104 CMR 31.05 - Research Standards, Monitoring and Audit

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.

(a) The informed consent process must begin with a description of the research and include an evaluation of the subject's comprehension. The process must also include an on-going assessment of each subject's continued consent to participate in the research.

(b) If research will involve clients of the Department as subjects, the informed consent process must provide the following information:

1. a statement to the effect that the provision of Department services to the client is not dependent on his or her participation in the research; and

2. where applicable, a description of any controlled substance as defined in the Massachusetts Department of Public Health regulations implementing M.G.L. c. 94, and any other substances to be used, and their anticipated effects, side effects and interactions.

(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.

Notes

104 CMR 31.05

Amended by Mass Register Issue 1326, eff. 11/18/2016.