Institutional Review Board

Welcome to the State of Connecticut, Department of Children and Families' Institutional Review Board (IRB). The DCF IRB is responsible for reviewing and approving research involving clients and staff prior to the initiation of research and through continuing review and monitoring of approved studies. The purpose of an IRB review is to ensure that studies are being conducted in accordance with the ethical principles of autonomy, beneficence and justice as set forth in the The Belmont Report, and in compliance with federal regulations and internal policies. The DCF IRB is established by policy of the agency.  The DCF IRB follows and is informed by federal guidelines.  Restoration of the Federal Wide Assurance concerning its operations is currently under consideration by DCF. 

 

Operations of the DCF IRB are governed by agency policy 26-8-1 which requires that “All requests for research involving human subjects (clients or DCF staff), which the department conducts or in which the department assists in providing patients or data, shall require consideration for approval by the Institutional Review Board (IRB).”

 

The Department of Children and Families is a multicultural agency serving children and families from different races, ethnicities, creeds, sexual orientations, gender identities and/or expressions.  Some families have limited English proficiency or it is not their preferred language.  Therefore, it is the expectation of the DCF IRB that studies submitted to the IRB for review are written in a way that is culturally and linguistically responsive and appropriate, and lead to the inclusion and increased knowledge that is relevant to our heterogeneous population.  If you have any questions, you may email the IRB at dcf.irb@ct.gov

Research Proposal Impact Assessment

provides an abstract of your research and how it will affect DCF.  Submission of the Research Proposal Impact Assessment to DCF Office For Research and Evaluation (ORE) is required prior to DCF IRB review.  The DCF ORE must review the impact on and specific value/benefit(s) to DCF.  ORE will determine whether DCF will allow the research to move forward.

 

The principle investigator(s) must submit the Impact Assessment via email to the DCF IRB.  The DCF IRB will provide the administrative support for submission and notification but does not have a role in the decision-making process.

 

Continuing Reviews and Amendments
should be submitted at least one month prior to IRB meetings for processing and review by members.  Forms can be located on the IRB Forms Library.  For continuing reviews, a copy of the Annual Summary is required in the submission. When a study is closing, a copy of the Final Report is required.

 

Continuing Review Guidelines

The Principal Investigator is responsible for submitting:  1) the Continuing Review form; and, 2) all supporting documentation concurrently for the continuing review no sooner than 45 days but no later than 30 days before the study’s expiration date.  This ensures adequate time for the IRB to process and review the Continuing Review information.

 

Principal Investigators and Study Coordinators are strongly encouraged to devise a tickler system for ensuring the timely submission of all information needed to continue the review.  Methods include setting reminder notices in electronic calendars, and conducting frequent meetings with study staff to review expiration dates.

 

Expired Studies (Full Board Hearings and Expedited Reviews) Guidelines

If the IRB approval expires, before the continuing review and approval process occur, the Principal Investigator and study staff must stop all research activities related to that study.  All research activities including ascertainment, recruitment, consent, data collection and data analysis must cease.  This includes intervening and interacting with subjects, and/or obtaining or analyzing identifiable private information about the participant(s), and using any data obtained after the expiration date for the research.


How To Resume The Study
The investigator may resume the research activity once the Continuing Review information is submitted and approval by the IRB has occurred.

Time Limits:
The IRB will permanently close the study and a new application must be submitted if the continuing review information is not received in a timely manner.

 

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IRB Resources and Training

The National Institutes of Health (NIH) online computer-based training course provides information to IRB Chairs, Co-Chairs and External Researchers about their roles and responsibilities.  Completion of these courses is required.

 

NIH Office of Extramural Research Training for External researchers, IRB Chairs and Co-Chairs.

 

NIH Human Subjects Assurance Training for IRB Chairs, Co-Chairs and Members.

 
The Federal Regulation establishing and governing the responsibilities of IRBs:  45 CFR 46: CFR, Protection of Human Subjects
 
Historical background on the origins of the ethical principles governing research:  The Belmont Report
 
A handbook for those with questions about being involved in Human Subjects research:  CDC Human Subject Information Brochure
 
PHI (Personal Health Information) Related Links:  HHS Office for Civil Rights - HIPAA
 
Guidelines to promote a shared understanding of the Principles of Collaborative Authorship:   Authorship Guidelines For Research Publications
 
International Committee of Medical Journal Editor's  Guidelines on Authorship

 

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IRB Forms Library

Impact Assessment_050515
IRB Application Form_052515
IRB Continuing Review Form
IRB Protocol Revision and Amendment Form
IRB Reporting Adverse Events Form
Research Proposal Impact Assessment form

 

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Board Members

The IRB is a multidisciplinary body of professionals who volunteer to serve as a reviewer of research proposals.  There is at least one Non-affiliated member of the IRB, meaning a person who is not affiliated with the agency.

