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Last Updated January 25, 2010
Office of Human Research

IRB Submissions

DETERMINE REVIEW CATEGORY
Decision Charts (New Studies)
Review these decision charts to determine your review category. Your review category determines which forms to use below.

FORMS (New & Ongoing Studies)
For new studies, determine your review category using above Decision Charts, then find the appropriate forms under one of the following review categories:
Exempt Review Forms
Expedited Review Forms
Full Committee (Convened) Review Forms

HIPAA FORMS
HIPAA Forms
Additional forms for studies using protected health information.

SPONSORED CLINICAL TRIAL FORMS
Western IRB Forms

 

NEW STUDY SUBMISSION INSTRUCTIONS:

***NOTE: Investigators are no longer required to obtain an IRB number before submitting new studies--one will be assigned upon submission.***

1. Complete the Human Subject Research Determination Worksheet and determine if your study needs to be submitted to the OHR.

2. If you are conducting "human subject research", per #1, complete CITI Training requirements or include proof of equivalency in submission documents.

3. Work your way through the Decision Charts #2-#8 to determine your review category (Exempt, Expedited or Full-Committee/Convened).

4. Consult the Submission Checklist to determine all materials to submit and retrieve appropriate forms from appropriate review category link at left (Exempt, Expedited or Full-Committee/Convened).

5. Submit 1 hard copy of all with signatures to the front desk "in-box" (or by mail) at the Office of Human Research at GWU Medical Center (Ross Hall), 2300 I St. NW, Room 613, Washington, DC 20037.

TURN AROUND TIMES, etc. Here's what happens after you submit:

  1. Pre-evaluation. Your submission is first pre-evaluated by an IRB Analyst for completeness and clarity, who will contact you within 3 business days of your submission date with a progress update. The analyst may request submission edits.  If your study is above minimal risk, you will be asked to make/submit 15 copies after all issues are resolved.
  2. Formal review. For minimal risk studies, after pre-evaluation an IRB Designee will then render an initial evaluation within approximately 7 business days from completion of step #1.  Above minimal risk (“Full-board”) studies will be formally reviewed by the full IRB Committee according to our posted Submission Deadlines.
  3. Resolve submission issues. The IRB Designee or IRB Committee will either issue an approval or ask for edits to your submission materials. The IRB Analyst will inform you of these requested edits and work with you to resolve them. Time to completion varies with complexity of outstanding issues.
  4. Upon approval, you will be emailed approval letter and stamped versions of any materials that will be viewed by subjects or the public (consent forms, flyers, surveys, etc).
GWUMC
Office of Human Research
2300 Eye St., NW - Ross Hall 613 Washington, DC 20037
Phone: 202.994.2715 Fax: 202.994.0247 Email: ohrirb@gwumc.edu