Code of Massachusetts Regulations
115 CMR - DEPARTMENT OF DEVELOPMENTAL SERVICES
Title 115 CMR 10.00 - Research
Section 10.08 - Research Approval
Current through Register 1537, December 20, 2024
(1) Basic Requirements. Before any research covered by these regulations may be approved by the Research Review Committee, the research proposal must satisfy all of 115 CMR 10.08(1)(a) through (f):
(2) Additional Requirements. For certain types of research as described in 115 CMR 10.08(2)(a) through (c), the research must meet additional requirements before the Research Review Committee may approve the project.
(3) Additional Review Procedure. The Commissioner shall designate a professional with experience with intellectual disability to participate as a consultant to the Research Review Committee. This professional shall take such steps as he or she determines appropriate to review and monitor the risks and benefits to the participants. In addition, if the professional determines that the risk-benefit requirements are not met for a particular individual, participation of the individual in the research shall terminate.
(4) Additional Consent Procedure. A witness appointed by the Research Review Committee must be present when consent is obtained for each participant, and the witness must determine that the investigator has obtained informed consent for that participant. The witness must be a person whose training and experience are sufficient for him or her to determine whether the consent of the prospective participant is informed. The Committee may appoint more that one witness for the research project.
(5) Notification. Within ten days of approving a research project, the Research Review Committee shall notify and send a copy of the research proposal and Committee minutes to the Commissioner, and where applicable, to the facility director or regional director and head of the provider with jurisdiction over the facility or program where the research activity will be conducted.
(6) Notwithstanding approval of the research by the Committee, the facility director, or the regional director or the head of the provider with jurisdiction over the site where the research is proposed to be conducted, or the Commissioner, may at any time take any of the following action with regard to the research:
(7) A statement of the reason(s) for the action shall be furnished promptly to the investigator(s). Any action taken pursuant to 115 CMR 10.08(6) is final and not subject to further review, judicial or otherwise.