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Committee for the Protection of Human Subjects (CPHS) of Biomedical and Behavioral and Statistical Research

Welcome to the State of Connecticut, Department of Children and Families' Committee for the Protection of Human Subjects (CPHS) of Biomedical and Behavioral and Statistical Research. The DCF CPHS 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 CPHS 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 CPHS is established by policy of the agency.  The DCF CPHS 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 CPHS are governed by agency policy 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 CPHS.

 

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 CPHS that studies submitted to the CPHS 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 CPHS at DCF.CPHS@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 is required prior to DCF CPHS review.  The DCF must review the impact on and specific value/benefit(s) to DCF. 

 

The principle investigator(s) must submit the Impact Assessment via email to the DCF CPHS.  The DCF CPHS 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 CPHS meetings for processing and review by members.  Forms can be located on the 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 CPHS 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 CPHS 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 CPHS has occurred.
 
Time Limits:
The CPHS 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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CPHS Resources and Training

 

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

 

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CPHS Forms Library

 

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Board Members

The CPHS 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 CPHS, meaning a person who is not affiliated with the agency.

Donald Shevchuk, JD (Co-Chair), Affiliated
Frank Gregory, PhD, Affiliated
Susan Reilly, MA, Unaffiliated
Iris Thompson, RN, MPH, MHA, Affiliated

 

IRB Meeting Schedule:    CPHS 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.

  

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

 

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CPHS 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 CPHSreview 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 CPHS 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 CPHS 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 CPHS review because it does deal with personally identifiable case data.  You will be contacted to schedule a presentation by phone or in person.

CPHS 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.

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Application Process

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

 

The CPHS will not consider a research proposal until the application package is received in its entirety.  In addition, the DCF CPHS will not review any research proposal until it has been cleared by all other applicable institutions’ CPHSs.  The CPHS 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 CPHS 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:

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

 

DCF CPHS
505 Hudson Street
Hartford, CT  06106

Electronic copies should be sent to: DCF.CPHS@ct.gov