Authority: IC 12-21-2-3; IC 12-25-1-2; IC 12-25-1-4

Affected: IC 12-25; IC 16-36-1

Sec. 12. (a) A private mental health institution shall have policies and a written plan in place that shall include clinical justification for the use of any of the following special procedures:

1. (1) Restraint or seclusion or the simultaneous use of restraint and seclusion.
2. (2) Electro-convulsive therapy.
3. (3) An investigational drug or an experimental drug.

(b) The use of restraint or seclusion or the simultaneous use of restraint and seclusion shall be governed by the provisions of section 13 of this rule.

(c) If any procedure listed in subsection (a) is used, the facility shall clearly state the rationale for the use in the consumer's record.

(d) Prior to using electro-convulsive therapy, an investigational drug, or an experimental drug, the facility shall obtain the written informed consent for the use as follows:

1. (1) From the consumer, if the consumer has the legal capacity to make such decision.

2. (2) If the consumer does not have the legal capacity to make such decision, from either of the following:

   1. (A) An individual appointed:

      1. (i) by the consumer under IC 16-36-1-7; or
      2. (ii) for the consumer under IC 16-36-1-8.
   2. (B) An individual legally authorized to make such decision for the consumer under IC 16-36-1-5 if clause (A) does not apply.

(e) A consumer with the legal capacity to make such decision or an individual acting on behalf of the consumer under subsection (d)(2) may withdraw consent at any time.

(f) The facility shall comply with all federal regulations regarding the use of any of the following special procedures:

1. (1) Restraint or seclusion or the simultaneous use of restraint and seclusion.
2. (2) Electro-convulsive therapy.
3. (3) An investigational drug or an experimental drug.

(Division of Mental Health and Addiction; 440 IAC 1.5-3-12; filed Oct 11, 2002, 11:26 a.m.: 26 IR 744; filed Aug 11, 2008, 3:40 p.m.: 20080910-IR-440070875FRA; readopted filed Nov 5, 2008, 3:50 p.m.: 20081119-IR-440080742RFA; readopted filed Aug 11, 2014, 11:21 a.m.: 20140910-IR-440140240RFA; readopted filed Nov 9, 2020, 3:09 p.m.: 20201209-IR- 440200502RFA)