Donald Shevchuk, JD (Co-Chair), Affiliated
Tracy Lovell, MSW (Co-Chair) Affiliated
Frank Gregory, PhD, Affiliated
Susan Reilly, MA, Unaffiliated
Mark Root, RN, Affiliated
Iris Thompson, RN, MPH, MHA, Affiliated
Isabel Turmeque, MSW (Coordinator), Affiliated

For Directions to Beacon Health Options, click HERE

IRB Meeting Schedule: 

IRB meetings are held on the first Tuesday of every month, from 1:00 p.m. until 4:00 p.m. at Beacon Health Options, 500 Enterprise Drive, 3rd floor, Litchfield Room, Rocky Hill, CT  06067.

 

January 2, 2018

February 6, 2018

March 6, 2018

April 3, 2018

May 1, 2018

June 5, 2018

July 10, 2018

August 7, 2018

September 4, 2018

October 2, 2018

November 6, 2018

December 4, 2018

 

Cancellations:  IRB meetings will be cancelled in the event that the Hartford and New Haven Public Schools close due to weather.  The IRB will meet as scheduled during school delay situations. 

 

 

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IRB Review Determination

 

An initial discussion and review of your proposed research will occur in order to determine whether it is:
  • Exempt - Proposed research is exempt from IRB review when it does not deal with personally identifiable case data.  If your proposed research is exempt, a letter will be sent to you from an IRB co-chairperson to that effect.
  • Expedited - Proposed research is expedited when it is suitable for review and the research does not directly involve DCF children.  If an expedited review is appropriate, the application package will be distributed to selected IRB members for review and you will be notified of the decision as soon as possible.
  • Full Board review - Proposed research that requires a full, in-person IRB review because it does deal with personally identifiable case data.  You will be contacted to schedule a presentation by phone or in person.

IRB approval does not constitute administrative permission to access data or subjects in DCF facilities, programs and services.  DCF administrative permission for access to specific records or subjects is a separate matter.  Permission must be obtained from DCF and the administrators of the respective facility, program, or service.

Contribution, Authorship and Acknowledgement

The Department seeks ongoing opportunities to engage in partnerships of mutual benefit as an outgrowth of its commitment to and investment in scholarly research. Therefore, the Department may be able to make significant contributions that support proposed research and build DCF staff capacity through involvement in activities such as formulating the research hypotheses and research design; and/or designing and conducting major data analyses and interpreting the findings.

The expectation is that DCF staff would be afforded opportunities for co-authorship by helping to draft or revise an article for critically important content; contributing to writing a major section of the manuscript; and providing final approval of the version to be published. Department staff that makes minor contributions should be acknowledged in the paper. The Department reserves the right to decide its level of contribution or initiate requests when these opportunities appear available and consistent with its priorities.

If you have any questions, you may e-mail the IRB at the DCF IRB mailbox at dcf.irb@ct.gov.

 

 

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Application Process

The principal investigator(s) must submit a completed application package to the DCF IRB.  A link to the application can be downloaded from the “Forms Library.”  The DCF IRB must approve your proposed research prior to the implementation of any research involving human subjects, records or charts.

 

The IRB will not consider a research proposal until the application package is received in its entirety.  In addition, the DCF IRB will not review any research proposal until it has been cleared by all other applicable institutions’ IRBs.  The IRB will review completed application packages in as timely a manner as possible, but no later than sixty (60) days after the receipt of the entire application package.

 

 

Please be aware that application packages submitted to the DCF IRB have been determined by the department to be disclosable under the Freedom of Information Act provisions, unless otherwise exempt.

 

Application Package

A completed application package must contain the following:

  • An IRB Application Form filled out completely.  Incomplete forms are likely to result in processing delays.
  • A sample of the consent form to be used. The consent must cover the specific risks and benefits to the individual subject.  Consent forms should be available in languages appropriate to the research population.
  • The questionnaires or other data collection instruments to be used in the research.
  • A copy of the grant application if the research is grant funded and a copy of the research design or proposal.
  • A copy of the IRB approval(s) of all other applicable institutions when the research proposal has been cleared. 
  • For any research at DCF sites, a letter from the chief administrator or Solnit South executive committee, is required indicating initial approval.  Solnit South's executive committee must approve research involving its patients.  
  • A current resume or Curriculum Vitae of the principal investigator and co-investigator(s).
  • A copy of the Exempt Research or Expedited Review Checklist, if applicable.
  • Assurance of completion of investigator training.

Application Submission:

The IRB application package must be submitted electronically with one signed original hard copy application.  The IRB application package must be forwarded to the DCF IRB BOTH electronically and by hard copy to the following:

 

DCF Institutional Review Board
Office For Research and Evaluation
505 Hudson Street
Hartford, CT  06106

Electronic copies should be sent to: dcf.irb@ct.gov