| (a) Consent under this section is not valid unless the person giving consent understands the information presented and consents voluntarily and without coercion or undue influence. (b) A person who gives consent may revoke consent for any reason at any time, with revocation effective immediately. (c) Prior to each individual ECT treatment, consent to electroconvulsive therapy must be obtained. Unless the person consents in accordance with this subchapter, ECT may not be administered to: (1) a patient who is 16 years or older and voluntarily receiving services; (2) an involuntary patient who is 16 years or older and who has not been adjudicated incompetent to manage his or her own personal affairs; (3) an involuntary patient who is 16 years or older and who has been adjudicated incompetent to manage his or her own personal affairs, unless: (A) the patient has an appointed guardian of the person of the patient; (B) the guardian of the person consents to treatment in accordance with this section; and (C) the consent of the guardian is based on knowledge of what the patient would desire, if known. (d) Consent shall be documented by the signature of the person giving consent on the form entitled "Disclosure and Consent for Electroconvulsive Therapy" which is referenced as Exhibit A of §405.117 of this title (relating to Exhibits), and which shall include a supplemental statement about the individual patient containing the information in the form entitled "Supplemental Statement" which is referenced as Exhibit B of §405.117 of this title (relating to Exhibits), including: (1) indications for therapy for the patient; (2) medical evaluation results; (3) contraindications to therapy; (4) results of psychiatric and other medical consultation(s) relevant to ECT; and (5) for a patient 65 years of age or older: (A) known current medical conditions that may increase the possibility of injury or death as a result of ECT; and (B) statement by two physicians that the treatment is medically necessary. (e) The consent form shall be fully completed to explicitly state the following information: (1) the nature and seriousness of the mental condition requiring ECT; (2) the nature of the procedures to be followed, including anesthesia, and their purposes, including the identification of any procedures which are experimental; (3) the nature, degree, duration, and probability of significant risks and/or side effects and/or adverse effects resulting from ECT commonly known by the medical profession, including: (A) memory changes of events prior to, during, and immediately following the treatment; (B) fractures and dislocations of bones; (C) the probability of significant temporary post-treatment confusion requiring special care; and (D) the possibility of permanent memory dysfunction, especially noting the possible degree and duration of memory loss, the possibility of permanent, irrevocable memory loss, the remote possibility of seizures, and the possibility of death; (4) that there is a division of opinion as to the efficacy of the procedure; (5) the benefits reasonably to be expected; (6) the probable degree or duration of improvement or remission expected with or without the procedure; (7) a disclosure of any appropriate alternative procedures that might be advantageous for the patient; (8) an offer to answer any inquiries concerning the procedures; (9) an instruction that the consenting party is free to withdraw consent and to discontinue an individual treatment or a series of treatments at any time without prejudice to the care of the individual; (10) an instruction that consent is for one individual treatment, and that additional treatments shall require renewed written informed consent; and (11) the side effects of anesthesia shall also be explained. (f) Before a patient receives ECT, the hospital, facility, or physician administering the therapy shall ensure that: (1) the patient and the patient's guardian of the person, if any, receive a copy of the completed consent form, a written supplement containing related information concerning the individual patient, in the patient's primary language, if possible; (2) the consent form and supplement are orally explained to the patient and the patient's guardian of the person, if any, in simple, nontechnical terms in the patient's primary language, if possible, or by means reasonably calculated to communicate with a hearing-impaired or visually-impaired person, if applicable; (3) the patient or the patient's guardian of the person, as appropriate, signs the consent form, which states that the person has read and understood the consent form and written supplement; and (4) the signed consent form is made a part of the patient's permanent medical record. (g) In cases in which the individual giving consent is the guardian of the person, the requirements of the consent process may be fulfilled through a phone conversation that includes all of the elements that would be discussed in person, witnessed by one individual who is not the physician who will be administering ECT. A copy of the consent form and written supplement must be mailed or faxed to the individual giving consent prior to obtaining the initial informed consent. The consent must be obtained for each individual treatment. (h) For a patient 65 years of age or older, before each treatment series begins the hospital, facility, or physician administering the procedure shall: (1) ensure two physicians sign the appropriate section of the supplemental statement described in subsection (d)(5) of this section stating that the treatment is medically necessary; and (2) inform the patient and the patient's guardian of the person, if any, orally and in the supplemental statement described in subsection (d)(5) of this section, of any known current medical condition the patient has that may increase the possibility of injury or death as a result of the treatment. |
