E-Submission

E-Review Submission Instructions

The IRB has implemented Electronic Review for ALL Submissions. Please note that in addition to the electronic submission, three (3) paper copies of the submission are also required to be submitted to the IRB office.

Full Board submissions (Greater than Minimal Risk studies): E-mail directly to the board (A, B or C see email for boards below). The Board it is submitted to is based on the deadline date. This should be done while concurrently submitting 3 hard copies to the IRB office. Email for Full Board submissions should be addressed to either

• Board A: irb-board-a@med.nyu.edu
• Board B: irb-board-b@med.nyu.edu
• Board C: irb-board-c@med.nyu.edu

NEW: Expedited and Exempt study submissions: Expedited and Exempt studies should not be submitted on full board submission deadline dates. E-mail directly to the new e-mail address listed below. This should be done concurrent with a submission of 2 hard copies to the IRB office. Once the IRB office receives your paper submission of your study a board will be assigned. The manager of the assigned board will contact you for follow-ups and updates for your study. This will assist with unnecessary delays in the pre-review and final review of your new study.

NEW: Expedited submissions should be e-mailed to IRB-New-Expedited@med.nyu.edu

NEW: Exempt submissions should be e-mailed to IRB-New-Exempt@med.nyu.edu* Do not use either email addresses above to submit amendment, continuations or any other submissions. Additional Submission Instructions

1. Obtain your NEW submission's R # (if applicable):
To obtain your new submission R #, please see the Office for Clinical Trials website for instructions.

2. Prepare your documents packet for submission. Place the given R# on all of your documents. Submit the packet of original documents and 2 hard copies to the IRB office for Full Board Review. For expedited and exempt, one packet of original document and 1 hard copy to the IRB office.

3. All documents submitted to the IRB in hard copy must also be transmitted electronically via email.

What to include in the email submission:

• Subject Heading
• R#
• Type of Submission (i.e. NEW, Continuation, Amendment, Personnel or Site Change, Reportable Event, Response) 
• IType of Review: please type either FB for Full Board Review, X for Expedited Review and E for Exempt
• PI Name 
• Board A, B or C: based on submission deadline schedule

Example:
To: irb-board-a@med.nyu.edu
Subject: R#07-876, NEW, FB, Smith, Board Ab) Body of the e-mail:
Specify the names of the documents submitted. It is important that they match the named hard copies submitted. Name them (ie Application, Consent Doc, Protocol, IB, Protocol Summary, Question, Advertisement, etc) and include the Version Date for all documents.) Documents required in E-Submission (Attachments):

All documents for which you submitted hard copies must be included in this email transmission. The IRB will accept documents saved in “pdf” format, however, we require that the application and consent forms be in Microsoft Word or Word Perfect format.

The e-review will allow for both the IRB staff during its pre-review of applications and the membership’s full board review to incorporate their recommended CONSENT DOCUMENT editorial changes via track changes. PI’s acceptance of these directed changes will be sufficient to advance protocol approval, providing other modifications are not required.

This will significantly minimize the administrative time and effort associated with responding to the IRB dispositions post meetings. The IRB will generally mark up the consent documents and at times provide alternative suggestions for the application.  

Examples by submission type:
New Study submissions:
-Application and Appendix if applicable, Consent Docs, Protocol, Protocol Summary, Investigators Brochures if applicable, Manuals, Questionnaires, Advertisements, etc.

Continuations:
-Application, Clean Consent Docs, Previously Approved Consent Docs, Protocol, Protocol Summary, DSMB reports, IB etc.

Amendments:
-Application including a detailed rationale, Clean Consent Docs if applicable , Previously Approved Consent Docs if applicable , Protocol, Protocol Summary, IB etc.

Responses:
-Response Letter from the IRB signed by the PI, Application, Consent Docs, Protocol, Protocol Summary, Investigators Brochures if applicable, Manuals, Questionnaires, Advertisements, etc.

4) Limit email to under 9mb -if necessary forward 2-3 emails when your documents amount to greater than 9 mb of space.

5) Projects that are DEFERRED by the full board at this time may not include tracked consents as the IRB generally requires clarifications in addition to consent form changes for re-review at a convened meeting.

6) Signed applications do not need to be scanned when forwarding via email as the IRB staff will have signed applications on file when the hard copies are received.

7) Make certain to submit the hard copies on or about the same time you forward your submission via email as this may contribute to a delay in the pre-review of studies. Submissions will be considered and logged in ONLY after BOTH hard copies along with electronic submissions have been received by the office. Please respond to IRB staff inquiries for email submission of documents as quickly as possible.

8) Notify appropriate board staff if your protocol or IB cannot be scanned.