Research Compliance Services
INSTITUTIONAL REVIEW BOARD SUBMISSION CHECKLIST/FACE PAGE
PI Name: Unit Box:: Correspondent Name: Unit Box::
Protocol # (if known): Protocol Title:
Instructions: When submitting documents to the Institutional Review Board, please check off all that apply for this submission. Be sure to include the protocol number and all attachments as noted on this sheet. A Face Page is not required for InfoEd submissions.
Please indicate whether this submission is for an expedited or full review and check all documents that are being submitted. Be sure to include the correct number of copies as indicated and all applicable documentation. If incomplete, the documents may be returned to you.
New Expedited or Full-Board Review Protocol Application Submissions (IRB-1, IRB-7 or IRB-9):
Expedited Review or Full Board Review
1original,signed*Protocol Application (required). *Signed application required for paper submissions only.
1 Appendix A Form (required)
Provide 1 copy of the following documents that may be applicable to this research study.
Consent/Parental Permission Form(s)/Information Sheet(s) Grant Application
Child Assent Form Drug/Device Supplemental Form (IRB-1A)
Survey Instruments/Interview Questions Genetic Testing Supplemental Form (IRB-1B)
Recruitment Materials (Flyer, Email, Newspaper) Treatment Study Supplemental Form (IRB-1C)
Medical Procedure SOPsScreening Instruments
Debriefing Statements Other documents in support of protocol submission
New Request for Exemption Protocol Application Submissions (IRB-5):
1 Original, Signed* IRB-5 Protocol Application Form(required) Appendix A Form (required)
*Signed application required for paper submissions only.
Provide 1 copy of any of the following documents that may be applicable to the research study:
Consent/Parental Permission Form(s)/Information Sheet(s) Grant Application
Survey Instruments/Interview Questions Recruitment Materials (Flyer, Email, Newspaper)
Other documents in support of protocol submission
Revisions to address Requires Modifications to Secure Approval or Deferral Determinations – All submissions (IRB-1, IRB-5, IRB-7 or IRB-9):
Expedited Review or Full Board Review
1 clean (signed*) &1 track-change version of any documents revised. *Signed application required for paper submissions only.
1 copy of any new documents being added
* When submitting revisions to full review protocols by InfoEd, the 16 copies are not required(unless contacted by the IRB Office).
Re-Approval of Expedited or Full-Board Review Protocols (IRB-1, IRB-7 or IRB-9):
1 original, signed*IRB-2 or IRB-8 Re-approval/Termination Form(required)
If applicable, 5 signed copies of Consent/Parental Permission/Assent Forms with last names blacked out. (Provide 1 copy only for full board review)
*Signed application required for paper submissions only.
If still enrolling new participants, the following documents must also be submitted to be validated for the new approval period:
1 Copy of Consent/Parental Permission Form(s)/Information Sheet(s) / Assent Form(s) (clean, unvalidated copies)
1 Copy of Recruitment Material (clean, unvalidated copies)Other previously validated documents (e.g. phone scripts, letters, etc.)
Amendments – All submissions (IRB-1, IRB-5, IRB-7 or IRB-9):
Please note: Any change to an existing protocol must be approved by the IRB prior to its implementation. Please submit a complete document.
Expedited Review or Full Board Review
1original, signed* IRB-3Amendment Review Form (required). *Signed application required for paper submissions only.
1 clean and1 track-change version of all documents amended
1copy of any new documents being added
Adverse Event (IRB-4) Protocol Deviation (IRB-6) Reports – All submissions (IRB-1, IRB-5, IRB-7 or IRB-9):
1 original,signed*Adverse Event Report (required) or 1 original,signed* Protocol Deviation Report (required)
Research Compliance Services Receipt
Submitted Material Received by: Date Received: New Submission Assigned Protocol #______
*Signed application required for paper submissions only.
IRB Face Page – March 2014