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