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