Code of Massachusetts Regulations › 115 CMR - DEPARTMENT OF DEVELOPMENTAL SERVICES › Title 115 CMR 10.00 - Research › Section 10.05 - Research Proposals

Current through Register 1525, July 5, 2024
(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.