Code of Massachusetts Regulations
115 CMR - DEPARTMENT OF DEVELOPMENTAL SERVICES
Title 115 CMR 5.00 - Standards To Promote Dignity
Section 5.08 - Informed Consent
Universal Citation: 115 MA Code of Regs 115.5
Current through Register 1518, March 29, 2024
(1) The informed and voluntary consent of the individual or of a guardian if the individual is incapacitated or is not capable of providing informed consent shall be required in the following circumstances:
(a) Prior to
admission to a facility;
(b) Prior
to medical or other treatment and, with respect to medication, in accordance
with
115 CMR
5.15;
(c) Prior to involvement of the individual in
research activities, in accordance with
115 CMR
10.00: Research;
(d) Prior to the initiation of a Targeted or
Intensive PBSP, in accordance with
115 CMR
5.14;
(e) Prior to the initiation of level III
interventions, in accordance with 115 CMR 5.14A; and
(f) Prior to the release of personal
information to other agencies, providers, or persons, unless there exists one
of the situations specified in
115 CMR
4.06: Access to Records and Record
Privacy, permitting release without the individual's
consent.
(2) Whenever the informed consent of the individual or guardian is required, the following criteria shall apply:
(a) The consent of the
individual or guardian shall be in writing and filed in the individual's
record;
(b) The written consent
shall be dated and shall expire as expressly stated or upon completion of the
specific procedure for which it applies; in any event an informed consent shall
expire one year after it is signed.
(c) No coercion or overbearing inducement
shall be utilized to obtain consent;
(d) A written record shall be made:
1. identifying the name, position, and
affiliation of the individual securing the consent; and
2. summarizing the information provided to
the individual from whom consent is secured, in accordance with 115 CMR
5.08(2)(d) and (e).
(e)
The person securing the consent shall:
1.
explain the intended outcome and nature of, and the procedures involved in, the
proposed treatment or activity;
2.
explain the benefits and the risks, including side effects, of the proposed
treatment or activity, as well as the risks of not proceeding;
3. explain the alternatives to the proposed
treatment or activity, particularly alternatives offering less risk or other
adverse effects;
4. explain that
consent may be withheld or withdrawn at any time, with no punitive action taken
against the individual;
5. present
the foregoing information in a manner which can be understood by the
individual, or guardian if any; and
6. offer to answer questions that the
individual or guardian may have regarding the matter for which consent is being
sought.
(f) The
appropriateness of the consent shall be reviewed as part of the annual review
of the individual's ISP.
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