational agents 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. Use of investigational agents shall include the use of stem cells in humans. Physicians using investigational agents are obligated to maintain their ethical and professional responsibilities.

(b)Prior to the use of investigational agents, physicians must have their proposed use either included in an FDA/NIH approved protocol/study or approved by an institutional review board (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); or

  (3)have received national accreditation by an organization acceptable to the TMB.

(c)Physicians engaged in use of investigational agents must be able to provide evidence that the agents are prescribed pursuant to the Texas Food, Drug, and Safety Act and the federal Food, Drug, and Cosmetic Act and are in compliance with the federal and state protocols for manufacturing, distribution and administration.

(d)Physicians engaged in the use of investigational agents shall be expected to conform to the following ethical standards:

  (1)Use of investigational agents should be part of a systematic program competently designed, under accepted standards of scientific research, to produce data that are scientifically valid and significant; and it is the physician's responsibility to ensure that such data is reported pursuant to generally accepted scientific standards. Such data must be available for review by TMB within 14 days of request by the TMB.

  (2)Physicians engaged in the use of investigational agents should demonstrate the same concern and caution for the welfare, safety and comfort of the patient involved as is required of a physician who is furnishing medical care to a patient independent of any clinical investigation; and

  (3)Physicians engaged in the use of investigational agents must have patients sign informed consent forms that are compliant with applicable state and federal regulations, and which indicate that investigational agents are to be used in these patients. These consent forms shall include at a minimum:

    (A)the objectives, expected outcomes, or goals of the proposed treatment, such as functional improvement, pain relief, or expected psychosocial benefit;

    (B)the risks and benefits of the proposed treatment, including probability of effectiveness of treatment;

    (C)the extent the proposed treatment could interfere with any ongoing or recommended medical care;

    (D)a description of the underlying therapeutic basis or mechanism of action of the proposed treatment purporting to have a reasonable potential for therapeutic gain that is written in a manner understandable to the patient; and

    (E)if applicable, whether a drug, supplement, or remedy employed in the treatment is a pharmaceutical compound not commercially available and, therefore, is also an investigation article subject to clinical investigation standards.

  (4)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 using investigational agents, unless it can be demonstrated that such use does not comply with subsections (a) - (c) of this section. 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 using investigational agents.

    (A)Patient Assessment. Prior to offering advice about using investigational agents, the physician shall undertake an assessment of the patient. Such assessment shall be documented in the patient's medical record and be based on performance and review of an appropriate medical history and physician examination of the patient;

    (B)Treatment Plan. A treatment plan tailored for the individual needs of the patient 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 testing, consultations, referrals, or the use of other treatment modalities. The treatment offered should:

      (i)have a favorable risk/benefit ratio compared to other treatments for the same condition;

      (ii)be based upon a reasonable expectation that it will result in a favorable patient outcome, including preventive practices; and

      (iii)be based upon the expectation that a greater benefit for the same condition will be achieved than what can be expected with no treatment.

    (C)Adequate Medical Records. A physician using investigational agents shall keep accurate and complete medical records to include:

      (i)any diagnostic, therapeutic and laboratory results;

      (ii)the results of evaluations, consultations and referrals;

      (iii)treatments employed and their progress toward the stated objectives, expected outcomes, and goals of the treatment;

      (iv)the date, type, dosage, and quantity prescribed of any drug, supplement, or remedy used in the treatment plan;

      (v)all patient instructions and agreements;

      (vi)periodic reviews;

      (vii)documentation of any communications with the patient's concurrent healthcare providers informing them of treatment plans.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 19, 2011


Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 30, 2011

For further information, please call: (512) 305-7016

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