Scope. 104 CMR 31.00 establishes the approval process and the standards for human subject research when:
(a) a Department employee, in his or her role as an employee, participates as a research investigator or subject;(b) the recruitment of any subjects for the research is conducted at a facility or program operated or contracted by the Department, or individuals are recruited as subjects for the research because they receive services from the Department;(c) the research is conducted at a facility or program operated or contracted for by the Department;(d) the research involves disclosure by the Department of private information or protected health information; or(e) the terms of another regulation or an agreement or contract with the Department specifically make 104 CMR 31.00 apply. No research within the scope of 104 CMR 31.00 may be conducted without the prior approval of the Department's Institutional Review Board.
Amended by Mass Register Issue 1326, eff. 11/18/2016.