Code of Massachusetts Regulations › 115 CMR - DEPARTMENT OF DEVELOPMENTAL SERVICES › Title 115 CMR 10.00 - Research › Section 10.02 - Definitions

Current through Register 1525, July 5, 2024
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.