(a) Patients rights are guaranteed under the provisions of this subchapter. Although under special circumstances set out in this subchapter, certain rights can be limited without informed consent, it is usually mandatory and always preferable to obtain informed consent when limitation of rights is contemplated.
(b) Except as otherwise noted in this subchapter, written informed consent must be obtained when a right guaranteed by law or department rule is limited.
  (1) The patient or legally authorized representative gives informed consent. Written informed consent is obtained from the:
    (A) adult individual, if legally competent and deemed to be capable of understanding the required elements which constitute informed consent;
    (B) guardian of the person of the adult individual if there has been a determination of mental incompetence by a court; or
    (C) parent or managing conservator of a minor under the age of 16.
  (2) Informed consent must be documented. Written informed consent is evidenced by a completed copy of the department's form for "Consent to Behavior Intervention," referenced as Exhibit A. Psychiatric hospitals and CSUs may use a different form provided that it includes all of the information included on the "Consent to Behavior Intervention" form.
  (3) Informed consent may be withdrawn at any time. If informed consent is withdrawn, the program must be discontinued immediately, and the treatment team must meet within three working days to modify the individual's treatment plan. Withdrawal of consent may be in any form including, but not limited to, passive noncompliance, active resistance, or a verbal or other expression of unwillingness to continue participating in any aspect of the program.
  (4) The limitation of the right or rights must be reviewed by the physician as appropriate but must occur at least on a monthly basis, unless otherwise specified.
  (5) Informed consent must be renewed. Written informed consent must be reviewed and renewed every six months.
(c) Any limitation on rights is included as a part of the individual's comprehensive treatment plan. The treatment plan also includes a program that emphasizes positive approaches and uses positive behavioral interventions.
(d) It is prohibited for limitation on rights to be used:
  (1) in retribution, as punishment, or as a means of controlling an individual by eliciting fear;
  (2) for the convenience of staff or as a consequence of insufficient staff;
  (3) as a substitute for a comprehensive treatment plan; or
  (4) in the absence of positive behavioral interventions.
(e) Any limitation on rights will not:
  (1) deprive an individual of a basic human need (e.g., a bed at night, food, personal clothing, etc.) or the essentials of a normal hospital environment; or
  (2) alter the texture of a food item or use techniques that could result in failure to provide a nutritiously adequate diet. Foods used as edible reinforcers within a behavior intervention program are evaluated by the treatment team, including a qualified dietitian and physician, with consideration of the individual's nutritional status, needs, and preferences.
(f) Additional approval required. Written informed consent must be obtained for behavior intervention programs using highly restrictive interventions. Additionally, the use of any procedures or programs employing aversive techniques, such as, but not limited to, faradic stimulation, require the unanimous documented written approval of the medical director of the facility, the CEO, and the Ethics Committee.

Source Note: The provisions of this §404.166 adopted to be effective October 1, 1996, 21 TexReg 8505