Submission Guidelines for Expedited Review Studies

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Studies that meet the requirements for expedited review are of minimal risk, and can be categorized into one of the categories identified by the Federal regulations to be reviewed by expedited review. The NHRMC IRB reviews expedited review studies throughout the month outside of the once a month fully convened IRB meeting. Expedited review is conducted by the IRB Chair in addition to one of the IRB members. The IRB members rotate on a monthly basis for expedited review duty. For additional information you may refer to the IRB Policy & Procedure #3 entitled, "IRB Procedure".

Please READ: Expedited review study submissions (new application, renewal, and update) should include the original submission form with supporting documentation, double-sided copies are appreciated. In addition, an electronic copy of the submission form and supporting documentation must be sent to Amy Southerland, IRB Coordinator via email (amy.southerland@nhrmc.org).

If you are unsure of the approval status of your study, this information can be obtained on your original IRB approval letter or contact Amy Southerland, IRB Coordinator at 667.4621. For new studies, you will be told at the point of initial review of your study.

New Studies

Documents to be submitted (*as required/available):

  • Study Application (with signatures)
  • Consent Form*
  • Protocol*
  • Promotional Materials*
  • Administrative Attachment* (if additional space is needed for study staff)
  • Financial disclosure forms for all investigators and study staff for funded studies*

Request for Renewal

Documents to be submitted:

  • Annual Renewal Report form.
  • Current approved consent form*
  • Information that has not yet been submitted to the IRB for review (preliminary outcome data, if available, audit reports, etc.)
  • Financial disclosure forms for all investigators and study staff for funded studies*

Continuing review of research previously approved by the convened IRB (Full Board Studies) may be reviewed by expedited review when one of the following criteria is met:

  • Where the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects.
  • Where subjects have been enrolled and no additional risks have been identified.
  • Where the remaining research activities are limited to data analysis.

Study Updates/Amendments

Documents to be submitted:

  • Closure report form.
  • Final report/abstract/presentation, etc.

Study Updates/Amendments

Documents to be submitted:

  • Update/Amendment Report form.
  • Protocol Update and/or Amendment if applicable 
  • Tracked change copy of the Consent Form pages that were revised (if changes were required)
  • Any new or changed financial disclosure forms that have been discovered since study approval or renewal.

Adverse Events/Safety Reports/Safety Information

Documents to be submitted:

  • Adverse Event Form.
  • Supporting documentation including a complete copy of the adverse event/safety report and/or safety information in the form of an ADEERS or MEDWATCH report.

Documents should be submitted as follows:

  • FOR LOCAL ADVERSE EVENTS ONLY: Original Adverse Event form with supporting documentation plus 13 copies (copied double-sided).
  • For external Adverse Events: Original Adverse Event form with supporting documentation

Closure Report

Documents to be submitted:

  • Closure report form.
  • Final report/abstract/presentation, etc.

Documents should be submitted as follows:

  • Original plus 13 copies (copied double-sided)

NOTES:

  • Use assigned IRB ID# on post-approval form submissions.
  • All forms must be typed and have legible signatures or they will be returned.