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    BRANY IRB

    Effective Monday, March 9, 2026 new minimal risk studies that are eligible for Exempt or Expedited review should be submitted to BRANY IRB rather than the UConn IRB, unless an exception has been granted.  This is in addition to studies that already meet existing criteria for BRANY submission (external funding, more than 2 external collaborators).

    If you are unsure whether your study would qualify for Exempt or Expedited review, please refer to our [Overview of Exempt and Expedited Research Criteria] for the types of IRB review.

    This webpage includes detailed instructions for UConn/BRANY cede submissions. Please review carefully.

     

    All new UConn/BRANY cede submissions originate in InfoEd. To initiate the local UConn cede review process, which investigators complete prior to submitting directly to the BRANY IRB, follow these steps:

     

    1. Create a new initial application in the Human Subjects/IRB section of InfoEd.

     

    1. In the General Information section at the top of the application, select the option “Request to rely on non-UConn IRB” when prompted to answer, “What type of IRB review are you requesting?

     

    1. In the External IRB Information section of the application, select “BRANY IRB” when prompted to answer, “What type of external IRB is proposed to review this study?

     

    1. Follow all other prompts within the application to complete and submit the cede submission.

     

    Emailed UConn/BRANY cede submissions will not be accepted.

    BRANY IRB is an independent IRB that UConn has contracted to perform certain IRB reviews on UConn’s behalf.

    For studies that will be reviewed by BRANY IRB, the UConn study team submits a cede application to the UConn IRB Office via InfoEd prior to submitting the study to BRANY IRB. This submission allows UConn to track research conducted at UConn and to ensure that all institutional and local requirements are met.

    After submission of the cede application to UConn, the study team completes the submission to BRANY IRB through BRANY’s IRB Manager online submission system. BRANY IRB then conducts the ethical review on behalf of UConn.

     

    Studies that will be reviewed by BRANY IRB:

    • Exempt and Expedited Research
      • Effective March 9, 2026 – New human subjects research that qualifies for exempt or expedited review, regardless of funding or number of participating sites/collaborators; OR
    • Externally Funded Research
      • New human subjects research that has external funding support (e.g., grant, contract, foundation). This applies to exempt, expedited, and convened (a.k.a. full) review types. This also includes externally funded multisite research and research involving external investigators or staff; OR
    • Multisite Research/External Investigators
      • New studies that involve more than 2 external sites or external investigators/staff for which single IRB (by UConn/BRANY) is being requested. This applies to externally funded, internally funded, and unfunded research. PLEASE NOTE: This refers to collaborating researchers/study personnel, not facilities that may be sites where research activities occur.

    Note that multisite studies where single IRB review is being requested but the proposed reviewing IRB is NOT UConn/BRANY should not be submitted to BRANY IRB (such as research where a collaborator’s institution will serve as the IRB of record). In these circumstances, please follow our current reliance procedures found here on the UConn Reliance webpage.

    For further guidance regarding where to submit your research project for IRB review, see the [BRANY Submission Decision Pathways].

    BRANY Initial Submission Process

    1. Confirm your project qualifies for BRANY IRB review. If you are unsure, reach out to irb-reliance@uconn.edu with questions.

    2. Submit the documents required for UConn local context review as a “Request to rely on a non-UConn IRB” InfoEd application. Documents that will be required uploads within the InfoEd application include the following:

      • UConn Standard IRB Protocol Template: Input study-specific information as appropriate. The protocol document should clearly describe the role of UConn in the study as UConn cannot cede IRB review to BRANY without knowing what study activities will be occurring at UConn.
      • BRANY IRB Consent Template: Follow instructions on updating with study-specific information. The consent template(s) include required language from both UConn and BRANY.
      • Cede Application: Download from the UConn Reliance webpage and provide information to facilitate the cede process.
      • Data Security Assessment Form: Download from the IRB Submissions, Forms, and Templates webpage.

    Within the InfoEd application you will be asked to upload additional study materials as applicable. Such documents might include conflict of interest management plans, recruitment materials, ancillary review determinations, surveys, interview guides, and other study materials.

      3. Once local context reviews are complete, you will receive a letter from the UConn IRB authorizing your submission to BRANY IRB. As part of your local approval, IRB Reliance will provide information on how to move forward with a full IRB application submission to BRANY IRB. *Please note that while UConn will authorize the request to rely on BRANY IRB, this does not constitute IRB approval. IRB approval will be granted by BRANY IRB as the IRB of record.*

      4. Upon receipt of the authorization letter, submit the complete BRANY IRB application package to BRANY IRB.

      5. Upon BRANY IRB approval, if there were any ancillary reviews conducted as a preliminary review (e.g., for D1 athletes), note that there must be final approval in place before research activities may commence.

      Post-Approval Requirements

      Once a study is approved under reliance on BRANY IRB, the UConn study team remains responsible for meeting ongoing post-approval requirements and for coordinating submissions and reporting between BRANY IRB and the UConn IRB Office, as outlined below.

