Post-approval Information

Post-Approval Information

Note: As of June 6, 2013, all human subjects related documents are to be submitted through our online protocol management system IRBNet.  More information about IRBNet may be found on the announcement page.  All forms may be found within IRBNet.

Once a project has been approved, you must communicate with ORIA in the following circumstances:

  • If you make any changes to the protocol, the instrumentation, or recruitment materials associated with the project: you must alert ORIA to these changes using the amendment/ continuing review form (available through IRBNet).  You should also use the amendment form to alert ORIA/the IRB to changes in funding source.
  • If a research participant experiences an unexpected problem related to the research activity: you must report this information to ORIA using the Reportable New Information form (available through IRBNet) within 72 hours of the occurrence.
  • When you have completed the project and are no longer recruiting participants or doing analysis: you must report this information to ORIA using the amendment/ continuing review form (available through IRBNet).
  • If your project was reviewed via the full IRB or through the expedited review procedure: you must complete the amendment/ continuing review form at least annually updating ORIA and the IRB of the progress you have made with your project.  ORIA will send reminders about this requirement via IRBNet and email.
  • If your project was considered exempt human subjects research: you must fill out an amendment/ continuing review form (available through IRBNet) if any aspect of your project design has changed.  You will also be required to submit an amendment/ continuing review form (available through IRBNet) once every three years to inform ORIA of the status of your research project.

Remember to review the human subjects review process page and the human subjects project triage page for information about IRB categories

Other useful information

As you review the information on this page, you may encounter terms with which you are unfamiliar.  Please check the glossary of terms for definitions.  If you still have a question about a term used that is not answered on the glossary page, please e-mail irb@gmu.edu.