Code of Massachusetts Regulations › 104 CMR - DEPARTMENT OF MENTAL HEALTH › Title 104 CMR 31.00 - Research Authorization And Monitoring › Section 31.02 - Definitions

Current through Register 1525, July 5, 2024
As used in
				104 CMR 31.00:
Client of the Department
. Any person
				receiving care or treatment through a facility or program operated or
				contracted for by the Department.
Human Subject
. A living individual
				about whom an investigator conducting research obtains data through
				intervention or interaction with the individual or identifiable private
				information. Intervention includes both physical procedures by which data are
				gathered and manipulations of the subject or the subject's environment that are
				performed for research purposes. Interactions include communication or
				interpersonal contact between an investigator and subject.
Human Subject Research
. Research
				involving human subjects or the use of protected health information or
				identifiable private information.
Informed Consent
. A voluntary
				agreement to participate in research given by a subject, or if the subject is
				legally incapacitated (
e.g
., a minor), by the subject's
				legally authorized representative, following a process that includes a
				description of the research and the associated risks and benefits. The subject,
				or legally authorized representative, must be able to exercise free power of
				choice to participate in research without undue inducement or any element of
				force, deceit, duress, or other forms or constraint or coercion. The subject or
				legally authorized representative must have the capacity to understand and
				weigh the risks and benefits of the proposed research for the research
				subject.
Institutional Review Board (IRB)
. The
				Department's Institutional Review Board registered with the U.S. Department of
				Health & Human Services Office for Human Research Protections.
Private Information
. Individually
				identifiable information about behavior occurring in a context in which an
				individual can reasonably expect no observation or recording is taking place,
				or information provided for specific purposes by an individual and which the
				individual can reasonably expect will not be made public.
Protected Health Information
.
				Individually identifiable information relating to the past, present or future
				physical or mental health or condition of an individual, provision of health
				care to an individual, or the past, present or future payment for health care
				provided to an individual.
Research
. A systematic investigation,
				including research development, testing and evaluation, designed to develop or
				contribute to generalizable knowledge. Research includes an experiment that
				involves:
(a) a drug other than the use of a U.S. Food and Drug
				Administration (FDA) approved drug in the course of medical practice;
(b) a medical device being evaluated for safety or
				effectiveness; or
(c) an article subject to regulation by the Federal Food, Drug,
				and Cosmetic Act where the results of the research are intended to be submitted
				to or held for inspection by the FDA.