      1. Compliance with BRANY IRB Requirements
        The study team follows BRANY IRB Standard Operating Procedures (SOPs) and submission requirements for all post-approval activities overseen by BRANY IRB, including but not limited to:
      • Continuing review submissions or Annual Status Reports, as applicable
      • Amendments
      • Reportable events and notifications
      • Study closures

      Submissions to BRANY IRB are completed through the BRANY IRB Manager system in accordance with BRANY IRB guidance.

      1. Personnel Changes
        The UConn IRB Office is responsible for the review of all study personnel changes. Study teams submit personnel updates to the UConn IRB Office via InfoEd.

      Following UConn IRB Office review, only the following personnel-related changes are submitted to BRANY IRB, as applicable:

      • Changes to the Principal Investigator (PI)
      • Personnel changes involving conflict of interest (COI) considerations

      All other personnel changes are retained within UConn IRB records and do not require submission to BRANY IRB.

      1. Changes to Conflict of Interest (COI) Information
        Updates to investigator or study team COI disclosures or management plans are submitted to the UConn IRB Office via a personnel change via InfoEd (the COI questions are in the study personnel section of the form). The UConn IRB Office will coordinate with the UConn FCOI in Research Office as needed and inform the study team when subsequent submission to BRANY IRB is required.
      2. Reporting of Significant IRB Determinations
        The study team reports the following determinations made by BRANY IRB to the UConn IRB Office via InfoEd in a timely manner (within 5 working days of being informed of the BRANY determination):
      • Serious or continuing non-compliance
      • Unanticipated problems involving risks to subjects or others
      • Suspensions or terminations of IRB approval

      This reporting supports UConn’s institutional oversight and reporting responsibilities.

      1. Local Administrative Check-In Submissions
        The study team completes Local Administrative Check-In submissions to the UConn IRB Office via InfoEd as required. These submissions support UConn’s ongoing local oversight and coordination for studies relying on BRANY IRB and may include updates such as:
      • Confirmation of study status and enrollment activity at UConn
      • Verification of human subjects training
      • Verification of other institutional requirements
      • Other administrative information requested by the UConn IRB Office

      Local Administrative Check-In submissions are generally required 1 month after the BRANY Continuing Review or Annual Status Report date and do not involve BRANY IRB review unless otherwise specified.

      1. Ongoing UConn Oversight
        Reliance on BRANY IRB does not replace UConn’s institutional responsibilities and requirements. Study teams remain subject to all applicable UConn policies, ancillary reviews, and local requirements throughout the duration of the study.

       

      BRANY IRB Review Contacts

      UConn IRB Reliance – irb-reliance@uconn.edu

      BRANY IRB Contact – Vanessa Rodriguez: vrodriguez@brany.com (516-514-2445)

       

      Federal Stop-Work Directives

      How to Report Federal Stop-Work Directives to BRANY IRB.pdf

       

      BRANY IRB Consent and Assent Template Documents

      Note: A BRANY-specific protocol template is no longer required. Please use the appropriate protocol template from the IRB Submissions, Forms & Templates webpage for BRANY IRB submissions.

      SBR Consent Template

      SBR Consent Template Instructions

      Exempt Consent Template

      Exempt Consent Template Instructions

      Assent Template

      Assent Template Instructions

      Parental Permission Template

       

      Training Information

      BRANY IRB Manager Training Information: https://www.brany.com/irb-manager

       

       

      BRANY FAQs

      What is meant by “External Site?”
      This refers to collaborating researchers/study personnel, not facilities that may be sites where research activities occur. This does not mean a site/location where UConn researchers may be conducting research activities.
      What is meant by “Single IRB (by UConn/BRANY) is being requested?”
      This refers to a situation where the UConn study team is requesting that the external sites/personnel cede IRB review to UConn and that UConn/BRANY serve as the IRB of record for these sites. If the external sites will have their home IRB review the study, then those sites would not satisfy the more than 2 external sites requirement. Please note that single IRB review is required for most federally-funded studies.
      What should I do if an external IRB is planning to serve as the single IRB of record for a multisite study where I will be engaged in human subjects research?
      If an external IRB will be the single IRB of record for your multisite study, please submit a “Request to rely on a non-UConn IRB” application in InfoEd to initiate a request to rely on a non-BRANY external IRB. The UConn IRB’s reliance team will review your request and help you to facilitate a reliance agreement between UConn and the reviewing IRB. If another IRB will be the single IRB of record, the study should not be submitted to BRANY.
      What are BRANY IRB review turnaround times?
      Please contact Vanessa Rodriguez, BRANY IRB’s liaison with UConn, for information on BRANY turnaround times. Vanessa can be reached at vrodriguez@brany.com or 516-514-2445.
      How quickly will UConn’s Reliance Team review a request to cede IRB review to BRANY?
      IRB Reliance will work to review cede requests within one week of receipt.