The institution defines the IRB policies and procedures; however, the
process outlined below illustrates IRB research review procedures
common to many organizations.
Research reviewed and approved by an IRB may be further reviewed by an official
of the organization and, at the discretion of the organization, may
be disapproved. However, officials of the organization may not approve
research that has been disapproved by the IRB.
- Researchers submit a project proposal to the IRB prior to initiating any research
activity. The Research Administrator assigns a number to each
research request and creates a file.
- The Research Administrator reviews the proposed research project using
a Project Analysis Worksheet to determine the applicability of
the Federal regulations that address the protection of human subjects
contained in 28 CFR Part 46, including questions concerning exemption
from the regulations and qualification for an expedited IRB review
process. Proposed research projects are classified as either (1)
subject to the Federal regulations; (2) not subject to the Federal
regulations; or (3) subject to but exempt from the Federal regulations.
If a proposed research project is subject to the Federal regulations,
the project will either qualify for an expedited review by the
IRB or require full review by the IRB.
- The Research Administrator submits a preliminary determination to
the IRB Chair for review and approval concerning the applicability
of 28 CFR Part 46.
- The Research Administrator notifies the researcher(s) in writing about
the IRB’s determination of the applicability of the Federal
regulations to the proposed research project. If necessary, the
Research Administrator will (1) schedule a review of the proposed
research project during the next meeting of the full IRB or (2)
the IRB Chair will review the proposed research project using
an expedited IRB review process. The researcher(s) will be notified
in writing as to the time and manner of IRB review.
- The Research Administrator is responsible for maintaining all records
pertaining to IRB review and approval for each proposed research
project conducted by the organization or its subcontractors or
- The Research Administrator forwards the IRB Project Monitoring Form
to the project director to be completed every three months after
the project has been approved.