104 CMR 31.03 - Research Review, Approval, Implementation, Termination, Suspension or Modification

(1) Promote the Mission of the Department. Research within the scope of 104 CMR 31.00 may only be conducted if the Commissioner, or designee, determines that the research will promote the mission of the Department as defined in M.G.L. c. 19, § 1.

(2) Mandatory Review by the IRB. All research involving human subjects must be reviewed and approved by the IRB prior to implementation. As determined by the IRB, for research to be approved it must meet the requirements and standards set forth in 104 CMR 31.05.

(3) Research Implementation. Department Area Directors, Facility Directors, or Directors of Programs operated by or contracted for by the Department must accept the approval or disapproval of research by the IRB. However, the applicable Area Director(s), Facility Director(s), and Directors of Programs may place restrictions on implementing research at a particular site. The restrictions that are placed must be reasonable and minimized as determined by the IRB.

(4) Power to Terminate, Suspend or Modify. The Commissioner or the IRB may as to any research, including research formerly approved by the IRB, take the following actions for good cause:

(a) terminate the research;

(b) restrict the implementation of the research at a particular Department site;

(c) impose additional conditions;

(d) require additional IRB review;

(e) delay the implementation of the research until the completion of the additional review; or

(f) temporarily suspend the research, pending other action.

(5) Final Decision. Any action pursuant to 104 CMR 31.03 is final and not subject to further review, judicial or otherwise. Written notice of the action taken and the reason for it will be given promptly to the principal investigator.

Notes

104 CMR 31.03

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