IRB Submission Instructions

As of July 18, 2016, all IRB/clinical research submissions should be done through IRBManager.


Click here to access IRBmanager for all IRB submissions.

Is it Research?

If you would like the IRB to determine whether your project requires IRB review, please submit a Human Subjects Research Determination Request through IRBManager. A link to IRBManager can be found on the right side of this screen. Once logged in to IRBManager, the form can be found on the left side of screen, under “xforms.”

Instructions for submitting through IRBManager
Change of PI Modification New Study (Exempt)
Chart Review Progress Report
Emergency Use of a Test Article Reportable Event
Expedited or Full Board New Study Request to use an External IRB
Final Report Respond to IRB Comments
Humanitarian Use Device Sign off as Department Chair
IRBManager Status Definitions Sign off as PI
Modification
(including personnel other than PI)

Miscellaneous forms that are not found in IRBManager
Enrollment Report Use this form for initial submissions and progress reports to indicate the target/actual enrollment of each ethnic category for your site Updated 5/17/13
Data Use Agreement for Research For use with a limited data set Updated 3/20/17
Optional Authorization for Research Contact Use this form to obtain optional authorization to contact patients about future research studies Updated 5/6/13
External Site Questionnaire Submit this form if an external site wants to rely on Northwell Health for IRB review  Updated 10/18/18
SMART IRB Letter of Acknowledgment Use this letter to document an external site’s reliance on Northwell IRB under the SMART IRB Agreement.  Updated   4/16/18
Individual Investigator Agreement Use this agreement to add a non-Northwell employee to your study (see guidance for applicability). Updated 9/17/18

Helpful Submission Tools

  • IRB Toolkit – This toolkit includes guidance on how to submit new study protocols to the IRB, as well as how to determine whether a study may be research or quality improvement/assurance, and if research qualifies for exemption or expedited review.
  • Top 10 tips for reducing the length of IRB review and approval process.
  • For information on collecting protected health information (PHI) in research, and storing data electronically, please click here.
  • IRB submission guidance and contact information

 Page updated 4/16/18