Code of Massachusetts Regulations
104 CMR - DEPARTMENT OF MENTAL HEALTH
Title 104 CMR 31.00 - Research Authorization And Monitoring
Section 31.05 - Research Standards, Monitoring and Audit
Current through Register 1531, September 27, 2024
Research at all times must meet the standards and requirements set forth in 104 CMR 31.04(2)(a) through (g). In addition, for research to be approved by the IRB it must meet the following standards:
(1) Informed Consent Process. The participation of each subject in a research project requires the written informed consent of the subject or the subject's legally authorized representative unless specifically waived by the IRB in accordance with the standards set forth in 104 CMR 31.04.
(2) Objection by the Subject. An individual's participation in a research project must cease if the individual objects, by verbal or nonverbal means, to participation. This applies even if the individual's legally authorized representative consents to the research.
(3) Monitoring. The IRB shall monitor all approved research at least once a year, or once during the duration of the study, whichever is shorter. The monitoring must be appropriate to the type of research and the degree of risk to subjects. At a minimum the research shall be monitored at last once a year, or once during the duration of the study, whichever is shorter.
(4) Subject to Audit. A person involved in conducting research who receives compensation, either money or in-kind, for the research must provide fiscal records pertaining to the compensation upon request of the IRB.