115 CMR, § 10.04

Current through Register 1536, December 6, 2024
Section 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 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.

115 CMR, § 10.04