Cooperative Research and Single IRB (sIRB) Review
You are here
Cooperative Research and Single IRB (sIRB) Review
Cooperative research projects involve more than one institution. According to 45 CFR.114 (effective January 20, 2020), cooperative research conducted or supported by HHS agencies must rely upon approval by a single IRB (sIRB) for the portion of the research that is conducted in the United States. Studies funded by NIH must comply with their Single IRB Policy for Multi-Site Research, which establishes the expectation that a sIRB be appointed to conduct the ethical review for all domestic sites participating in any NIH-funded, multi-site study (effective January 25, 2018).
While there are exceptions to both the Common Rule Regulation and the NIH Policy, most multi-site research will use sIRB review. The aim of sIRB review is to reduce administrative burden associated with duplicative reviews and to increase efficiency.
The University of Illinois is a participating institution in SMART IRB, an online reliance system that aids in cooperative research between institutions. When providing oversight for another institution, UIUC requires the use of SMART IRB to document reliance.
Guidance for Cooperative Research
This guide provides information for University of Illinois researchers who are collaborating with co-investigators/research team members who are affiliated with other institutions or are independent investigators. For collaborative human subjects research, one of the following will hold true:
- If the person or persons you are collaborating with are not affiliated with an institution that has an active Federalwide Assurance (FWA) with the Department of Health and Human Services Office for Human Research Protections (OHRP), they may be listed on your application and conduct human subjects research after signing a Collaborating Investigator Agreement (CIA). The purpose of the CIA is to ensure the collaborating investigator agrees to conduct research activities in accordance with University of Illinois policy and federal regulations. Information about these agreements is provided below in Section A.
- If your collaborator(s) are affiliated with an institution that has an IRB with an FWA, your collaborators will need to consult with their home institution IRB office to see what type of review is required as UIUC IRB approval only covers UIUC students, faculty or staff. Instituations may mutually agree that one IRB may serve as the IRB of record for the study. Should this be the case, an agreement will be established. More information about reliance agreements is provided below in Section B.
- If your collaborator is affiliated with an institution that frequently collaborates with UIUC investigators, such as Carle or the University of Illinois-Chicago (UIC), a Memorandum of Understanding (MOU) can potentially be used to allow one IRB to serve as the IRB of record. More information about MOUs is provided below in Section C.
IMPORTANT NOTE ABOUT EXEMPT PROTOCOLS: If the study can be approved using an allowable exemption category UIUC does not require a formal collaborating investigator agreement or a reliance agreement. UIUC will not enter into an agreement to rely on another IRB for exempt research. However, if the protocol was approved after a limited IRB review, reliance must be documented. Questions about cooperative exempt protocols should be directed to IRB-Reliance@illinois.edu.
A- Collaborating Investigator Agreements
A Collaborating Investigator Agreement allows an institution such as University of Illinois that has a Federalwide Assurance with OHRP to extend the applicability of its FWA to cover collaborating investigators who do not work at an institution with an FWA.
These are the steps involved with establishing a Collaborating Investigator Agreement:
- First add the person’s contact and CITI training information to your Research Team Form and send this attachment to the Office for the Protection of Research Subjects with the initial application. NOTE: Independent investigators may do CITI training by registering at www.citiprogram.org and indicating University of Illinois at Urbana-Champaign affiliation for the purposes of your research, or forward their CITI training information if completed previously.
- OPRS will assess the role of the non-affiliated researcher to make sure they are engaged in human subjects research (such as being involved with recruitment, the consent process, data collection and/or data analysis); their role should be clear on the application.
- The OPRS office staff conducing the pre-review will arrange for a Collaborating Investigator Agreement to be sent to all unaffiliated individuals on the team. NOTE: This form is always sent to your collaborators by OPRS rather than being completed by Illinois researchers.
- The unaffiliated staff should review the one page agreement, sign, and return the signed form to the OPRS office (mail, email or fax is fine). NOTE: There is a signature line on the CIA for a signature from an authorized person at the investigator's institution. It is expected that the collaborating investigator will have this signed when their affiliated institution deems it to be necessary. When the form arrives without such a signature, OPRS assumes that the agreement does not require an authorized, institutional signatory.
