IRB Submission Checklist for Human Subjects Research

Three checklists are enclosed: one for an initial review, a second for a continuing review submission, and a third for a closure submission. The list is to be used as a guide. You may be asked for documentation that is not on the list.

Please feel free to contact Joselyn McLaughlin, PhD, the IRB Coordinator (973-676-1000 x3879) for assistance.

Please contact Sean Johnson (973-676-1000 x3879) about Safety/Biohazard Committee requirements.

Initial Review Submission

Please enclose an original & 19 copies for Full Board Review
or an original & 3 copies for Expedited Review
Note that the IRB Staff will determine if the submission meets
the criteria for expedited review. / 
Space cover page
Request to Review Research Proposal (pages 1 and 2)
Abstract (Page3)
Application to Undertake Research Involving Human Subjects
Institutional Support Letter(s)
Financial Disclosure form signed byeach investigator
Investigator Agreement form signed byeach investigator
Informed consent form 10-1086 with HIPAA Authorization and IDMC screening (if enrolling human subjects)
Attachment B (if requesting a HIPAA waiver)
Questionnaires and/or data collection tools
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Budget page (if a funded study)
CV/resume(s)
Please enclose an original & 4 copies for Full Board Review
or an original & 3 copies for Expedited Review
Protocol
Grant (if a funded study)
Investigator’s Brochure (if sponsor initiated)
Please enclose an original
10-9012 Investigational Drug Information Record (when applicable)

Continuing Review Submission

Please enclose an original & 19 copies for a Full Board Review
or an original & 3 copies for Expedited Review
Note that the IRB Staff will determine if the submission meets
the criteria for expedited review. / 
IRB Continuing Review Notice
Continuing Review/Closure Request
Updated Project Data Sheet
Updated Abstract
Informed consent form 10-1086 with HIPAA Authorization and IDMC screening (if enrolling human subjects)
Attachment B (if requesting a HIPAA waiver)
Questionnaires and/or data collection tools
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Please enclose an original & 4 copies for Full Board Review
or an original & 3 copies for Expedited Review
Protocol
Investigator’s Brochure (if sponsor initiated)
Please enclose an original
Human Research Scope of Practice
Please enclose a copy
Consent log plus copies of all consent forms unless scanned into the electronic medical records

Closure Submission

Please enclose an original & 19 copies for Full Board Review / 
Continuing Review/Closure Request
Updated Project Data Sheet
Updated Abstract
Any reports from Sponsor (if applicable)

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VANJHCS Checklist Version April 16, 2010