The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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IRB Research Review Process
Federalwide Assurance
IRB Membership
IRB Meetings
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IRB Research Review Process
Types of IRB Review
Issues Relevant to the IRB Review Process
Modificationof Amendment of the Research Project
Project Suspension or Termination
Re-certification of Research Project
Non-compliance with Human Subjects Regulations
Assurance and Educational Training
 
The institution defines the IRB policies and procedures; however, the process outlined below illustrates IRB research review procedures common to many organizations.

  1. 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.

  2. 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.

  3. The Research Administrator submits a preliminary determination to the IRB Chair for review and approval concerning the applicability of 28 CFR Part 46.

  4. 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.

  5. 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 subgrantees.

  6. 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.

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.
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