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2.1 Submission for Items for Review by the IRB

Last Revised: 6/26/2026

1.0 Purpose

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

2.0 Policy

It is the policy of the Organization that:

  • 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 and reviewed by the appropriate board in a timely manner
  • 2.3. Number of agenda items at any convened IRB meeting will be limited to allow for thorough and thoughtful review by the IRB.

3.0 Submission of Items

  • 3.1. All applications and research related forms and reports will be submitted using the online Research Support System RSS
  • 3.2. 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.
  • 3.4. Exceptions to the above deadlines may be made on a case-by-case basis by the IRB Executive Chair or their designee.
  • 3.5. Items that qualify for expedited review in accordance with HRPP policy 2.3 (Expedited Review) have no deadlines for submission.
  • 3.6. Items that qualify as exempt in accordance with HRPP policy 2.6 (Exempt Research) have no deadlines for submission.

4.0 IRB Review Limits

  • 4.1. The IRB will normally review no more than 6 protocols (new submissions and previously tabled protocols) at each convened 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 the above limits will be assigned to the next 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. The IRB will review reports of internal Adverse Events, Requests for Change, Incident Reports and Special Review Items at the next appropriate convened IRB meeting without review limits.

5.0 Determination of Required IRB Review

  • 5.1. IRB Analysts, in consultation as necessary with the IRB Executive Chair or Assistant Director of ORA (or designee), will determine whether or not a protocol or other action item requires review by the convened 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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