Generally, a person or institution is engaged in human subjects research if they have a key role in designing or conducting the research, analyzing identifiable information, or obtaining informed consent. Determining whether an external person or an external institution is engaged in a research project is typically the first step for an IRB Office in determining whether an external agreement may need to be executed.

Detailed federal guidance regarding engagement, including specific scenarios, can be found here: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html.

Refer to the Guidelines for Collaborative Research with UConn Health found on the IRB Reliance webpage for guidance.

Reliance agreements may be executed when researchers from different institutions with their own IRBs collaborate on a nonexempt research project. If you are conducting research at an elementary school, and the school staff will not be part of the study team, you will need to obtain permission to conduct the research at the school, but a reliance agreement will probably not be required. In your IRB submission, be sure to provide a detailed explanation of any research-related activities that will be undertaken by school staff so that your reviewer can appropriately advise you if any types of external agreements may be necessary.

If the external agency does not have their own IRB, then within your InfoEd application you will need to request that UConn serve as the IRB of record for external investigators and note that these investigators are individuals who are not affiliated with an institution with an IRB.

UConn does not enter into reliance agreements for exempt research. Each institution involved in the research will need to issue an exemption determination to cover their own affiliates’ activities. As you develop your study materials, please refer to the Guidance for Multisite Exempt Research on our IRB Reliance webpage for more information.

The UConn IRB generally does not review the activities of external personnel who are affiliated with an institution with an IRB when a study qualifies for exempt status. Collaborators should reach out to their home institution’s IRB to determine local review requirements and/or obtain their own exemption determination. Although these external collaborators should not be listed individually on the UConn IRB application, if the collaboration will necessitate significant changes to the approved study materials or updates to the information provided to the IRB during the initial review, an amendment to address these changes may be necessary. Please refer to the Guidance for Multisite Exempt Research on our IRB Reliance webpage for more information.

If you intend to collaborate on a project that another IRB has already determined is exempt research, you will need to create an “External Exempt” Initial Application in InfoEd and attach the materials from the external IRB as requested in the electronic application. The UConn IRB Office will review the submission for local context and attempt to issue our own exemption determination based on the materials approved by the other IRB. Refer to our Guidance for Multisite Exempt Research found on the IRB Reliance webpage for more information.

Note that all materials to be used for multisite research, whether the study is exempt or nonexempt, should properly reflect the involvement of each engaged site.

Yes, you will need to submit your activities to the UConn IRB as UConn is responsible for reviewing the research activities undertaken by our own affiliates as part of their role at UConn.

If the datasets are considered to be de-identified, you should submit a “Not Human Subjects Research” application in InfoEd. Note that datasets that may be referred to as “de-identified” may not meet federally-defined IRB standards for “de-identified” so it is best to seek an official IRB determination before beginning any analyses on data collected from human subjects.

If you intend to analyze identifiable data (which includes any type of recording), you should submit a “Request to rely on a non-UConn IRB” submission if your colleague’s IRB is willing to serve as the IRB of record. If your colleague’s IRB is not willing to serve as the IRB of record, you should submit an IRB application for “Expedited/Full Board” review that focuses on your role in the overall project.

Your colleague should consult with their IRB (if they haven’t already) and establish if their IRB would be willing to serve as the IRB of record with UConn as a relying site. If your colleague’s IRB is willing to serve as the reviewing IRB, then you should submit a “Request to rely on a non-UConn IRB” Initial Application in InfoEd so that our IRB Office can review your request. To complete the InfoEd application, you will need to have copies of the approved study materials, the initial approval letter from the IRB of record, and any forms the IRB of record would like the UConn IRB to complete.

If your colleague’s IRB is not willing to serve as the IRB of record, and the study is not subject to the single IRB mandate due to federal funding, you should submit an Initial Application in InfoEd for an “Expedited/Full Board” review. The application should focus on your planned study activities.

For multisite research, you should develop your IRB review plan well in advance of your IRB submission. If your study is federally funded by one of the agencies subject to the single IRB mandate (this includes most federal funding), you may be required to designate one IRB to serve as the IRB of record. The IRB should be consulted in advance before designating it to serve as the IRB of record. If the single IRB mandate is not applicable, you should discuss with your collaborators if it makes sense to designate a single IRB of record and have the other institutions rely on that IRB’s review or if you would prefer to have each IRB conduct their own review.

Refer to the Guidance for UConn Serving as the IRB of Record for Multisite Research on the IRB Reliance webpage for additional information on how to develop an IRB review plan and how to create study materials for multisite research.

If you would like to request that UConn serve as the IRB of record, please complete the “Request for UConn to Serve as the IRB of Record” form found on the IRB Reliance webpage and email the completed form to irb-reliance@uconn.edu.

Currently, research that is externally funded and/or involves more than two engaged external relying sites or external investigators is eligible for review by BRANY IRB. Please see our BRANY IRB webpage for more information and to confirm study eligibility.

Refer to UConn’s Guidelines for Students Conducting Research at External Institutions found on the IRB Reliance webpage for guidance.

For “RELY” studies where an external IRB is serving as the IRB of record, all changes to the local UConn personnel should be submitted as a “Personnel Change” submission in InfoEd. UConn is responsible for verifying training and checking for COI. You and/or the Overall PI should also consult with the IRB of record to be sure you understand their amendment submission requirements and whether they require amendments to update relying site personnel changes.

For local relying site personnel changes where UConn serves as the IRB of record, an amendment is not required to notify the UConn IRB each time there is an update to the personnel at a relying site unless the local PI is changing or the personnel change could affect study safety (such as the removal of a medical monitor). All other local personnel changes should be reviewed and processed by the relying IRB where those changes are occurring. However, although individual amendment submissions are not required to update the UConn IRB of most relying site personnel changes, the Overall PI at UConn is required to keep an updated list of study personnel at each site and will be asked to submit this list on the External Personnel Log form with their annual continuing review or administrative check-in submission. The External Personnel Log form is available on the IRB Reliance webpage.