1. Service Units
  2. Research Integrity & Compliance
  3. Human Subjects Research
  4. New Researchers
    Page content relevant to:

    New Researchers

    Welcome to the University of Connecticut (UConn) and to UConn’s Human Research Protection Program (HRPP). The mission of the HRPP is to:

    • Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;
    • Provide guidance and support to the research community in the conduct of research with human subjects;
    • Assist the research community in ensuring compliance with relevant regulations;
    • Provide timely and high-quality education, review, and oversight of human research projects; and
    • Facilitate excellence in the conduct of human subjects research.

     

    We would like to give you a head start on your success at UConn by providing you with information about the Institutional Review Board. We urge you to familiarize yourself with the following information at your earliest convenience. 

     

    IRB Website – Contact Information for HRPP/IRB leadership and IRB staff is available on our website.  Our website also includes a list of staff assignments so please use that as a guide for help with questions.  When in doubt, send an email to the general IRB inbox and your email will be directed to an appropriate staff member.

     

    UConn and HRP Consulting Group – HRP Consulting Group supports UConn by providing staffing services and expert consultation. HRP supports the management of the IRB office, IRB Reliance, IRB staffing, IACUC staffing, and the current endeavor to make improvements to the IRB’s electronic platform, InfoEd.

     

    Turnaround Times – Turnaround times vary based on the type of submission, the quality of the submission, the level of review required, and whether the review will be conducted by the UConn IRB or BRANY IRB.  In general, please submit well in advance of when you plan to implement the research to allow sufficient time for review, response, and approval.  Submission windows for convened board reviews are posted on the IRB website. Submissions are processed in the order in which they are received.

     

    UConn and UConn Health – UConn and UConn Health have unique Human Research Protection Programs.  Each has their own IRB.  UConn and UConn Health have a reliance agreement (aka cooperative agreement) to facilitate research that involves both institutions.  Note that both IRBs are overseen by the Associate Vice President for Research Integrity & Compliance under the Vice President for Research, Innovation and Entrepreneurship.  Refer to these guidelines for additional information about UConn and UConn Health research studies (studies not externally funded and only involve UConn or UConn Health)

     

    Training – Please complete UConn’s CITI training or affiliate your existing CITI training with UConn. Note that you can log in to CITI with your UConn NetID and password.  Be aware that UConn (Storrs) and UConn Health have different training requirements.  If you are Storrs based, be sure that you affiliate with UConn – Storrs and Regional Campuses in your CITI profile.  Note that you can log in to CITI with your UConn NetID and password.  When you affiliate your existing training, there is a good chance that a good number of the modules you already completed will transfer to UConn.  When you affiliate with UConn – Storrs and Regional Campuses your training will be visible to the IRB office for verification when you submit.  Alternatively, you can upload a CITI Completion Report (not CITI Training Certificate) into InfoEd. The IRB Office will review the training to confirm that it is current (within 3 years) and that it meets UConn’s training requirements or is substantially equivalent (at least 70% of the modules align). Any listed personnel in your protocol submissions must have also completed training.  Additional information is available on the IRB’s Required Training webpage. If you have questions about training requirements, please contact irb@uconn.edu.

     

    BRANY IRB – In June 2023, UConn designated BRANY IRB as its IRB for externally funded research and certain multisite studies. BRANY IRB is an independent IRB that is able to provide timely expert review of both SBER and Biomedical studies. Become familiar with the External IRB Guidelines and review with UConn.  Specific information about the BRANY IRB process is available on our website. If you have any questions, please contact irb-reliance@uconn.edu.  Please include BRANY in the subject line.

     

    UConn IRB Protocol Submission Forms – For each submission, be sure to download the most recent versions of the forms from the IRB Submissions, Forms and Templates webpage.  For the two most common submission types, exempt and expedited/full board, there is a list of common submission components that may be applicable to your research.  Please review these before you submit. Forms and templates are regularly updated so please be sure to visit the website prior to submitting to ensure that you are using the current versions.  When submitting a protocol for review under the exempt criteria, you might like to familiarize yourself with our Quick Tips for Exempt Submissions document.  Be sure to use the consent form template that is appropriate for the level of review.

     

    Level of Review – If you have questions as to what level of review your research may require, contact irb@uconn.edu.

     

    Human Subjects Research Determinations – As noted in the External IRB Guidelines, the UConn IRB makes human subject research determinations. HSR determinations are encouraged whenever it is unclear whether IRB review is required and whenever there are plans to disseminate results beyond immediate stakeholders. If you would like a determination, complete the determination form available on our website and follow the instructions for submission.

     

    118 (Just in Time) Determinations – As noted in the External IRB Guidelines, the UConn IRB issues 118 determinations.  118 Determinations (aka “just in time” or “development only”) apply to federally funded research and certain grant types when the human subjects activities are not yet fully known or developed and cannot be clearly articulated in an application or proposal.  If you need a 118 determination or have questions, please contact Doug Bradway via email at doug.bradway@uconn.edu or contact irb@uconn.edu.

     

    InfoEd – UConn uses InfoEd for protocol development and for protocol management.  InfoEd is an enterprise-level, web-based application.  The IRB developed guides to assist researchers with various functions.  You might have to log in with your NetID and password to see the guides.  We strongly suggest that you review these guides before submitting.  Support is available if you require technical assistance.  Please contact the IRB office if you have non-technical questions.  The IRB is working on major enhancements to InfoEd.  Additional information is forthcoming.

     

    Reliance and Protocol Transfers – New faculty and researchers are strongly encouraged to contact UConn reliance as early as possible to facilitate reliance with a previous institution or to initiate submission of research previously approved by another IRB.

     

    Research Data Security & IT Resources – Review the UConn IRB’s Guidance on Data Security for Human Subjects Research.  In addition, Information Technology Services (ITS) lists resources available to all UConn employees.