Collaborating with an External Researcher? 

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