Tufts OpenCourseware
Authors: John Morgan, Bonnie F. Zimble

Special Considerations in Special Care Dentistry:

Informed Consent

Special Care in Dentistry
John Morgan, DDS
Tufts University School of Dental Medicine, 2008

Study Questions:

  1. Under what conditions in dental practice is informed consent required?
  2. How is informed consent defined in the Massachusetts DMR Regulations?

Informed Consent 

Written informed consent is required for any dental procedure that is invasive and/or non-reversible, and/or requires hospitalization, sedation or anesthesia. 

The following outlined material is taken from Massachusetts DMR regulation 115 CMR 5.12. 

  1. The informed and voluntary consent of the individual or of a guardian if the individual is not competent or is incapable 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;

(c)   Prior to involvement of the individual in research activities, in accordance with the requirements of the Department’s regulations on research;

(d)   Prior to the initiation of a level II or level III behavior modification interventions;

(e)   Prior to the release of personal information to other agencies, providers,or persons. 

  1. Informed consent means the knowing consent voluntarily given by an individual (or by the individual’s guardian, if applicable) who can understand and weigh the risks and benefits involved in the particular decision or matter.
  1. 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 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 which:

1-     details the procedure utilized to obtain the consent;

2-     identifies the name, position, and affiliation of the individual securing the consent;

3-     summarizes the information provided to the individual from whom consent is secured.

(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 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;

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. 

Click here if you would like to read an article on informed consent with special needs populations: [enter TUFTS link to this article]

Ferguson, F.S., Cinotti, D., Kin, W. & Berensten, B.J. (1996). Facilitation of informed consent for agency residents with developmental disabilities. Special Care in Dentistry, 16(1), 15-7.