Cornell University (CU) researchers often engage in collaborative research with individuals and organizations external to the university. In many cases, agreements between collaborators are necessary and must be in place before research with human subjects may begin. This page provides guidance on the most common agreements used in collaborative research and links to additional resources.
Note 1: Before you begin the process of seeking IRB approval for multi-site or collaborative research, please contact the IRB office to help determine whether a reliance agreement is necessary for your specific collaboration. In some cases, not all collaborators will be considered engaged in the human subject research, which means multiple IRB reviews or a reliance agreement may not be required.
Note 2: Because Cornell University and Weill Cornell Medicine IRBs retain different registrations and federal-wide assurances with the U.S. federal government, collaborations across campuses are considered collaborative/multi-site. See more details below.
Table of Contents
- Key Terms
- How do I determine if a Reliance Agreement is necessary?
- How do I request a Reliance Agreement?
- What is SMART IRB and how does it work?
- How else can I establish reliance? (IRB Authorization Agreement)
- What if my collaborator is not affiliated with a research institution? (Individual Investigator Agreement)
- What else should I know about reliance (e.g., review level, local context, training, etc.)?
- How do I handle Cornell-Ithaca or Cornell Tech collaborations with Weill Cornell Medicine (WCM)?
Key Terms
| Term | Description |
|---|---|
| Collaborative (aka cooperative) research | Involves investigators from two or more institutions working together to conduct a research project. Different research activities can occur at different sites, or the study can be conducted at a single site and involve personnel from multiple institutions. Examples: a) Cornell and University of Rochester faculty members conduct an experiment together on Cornell's Ithaca campus, or b) samples are collected by a Cornell researcher while analyses are conducted by the U of R collaborator at her home lab. |
| Multi-site research | Multi-site studies use the same research procedures carried out at multiple locations. The protocols across sites are identical except for variations due to local context considerations. Example: Cornell's Ithaca campus is one of several participating sites in a clinical trial, where each site enrolls participants and collects data. |
| Reliance Agreement (aka Authorization Agreement) | A formal agreement between two or more institutions involved in the same human subjects research project. This agreement allows one institution to rely on the other institution’s IRB for review. A Reliance Agreement outlines the respective authorities, roles, responsibilities, and communication protocols between the institutions, helping to prevent duplicate reviews and regulatory oversight. These agreements can apply to individual studies, categories of studies, or all human subjects research under an institution's Federalwide Assurance (FWA). |
| Relying IRB | Under a Reliance Agreement, the IRB that is ceding responsibility for IRB review and oversight to a Reviewing IRB. |
| Reviewing IRB (aka IRB of Record or Single IRB/sIRB) | Under a Reliance Agreement, the IRB that is responsible for IRB review and oversight of a collaborative or multi-site human subjects research project. |
How do I determine if a Reliance Agreement is necessary?
A Reliance Agreement may be necessary when collaborating with external researchers engaged in non-exempt human subjects research. Generally, an institution is considered engaged in non-exempt human subjects research if its employees or agents, for the purposes of the research, obtain:
- data about the subjects through intervention or interaction;
- identifiable private information about the subjects; or
- the informed consent of human subjects for the research.
If you and an external collaborator are engaged in human subject research, a reliance agreement may be required to define the roles, responsibilities, and oversight between institutions.
Receiving a direct federal award to support human subjects research also engages the recipient institution, even if all human subjects activities are carried out by agents or employees of another institution (e.g., if Cornell is the primary recipient of a federal award, with a subaward to Penn State where collaborators will conduct all human subjects research activities).
In most cases, federally-funded, collaborative human subjects research projects taking place in the U.S. must operate under a single IRB, with Reliance Agreements implemented to establish the relying/reviewing relationships. For projects funded by other means, a Reliance Agreement may be useful, but not required from a regulatory perspective.
Note: The Cornell IRB is not always equipped to serve as the sIRB/Reviewing IRB, depending upon the specifics of the research. Researchers should contact the Cornell IRB office prior to submitting a proposal to NIH or any other federal agency for a multi-site project. The IRB staff will assist PIs with identifying a suitable partner to act as the sIRB (e.g., BRANY), if Cornell is unable to serve in that capacity.
How do I request a Reliance Agreement?
