115 CMR, § 10.02
As used in 115 CMR 10.00, the terms listed below have the following meanings:
Committee means the Research Review Committee of the Department of Developmental Services.
Guardian means with respect to persons under the age of 18 years, a natural or adoptive parent, or the individual or agency with legal guardianship of the person; and with respect to persons 18 years of age and older, the individual, organization or agency, if any, that has been appointed legal guardian of the person found to be incompetent by a court of competent jurisdiction. If a guardianship has been limited in any way by the court, the guardian's informed consent must be obtained only in those cases where a decision regarding participation in the research falls within the scope of the limited guardianship.
Informed Consent means the knowing consent voluntarily given by a participant (or if the participant is legally incompetent, by his guardian, if applicable) who can understand and weigh the risks and benefits of the proposed research for the participant.
Minimal Risk means that the risk of physical or psychological harm or discomfort anticipated in the proposed research are not greater, in terms of probability and magnitude, than those ordinarily encountered in daily life.
Research means a systematic investigation designed to develop or contribute to generalizable knowledge and involving access to human subjects or private information, but shall not include:
(a) any nonexperimental activity, such as diagnosis, preventive treatment and therapy, designed solely to enhance the well being of a particular individual;
(b) any collection of information by the Department or its designee, or by an authorized federal or state governmental entity, for any purpose related to the operation, administration or management of the Department;
(c) any compilation or study of information, including information obtained through the interview of individuals, specifically designed by the Department or its designee (or a provider) for the purpose of evaluating the quality or availability of services, or opportunities or needs of persons eligible to receive or receiving services from the Department (or receiving services from the provider).
(d) any survey procedures, except where responses are recorded in such a manner that the survey participants or individuals receiving services from the Department can be identified, directly or through identifiers linked to the survey participants or to the individuals; provided that all surveys shall be submitted to the Committee for a determination as to whether such surveys are exempt from Committee review.
Activities which meet this definition constitute research for purposes of 115 CMR 10.00, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration projects may include research activities that would require review by the Research Review Committee.
Participant means a person, whether or not such person is served by the Department, about or from who man investigator conducting research will obtain data through intervention or interaction with the person, or other through private information.
Private Information means any information concerning an individual which because of name, identifying number, mark, or description can be readily associated with a particular person, or information which has been provided for a specific purpose by an individual and which the individual can reasonably expect will not be made public, or which is about his or her behavior occurring in a context in which an individual can reasonably expect that no observation or recording is taking place.
115 CMR, § 10.02