115 CMR 10.04
Research Review Committee of the Department
(1) Membership.
(a) The Research Review Committee shall have at least five members, appointed by the
Commissioner, who have expertise and experience in relevant areas to promote complete and
adequate review of research activities subject to 115 CMR 10.00. Membership should reflect a
diversity in racial and cultural backgrounds and shall not consist entirely of men or entirely of
women.
(b) The membership shallinclude one attorney, one physician, one Ph.D. level psychologist, one
person receiving services provided or purchased by the Department or family member of such a
person, and one individual who is neither employed bynor receives funds directly or indirectly from
the Department and who is not part ofthe immediate family of a person employed by or receiving
funds directly or indirectly from the Department.
(c) Additional members may be appointed from time to time for regular terms.
(d) The members shall serve without compensation and shall be special state employees for the
purposes of tort claims and conflicts of interest.
(2) Term of Office. Members of the Research Review Committee shall be appointed to terms of
office as follows:
(a) Upon the establishment of the Committee, the Commissioner shall appoint members to a term
of one to three years;
(b) Upon the expiration of the termofanymember, the Commissioner shall appoint a successor
for a term of three years;
(c) In the event a vacancy occurs prior to the expiration of the applicable term, the Commissioner
may appoint a person to serve the remainder of the unexpired term.
(3) Removal. The Commissioner, after consultation with the other Committee members, may remove
a person as a member. Grounds for removal shall include serious disregard or gross neglect of
responsibilities or other actions which are in violation of the regulations or policies of the Department
or the procedures of the Committee.
(4) Powers and Duties. The Research Review Committee shall have the following powers and duties:
(a) To hold regular meetings during each year at which a quorum consisting of a majority of the
appointed members must be present to act on any research proposal requiring the Committee's
attention;
(b) To review research proposals and conduct continuing review of research projects;
(c) To develop procedures and guidelines related to its duties and consistent with the
Department's regulations and policies;
(d) To approve, approve with conditions, defer discussion pending receipt of additional
information, or disapprove by a majority vote of the members present at the meeting, research
proposals and projects;
(e) To suspend or terminate approvalofresearchthat is not beingconducted in accordance with
the Committee's requirements or approval, or that has been associated with unexpected harm to
participants;
(f) To maintain written minutes of every meeting of the Committee which will record the names
of the members present, those absent, the names of non-members who are present and the
numerical vote of the Committee members on each research proposal and research project
reviewed.
(g) To maintain a permanent record which will list, inchronologicalorder, every research proposal
submitted to the Committee and contain the following informationoneachproposal: name/title of
the research project, name and address of the investigator, date of receipt, date of
approval/disapproval, date of subsequent annual review, and date of withdrawal or termination.
(h) To invite, at its discretion, experts in special areas to assist in the review of a particular
research project which requires expertise beyond or in addition to what is available on the
Committee. These experts may not be associated with the proposed research in any way and may
not vote with the Committee.
(i) To serve, subject to the approval of the U.S. Department of Health and Human Services, as
the Institutional Review Board of the Massachusetts Department of Developmental Services.