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Over the past years, research collaborations have increased across all disciplines. The term collaboration refers to not only researchers working together within the same field and institution, but also between different disciplines and institutions. These collaborations can be as simple as a sole researcher sharing information within the same lab or they can be as complex as multi-centered clinical trials that can involve academic research centers, private hospitals, and for-profit companies studying thousands of patients in different states or countries.
Guidance for Collaborative 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 FWA (Federalwide Assurance) with the DHHS 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) (See section A below) that the University of Illinois Office for the Protection of Research Subjects (OPRS) prepares and sends to them. The purpose of the Collaborating Investigator Agreement is to ensure that the collaborating investigator agrees to conduct research activities in accordance with University of Illinois policy and federal regulations. Information about these agreements is presented below.
- If your collaborator(s) are affiliated with an institution that has an IRB with an FWA (Federalwide Assurance) with the DHHS Office for Human Research Protections (OHRP) then usually they will need to obtain IRB approval from their own institution, as University of Illinois IRB approval only covers Illinois students, faculty or staff. The exception is when the IRB’s at both institutions mutually agree that one institution may serve as the IRB of record. In that case an Institutional Authorization Agreement (See section B below) can be established. Information about these agreements is presented below.
- If your collaborator is at one of a very small number of institutions who frequently collaborate with Urbana-Champaign campus researchers to the point that a formal Memorandum of Understanding (MOU) has been established (such as the University of Illinois-Chicago or Carle) then the MOU can potentially be used to allow one IRB to serve as the IRB of record. More information about Memorandums of Understanding is provided below (See section C below).
IMPORTANT NOTE: if the study can be approved using an allowable exemption category then you may just add the non-University of Illinois unaffiliated investigator to your Research Team Form, and there will be no need for a formal Collaborating Investigator Agreement or an Institutional Authorization Agreement (unless your collaborator’s institution requires a formal institutional authorization agreement for exempt research; the Urbana Campus IRB does not have such a requirement)
To view guidance from the DHHS Office for Human Research Protections on collaborative research see:
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.
- 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 following Graduate College policy (http://www.grad.illinois.edu/leavepolicies) 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- Institutional Authorization Agreements
When we receive an IRB application that indicates there is a co-investigator from another institution that has a Federalwide Assurance with OHRP (or a research amendment to an approved application adding such a collaborator is submitted), it is our policy to require written documentation of IRB approval from your collaborator’s IRB. In these cases you may obtain University of Illinois IRB approval before your collaborator’s IRB approval is obtained, but you must submit a copy of their IRB approval letter before they can engage in human subjects research activities related to your approved protocol.
An exception to this policy is made on a case-by-case basis by the Urbana-Champaign Office for the Protection of Research Subjects (with input from the IRB as necessary). We consult with the IRB office at your collaborators institution and make a mutual decision that an Institutional Authorization Agreement that makes one IRB the “IRB of record” is appropriate. An Institutional Authorization Agreement is a written agreement between two federally assured institutions which allows the IRB of one institution to rely on the IRB review and approval of the other for a specific research study. In these cases, researchers at the institution with the IRB that will be the IRB of record obtain formal IRB approval, while those at the other institution will rely on the institutional authorization agreement (rather than being required to file an IRB application at their own institution).
There are two types of Institutional Authorization Agreements
An external institution relies on the University of Illinois IRB for review and approval of a specific IRB application. Our IRB office consults with the respective office of the other institution and makes a decision as to whether this agreement is appropriate.
Procedures for when an external institution agrees to rely on the University of Illinois IRB to the IRB of record:
- The first step for Illinois researchers is to add any non-University of Illinois collaborators to your Research Team Form, supplying their contact and CITI training information.
- If we receive an IRB application that lists a co-investigator from another institution on the Research Team Attachment, OPRS reviewers will request (in the initial pre-review) that the RPI submit IRB approval from the co-investigator’s institution.
- However, if the University of Illinois RPI (Responsible Project Investigator) indicates that the co-investigator’s institution has asked about the possibility of an Institutional Authorization Agreement, OPRS staff will check OHRP’s FWA website to see if that institution has a current Federalwide Assurance.
- If the other institution does not have an FWA, the procedures for establishing an Individual Investigator Agreement will be followed.
- If the other institution does have an FWA, OPRS staff will consult with the OPRS Director to determine whether an Institutional Authorization Agreement is appropriate.