- Researchers requesting Cornell to serve as the Reviewing IRB should create a regular IRB protocol in RASS-IRB, and indicate this ‘ask’ in the Review Type Determination section of their IRB protocol application.
- Researchers requesting to rely on the IRB of another institution must submit a reliance request through Cornell’s IRB Protocol Management System (RASS-IRB). Use this link to create the reliance request application and refer to this link for instructions on how to do so.
- If a reliance request is initiated after the Reviewing IRB has approved the study, the addition of sites and/or collaborators will need to be specifically reviewed and approved, typically through an amendment to the existing study.
- Cornell can also accept reliance requests when the reviewing IRB has not yet approved the study; however, the reliance agreement will not be finalized until all required approvals are in place. In these cases, investigators are encouraged to reach out to our office early to coordinate the process and ensure the appropriate review pathway is followed.
Note: The reliance arrangement must be executed either using SMART IRB or an IRB Authorization Agreement (IAA). Please refer to the following sections for additional information about these options.
What is SMART IRB and how does it work?
SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is a platform designed to ease common challenges associated with initiating multi-site research.
Note: SMART IRB is not an actual IRB that provides regulatory approval. Instead, the SMART IRB provides a roadmap for institutions to implement federal Single IRB Review requirements. Through a flexible IRB Reliance Agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across research institutions.
Cornell University (CU) is a participating institution in SMART IRB. Using the SMART IRB Agreement as the "Reliance Agreement" for a collaborative/multi-site research project is an option if the other engaged institutions also participate in SMART IRB. The decision to use the SMART IRB Agreement is then made on a study-by-study basis by each participating institution, through negotiation between their IRB/Human Research Compliance offices.
Please contact irb-reliance@cornell.edu to discuss use of SMART IRB for your collaborative project.
After initiating the reliance request in RASS IRB, if the collaborating researchers belong to participating institutions, the SMART IRB agreement can be used to establish reliance on a single IRB. The use of SMART IRB to establish reliance can be documented either through a Letter of Acknowledgement or the SMART IRB Online Reliance System. IRB/Human Research Compliance staff will facilitate this process.
The SMART IRB Letter of Acknowledgement (LOA) allows research teams to utilize a paper or electronic document to execute reliance agreements under the terms of the SMART IRB Agreement. This document follows a similar process as other types of reliance agreements. Each site will need to sign a separate LOA with the proposed Reviewing IRB.
Each institution that participates in SMART IRB typically has their own preferred LOA template. Whichever site is the proposed Reviewing IRB will often request their template be used. The Cornell template contains signatures lines per our local process and we request signature lines be added to any SMART IRB LOA template used to establish reliance between Cornell and another institution.
The SMART IRB online reliance system allows research teams to submit an electronic request to execute reliance under the terms of the SMART IRB Reliance Agreement. The request is typically initiated by the lead study team whose IRB will be serving as the Reviewing IRB for all sites.
Note: The Cornell IRB does not use the SMART IRB online tracking system to document reliance when we are the Reviewing IRB, but we will use the system to confirm reliance on another IRB when that Reviewing IRB uses the SMART system for their documentation purposes. Cornell documents reliance in RASS-IRB.
Reliance decisions using SMART IRB apply only to the determination of reliance and do not constitute IRB approval for the research project itself. Approval for each collaborating institution’s involvement in the research project must be obtained from the Reviewing IRB before beginning research at that site or with its collaborators.
If the reliance request is initiated after the Reviewing IRB has approved the study, the addition of sites and/or collaborators will need to be specifically reviewed and approved, typically through an amendment to the Reviewing IRB’s protocol.
IREx is the IRB Reliance Exchange, a web-based portal for documentation and coordination for multi-site clinical trials. It operates similarly to the SMART IRB online system, but reliance relationships use the SMART IRB Reliance Agreement rather than a separate IREx agreement.
Note: While Cornell is registered as a participating institution with IREx, it is not our preferred method of documenting reliance. If a Reviewing IRB only uses IREx to document reliance, we may be able to oblige, but please contact our office first to confirm.
How else can I establish reliance? (IRB Authorization Agreement)
What is an IRB Authorization Agreement (IAA)?
