Informed Consent

(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 explain that consent may be withheld or withdrawn at any time, with no punitive action taken against the individual; 5.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.