Every application in ERICA displays a status viewable to the investigator. The application status changes each time the application advances a step in the review process. The status label is intended to assist investigators as they follow the application through to approval, or to direct them to the appropriate committee if they have questions or concerns.
| Status | What Does It Mean? |
|---|---|
| Creation | The application is in the study team’s hands and is fully editable. It has not been submitted to the IRB yet. |
| Reliance Confirmation | An IRB Reliance Manager has been assigned to begin reliance negotiations for your single IRB (SIRB) study. IRB review is not started during this stage. |
| Reliance Corrections | The application is in the study team’s hands and is fully editable. It has not been submitted to the IRB for review yet. |
| PRMC Review | The Protocol Review and Monitoring Committee (PRMC, formerly the "CCIC") is reviewing the application. Please contact PRMC if you have questions. |
| PCH Review, PCH Corrections | The Primary Children's Hospital (PCH) Privacy Board is reviewing the application. Please contact the PCH Privacy Board if you have questions. |
| RDRC-HUS Review | The Human Use Subcommittee of the Radiation Safety Committee (HUS-RSC) is reviewing the application. Please contact RSC if you have questions. |
| IBC Review, IBC Corrections | The Institutional Biosafety Committee (IBC) is reviewing the application. Please contact IBC if you have questions. |
| RGE Review, RGE Corrections | The Resource for Genetic & Epidemiologic Research (RGE) is reviewing the application. Please contact RGE if you have questions. |
| VA Review, VA Corrections | The Veteran's Affairs (VA) office is reviewing the application. Please contact the VA if you have questions. |
| Faculty Approval | Your faculty sponsor needs to review and approve your submission. The IRB has not yet received the application and no review has begun. |
| Responsible PI Approval | The Responsible Principal Investigator needs to review and approve the site-specific submission. The IRB has not yet received the application and no review has begun. |
| New PI Approval | This status occurs when the PI of the study is changing. After the original PI submits, the "new PI" (i.e. the investigator taking over responsibility of the study) also needs to review and submit the application. The New PI takes over responsiblity for submitting in ERICA at that point and the original PI no longer receives notifications. The IRB has not yet received the application and no review has begun. |
| Status | What Does It Mean? |
|---|---|
| Pre Review | This is the first stage of the IRB review process. Your application has been assigned to an IRB staff member for a pre-review. The staff member will review your application for common errors and request clarifications/revisions as needed. |
| PI Corrections | Revisions have been requested by the IRB staff as a result of the pre-review process. The application is in the study team’s hands and is fully editable. It must be re-submitted to the IRB before the pre-review process can continue. |
| CoI Pending | A member of the study team must complete a Conflict of Interest (CoI) Disclosure for the pending application. Please contact CoI if you have questions. |
| CoI Complete | All conflict of interest disclosures have been completed and the IRB has been notified. The application will be assigned to the next stage of the process soon. If your study sits in this status for longer than 1 week, please contact the IRB. |
| Pending | An ancillary review is still in process and must be completed before the IRB may continue the review. Ancillary reviews that may trigger this status include: Conflict of Interest (CoI), Human Subjects Research training, OSP review, RGE review, and Health Literacy review (for Study Locator). |
| IRB Reviewer Assignment | The pre-review is complete. Your application has been assigned to an IRB agenda. The
assigned meeting date will display in ERICA; however, this date is subject to change
when meeting agendas exceed reviewer capacity, or when appropriate expertise is not
available on the assigned date. It is recommended that you check your assigned date
often as the board review date approaches. This status does not distinguish between "expedited" and "full board review" applications. All applications will hold in this state as they await assignment to a board reviewer. |
| Status | What Does It Mean? |
|---|---|
| Pending SIRB Approvals from PI | The University of Utah Human Research Protections Program (HRPP) has completed the local review of your application. A letter has been sent outlining next steps, including any pending items we still need before we can activate your study at Utah. Click "Submit Revisions" to send the items back to the HRPP Reviewer. The application is in the study team’s hands and is fully editable. It must be re-submitted to the IRB/HRPP before the pre-review process can continue. |
| UU HRPP Final Review | The University of Utah Human Research Protections Program (HRPP) has received final documentation from the local study team and are reviewing the file for completion. The SIRB Reliance Team has at least one business week to complete their final review and either send the application back for further clarifications, or process the file. |
| Status | What Does It Mean? |
|---|---|
| Full Board Review | Your application has been assigned to a qua lified board member for full board review.
