The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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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
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All proposed research projects involving human subjects and supported directly or indirectly by Federal funding must be reviewed by the IRB prior to beginning any research efforts. IRB review can adopt a number of different forms, depending on the phase of the research project and the nature of the activity.

TYPE OF REVIEW PROCESS/ PROCEDURES REVIEW PHASE
Preliminary Review The IRB Chair and IRB Research Administrator review the proposed research project to determine whether the regulations contained in 28 CFR Part 46 apply. Prior to any Initial Board Review
Exempt Review During or immediately after the preliminary review, the IRB Chair and IRB Research Administrator review the proposed research project to determine whether the research meets the criteria of low risk research and is within one of the categories of exempt research as defined by the Common Rule. During or Immediately After Preliminary Review
Expedited Review Only the IRB Chair and the Research Administrator review a proposed research project when the project presents only minimal risk to the human subjects or an ongoing project when any change in the research project presents only minimal risk to the human subjects.

After the Preliminary Review

· New research project where risk to human subjects is minimal or non-existent (the project must be subjected to Full Review within one year)

· Ongoing research project involving human subjects requires modification or amendment and risk to human subjects is minimal or non-existent

Full Review The full IRB reviews the proposed research project.

After the Preliminary Review

· New Research project involving human subjects is proposed and risks to subjects are not minimal.

· Ongoing research project involving human subjects requires modification or amendment and risk to human subjects is not minimal.

· Annual Re-certification review.

Re-certification Review The full IRB reviews the research project, if non-exempt. At Least Once Yearly

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