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Frequently Asked Questions (FAQ)

Below are a number of commonly asked questions. The questions will either provide an answer or will link to the appropriate section of the guidebook. The Page Navigation found in the upper left side of the page can be used to scroll directly to the answer needed and are organized by question. If you do not see your questions listed below, the Book Navigation on the lower left side of the page can be used to browse the various sections. The search bar at the top of the page may also help you navigate to the appropriate section.

Feel free to contact us at irbora@unmc.edu if you cannot find the needed content.

Do I need an IRB?

What application should I use?

What does Exempt mean?

<<<<The insertterm answerExempt here>>>>can sometimes be misunderstood in regards to the IRB. When the IRB uses the word Exempt in reference to a research project, that means a project falls under a certain set of criteria for Human Subject Research. Often times, the IRB will be asked if a project is exempt meaning: is my project considered Human Subject Research that the IRB needs to review my project?

  • Information regarding Exempt category research can be found here: HRPP 2.6 (Exempt Research)
  • If you would like to know if your project requires IRB review, please use our Determination Survey.

Is my research project expedited or full board?

<<<<The insertdetermination answerof here>>>>whether a project will be considered Expedited or Full Board will be made by the IRB analyst during the review of the application. If you have a application deadline that requires an expedient review, this can be notated in the IRB application itself in Section 1.4: expedite.png

How long does it take for my research project to get approved?

<<<<There insertare answermany here>>>>factors involved in IRB review depending on the complexity of the application and how many departments in the Office of Regulatory Affairs must be involved. On average an application will be reviewed between 7 and 28 working days. study_approval_irb_vs_ora.png

I have a CITI question!question.

I have an RSS question!question.

My protocol closes soon, what do I do?

Any protocol which needs to be renewed for another year will fall under one of two scenarios: Continuing Review (Full Board or greater than minimal risk studies) or a Demographic Recruiting Numbers form (EX, EP, CB, and minimal risk). Each will have their own respective form to be completed.

  • The Continuing Review period will begin two months prior to the expiration of a study.
  • The Demographic Recruiting Numbers form will be generated on the first day of the month a study expires.
  • RSS will generate an email notification sent to the PI and Lead Coordinator for both types of renewal.

How do I complete a Continuing Review?

Do I need data from other sites on my Continuing Review?

How do I know my Accrual Numbers?

How do I close my study?

  • For studies that require Continuing Review that needs to be closed, a Study Completion Report can be created using the Forms button in RSS.
  • For studies that require Demographic Recruiting Numbers forms to be closed:
    • If the study is in the month of expiration and the form has already been generated, the form can be used to mark the study as Complete.
    • If the study is NOT in the month of expiration, send a message to the IRB via the RSS message portal for that protocol. The message will act as official documentation of the request and the IRB will complete the process.

What do I do if I have a problem?

If the answer to your question cannot be found in the IRB Guidebook, please email irbora@unmc.edu

How often does the IRB meet?

How

The doIRB IBoards usemeet RSS?

once per month.

  • IRB-01 (Adult; first Thursday of every month except January and July)
  • IRB-02 (Adult; third Thursday of every month)
  • IRB-04 (Pediatric; fourth Tuesday of every month)
  • IRB-05 (SIRB; second Friday of every month)

How do I delete a document or consent form?

Once a document or consent form has been deleted, it will be irretrievable. To avoid any accidental deletion of these documents, the request must be performed by a member of the IRB team. Please contact us at irbora@unmc.edu if this needs to be done.

How do I make a Change Request?

How do I reset my application to edit?

When going into the protocol in RSS, the Reset Edit button should be available at the top of the protocol page. If this does not appear, contact irbora@unmc.edu and the IRB can change the status. reset-edit.png

I'm a student, who needs to be listed on my protocol?

The student must be listed as the PI of the project, while the student's faculty advisor must be listed as both Secondary Investigator and Faculty Advisor. The Faculty Advisor role in RSS will appear when question 2.G in the application is answered "Yes".

  • If multiple students are involved in a project, only one may be listed as PI. All other students will fill the role of Secondary Investigator. The PI will be the only role capable of signing off on the application and any changes that may occur.

How do I edit a consent form?

I'm leaving UNMC, what do I do with my research before I leave?

I have a cIRB/sIRB question!question.

My project was closed, what do I do?

Please contact irbora@unmc.edu with the protocol number. The circumstances of when and why a protocol was closed will depend on if and how the protocol can be reopened.

How does ClinicalTrials.gov work?

How do I compensate my participants?

I'm trying to add someone to my study in RSS, but I don't see their name.

What do I need to report with an Incident Report?

How do I know if I need a Data Use Agreement?

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