Board members may contact investigators during this time to request clarifications/revisions
as needed. Your application will be presented at the convened board meeting on the
date displayed in ERICA. IRB meeting coordinators have up to one business week to complete post-board correspondence and inform you of the board’s decision at the meeting. |
| Expedited Review | Your application has been assigned to a qualified, designated expedited board member
for "expedited" review. (Please note: the term "expedited" means the application only
requires the approval of one board member, rather than a majority approval from a
convened panel of members. It does not refer to the amount of time it takes to review/approve
the application. Expedited applications are reviewed on the same assigned schedule
as full board applications.) Board members may contact investigators during this time
to request clarifications/revisions as needed. Your application will be handled electronically
during the week before and after the meeting date displayed in ERICA. IRB meeting coordinators have up to one business week to complete post-board correspondence and inform you of the expedited board reviewer’s decision. |
| IRB Staff Review | The expedited reviewer assigned to your study requested clarifications and sent the study back to the IRB staff. The IRB staff member assigned to handle your study post-board (usually the meeting coordinator) should be getting in touch with you soon for clarifications. |
| PI Revisions | Revisions have been requested by the convened board, or the expedited reviewer for your application. The application is in the study team’s hands and is fully editable. It must be re-submitted to the IRB before the review process can continue. |
| Revision Review | The IRB meeting coordinator is working with the board reviewer to verify whether the requested changes/clarifications have been adequately provided. |
| Pending Ancillary Review | An ancillary committee was reviewing your project at the same time as the IRB, but they haven’t finished yet. The study cannot be processed by the IRB until the ancillary committee has completed their review. Contact the IRB to find out which committee is holding your study. Contact the individual committee to find out what is pending. |
| Chair Review/Signature | An IRB chair is performing a final check of your application. When the chair signs off, the application will move to final processing. |
| Final Processing | The IRB meeting coordinator is processing your documents. This is the final stage
in the approval process. Delays in this stage of the process usually mean the IRB is holding the application pending submission of information or documentation needed before final approval. Please contact the IRB if you have questions. |
| Status | What Does It Mean? |
|---|---|
| Approved, Exempt, Non-Human Subjects Research (NHSR) | "Approved" means your study is currently approved by the IRB. "Exempt" means your study has been exempted from continuing review by the IRB. "Non-Human Subjects Research" means the IRB has formally determined that the project submitted in the application does not satisfy the federal definition of "human subject research". |
| Expired IRB Approval | Your study is expired. By law, once a study has expired, all research activities associated with the study must cease until the study is renewed. Expiration means, by definition, that the study is not currently approved by the IRB and it constitutes research misconduct to continue work on it. |
| Administrative Hold | An administrative hold is a voluntary action by an investigator to temporarily or permanently stop some or all approved research activities. Contact the IRB to move your study out of this status. |
| Suspended | A suspension of IRB approval is a directive of the convened IRB either to temporarily or permanently stop some or all previously approved research activities. Suspended protocols remain open and require continuing review. Contact the IRB to move your study out of this status. |
| Terminated | A termination of IRB approval is a directive of the convened IRB to permanently stop all activities in a previously approved protocol. Terminated protocols are considered closed and no longer required continuing review. |
| Long-Term Follow-Up | Some studies are put into this status when a long-term follow-up protocol is created in collaboration with the IRB and department. |
| Withdrawn | The application was withdrawn from consideration. The study is not approved or under review of any kind. |