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2.1 Submission for Items for Review by the IRB

1.0 Purpose

The purpose of this policy and procedure is to describe Organization’s requirements for submission and pre-review of: 1) new IRB applications (exempt and non-exempt); 2) continuing review (CR), 3) requests for change in protocol (RFC); 4) single subject protocol deviations (SSPD), 5) adverse events (AEs); 6) reports of potential unanticipated problems involving risks to subjects or others (UPs), 7) noncompliance reports (NCR), 8) complaints (C), and 9) study completion reports (SCR).

2.0 Policy

It is the policy of the Organization that all submissions will be processed efficiently by the Office of Regulatory Affairs (ORA) for review in accordance with applicable HRPP policies.

3.0 Submission Requirements

  • 3.1. All new IRB applications must be submitted using the online Research Support System (RSS).
  • 3.2. All CRs, RFCs, SSD, NCRs, and SCRs for research protocols approved after January 16, 2012, are submitted through RSS. UPs and Cs are submitted by a variety of mechanisms specified in HRPP policies 8.2 (IRB Review of Study Related Complaints) and 8.3 (IRB Review of Unanticipated Problems Involving Risk to the Subject or Others).
  • 3.3. All CRs, RFCs, SSD, NCRs, and SCRs for research protocols approved prior to January 16, 2012 will 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.
  • 3.4. All internal adverse events that meet the criteria specified in HRPP policy 8.1 (IRB Review of Adverse Events and Adverse Device Effects) will continue to be reported to the IRB through RSS system.

4.0 Deadlines for Submission

  • 4.1. The deadline for submission of any materials requiring review by the full IRB is 2 weeks 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.
    • 4.1.2. Exceptions to the above deadline may be made on a case-by-case basis by the IRB Executive Chair or his/her designee.
    • 4.1.3. Since CRs are only reviewed by IRB-02 on the third Thursday of the month, CRs and SCRs must be submitted by the last day of the previous month (e.g., the last day of January to be reviewed by the third Thursday of February).
    • 4.1.4. Items that qualify for expedited review in accordance with HRPP policy 2.3 (Expedited Review) have no deadlines for submission.
    • 4.1.5. Items that qualify as exempt in accordance with HRPP policy 2.6 (Exempt Research) have no deadlines for submission.

5.0 IRB Review Limits

  • 5.1. The IRB will normally review no more than 15 protocols (new submissions and previously tabled protocols) at each full meeting. Assignment to the IRB meeting are made on a first-come, first-served basis. Protocols in excess of 15 will be assigned to the following IRB meeting.
  • 5.2. The IRB will review reports of internal AEs, potential UPs, NCRs, Cs, and RFCs at the earliest possible full IRB meeting without review limits.

6.0 Determination of Required IRB Review

  • 6.1. 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, in consultation as necessary with the IRB Executive Chair, will determine whether or not a protocol or other action item requires review by the full IRB or qualifies for expedited review in accordance with HRPP policies 2.2 (Full IRB Review) and 2.3 (Expedited Review.)

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED FEBRUARY 5, 2018

 INITIAL APRIL 4, 2016

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