Code of Massachusetts Regulations
115 CMR - DEPARTMENT OF DEVELOPMENTAL SERVICES
Title 115 CMR 10.00 - Research
Section 10.04 - Research Review Committee of the Department
Universal Citation: 115 MA Code of Regs 115.10
Current through Register 1518, March 29, 2024
(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 shall
include 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 of the 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 term of any member, 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 approval of
research that is not being conducted 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, inchronological order, every
research proposal submitted to the Committee and contain the following
information one ach proposal: 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.
Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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