AARHPP

First-Time Submitters

So, you've never submitted an application to the Institutional Review Board (IRB) before? These tips have been designed to assist you with your first human subjects research application.

Description

To submit a research application to the University of Utah IRB, please complete the following:

  1. Register in ERICA. The Electronic Research Integrity and Compliance Administration (ERICA) system is the primary electronic resource for the IRB review process. ERICA is used to enter, submit, track review, and approve all studies submitted to the IRB. For information on completing this process, please see the ERICA login information page.
  2. Complete CITI Training. Please provide a completion certificate of the University of Miami Collaborative IRB Training Initiative (CITI) Course online. You can learn more about the training and access by visiting the CITI website. Please begin working on these items to avoid any delay in the final approval of your study. If you have already completed CITI training and need a new completion certificate, you can log onto the CITI website to obtain a new one. If you have completed the NIH/NCI human subjects protection program or the training required by the VAMC, we will accept this in lieu of CITI. Please email or fax (801.587.9138) completion certificates to our office. This needs to be completed prior to final approval so it is advised that you complete this training as soon as possible.

    Note:The University of Utah deems completion certificates valid for 5 years from the date of completion. You may be notified by the institutions offering the training with a notice that your training has expired, but we will still see it as valid.
  3. Begin a New Study Application. Please visit this page for tips and details.
  4. Attach the Required and Supporting Documents to the Documents and Attachments Page of the Study. Additional forms within the ERICA system and documents created outside of the ERICA system may be required to complete and ERICA New Study Application. Documents should be attached to the Documents and Attachments page of the ERICA New Study Application. Templates for documents can be found on the IRB Forms page. Generally, all submissions require a Protocol Summary (the "Study Summary" for non-medical researchers), some form of Consent Document and the Curriculum Vitae (CV) or resume of the Principal Investigator. If you are using recruitment materials (newsletters, fliers, etc.), they must be attached under the "Other Documents." If you are using instruments such as questionnaires or surveys, they must be attached under "Surveys."
  5. Complete a Conflict of Interest (COI) Disclosure. Information on completing a Conflict of Interest Disclosure can be found on this page.

    Note: Once you have completed the disclosure for your study, please go back to the Conflict of Interest Disclosure page of the New Study Application. Select the appropriate disclosure for the study and finish.

Additional Considerations

  • External Institutions: If you are not associated with the University of Utah, or if you will be engaging in research at a location that is not part of the University of Utah and would like our IRB to serve as the IRB of record for your research, our External Institutions Policy may be applicable.
  • Overview of the IRB Review Process: Complete details of this part of the review can be found on page 20 of the Board Member Handbook. Keep in mind that once you submit your application, one of the IRB Administrators will conduct a pre-review of the application. If we need clarification or if any additional information is required, we will contact you at that time.
  • Board's Response to your Study: Once your study has been reviewed and discussed at a board meeting, the IRB coordinators who organized the meeting have 7 business days to notify you of the outcome of the discussion. If it has been 7 days from the meeting date and you still haven't received a notice from our office, contact us for additional information.
  • Frequently-Asked Questions: It is highly recommended that you review the IRB Website. The A-Z Index has been designed to address common topics in human subjects research and is constantly being updated and revised.

Reference & Links