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Scientific Review and IRB Submissions

All IRB submissions, including Protocol Revision and Amendment Forms, must be submitted through the administrative offices of the Helfgott Research Institute. The IRB does not accept forms directly from investigators or researchers.

Forms

Investigators may download all the forms necessary for a complete IRB submission on the IRB Documents Page (in the left menu). Please note that a complete protocol must be submitted with these forms.

Student Researchers who are designing a study should be in close contact with Student Research Specialist, Morgan Schafer (mschafer@ncnm.edu), well before any IRB submission date.

Special Note to Student Researchers: Once you and your mentor have solidified your research proposal idea, please submit the Student Proposal for Scientific Review form electronically to the SRC Liaison. Once the SRC has received your Student Proposal for Scientific Review form, you and your mentor will be contacted by the SRC to schedule a meeting for discussion about your study design and to address any potential concerns. After the meeting and when all of your study documents have been finalized, all study documents are then resubmitted to the SRC for a formal review process.

Scientific Review and IRB Submissions

Complete IRB submissions must be sent, in electronic form, to Krista Bargsten (kbargsten@ncnm.edu) by the submission due dates listed below (the first Monday of the month, excluding holidays). If at all possible, please do not submit paper forms. 

As a matter of procedure, all IRB submissions will be reviewed by the Helfgott Scientific Review Committee (SRC) prior to its being sent to the IRB. Your protocol and all necessary forms and addenda should be considered final and complete upon their submission to the SRC. Use of the Document Checklist is strongly encouraged to assist investigators with their document submission preparations. During review, SRC members will work with you to make any appropriate revisions and edits. If the submission passes SRC review, applications are then sent, at the beginning of the following month, to the IRB for review.

Please note that this means that from the time you submit your application for scientific review to the earliest possible approval date by the IRB is about a month and half. An IRB deferment or "approval with modifications" will necessarily add to that turn around time.

Scientific Review Committee (SRC) submission due dates (first Monday of the month):

  • July 7 (for August 2014 IRB meeting)
  • August 4 (for September 2014 IRB meeting)
  • September 1 (for October 2014 IRB meeting)
  • October 6 (for November 2014 IRB meeting)
  • November 3 (for December 2014 IRB meeting)
  • December 1 (for January 2015 IRB meeting)
  • January 5, 2015 (for February 2015 IRB meeting)
  • February 2, 2015 (for March 2015 IRB meeting)

Full IRB Meetings are generally convened on the third Tuesday of the month.

Protocol Revision/Amendment Forms (PRAFs)

PRAFs (modifications to approved studies) must be sent electronically to the IRB Liaison, Krista Bargsten (kbargsten@ncnm.edu). The IRB does not accept PRAFs directly from investigators. Typically, a PRAF does not need to go through the full SRC review process. Assuming that it is accurate and complete, Helfgott will gather all PRAFs and forward them on to the IRB every two weeks for immediate consideration. However, if the modification is complex or may substantially affect human subjects, the PRAF may not be expeditable by the IRB Chair and will need to go to the next scheduled IRB meeting.

PRAF submission dates are every other Thursday as follows:

  • July 10, 2014
  • July 24, 2014
  • August 7, 2014
  • August 21, 2014
  • September 4, 2014
  • September 18, 2014
  • October 2, 2014
  • October 16, 2014
  • October 30, 2014
  • November 13, 2014
  • November 27, 2014
  • December 11, 2014
  • (no December 25 submission due to holiday)
  • January 8, 2015
  • January 22, 2015
  • February 5, 2015
  • February 19, 2015
  • March 5, 2015
  • March 19, 2015

Please Note: In order for a PRAF to undergo a full IRB review in a given month, it must be submitted by the IRB Liaison to the IRB by the first Tuesday of that month. If you have a concern that your modification may require full review, please be in contact with the IRB Liaison (kbargsten@ncnm.edu) to assure that your PRAF gets to the IRB in time for the next scheduled IRB meeting or you may need to wait for the following month's full review.