Ariz. Admin. Code § 9-21-206.01

Current through Register Vol. 30, No. 45, November 8, 2024

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 circumstances:

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 a client participates in research activities; 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. The client, if the client is determined to be competent according to R9-21-206,; or

2. The client's guardian, if a court of competent jurisdiction has adjudicated the client incompetent.

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 mental health agency;

3. The intended outcome of the proposed treatment, the client'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 mental health agency;

5. The risks of not proceeding with the proposed treatment, the client's participation in a research activity, or the client'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 admission 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 treatment, 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 information in subsection (C) and gives informed consent to the proposed treatment, participation in a research activity, 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 medication or telemedicine and the client or, if applicable the client'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 medication 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 program operated by a mental health agency shall be immediately discontinued, or

2. If abrupt discontinuation of a treatment poses an imminent 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 assistance with revoking informed consent according to subsection (F), the client or, if applicable, the client's guardian shall receive the assistance.

Ariz. Admin. Code § R9-21-206.01

New Section made by exempt rulemaking at 9 A.A.R. 3296, effective June 30, 2003 (Supp. 03-2). Amended by final rulemaking at 22 A.A.R. 2019, effective 7/12/2016.