Amendments (Changes to a Project)

The IRB must approve all modifications to the research activities and applications prior to implementation unless it is to eliminate apparent hazards to the participant. Modifications/changes include: protocol changes, personnel changes, recruitment material, form additions/changes (consents, questionnaires), enrollment changes, etc.

1. Complete the appropriate Request for Amendment Form
• Request for Amendment Form – PI Initiated
• Request for Amendment Form – Sponsor Initiated
• Request for Amendment Form – VOTF (For study personnel changes)
• The forms can be found at http://www.irb.arizona.edu/.
  
  
2. Submit the completed form via e-mail to Alice Pasvogel (Office of Nursing Research) at pasvogel@nursing.arizona.edu.
• Include a copy of all revised documents (consent documents, recruitment material, etc). Highlight the changes to the revised documents and include a clean copy of consenting documents for approval stamp.

The Principal Investigator will be notified if additional information is needed.

3. The Office of Nursing Research will send the documents to the University of Arizona Human Subjects Protection Program.
   
   
4. The Human Subject Protection Program will notify the PI of approval for the amendment or the need for additional information.

All changes/modifications require approval prior to implementation.

 

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