IRB Approval Requirements
Module Six: IRB Approval Requirements for Human Subjects Research
Overview of IRB Approval
Module six focuses on the requirements for Institutional Review Board (IRB) approval for projects involving human subjects research.
IRB approval is mandated for any grant applications that include plans to conduct research involving human subjects.
Role of the IRB
The IRB serves as an Objective Oversight Committee.
Governed by TCSPP's federal wide assurance, which requires annual renewal based on compliance with federal regulations.
The primary purpose of the IRB is to
Protect the welfare and rights of human participants,
Manage risks associated with their involvement in research.
These regulations are applicable to all research involving human subjects, irrespective of the funding sources or types of activities involved.
Importance of Time Management in the IRB Process
TCSPP faculty and staff must allow sufficient time for the IRB review process.
Delays may occur due to
Concerns or questions raised by reviewers.
Proposals may be returned to the applicant for
Minor clarifications or
Major changes that need to be addressed.
It is advisable to manage time effectively and anticipate potential delays in the IRB process.
Initial Steps for Initiating the IRB Process
Review the TCSPP IRB webpage:
Contains crucial information to help navigate the IRB review process.
Required Training and Documentation
Complete the City Human Subjects Protection Training course.
Create an IRB user profile.
Review the PI User Guide for additional guidance.
Note that the entire preparation process may take up to six weeks, suggesting the need for early planning.
Additional Resources and Contact Information
A graphic is provided which outlines the IRB process specific to the Chicago School.
For further information or assistance, individuals are encouraged to
Contact a member of the IRB team for support and clarification.