Section 10.08 - Research Approval(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): (a) selection of participants is equitable to the extent practicable by the objectives of the research;(b) risks to participants are minimized by using procedures consistent with sound research design and which do not present unnecessary risks to the participants;(c) risks to participants are reasonable in relation to anticipated direct benefits to participants and importance of the knowledge to be gained;(d) informed consent will be sought and documented in accordance with and to the extent required by 115 CMR 10.07;(e) the research provides for the protection of the participant's privacy and the confidentiality of private information; and(f) where appropriate, the research provides for the safety of participants through monitoring procedures and corrective interventions.(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. (a) If the research involves more than a minimal risk of physical or psychological injury to participants, then: 1. the probability and magnitude of the anticipated benefit for each participant as a result of the research must equal or exceed such risk of injury; and,2. where applicable, there is specific authorization by a court of competent jurisdiction for any individual not competent in fact of consent to participate in such research; and,3. the additional consent and review procedures set out in 115 CMR 10.08(3) and (4) are met.(b) If the research involves the administration of an experimental drug to a participant, then: 1. the use of the drug must be approved for trial in human beings by the Federal Food and Drug Administration;2. the additional consent and review procedures set out in 115 CMR 10.08(3) and (4) are met; and,3. the procedures and requirements of the Massachusetts Department of Public Health that are applicable to research involving new drugs are met.(c) For any research project which the Commissioner, in his or her discretion, determines additional safeguards are required, one or more of the following requirements must be met: 1. the additional review procedure set out in 115 CMR 10.08(3); or,2. the additional consent procedure set out in 115 CMR 10.08(4); or,3. such other measures as the Commissioner, or his or her designee, determines appropriate to protect participants.(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:(a) terminate the research, if he or she determines that it is too disruptive or burdensome on the programs involved or is not in the interest of the Department or the provider;(b) impose additional conditions on the research;(c) delay the initiation of research until further review is completed;(d) suspend the research temporarily pending further investigation or other action.(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.