There are three mechanisms to formalize a relationship among separate IRBs: Reliance Agreements (also known as Institutional Authorization Agreements), Letters of Acceptance of an Exemption Determination, or Individual Investigator Agreements. These agreements or letters allow for collaborative research with human subjects to take place with appropriate IRB oversight — without undue burden on researchers and IRB staff.
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 this PDF tutorial — with screenshots and step-by-step instructions.
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 the research is called the “IRB of Record.” The IRB that does not review the research and relies on another IRB 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 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, location of research efforts, IRB expertise, and funding when determining which IRB will serve as the IRB of Record.
Request a Reliance Agreement: When the NC State IRB is Relying on Another IRB
Reliance Agreement Requests are processed via the eIRB system. When submitting the request, be sure to provide all the necessary documentation, such as the reliance agreement request form, proof of training, site context forms, COI attestations, and information regarding ancillary reviews.
When the application is finalized, the NC State University IRB will provide a “Site Context Approval Letter” that you can keep for your records or provide to the reviewing IRB. Once the agreement is fully executed it will be uploaded to the eIRB for record-keeping purposes. If you need assistance, please email the NC State IRB office at email@example.com.
Request a Reliance Agreement: When NC State is the Reviewing IRB and Providing Oversight for Other Researchers at Different Institutions
Reliance Agreement Requests are processed via the eIRB system. When submitting the request, be sure to provide all the necessary documentation, such as the reliance agreement request form, proof of training for all collaborating researchers, completed site context forms from other institutions, COI attestations form collaborating researchers, and information regarding necessary ancillary reviews from other sites.
When the application is finalized, the NC State University IRB will provide an “Approval Letter” that you can keep for your records or provide to the relying IRB. Additionally, an executed reliance agreement will be uploaded to the eIRB for recordkeeping purposes. If you need assistance, please email the NC State IRB office at firstname.lastname@example.org.
Letters of Acceptance of Exemption Determinations
If an IRB determines that a study is exempt from the 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 burden, if all research procedures are approved by another IRB — and it is clear in the approved protocol that an NC State 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 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.
Request a Letter of Acceptance for an Exemption Determination
Exemption Determination Requests are processed via the eIRB system. When submitting the request, be sure to provide all the necessary documentation, such as the exemption determination request form and proof of training.
When the application is finalized, the NC State University IRB will provide a “Letter of Acceptance of an Exemption Determination” that you can keep for your records. If you need assistance, please email the NC State IRB office at email@example.com.
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 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.
Request an Individual Investigator Agreement
Individual Investigator Agreement Request are processed via the eIRB system. When submitting the request, be sure to provide all the necessary documentation, such as the agreement request form, training attestation and COI attestations.
When the application is finalized, the NC State University IRB will provide an executed individual investigator agreement and it will be uploaded to the eIRB for record-keeping purposes.
If you need assistance, please email the NC State IRB office at firstname.lastname@example.org.
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.
Selecting a single IRB, applicants should discuss this with their IRB. Specifically, topics such as:
- The history and experience of the IRB
- 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 NC State 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 email@example.com 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 IRB Office at 919.515.7515 or email firstname.lastname@example.org.
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 involving invasive procedures; studies requiring an IDE/IND with the FDA; some large-scale multisite/multicenter studies; studies using a drug or biologic; and some other rare cases. For studies that are sponsored, the use of this IRB must be budgeted for in the funding application.
- NIH Grants and the IRB
- Policy and SOP for BME IRB Review and Approval
- BME Study Submission or Update
- Individual Investigator Information about Training Requirements
- Multisite Study Checklist