Cooperative Research

How it Works at NC State

There are three mechanisms to formalize a relationship among separate IRBs: reliance agreements (also known as institutional authorization agreements), letters of acceptance of exemption determinations, or individual investigator agreements. These agreements allow for collaborative research with human subjects to take place with appropriate IRB oversight — without undue burden on researchers and IRB staff. 

Once you know which of these three mechanisms you should use, you’ll need to fill out the cooperative research agreement request form appropriately and then submit a request via the eIRB system.

For further instructions, please refer to the cooperative research screenshot tutorial.

Reliance Agreements

A reliance agreement (sometimes called “institutional authorization agreement” or “IAA”) is a contract that allows one IRB to rely on another IRB for protocol review and oversight. 

The IRB that reviews and approves a cooperative research project and provides oversight for other researchers at different institutions is called the “IRB of Record.” The IRB(s) that do not review the cooperative research project because they rely on the IRB of Record to review the project is called the “Relying IRB.” 

Reliance agreements are typically implemented for research with human subjects that requires review at the expedited or convened full board level. In rare cases, these may be completed for exemptions. NC State University does not require a reliance agreement for exemptions but will enact one if a partnering IRB requires it.

Reliance agreements save research teams the undue burden of undergoing protocol review and approval from multiple institutions for the same study — while ensuring consistent protections for human subjects. With an institutional authorization agreement, it’s expected that all researchers implement the procedures that were reviewed and approved by the IRB of Record noted in the reliance agreement and approved IRB protocol. 

The IRBs involved in cooperative research consider the roles and responsibilities of researchers, the location of research efforts, IRB expertise, and funding when determining which IRB will serve as the IRB of Record.

Letters of Acceptance of Exemption Determinations

If an IRB determines that a study is exempt from federal regulations, it typically does not enter into a formal reliance agreement as described above. This often leads to both IRBs reviewing and approving the same exempt project. To reduce the burden, if all research procedures are approved by another IRB — and it is clear in the approved protocol that an NC State University researcher is involved with the project — then instead of the NC State IRB re-reviewing the same protocol, we will provide the NC State researcher with a letter stating that the NC State IRB accepts the exemption determination from the other institution. This is only used if all procedures that the NC State researcher completes have been reviewed and approved by the collaborating IRB — and there are no differences. 

When the NC State University IRB provides this letter, it is only considered IRB approval for the NC State researcher and is not applicable to anyone not listed on the letter. If the NC State researcher’s roles and responsibilities change, they must immediately contact the NC State IRB before doing any unapproved activities. This is considered NC State relying on another IRB’s review and approval — but it is not executed through a formal reliance agreement. 

Individual Investigator Agreements

For NC State University researchers who want to involve research team members or other investigators who are not affiliated with an IRB, NC State may choose to enact an individual investigator agreement. This agreement allows NC State’s IRB to provide oversight for the unaffiliated researcher because, through this agreement, the unaffiliated researcher agrees to the rules and regulations set forth by NC State. In order for this to occur, the individual investigator must read through and sign the agreement; complete appropriate human subjects research training; enact the research protocol as approved by the IRB; and follow all federal laws and NC State University regulations and policies. An individual investigator agreement is not appropriate for individuals affiliated with an institution that has an IRB with an FWA number.

Discussing IRB Approval and Cooperative Research at the Funding Proposal Stage

Many funding agencies ask about IRB approval in the grant application. When completing a grant application for multi-site research, the researcher must describe the sIRB/IRB cooperative research arrangements — including which institution will act as the lead site (i.e., the IRB of Record). Any of the participating sites may serve as the IRB of Record — so long as it is registered with the Office for Human Research Protections (OHRP) and has the expertise necessary to review the proposed research.

In selecting a single IRB, applicants should discuss this with their IRB. Specifically, topics such as: 

• The history and experience of the IRB to review the research.
• The IRB’s capacity to serve as the IRB of Record for the particular protocol. 
• A private IRB or another qualified IRB may be proposed — but information about who will pay for this private review must be addressed in the budget for a single IRB review.

Sites should agree to a single IRB arrangement prior to the submission of an application or proposal. If you want the NC State University IRB to serve as the IRB of Record, you must check with the NC State IRB office before putting this information in a grant application. Contact irb-coordinator-admin@ncsu.edu to ensure it is appropriate for the NC State IRB to serve as the IRB of Record. Additionally, you must check with the other sites to ensure they will rely on the review and approval of the selected reviewing IRB. 

The grant applicant should indicate the participating sites’ willingness to rely on the selected single IRB in the single IRB plan. The IRB can provide an official letter to submit with the grant application, indicating a willingness to serve as the IRB of record or rely on the reviewing IRB. This should occur before grant application submission.  

If you need assistance regarding cooperative research, reliance agreements, or the Single IRB policy, please contact the NC State University IRB office at 919.515.7515 or email irb-coordinator-admin@ncsu.edu.

Special Exceptions

NC State and UNC-Chapel Hill’s Joint Department of Biomedical Engineering

The uniquely collaborative nature of NC State University and UNC-Chapel Hill’s Joint Department of Biomedical Engineering adds complexities to compliance review for research endeavors. Either UNC-CH or NC State’s IRB can serve as the IRB of Record for human subjects research that takes place within this department. Faculty in the Joint Department of Biomedical Engineering (BME) should identify their “home” institution (i.e., where their paycheck comes from) and utilize that IRB as the IRB of Record. All studies involving researchers who are faculty, staff, or students at either university require a reliance agreement. 

Use of the WCG Private IRB

NC State University has partnered with the WCG IRB. In very rare cases at NC State, the NC State IRB will allow studies to be reviewed and approved by the WCG IRB when NC State should be the reviewing IRB. The use of this private IRB is for studies where a research team member is an agent of NC State University,  acting within the scope of their role, and the study involves invasive procedures,  requires an IDE/IND with the FDA, may be a large-scale multisite/multicenter study, uses a drug or biologic, or in some other rare cases. For studies that are sponsored, the use of this IRB must be budgeted for in the funding application. Please refer to the NC State IRB Unit Standard on NCSU Researchers’ Use of a Private IRB for further details on when a private IRB is appropriate and to the WCG IRB Request Form that must be submitted to the IRB office.

If an investigator is engaging in outside research for another entity and there is no NC State University involvement, the NC State University IRB cannot serve as the IRB of record (reviewing IRB). This includes when an NC State person is serving as an investigator and completing human subjects’ work as a part of their “Start-Up,” or other External Professional Activities for Pay. For faculty innovators and NC State Start-Up companies, please refer to the NC State Office of Research Commercialization for additional information.

Guidance

• NIH Grants and the IRB
• NC State IRB Review and Approval for Research Involving Human Subjects from the Joint Department of Biomedical Engineering (BME)
• BME Study Submission or Update Checklist
• Individual Investigator Information about Training Requirements
• Multisite Study Checklist

Forms and Templates

• BME Procedures Template
• Reliance and Individual Investigator Agreement Request Form
• Reliance Agreement Conflict of Interests (COI) Attestation Form
• Individual Investigator Training Completion and Affirmation Form
• Reliance Agreement Site Context Worksheet
• Medical Devices Used in Research Form