Section R9-21-206.01. Informed Consent

A.       Except in an emergency according to A.R.S. §§ 36-512 or 36- 513 or R9-21-204, or a court order according to A.R.S. Title 36, Chapter 5, Articles 4 and 5, a mental health agency shall obtain written informed consent in at least the following cir- cumstances:

1.        Before providing a client a treatment with known risks or side effects, including:

a.        Psychotropic medication,

b.        Electro-convulsive therapy, or

c.        Telemedicine;

2.        Before having a client participate in research activities approved under Department rules or policy; and

3.        Before admitting a client to any medical detoxification, inpatient facility, or residential program operated by a mental health agency.

B.       The informed consent in subsection (A) shall be voluntary and shall be obtained from:

1.        If the client is determined to be competent according to R9-21-206, the client; or

2.        If a court of competent jurisdiction has adjudicated the client incompetent, the client’s guardian.

C.       If informed consent is required according to subsection (A), a medical practitioner or a registered nurse with at least one year of behavioral  health experience shall, before obtaining the informed consent, provide a client or, if applicable, the client’s guardian with the following information:

1.        The client’s diagnosis;

2.        The nature of and procedures involved with the proposed treatment, the client’s participation in a research activity, or the client’s admission to a program operated by a men- tal health agency;

3.        The intended outcome of the proposed treatment, the cli- ent’s participation in a research activity, or the client’s admission to a program operated by a mental health agency;

4.        The risks, including any side effects, of the proposed treatment, the client’s participation in a research activity, or the client’s admission to a program operated by a men- tal health agency;

5.        The risks of not proceeding with the proposed treatment, the client’s participation in a research activity, or the cli- ent’s admission to a program operated by a mental health agency;

6.        The alternatives to the proposed treatment, the client’s participation in a research activity, or the client’s admis- sion to a program operated by a mental health agency, particularly alternatives offering less risk or other adverse effects;

7.        That any informed consent given may be withheld or revoked orally or in writing at any time, with no punitive action taken against the client;

8.        The potential consequences of revoking the informed consent; and

9.        A description of any clinical indications that might require suspension or termination of the proposed treat- ment, research activity, or program operated by a mental health agency.

D.       A client or, if applicable, the client’s guardian who gives informed consent for a treatment, participation in a research activity, or admission in a program operated by a mental health agency, shall give the informed consent by:

1.        Signing and dating an acknowledgment that the client or, if applicable, the client’s guardian has received the infor- mation in subsection (C) and gives informed consent to the proposed treatment, participation in a research activ- ity, or admission of the client to the program operated by a mental health agency; or

2.        If the informed consent is for use of psychotropic medica- tion or telemedicine and the client or, if applicable the cli- ent’s guardian, refuses to sign an acknowledgement according to subsection (D)(1), giving verbal informed consent.

E.       If a client or, if applicable, a client’s guardian gives verbal informed consent according to subsection (D)(2), a medical practitioner shall document in the client’s record that:

1.        The information in subsection (C) was given to the client or, if applicable, the client’s guardian;

2.        The client or, if applicable, the client’s guardian refused to sign an acknowledgement according to subsection (D)(1); and

3.        The client or, if applicable, the client’s guardian gives informed consent to the use of the psychotropic medica- tion or telemedicine.

F.       A client or, if applicable, the client’s guardian may revoke informed consent at any time orally or by submitting a written statement revoking the informed consent.

G.      If informed consent is revoked according to subsection (F):

1.        The treatment, the client’s participation  in a  research activity, or the applicant’s or client’s admission to a pro- gram operated by a mental health agency shall be imme- diately discontinued, or

2.        If abrupt discontinuation of a treatment poses an immi- nent risk to a client, the treatment shall be phased out to avoid any harmful effects.

H.      If a client or, if applicable, the client’s guardian needs assis- tance with revoking informed consent according to subsection

(F), the  client or,  if  applicable, the client’s guardian shall receive the assistance.

Historical Note

New Section made by exempt rulemaking at 9 A.A.R.

3296, effective June 30, 2003 (Supp. 03-2).