Institutional Review Board Process

OHR Submission Process

OHR accepts applications from faculty, students, and staff of The George Washington University, GW Medical Faculty Associates (MFA), and The GW Hospital.

Please see our "When is IRB Review and Approval Needed" for assistance in determining if your study requires IRB review and approval.

Please download IRB submission forms only when you are ready to use them. If out-of-date forms are submitted you will be requested to resubmit using current forms and this will delay your review process.

Please submit all IRB application packets directly to the OHR. Electronic submissions via email will be accepted only if the required signatures have been obtained. All new submission forms MUST include the signatures of the Principal Investigator (PI) AND the Department Chair. Upon receipt of a complete application, your study will be registered in our database, assigned to an IRB Analyst for review, and assigned an IRB number. The IRB Analyst will be in touch with you to communicate any issues that may need to be addressed.

In accordance with GW's Faculty Handbook, all PIs must be full-time, regular faculty members. The following CAN serve as PI: Full, Associate, or Assistant Professors; Research Scientists and Research Professors. The following CANNOT serve as PI: Students (graduate or undergraduate), Residents, Fellows, Lecturers, or Adjunct Professors. PI exceptions are permitted on a case-by-case basis; a PI Eligibility Exception Form must be completed and submitted to the OHR for review. Contact the OHR for additional information.

Please note, some Schools and Departments have adopted their own policies and practices involving the submission of an IRB application. Please check with your PI and/or Department's Administrative office prior to submitting to our office to ensure you are within their guidelines. (GSEHD, SPHHS)

General Steps

Preliminary Review (Pre-Review)

Your submission is first evaluated by an IRB Analyst (exempt or expedited studies) or IRB Administrator (full board studies) for completeness and clarity. The Analyst or IRB Administrator will contact you with an initial correspondence and may request preliminary submission edits. For research submissions meeting one of the exempt categories, an IRB Analyst will either issue an approval or ask for final edits to your submission materials. The IRB Analyst will inform you of these final requested edits and work with you to resolve them.

The time for completion varies with complexity of outstanding issues and responsiveness of the research team.

Formal Review

For research submissions that are minimal risk but do not meet one of the exempt categories, an IRB Designee will then conduct a formal review of the study and render an evaluation of your study submission. The IRB Designee  will either issue an approval or ask for final edits to your submission materials. The IRB Analyst will inform you of these final requested edits and work with you to resolve them.

For Full Board studies, the IRB Administrator will advise you when the study is scheduled for full board review. The ability to schedule a study for Full Board review is related to the pre-review response time, time on the IRB's agenda, and expertise that may be required for the review. Once a study is reviewed by the Full Board, the IRB Administrator will communicate any changes requested by the IRB and will work with you to resolve any issues. 

Approval

An approval letter and stamped versions of any materials that will be viewed by subjects or the public (consent forms, flyers, surveys, etc.) will be sent to you via email. You must receive an exemption determination or IRB approval letter before you begin any human subjects research activities. 

Additional Considerations for IRB Approval

  •  Greater than Minimal risk studies (Full Board) will be assigned to a full board meeting. Dates for full board meetings can be found on the IRB Meeting Dates page.
  • Expedited or Exempt Studies are not assigned to a meeting; these submissions are reviewed on a rolling basis. 
  •  No hand-written forms will be accepted.
  •  CITI Training requirements must be met prior to study submission.

 

OHR Announcements!

Over the next year, the Office of Human Research (OHR) will be involved in updating and revising all of the policies, procedures, and operations of OHR and the Institutional Review Boards (IRB).

@GWOHRIRB