What do the terms “external investigators” or “external collaborators” mean in relation to my UConn IRB submission?
The terms “external collaborators” and “external investigators” refer to study personnel who are engaged in human subjects research under the purview of the UConn IRB but who are not affiliated with UConn Storrs or any of the UConn Regional Campuses.
Please note that UConn Health is a separate entity with its own IRB. UConn Health faculty and personnel are considered external collaborators/investigators for the purposes of IRB protocols unless the individual has a dual affiliation and their role in the research is primarily related to their UConn Storrs/Regional Campuses role.
Possession of a NetID does not necessarily mean that an individual is affiliated with UConn. For example, if an individual’s only association with UConn is a sponsored affiliate account, this individual would likely be considered an external study team member. Please explain the UConn association (e.g., paid contractor for this study) for any individual with an affiliate account in your IRB application.
What does an “engaged” external collaborator mean in relation to human subjects research?
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.
A colleague from UConn Health and I plan to be co-investigators on a new study. Which IRB should we submit to?
Refer to the Guidelines for Collaborative Research with UConn Health found on the IRB Reliance webpage for guidance.
I am planning to conduct research at a local elementary school. No one from the school staff will be on my study team. Will I need a reliance agreement?
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.
I am planning to conduct research in collaboration with a local nonprofit agency. Some of the agency staff will be part of the study team. These staff members will be obtaining consent from participants. The agency does not have their own IRB. How do I list these external collaborators on my InfoEd application
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.
I am designing a research project with a colleague at another university. We anticipate that the project will be reviewed as exempt research. Will I need a reliance agreement?
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.
I would like to add a colleague from another university to my study team for my ongoing exempt research. What do I need to do?
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.
A colleague from another university would like to add me to their study team for a project that their IRB determined was exempt research. What should I do?
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.
A colleague at another university has asked me to join their study team to conduct statistical analyses for an ongoing project. My colleague’s IRB has already approved the research via expedited (nonexempt) review. Do I need to submit anything to the UConn IRB?
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.
A colleague from another university would like to add me to their study team for a project that their IRB determined was nonexempt research. What should I do?
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.
I intend to serve as the PI for a nonexempt study that will include study team members from other universities. Where should I start with my IRB submission?
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.
I am a student at UConn, and I plan to work on an ongoing research project related to my major at a local hospital. The project was approved by the hospital’s IRB. What do I need to submit to the UConn IRB?
Refer to UConn’s Guidelines for Students Conducting Research at External Institutions found on the IRB Reliance webpage for guidance.
I am the UConn PI for a multisite study where we are relying on the IRB at my colleague’s university. A reliance agreement is already in place, and the study has a RELY submission record in InfoEd. I have some personnel changes I would like to make to the UConn study team. To which IRB do I submit these changes?
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.
I am the Overall PI for a multisite study for which UConn serves as the IRB of record. A collaborator at one of the relying universities is adding new personnel to their local study team. Do I need to submit an amendment to both UConn and the relying IRB?
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.
I have a question about external collaborations in human subjects research that is not covered here. Who should I contact for assistance?
Please email irb-reliance@uconn.edu with your question, and someone will get back to you as soon as possible. If you are reaching out with an initial inquiry about a new multisite study, in your email please identify all external collaborators and sites that will be engaged in the research, identify who will serve as the overall PI, identify who will serve as the UConn PI, provide a brief description of the research, describe any funding, and include any other information that may be relevant to your inquiry.
