The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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IRB Meetings
Federalwide Assurance
IRB Membership
IRB Meetings
IRB Voting
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 IRB must meet at least once per year and may meet more often to review research proposals. Any Principal Investigator or IRB member may request an interim meeting, but all meetings are called at the discretion of the IRB Chair. At no point may research on a project continue if the project has not been reviewed within the preceding 365 days.

The IRB Research Administrator prepares an agenda for each meeting, provides IRB members with the minutes from the prior meeting, and distributes to IRB members all relevant documentation regarding each research project under review, including any regulations, guidance, or education materials that may assist the IRB members in evaluating the research project with respect to the protection of human subjects.

Minutes of each IRB meeting are maintained by the IRB Research Administrator and include: the time of the meeting; the names of the IRB members present; the arrival and departure of IRB members during the course of the meeting; and a comprehensive review of all the meeting discussions. Documentation must also include:
  • Copies of all research proposals reviewed.
  • Records of continuing review activities.
  • Copies of all correspondence between the IRB and the investigators.
  • Statements of significant new findings provided to the subjects.
  • Actions taken by the IRB and the votes taken on those actions.
  • The basis for requiring the investigators to make changes in research or for disapproving the research.
  • A written summary of the discussion of disputed issues and their resolution.

The IRB may develop optional research status forms for Principal Investigators. These documents assist researchers in meeting timelines and providing applicable information for IRB review and monitoring of research projects.

OPTIONAL IRB FORMS
Form Description
IRB Review Application Form Lists required materials for submission to IRB.
   
IRB Project Analysis Worksheet Details specific information about the proposed research project relative to applicability of Federal human subjects regulations. Submitted by the Principal Investigator and reviewed by the Research Administrator.
   
IRB Decision Form Indicates IRB approval, required modifications, or disapproval.
   
IRB Adverse Event Report Form Describes negative physical or psychological reaction from a research subject.
   
IRB Project Monitoring Form Documents changes or expected changes to the project as submitted to the IRB at the time of approval.

In the event of a negative reaction from a research subject, either physical or psychological, during the conduct of the research, the Principal Investigator with the IRB Administrator must file an IRB Adverse Event Report with OHRP. Regulations at 45 CFR specify "prompt" reporting which may mean reporting a more serious incident within days and a less serious incident within a few weeks. The IRB Administrator typically forwards copies of this filing to the IRB Chair, the Granting Agency, and OHRP. The IRB Chair will decide whether or not the research should continue, either through Expedited or Full IRB Review. OHRP responds to the incident report in writing and states either that the report is adequate or requests additional information.

All IRB meeting records must be retained for three years. Records relative to research approved by the IRB must be retained for three years beyond the completion of the research.

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