External Collaboration

All investigators on the study team must be covered by an IRB approval regardless of their affiliation with NKU. However, study team members who do not meet the Office of Human Research Protections (OHRP) definition of “engagement” do not need to be added to the protocol. Individuals who are engaged may be obtaining informed consent, directly collecting data from participants or have access to data that contains identifiable information. If an individual is only analyzing de-identified data, they do not need to be added to the IRB protocol.

There is a mechanism in place for one IRB to defer oversight to another (also called a reliance agreement).  This reduces the need for multiple IRBs to review a single study. 

There are three options for ensuring that researchers from multiple institutions are covered by an IRB approval for a single study:

1. The NKU IRB can accept responsibility for oversight of the research study (also known as the "reviewing" IRB).

2. The NKU IRB can rely on an external institution's IRB (also known as the "relying" IRB).

3. Each institution can oversee the research separately.

The NKU PI completes an application in Mentor IRB. On the protocol submission page in Mentor IRB, the PI should answer “Yes” for the question “Is another institution requesting that NKU act as the IRB of record?” The PI will be prompted to answer various questions related to the external site within the application sections.

The NKU PI submits an abbreviated study in Mentor IRB.

On the protocol submission page, the PI should only answer the following:

• Enter the protocol title.
• Enter the project start date.
• Select “Delegate to an External IRB” in the “Review Type”.
• Answer questions under the “Delegated to External IRB Questions” gray bar.
• Upload the study protocol submitted to the IRB of record.
• Upload the approval letter from the IRB that will serve as the IRB of record.
• Click “Save”.

Once a reliance agreement is in place, researchers are responsible for ensuring that all IRBs have the same documentation. If NKU is the IRB of record, the NKU approval notice and approved documents should be submitted to the external IRB(s) by the external collaborator(s). If NKU is deferring oversight to an outside IRB, the NKU PI is responsible for ensuring that the NKU IRB has all study documents, approvals, continuing reviews, revisions, etc. related to the project.