Section 10.05 - Research Proposals(1) A research proposal must be submitted to the Research Review Committee for any research covered by 115 CMR 10.00. The Committee, by written communication, will notify the researcher of the number of copies to be submitted and the time lines for submission.(2) Each proposal must include, ata minimum, the following information about the proposed research:(a) identification of the investigators conducting the research and their credentials;(b) purposes and objectives of the research;(c) location(s) where the project will be conducted;(d) the private information or participants to which access is sought, including a description of the type of private information or the manner of access to the participants and the number of participants who will be involved in the study;(e) the direct benefits of the research to the participants, or the potential for contributing new knowledge that might benefit persons with intellectual disability or their families or the field of intellectual disability;(f) description of any foreseeable cost(s) to the individual as a result of participating in the research (e.g. loss of wages, travel and parking expenses, lunch, etc.), and any compensation or reimbursement that will be offered to the participant to offset such cost(s).(g) justification for the participation of persons with intellectual disability and a description of why the research questions cannot be answered without the participation of such persons;(h) description of the research methods and procedures to be used;(i) duration of the project;(j) identification of all foreseeable risks (physical, psychological, social, economic, legal or other), and a full discussion of their likelihood and potential severity;(k) discussion of why risks to participants may be considered reasonable in relation to the anticipated benefits to participants and in relation to the importance of the knowledge that may reasonably be expected to result.(l) procedures to be followed in the event there is any adverse effect to a participant;(m) description of how the research may affect the care or treatment of the participant during the research and after the research has ended;(n) information to be provided to the participant and their guardian, if applicable, prior to obtaining informed consent and a copy of the informed consent form to be used, where applicable;(o) safeguards for confidentiality to be maintained;(p) manner of disposal of the private information at the termination of the project;(q) type of final product to be produced, its intended use and the manner of dissemination or publication, where applicable;(r) where applicable, disclosure of intent to establish copyright, patents, or any other rights to the product and disclosure of the organization or persons in whom such rights are vested;(s) a budget showing the projected expenditures and sources and amounts of funding for the project;(t) the method to be used for the recruitment of participants and copies of any advertisement or written material to be employed; and(u) where applicable, the manner in which the investigators intend to rely on Department or provider resources for assistance in conducting the research, collecting data, or providing private information.(3) At the time the proposal is submitted, the investigator(s) must also submit to the Research Review Committee evidence of favorable peer review.(a) For investigators (including students) affiliated with a hospital or university, the requirement for evidence of favorable peer review shall be met by submission of a copy of written approval of the proposal by the hospital's or university's institutional review board;(b) For investigators who are not affiliated with a hospital or university, the requirement for evidence of favorable peer review shall be met by submission of three letters of approval of the proposal from three independent peers knowledgeable in the field of the proposed research.