Submitting to an Internal vs. External Institutional Review Board

What is the difference between internal and external institutional review boards?

An internal, or local, Institutional Review Board (IRB) is the institution’s IRB, or the Hackensack Meridian Health IRB (HIRB). It is a system-wide institutional review board that only reviews research that is being conducted within the network. An external IRB is an institutional review board that is an outside entity. It is also referred to as a central or commercial IRB. These types of IRBs work with many research programs and institutions. Some examples of external IRBs include Western IRB (WIRB) or Central IRB (CIRB).

How is it determined whether a study will go to an external or internal IRB?

If the study is supported by a commercial sponsor/pharmaceutical company, they generally require a central/commercial IRB to review the study on behalf of all the sites involved. Additionally, due to the changes to the Common Rule (the federal regulations governing human subjects research), if a multi-site study receives federal funding, then a single IRB of Record is required. The Research Integrity Office has Master IRB Reliance Agreements (agreements detailing how one IRB can relinquish jurisdiction to another IRB) in place with several central/commercial IRBs.

How are the processes different? What does the PI have to do differently?

Initially, the process is the same regardless of which IRB serves as the IRB of record. In both cases, the PI will need to complete a new submission through the local IRB system. If the PI is utilizing an external IRB, the application through the local system will be abbreviated and will be in addition to the external application. The PI will need to provide the local IRB with the approval documents once received from the external IRB. In addition, it is necessary to utilize the IRB of record’s ICF and add in local content information such as injury language, local contact information, confidentiality language, and disclosure of financial conflict of interest.