Fordham University            The Jesuit University of New York
 


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Procedural Highlights









   
 

All those who submit a research project to the IRB should be familiar with The Belmont Report for the ethical treatment of human subjects, Fordham's Guidelines and Procedures for the conduct of research with human subjects, and those federal regulations promulgated by the Office of Human Subjects Research  (Title 45 CFR Part 46).

     
  As of 1/1/13, all new and continuing research submissions must include a copy of the completion report from CITI, the human subject protection online course. This applies to faculty research, student research and their faculty advisors.

If you are taking the course for the first time, please take the Social/Behavioral Research basic course. If you have taken the course already, then you can complete the Social/Behavioral Refresher Course.
 
     
   SUBMITTING A PROTOCOL
   
 

To apply for approval, submit the IRB Protocol (initial review) form to the IRB via email.  Enclose the completed protocol and any informed consent letters as MS Word attachments to IRB@fordham.edu.  You must also send copies of any supplementary electronic materials, including site approval letters, and a copy of your CITI completion certificate to the IRB via email.  

If you are a student researcher, your protocol must have the relevant box checked.  This informs us that your faculty sponsor has previously read your submission in its entirety.  If your research will be used as part of your dissertation, please indicate the date of your successful dissertation proposal defense as well.

If you are uncertain what qualifies as research, please review the Definitions section of Guidelines and Procedures. The judgment about whether or not your research is exempt from review or qualifies for expedited review is an IRB decision. Therefore, all research, including research you believe exempt, must be submitted for review by the IRB.

If you have any questions, please contact us by phone (718-817-0876) e-mail (IRB@fordham.edu), or by selecting Contact Us in the left margin.

   
   THE REVIEW PROCESS
   
 

Once you submit your protocol, you will receive an e-mail confirmation of receipt. Please allow up to 5 working days for preliminary review of the protocol by the IRB staff  to assure all required information and documents have been included. If any additional information or documents are found to be missing from the protocol, you will be notifed by e-mail before the protocol can be reviewed either by the full board, via expedited review or exemption determination is granted.

Expedited or Exempt
Many research activities qualify for expedited review or are exempt. Under expedited review or exempt review, the member of the Board assigned as the primary reader approves your research.

Full Board Reviews
If a full board review is required, you will need to submit 3 additional copies of the protocol and all supplementary materials to the IRB.
  Your research protocol will be placed on the agenda of the next meeting of the full IRB (see Schedule of Meetings page). Please note that there is a cap of 5 protocols per meeting and protocols are reviewed on a first come first serve basis.

   
   AFTER THE REVIEW
   
 

A Report of Action is sent to the researcher after a review.  If changes are required, the report will detail them and indicate the IRB action as "approval pending."  Once the recommended changes are made to the satisfaction of the primary reader, the review process is complete and IRB approval is given.  

Following approval, you must notify the IRB of any changes in the structure, methodology, or application of your research.  Each approved project is reevaluated annually if an extension in approval is needed.

   
 
 

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