104 CMR 31.06 - Complaints and Sanctions

(1) Complaints Regarding Human Subject Research. Any person may file a complaint about a human subject research project with the chairperson of the IRB. Such complaints shall be resolved in accordance with the standards set forth in 104 CMR 31.06.
(2) Initial Review. The chairperson, or designee, shall conduct a preliminary investigation. If the chairperson determines the complaint has merit it shall be referred to the IRB for further review. The chairperson has the right to immediately suspend a study that poses an immediate risk to participants. The complaint shall be investigated by the chairperson or referred to the Department's Office of Investigations. If the chairperson determines that the complaint falls within the scope of 104 CMR 32.04(2)(d), it shall be referred to the Office of Investigations and resolved in accordance with 104 CMR 32.00: Investigation and Reporting Responsibilities. However, in making the referral, the IRB retains its authority under 104 CMR 31.03(4) to make decisions with respect to research that may relate to the complaint.
(3) IRB Investigation. The IRB, as part of its investigation of a complaint, shall provide the complainant and the principal investigator the opportunity to present relevant information to the IRB. Within 30 days of receiving the complaint, or as soon thereafter as practical, the IRB shall take such action as it determines appropriate, including, but not limited to:
(a) termination of the research;
(b) imposition of additional conditions on the research;
(c) temporary suspension of the research pending further investigation or other action; or
(d) dismissal of the complaint.
(4) Notification. The IRB shall give prompt notification to the complainant and the investigator(s) of its action. The IRB shall keep written records of all complaints, investigations, action taken, and reasons for such action.
(5) No Appeal. Any action taken by the IRB with respect to research is final and not subject to further review, judicial or otherwise.
(6) Department Complaint Process. Nothing in 104 CMR 31.06 shall preclude the chairperson from referring a complaint for investigation under 104 CMR 32.00: Investigation and Reporting Responsibilities.


104 CMR 31.06
Amended by Mass Register Issue 1326, eff. 11/18/2016.

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