Submission Process

Full Board Review (initial submission)

Investigators will no longer be required to supply copies (paper packets) to the IRB office after the electronic submission has been given an IRB#.  Investigators will be notified of the assigned IRB# by email. Applications for Full Board Review will be reviewed at the next possible IRB meeting. 

These documents must also be attached in the "ADD DOCUMENTS" section of the online application at the time of electronic submission:

New Submissions (Initial)

  1. Subject Recruitment Material (as applicable)
  2. External study site approval letters (as applicable)
  3. Full protocol (as applicable)
  4. Investigator's Brochure (as applicable)
  5. Grant application (as applicable)
  6. Clinical Trial Master Matrix (as applicable)
  7. IRB Review Fee Form (as applicable)
  8. Other relevant material (eg. surveys) (as applicable)

Tabled - Re-Submissions

  1. Investigator's response letter
  2. Other revised materials (as applicable)

Expedited Review (initial submission)

Certain studies involving no more than minimal risk may qualify for expedited review status under 45 CFR 46:110 or 21 CFR 56:110. View a list of categories which may qualify for expedited review. Expedited reviews of new protocols are now handled through the electronic submission only.  Paper copies of applications are no longer accepted.   New submissions eligible for expedited review will be reviewed by the IRB Executive Chair/designee and the investigator will be informed of the IRB’s decision by email.

Exempt Protocols (initial submission)

Research activities in which the only involvement of human subjects will be in one or more of the categories specified by 45 CFR 46:101(b) are exempt from the requirements of 45 CFR 46. The exempt categories do not, however, apply to research involving deception of subjects, sensitive behavioral research, or to research involving pregnant women, prisoners, individuals who are decisionally impaired and other subject populations determined to be vulnerable.

Reviews of new Exempt protocols are now handled through the electronic submission only.  Paper copies of applications are no longer required.  NOTE: Exempt studies existing prior to January 16, 2012 will have to be entered into the electronic system at the end of the 5 year approval period if the study is to continue.  New submissions eligible for exempt review will be reviewed by a member of the IRB staff and the investigator will be informed of the IRB’s decision by email.

Continuing Reviews

Federal Regulations prohibit the IRB from granting extensions or temporary approval. Should expiration of IRB approval occur, all subject accrual must cease as of the date of expiration. In addition, research related procedures can no longer be performed on human subjects who are currently enrolled in the study for follow-up or other reasons unless this restriction represents a health hazard to the subjects. In this case, the IRB will grant an exception upon receipt of written justification.

The IRB Application for Continuing Review for Full Board studies must be submitted no later than the last business day of the month prior to the expiration date (which is 12 months from the date of the last IRB review). The IRB re-reviews continuing reviews for full board protocols only during the 3rd Thursday IRB meeting. The IRB Application for Continuing Review for Expedited Studies must be submitted no later than three (3) weeks prior to expiration.

Existing studies (full board or expedited) that are still in paper format:

If you have not created an "Existing Paper Format" application for your study, you will need to do so since all submissions are now done through the electronic IRB system. You will only need to create an "Existing Paper Format" application one time per study. First, a new online application (#13 - Existing Paper Format) must be started.  This is NOT a full application.  It requires only the IRB# and title.  You will complete all of your forms using the Microsoft Word documents (www.unmc.edu/irb/forms).  After uploading the documents listed below into the "ADD DOCUMENTS" section of the electronic IRB application, click SUBMIT.  If you have any questions regarding this submission process, please contact the IRB Office at (402) 559-6463.

  • Signed Continuing Review form
  • IRB application (clean)
  • Consent form(s) (Word format and clean) to be used for stamping
  • Information sheet(s) (Word format and clean) to be used for stamping
  • Last signed consent form with subject's name, signature and other identifiers blacked out. Date and signature of the person who obtained consent and the date that the subject signed must be visible. 
  • Publications (as applicable)
  • DSMB, safety report, progress report (as applicable)
  • Other supporting documents (as applicable)
  • If you are making changes (other than personnel), you will also need to upload the following:
    • Signed Request for Change Form (form is available at www.unmc.edu/irb/forms)
    • Revised IRB application (with tracked changes)
    • Revised Consent forms/information sheets (with tracked changes)
    • Other revised document (as applicable)

Studies submitted through the electronic system:

To create an electronic Continuing Review form, open the "VIEW/EDIT" screen and click the "NOTEPAD" icon on the Application List page, which is in the far right column.  After uploading the following documents into the "ADD DOCUMENTS" section of the electronic Continuing Review, click "SUBMIT":

  • Last signed consent form with subject's name, signature and other identifiers blacked out. Date and signature of the person who obtained consent and the date that the subject signed must be visible.
  • Publications (as applicable)
  • DSMB, safety report, progress report (as applicable)
  • Other supporting documents (as applicable)
  • If you are making changes, you will also need to do the following:
    • Make changes to the IRB application, consent forms and/or information sheets
    • Attach other revised document (as applicable)
    • Click "CHANGE REQUEST" button on the left
    • Answer the additional questions regarding the changes
    • After the PI has electronically signed the Change Request, click "SUBMIT".

Request for Change

Any proposed change in a research activity must be reviewed and approved by the IRB prior to implementation in accordance with the requirements of 45 CFR 46.103(b)(4); 21 CFR 56.108(a)(4) except when: 1) a change is necessary to eliminate an apparent immediate hazard to the subject(s), or 2) a subject needs to be advised immediately of significant new information.  Administrative changes do not require IRB review and can, accordingly, be approved by ORA.

Studies which are not in the electronic submission system:

If you have not created an "Existing Paper Format" application for your study, you will need to do so since all submissions are now done through the electronic IRB system.  You will only need to create an "Existing Paper Format" application one time per study.  First, a new online application (#13 - Existing Paper Format) must be started. This is NOT a full application. It requires only the IRB# and title. You will complete all of your forms using the Microsoft Word documents (www.unmc.edu/irb/forms). After uploading the  documents listed below into the "ADD DOCUMENTS" section of the electronic IRB application, click SUBMIT.  If you have any questions regarding this submission process, please contact the IRB Office at (402) 559-6463.

  • Signed Request for Change Form (form is available at www.unmc.edu/irb/forms)
  • Revised IRB application (with tracked changes)
  • Revised Consent forms/information sheets (with tracked changes)
  • Other revised document (as applicable)

Studies submitted through the electronic system:

  • Make changes to the IRB application, consent forms and/or information sheets
  • Attach other revised document (as applicable)
  • Click "CHANGE REQUEST" button on the left
  • Answer the additional questions regarding the changes
  • After the PI has electronically signed the Change Request, click "SUBMIT".

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