This section of the Investigator Manual outlines when IRB review may not be required, research that requires a protocol, research that does not require a protocol, types of applications, and institutional requirements.

Institutional Requirements

In addition to IRB review and approval, your study may require review by other entities separate from the IRB (e.g., HIPAA security review, radiation safety). Some of these reviews should be started before you submit an IRB application. See HRP 309-WORKSHEET – Ancillary Review Matrix for more information about the non-IRB requirements that may apply to your study. You may also contact the Reliance and Navigation Team (RELIANT) for assistance.