- In making our determination, major considerations include 1) the funding source, 2) the role of the non-University of Illinois collaborator 3) the ability of the University of Illinois IRB to oversee the co-investigator’s activities and 4) the willingness of the co-investigator’s IRB to enter into such an agreement.
- Once it is determined that an institutional authorization agreement is appropriate and that the Illinois IRB will be willing to be the IRB of record, ORPS staff will send a copy of our Institutional Authorization Agreement form (this is a standard template approved by University of Illinois Legal Counsel for this situation) to the appropriate person (e.g., IRB Office director or equivalent) at the other institution for signature by their Institutional Official(s).
- When the signed copies are returned, they are routed by OPRS staff for signature by University of Illinois’s institutional officials (currently the Vice Chancellor for Research and the University Comptroller).
- OPRS will forward a copy of the fully executed Institutional Authorization Agreement to your collaborator’s IRB, the University of Illinois RPI, the collaborator, and the Office of Sponsored Programs. A physical copy is placed in the file and the existence of an institutional authorization agreement is noted in the OPRS online protocol tracker system.
Note: The formalization of the Institutional Authorization Agreement can coincide with the final stage of the pre-review and of the IRB review. However, an initial approval letter will not be sent to the University of Illinois researchers until the institutional authorization agreement is fully executed. For research amendments to approved studies (when Illinois researchers are adding non-campus collaborators <after> initial IRB approval), the amendment approval letter will not be sent to the Urbana-Champaign campus researchers until the institutional authorization agreement is fully executed.
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. Our Office for the Protection of Research Subjects staff consults with the respective office of the other institution and makes a decision as to whether this agreement is appropriate.
Procedures for when the campus IRB agrees to rely on an external institution’s IRB to be the IRB of record are as follows:
- Most typically, when Urbana-Champaign campus researchers ask whether the University of Illinois IRB/Office for the Protection of Research Subjects would be willing to rely on the IRB of another institution to be the IRB of record, they do so prior to submitting a formal Illinois IRB application. However OPRS staff may also, upon receipt of an IRB application where it appears that Illinois researchers have a limited role, suggest that an institutional authorization agreement might be appropriate.
- When relying on your collaborator’s institution to be the IRB of record might be appropriate, OPRS staff check the OHRP website to see if that institution has a current Federalwide Assurance.
- If the other institution does not have an FWA, see the procedures for the Individual Investigator Agreement. In that case the UNIVERSITY OF ILLINOIS researchers will need to file a University of Illinois IRB application.
- If the other institution does have an FWA, ORPS staff will consult with the OPRS Director and/or IRB chair to determine whether relying on the other IRB is appropriate.
- When it is appropriate, OPRS staff will consult with staff at the non-Illinois collaborator’s IRB. If the non-Illinois IRB agrees that University of Illinois can rely on them to be the IRB of record, the other institution typically initiates the paperwork, using their own authorization agreement template or the Institutional Authorization Agreement available from OHRP.
- Once the other institution’s authorization agreement form is received, it is routed by OPRS staff for signature from UNIVERSITY OF ILLINOIS’s institutional officials (currently the Vice Chancellor for Research and the University Comptroller).
- Once signed by University of Illinois institutional officials, it is sent to the IRB office of the other institution for signature of their institutional official(s).
- Once the fully executed agreement is returned, OPRS will forward a copy of the fully executed Institutional Authorization Agreement to the University of Illinois RPI, the collaborator, and the Office of Sponsored Programs. A physical copy is placed in the IRB application file (when such exists) and the existence of an institutional authorization agreement is noted in the OPRS online protocol tracker system As mentioned, typically when UNIVERSITY OF ILLINOIS relies on the other institution’s IRB, Urbana-Champaign researchers won’t need to file a Illinois IRB application. In that case the fully executed institutional authorization agreement is simply filed with similar agreements at OPRS.
IMPORTANT NOTE All requests for Institutional Authorization Agreements (IAAs) are reviewed on a case-by-case basis. The Illinois IRB will typically not rely on the collaborator's IRB as IRB of record if Illinois researchers actively engage in recruitment, consent, and/or data collection. The Illinois IRB will often agree to rely on the other IRB as IRB of record when the Illinois researcher's role is limited to data analysis and/or other consultation activities that do not require active engagement with human subjects. Please click here for more information on institutional engagement in research.
The University of Illinois will not rely on other IRBs to be IRB of record when the other institution does not have a Federalwide Assurance (FWA) with OHRP.
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 our Vice Chancellor for Research Office), 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