Code of Massachusetts Regulations
115 CMR - DEPARTMENT OF DEVELOPMENTAL SERVICES
Title 115 CMR 10.00 - Research
Section 10.05 - Research Proposals
Universal Citation: 115 MA Code of Regs 115.10
Current through Register 1537, December 20, 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.
(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.
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