If the non-Cornell institution(s) engaged in research do not participate in SMART IRB or prefer to use an alternate or study-specific agreement in its place, an IRB Authorization Agreement (IAA) can be executed to establish reliance. Cornell IRB staff will work with the research team to create this documentation. An IAA must be signed by the IRB signatory official at each institution; this will be managed by IRB/HRP staff.
What if my collaborator is not affiliated with a research institution? (Individual Investigator Agreement)
An Individual Investigator Agreement (IIA) is a formal written agreement between an institution conducting research and an independent, external investigator who is collaborating on the research. This type of agreement is used when the external investigator is engaged in human subject research, and their work is not being performed as an agent of an institution with its own Federal Wide Assurance (FWA). Through the IIA, the institution agrees to extend its FWA) to cover the independent investigator for their involvement in the human subject research activities. The agreement is signed by the independent investigator and the institution’s IRB signatory official.
At Cornell, we use IIAs in rare cases, and only for non-exempt research projects. The IRB staff will assist with this documentation.
If you believe an Individual Investigator Agreement is appropriate for your human subjects research project, when adding the external researcher to your IRB protocoln, please make clear that they are unaffiliated with a research institution with its own FWA, or clarify how their involvement in this project is not being conducted on behalf of their home institution. You can look up whether an institution has an FWA on the OHRP FWA database.
What else should I know about reliance (e.g., review level, local context, training, etc.)?
Cornell restricts Reliance Agreements and Individual Investigator Agreements to non-exempt human subjects research, unless a study requires Limited Review under applicable exemption categories. Each institution must follow its own practices for exemptions. If you are joining a research project that has already been deemed exempt by another IRB, you will likely need to submit a protocol application to Cornell for an exemption determination. Please reach out to our IRB office for further guidance
When Cornell is acting as the Reviewing IRB, Cornell's training requirements apply. Likewise, if another institution is reviewing your project, you will need to comply with that institution's training requirements. Note that Weill and Cornell's Ithaca campuses have different training requirements; If Weill is providing IRB review for your study, you will need to complete training in Good Clinical Practice in addition to human subjects training.
When Cornell cedes IRB review to another institution's IRB, the Cornell PI is still responsible for ensuring compliance with other university requirements at their site, including appropriate submission and completion of any ancillary reviews such as Conflicts of Interest (COI), Environment, Health and Safety (EHS) andInstitutional Biosafety Committee (IBC).
For multi-site or collaborative research projects, the Reviewing IRB will often require the Relying Site to complete a local context form, which provides information about that institution and its local context, as it pertains to human subjects research.
Under the revised (2018) Common Rule, federally-funded, multi-institution studies--with very few exceptions--are required to use a single IRB (sIRB) for review and approval of cooperative studies conducted in the United States. This applies to all cooperative research applications and contract proposals submitted on or after January 20, 2020.
For NIH-supported studies, a version of the sIRB requirement has been in effect since January 2018. For applications submitted on or after January 25, 2018, NIH-funded multi-site studies involving non-exempt research must use an sIRB, when the same protocol is used at multiple domestic study sites. Since implementation of the Common Rule Cooperative Research requirement in January 2020, though, all NIH-supported projects must comply with the Common Rule’s requirement, which is more expansive than NIH’s.
How do I handle Cornell-Ithaca or Cornell Tech collaborations with Weill Cornell Medicine (WCM)?
Cornell University includes both the Ithaca-based campuses (Ithaca, Geneva and Cornell Tech campus) and the Weill Cornell Medicine Campus (“WCM”). The Ithaca-based campuses and WCM operate separate IRBs and maintain separate Federal Wide Assurances (FWAs) with the U.S. Department of Health and Human Services; however, an umbrella reliance agreement has been put in place between the IRBs to facilitate the timely, streamlined review of research collaborations spanning the campuses.
Documentation of use of this umbrella agreement requires submissions to both the Cornell-Ithaca and WCM IRBs.
- We strongly recommend you reach out to our office before you begin this process.
- To request reliance on WCM, a Cornell investigator from the Ithaca or Tech campus must initiate a request for IRB reliance through the Cornell IRB Protocol Management System(RASS-IRB) - see this how-to guide for instructions.
- For collaborative Ithaca/Tech-WCM human subjects research where the Ithaca-based Cornell IRB will be the Reviewing IRB—submission and documentation with the WCM IRB is required for the WCM-based collaborator(s), as well. See more details on the WCM Human Research Protections website.