DEPARTMENT OF DEVELOPMENTAL SERVICES

DDS RESEARCH REVIEW COMMITTEE - ADVISORY TO PRINCIPAL INVESTIGATORS
FEBRUARY 2020

Authority and Scope of the DDS Research Review Committee

The authority of the Department of Developmental Services’ (“DDS” or the “Department”) Research Review Committee (the “RRC” or the "Committee") is derived from the Department's statutory mandate to "… take cognizance of all matters affecting the welfare of the persons with an intellectual disability or persons with a developmental disability..." See M.G.L. c. 19B, §1.  Pursuant to this authority, the Department promulgated regulations  (115 CMR 10.00, et seq.) which created the RRC and established a process for safeguarding the human rights and privacy rights of persons involved with the Department and who may or seek to participate in research. See 115 CMR 10.01. 

The Department promulgated its chapter 10 regulations in conformity with Part 46 of Title 45 of the Code of Federal Regulations, which is intended to protect participants of federally-funded research.  See 115 CMR 10.01. The federal regulations, 45 CFR 46.101, et seq., require that an Institutional Review Board ("IRB") review all research by or involving the institution and enforce standards concerning informed consent and risk-benefit analysis.  The RRC shall have the duty to serve, subject to the approval of the U.S. Department of Health and Human Services, as the IRB of DDS. See 115 CMR 10.04(4)(i). 

All research involving consumers of DDS services or supports, private information of DDS consumers, or data concerning DDS consumers, must be reviewed by the Committee unless a regulatory exemption or other exception applies. See 115 CMR 10.03.

The Committee has authority to approve research proposals, disapprove them, or approve them under conditions.  See 115 CMR 10.04(4). Research required to be reviewed by the Committee may not proceed without the approval of the Committee. See 115 CMR 10.03(2) and (3). 

Goals of the Research Review Committee

The Committee is tasked with protecting of the rights and welfare of Department consumers who may or seek to be involved in human subject research. See 115 CMR 10.06(1).  At the same time, the research review process reflects appreciation of the fact that well-conceived research is an indispensable tool for the advancement of knowledge concerning the lives and needs of persons with intellectual and developmental disabilities.  By its review of research proposals, the Committee seeks to encourage valuable research while simultaneously protecting the rights of research participants through a close examination of confidentiality procedures, information provided to participants by investigators, steps taken to ensure valid informed consent is obtained, risks of the research and the safeguards in place to minimize the risks to participants, and the potential benefits, as well as costs, to individuals participating in the research. See 115 CMR 10.05(2). 

INSTRUCTIONS FOR SUBMISSIONS OF RESEARCH PROPOSALS TO THE RRC

SECTION A - General Information

The RRC generally meets on the first Friday of each month at 1:00 p.m. at the DDS Central Office, 500 Harrison Ave., Boston, MA 02118.  The meeting schedule is subject to change as necessary to accommodate Committee members or invited guests. Scheduling of interim meetings occurs from time to time in the discretion of the Committee.

A proposal for research and supporting documents should be submitted to the Committee Chairperson no later than three weeks prior to the meeting at which the proposal is to be considered. Proposals received after this period will be considered at the next meeting.  Proposals should be emailed to Erin.Brown@mass.gov or mailed to:

			Erin G. Brown, Chairperson
			Research Review Committee
			Department of Developmental Service
			500 Harrison Avenue
			Boston, MA  02118

To confirm when the next meeting of the Committee will be held, or if you have questions regarding the Committee, this advisory, or the Committee's review process, direct your inquiries to the RRC Chairperson, Erin G. Brown, at (617) 624-7517.

Certain proposals, which, by their nature, present minimal risk of harm, may meet the requirements for expedited review.  After submission, investigators will be notified if their proposals will be subject to full Committee review or expedited review.

SECTION B - Contents of Submission

The information provided on attached RRC Forms 1, 2, plus an appropriate research protocol will provide the basis for the review.  All questions should be answered on these RRC forms. Where applicable, a reference to the appropriate page number in the protocol can be given.	
	
Peer Review - At the time the proposal is submitted to the Committee, the investigator must also submit evidence of favorable peer review.  For investigators (including students) affiliated with a hospital or university, this requirement can be met by submission of a copy of written approval of the proposal by the hospital's or university's IRB.  For investigators who are not affiliated with a hospital or university, the investigator must instead submit with RRC Form #1 three letters of approval of the proposal from three independent peers knowledgeable in the field of the proposed research.  

SECTION C - Presentation by Investigator

In cases where the Committee has many questions or where the nature of the research is such that additional explanation by the investigator would be helpful to the Committee's understanding of the research, the Committee may require the investigator's presence at the meeting at which it is considering the research.  The investigator would be notified of the time and place of the meeting and alerted to particular issues identified by the Committee, which require or would benefit from further explanation.  The investigator should be prepared to give a brief and informative overview of the research proposal.

SECTION D - Notification to Investigator

Within 10 days after its consideration of the research, the Committee will notify the investigator regarding whether the research is approved, disapproved, approved contingent upon certain modifications, or approved subject to certain conditions.  See 115 CMR 10.04(4), 10.08(5).  In the latter two instances, approval will be withheld until the Committee receives written confirmation to its satisfaction that the modifications have been made or that the conditions will be satisfied.  After the research is approved, the investigator must submit to the Committee an annual progress report (RRC Form #3), as well as a final report upon completion of the research.  Also, any alterations to a previously approved research protocol must be approved by the Committee before they can be implemented by the investigator.  Follow-up communication concerning modifications and conditions of approval can typically be accomplished through written correspondence between the investigator and RRC chairperson.