- Once the Collaborating Investigator Agreement is received from your independent collaborator, OPRS will arrange for this form to be signed by the University of Illinois Vice Chancellor for Research and Innovation.
- Once the fully executed Collaborating Investigator Agreement is in place, a copy will be kept in the IRB application file and will be sent to the research team. Once IRB approval is obtained, then the person(s) may engage in human subjects research as assigned. NOTE: when a Collaborating Investigator Agreement is required, this agreement must be in place before initial IRB approval can be granted.
NOTE: When a University of Illinois student, faculty, or staff leave campus but continue to conduct human subjects research on an approved non-exempt IRB application, a Collaborating Investigator Agreement should be established for them. When an Illinois graduate student is temporarily on leave of absence or is absent without leave, the Graduate College policy will be consulted to determine whether a Collaborating Investigator Agreement is necessary.
NOTE: If University of Illinois researchers have already obtained initial IRB approval but subsequently want to add non-University of Illinois collaborators the same steps outlined above would apply, and the appropriate Collaborating Investigator Agreement established for non-exempt research before your collaborator engages in human subjects research.
A copy of our OPRS Collaborating Investigator Agreement form is supplied for your reference; this form is always completed and sent to the collaborator by OPRS staff rather than the Illinois researcher.
B- Reliance Agreements
If IRB reliance is requested, OPRS will consult with the IRB office at your collaborator's institution and make a mutual decision that an agreement making one IRB the “IRB of record” is appropriate.
There are two types of reliance agreements:
An external institution relies on the UIUC IRB for review and approval of a specific IRB application.
Should investigators wish to submit a request that the UIUC IRB serve as the IRB of record for a study, please complete the request form linked on the OPRS website here. A protocol application should have already been submitted to OPRS for review before a reliance request is initiated.
Important Note: UIUC requires the use of the SMART IRB reliance agreement when providing oversight. We will use information provided in the reliance request to reach out to the relying site IRB contact to convey this information and initiate the reliance process.
The University of Illinois IRB relies on an external institution’s IRB for review and approval of a specific IRB application approved by the non-Illinois IRB.
Should investigators wish to submit a request that the UIUC IRB defer oversight and rely on another IRB for oversight of a project, please complete the request form linked on the OPRS website here.
It is important to note that ancillary reviews may be required when UIUC is deferring oversight to another IRB, including but not limited to:
Conflict of Interest
HIPAA / PHI
Before proceeding to complete the reliance intake form, please be prepared to answer questions related to ancillary reviews that may apply to your study.
Questions about reliance should be directed to IRB-Reliance@illinois.edu
C- Memorandums of Understanding
The purpose of a “Memorandum of Understanding” (MOU) is to formalize an affiliation between University of Illinois and another institution that have researchers who frequently collaborate with UNIVERSITY OF ILLINOIS researchers on protocols that involve human subjects research. The MOU is established by each institution’s office for research (such as the Office for the Vice Chancellor for Research and Innovation), IRB, human subjects research office, legal counsel, etc. The difference between an MOU and an Institutional Authorization Agreement is that the MOU can be used to cover any collaborative research that includes researchers from both institutions on protocols involving human subjects research, where each IRB agrees that the MOU can be used so that one IRB will be the IRB of record (as opposed to institutional authorization agreements, which are protocol specific).
When each IRB agrees to use the MOU for the project a brief letter is sent from the institution that will use the MOU to rely on the other IRB. As with institutional authorization agreement Type 2 above, in cases where the University of Illinois IRB will rely on your collaborators IRB to be the IRB of record, University of Illinois researchers will not need to file a University of Illinois IRB application (as we will rely on the approved application at the other IRB). Conversely, when the other institution is using the MOU to rely on the Illinois IRB, then the campus researchers will need to file an IRB application and get approval.
MOU’s are relatively limited, and currently exist between University of Illinois and:
- Mayo Clinic
- National University of Singapore
- University of Illinois-Chicago
If you plan on doing research with Carle collaborators or with Carle resources, begin the collaboration process by filling out the Carle Research Services Form. Please provide documentation (email or letter) from Carle stating that the review of your Research Services Request Form is complete.