I. DETERMINE IF A PROJECT IS HUMAN SUBJECTS RESEARCH
These worksheets serve as guides to help investigators determine if research requires submission to the Office of Human Research (OHR).
1. Human Subject Research Determination Worksheet
2. FDA Human Subject Research Determination Worksheet (for clinical investigations).
- If you are not the PI, you should first discuss your research with the PI before submitting this form
- If you are unsure, the OHR will review completed forms upon request.
II. DETERMINE IRB REVIEW CATEGORY
Decision Charts (New Studies)
Work your way through decision charts 1-8 to determine IRB review category.
This will also determine which forms to use (Exempt, Expedited or Full-Committee).
III. NEW STUDY SUBMISSION INSTRUCTIONS
If you determine you are conducting "human subjects research", complete the follwoing:
1. Consult the Submission Checklist to determine all materials to submit and retrieve appropriate forms from appropriate review category.
2. Complete CITI Training requirements or include proof of equivalency.
3. An IRB number will be assigned upon receipt of all new submission.
4. Submit 1 typed hard copy of all documents 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. |
IV. IRB SUBMISSION FORMS
For New & Ongoing Studies
After determining your review category using the Decision Charts, find the appropriate forms under one of the following review categories:
Exempt Review Forms
Expedited Review Forms
Full Committee Review Forms
HIPAA
HIPAA Forms
Additional forms for studies using protected health information.
Sponsored Clinical Trial Forms
Western IRB Forms
Researcher Responsibilities FAQs
- Responsibilities After Initial IRB Review for Expedited and Full Board Studies/FAQ
- Responsibilities for Exempt Research/FAQ
Link to Forms Tool
Quick Links to OHR Forms for Desktop
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