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.
- Complete the appropriate modification form. The form can be found at http://orcr.arizona.edu/hspp.
- Submit the completed form via e-mail to Alice Pasvogel (Office of Nursing Research) at email@example.com.
- Include a copy of all revised documents (consent documents, recruitment material, etc).
The Office of Nursing Research will obtain the signature of the Department Head or Designee and send the documents to the University of Arizona Human Subjects Protection Program.
The Principal Investigator will be notified if additional information is needed.
The Human Subject Protection Program will notify the PI of approval for the modification or the need for additional information.
All changes/modifications require approval prior to implementation.