The George Washington University

Office of Human Research- Institutional Review Board

Phone: 202-994-2715

New Submission Checklist (HRP-299)

This checklist is intended to be a reference tool. Not all studies will be required to submit all documents. If you are unsure if you need to submit a document that is listed here, please contact the Office of Human Research (OHR) at .

IRB Application(HRP-200) signed by the PI and Department Chair
Protocol(if Greater than Minimal Risk study)
Research Personnel Form (HRP-201)
Informed Consent Document or Information Sheet(HRP-500, 501, or 503) (if applicable)OR Waiver or Alteration of Consent Supplement (HRP-294)
Student Investigator Responsibilities Agreement (HRP-290) (if student initiated)
Children Supplemental Checklist (HRP-292) (if study involves children)
Assent Form, 7-12 years of age old (HRP-506)
Assent Form, 11-17 years of age (HRP-507)
Parental Permission Form(HRP-500, 501, or 503)
Prisoner Certification Supplement (HRP-291) (if study targets prisoners)
International/Non-English Speakers Supplement (HRP-293) (if study involves international or non-English speaking subjects)
Translated documents (if applicable)*
Back-Translated Documents(for Greater than Minimal Risk studies only)
Recruitment Materials
Email/Phone Script
Flyers
Online Adverstisements
Verbal Announcement Script
Data Collection Tools
Surveys
Interview or focus group guides
Case Report Forms (CRFs)
Code Book or Variable list
(for chart review or secondary data analysis)
Other
Funding Source Supplement (HRP-220)(if applicable)
Grant or Contract (excluding budget information)
Dissertation, Chapter 3(if applicable)
Site permission letter or IRB Approval (for studies being conducted outside of GW)
Certificate of Confidentiality (if applicable)

For Studies Using Drugs, Devices, or Biologics:

Drug Supplement (HRP-295) or Device Supplement (HRP-296)
IND/IED/HDE Approval Letter
FDA 1572
Investigator Brochure, Device Manual, or Labeling

For Studies Involving Protected Health Information (PHI):

HIPAA Authorization Included in Consent
(for studies accessing Protected Health Information [PHI] after consenting subjects)
HIPAA Waiver Request:
Partial HIPAA Waiver Request (HRP-281)
(for studies accessing PHI to recruit subjects)[1]
Full HIPAA Waiver Request (HRP-280)
(for studies accessing PHI without consenting subjects)
Data Use Agreement for Restricted or Limited Data Set (signed by Office of Sponsored Projects)

New Submission Checklist (HRP-299)

V.5/7/15

[1]Be advised that Waiver of Authorization for studies involving PHI requires approval from the covered entity’s Privacy Officer. This is separate from IRB approval.

*It is recommended that you submit translations once the pre-review and IRB review is near completion.