When relying on an IRB approval from another institution, which document is typically required?

• A. Data and safety monitoring plan
• B. Documentation of IRB approval from another institution
• C. Research funding
• D. Informed consent forms

Answer: (B)

When a site relies on another institution’s IRB, the crucial item is the official record that the external IRB has approved the study. The external IRB approval letter (or equivalent documentation) provides the actual authorization to conduct the research at the relying site and includes details like the approved protocol, approval date, expiration, and any conditions. This document proves that oversight is in place and that the study is being conducted under an approved review.

Informed consent forms matter, but they are part of what the external IRB approves and would be aligned with that approval. Data and safety monitoring plans or funding information aren’t the specific documents that establish the external IRB oversight for relying on another institution.