700-1-IRB Standard Operating Procedures
| Title: |
IRB Standard Operating Procedures |
| Owner: |
IRB |
| Last Update/Revised: |
05/01/2024 |
Policy: The Institutional Review Board (IRB) at United States University (USU) functions independently. This authority is granted through federal regulations governing human subjects research and USU Administration through the Institutional Official.
The IRB is registered with OHRP and maintains an active Federal Wide Assurance (FWA). The IRB applies 45 CFR 46 whenever USU is engaged in research with human subjects, regardless of whether the research is conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule).
Research that is not federally funded, supported or otherwise subject to federal oversight, and that is outside of the FWA is subject to commensurate protections by the USU IRB except where otherwise described in USU IRB policy (see 700-20: Non-Federally Funded Research).
USU’s IRB applies the standards of the HIPAA Privacy Rule (located at 45 CFR Part 160 and Subparts A and E of Part 164) to research that involves the use of protected health information.
The IRB maintains a Standard Operating Procedures (SOP) Manual that details IRB-specific policies and procedures (the manual is section 700 of the USU Policy and Procedure Manual). IRB procedures specific to investigators (including doctoral students) can be found in the IRB Handbooks.
Purpose: Policies and procedures related to the IRB at USU are published in the IRB Standard Operating Procedures (SOP) Manual (section 700 of the USU Policy and Procedure Manual). Information specific to investigators (including doctoral students) is published in IRB Handbooks. These documents ensure that the rights and welfare of human research subjects are overseen and protected uniformly.
Scope: This policy applies to the USU IRB.
Documents and Forms:
IRB Handbook - Doctoral Student Edition
IRB Handbook - Faculty & Staff Edition