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2.1 Submission for Items for Review by the IRB

Last Revised: 7/19/20226/26/2026

1.0 Purpose

The purpose of this policy is to describe Organization’s requirements for submission and pre-reviewprocessing of all applications and research related forms and reports.reports for review by the IRB/ORA.

2.0 Policy

It is the policy of the Organization thatthat:

all
    submissions
  • 2.1. Applications and research related forms and reports requiring convened IRB review will be submitted by research teams enough in advance of the scheduled meeting to allow for processing and pre-review by the ORA.
  • 2.2. Applications and research related forms and reports will be processed efficientlyand reviewed by the Officeappropriate board in a timely manner
  • 2.3. Number of Regulatoryagenda Affairsitems (ORA)at any convened IRB meeting will be limited to allow for thorough and thoughtful review inby accordancethe withIRB.
    • applicable HRPP policies.

3.0 Submission Requirementsof Items

  • 3.1. All applications and research related forms and reports will be submitted using the online Research Support System RSS, except as below:
  • 3.2. CRs and certain other forms related to research protocols approved prior to January 16, 2012 may continue to be submitted on paper. All necessary forms are available on the UNMC IRB website and the IRB will maintain paper files for the duration of these studies.
    • 3.2.1. Research protocols remaining in paper format will continue to be transitioned to RSS as appropriate.

4.0 Deadlines for Submission

  • 4.1. The deadline for submission of any materials requiring review by IRB-01, -02, and -04 is 10 working days prior to each meeting.
  • 3.3. The deadline for submission of any materials requiring review by the IRB-05 is 6 working days prior to each meeting. The deadlines are published on the IRB website.
    • 4.1.1. All new applications and re-submissions of tabled protocols will undergo pre-review to the greatest extent possible in consideration of the submission date, and ORA workload.
    • 3.4.1.2. Exceptions to the above deadlinedeadlines may be made on a case-by-case basis by the IRB Executive Chair or his/hertheir designee.
    • 4.1.3.5. Items that qualify for expedited review in accordance with HRPP policy 2.3 (Expedited Review) have no deadlines for submission.
    • 4.1.4.3.6. Items that qualify as exempt in accordance with HRPP policy 2.6 (Exempt Research) have no deadlines for submission.

5.4.0 IRB Review Limits

  • 5.4.1. The IRB will normally review no more than 106 protocols (new submissions and previously tabled protocols) at each fullconvened meeting.meeting of IRB-01 and -02.
  • 4.2. The IRB will normally review no more than 4 protocols (new submissions and previously tabled protocols) at each convened meeting of IRB-04 and -05.
  • 4.3. Assignment to the IRB meeting are generally made on a first-come, first-served basis. Protocols in excess of 10the above limits will be assigned to the followingnext appropriate convened IRB meeting.
  • 4.4. Exceptions to the above limits may be made on a case-by-case basis by the IRB Executive Chair or their designee.
  • 4.5.2. The IRB will review reports of internal Adverse Events, Requests for Change, Incident Reports and Special Review Items at the earliestnext possibleappropriate fullconvened IRB meeting without review limits.

6.5.0 Determination of Required IRB Review

  • 6.5.1. Protocols and other action items submitted through RSS will be triaged to the appropriate IRB administrator and processed in accordance with ORA SOPs.
  • 6.2. The IRB Administrator,Analysts, in consultation as necessary with the IRB Executive Chair,Chair or Assistant Director of ORA (or designee), will determine whether or not a protocol or other action item requires review by the fullconvened IRB or qualifies for expedited review in accordance with HRPP policies 2.2 (Full IRB Review) and 2.3 (Expedited Review.)

DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 2/5/2018 - revision not documented

 Revised: 7/19/2022 - Deleted list of types of forms for review; clarified which items allowable for submission in paper format; corrected deadlines for submission; clarified maximum number of protocols to be reviewed.

 Revised 6/26/2026 – revised section 2.0 to reflect content of the policy; revised maximum number of protocols to be reviewed at convened meetings; stylistic changes

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