Amendment/Changes to IRB Approved Research

Amendment/Changes to Research version 1.1 - Updated August 31, 2007

• Appendix O
  Change in Study Personnel
• Appendix Q
  Change in Number of Participants
• Appendix T
  All Other Research Changes

Guidelines

The Amendment/Changes to Research form must be submitted by Investigators when any document or procedure within an IRB approved research protocol is revised. There is only one exception to this rule, specifically where the change is necessary to eliminate apparent immediate hazards to the subjects. In such cases, the investigator must submit a report to the IRB explaining the protocol deviation. Amendments involving minor changes that pose no more than minimal risk to subjects will be reviewed on an expedited basis. Amendments involving more than minor changes or involving changes that pose more than minimal risk will be reviewed by the full Committee, at the next available IRB meeting.

Changes may not be implemented until final written IRB approval is received.

Submission Instructions

1. Submit the application form and relevant appendices with the following:
   1. Current version of the document(s) being modified
   2. Proposed changes underlined (or "tracked changes") within the document(s)
   3. Proposed changes incorporated ("clean" copy) within the document(s)
   Note: Only the relevant appendices, not the main amendment form, are required when submitting amendments with continuing review applications.
2. Click here for complete submission instructions.
3. Need Help? Contact ORRP at (614) 688-8457 for regulatory and procedural questions.
   

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