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.