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.
Notes
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