New Study Submission Forms Checklist

THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 http://humanresearch.gwu.edu/ New Submission Checklist (HRP-298) This checklist is intended to be a reference tool for researchers to use when preparing their IRB submission package. 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 [email protected]. 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, 13-17 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 Advertisements 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)

New Submission Checklist (HRP-298) V.6/11/15 THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 http://humanresearch.gwu.edu/ New Submission Checklist (HRP-298) 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)

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.

New Submission Checklist (HRP-298) V.6/11/15