Submission and Review Process
On this page, you will find relevant information regarding how to submit a protocol to the IRB, as well as a few necessary steps to take before doing so.
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 investigators, faculty sponsors, or any research team members involved with a study must complete the required CITI training. The CITI training is an online course.
Based on feedback from Fordham researchers, the average time it takes to complete the training is:
- 1-2 hours for the Students Conducting No More Than Minimal Risk Research course
- 2 hours for the Refresher of Social and Behavioral Research Investigators course
- 2-3 hours for the Social and Behavioral Research Investigators course
- 4 hours or more for the Biomedical Research Investigators course
Submitting a Protocol
All submissions should be submitted through the electronic system, IRB Mentor. You may access Mentor IRB from your my.fordham.edu account by clicking the Institutional Review Board button located on the MyApps tab.
On the Info Page in Mentor IRB, you will find instructions on how to navigate the system, how to create a protocol, how to submit for review, forms/templates and other helpful information.
If you have any questions, please contact us by phone at 718-817-0876 or email us.
The Review Process
Once you submit your protocol through Mentor IRB, you will receive an email confirmation of receipt. Please allow up to 5-10 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 notified by email 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. You may read more about Expedited and Exempt criteria on our Categories of Review page.
Full Board Reviews
Your research protocol will be placed on the agenda of the next meeting of the full IRB. See the Full Board meeting schedule.
After the Review
The PI will be notified if anything further is needed 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.
After approval: if you plan on making any changes to your approved study.
Investigators are responsible for reporting any proposed changes to the IRB, including changes to the human subjects research protocol, measures, or informed consent documents. This applies to changes in the research design, changes to procedures that could introduce new or increased risks to human subjects, and anything which may change the nature of the research. Any such changes, or "amendments," require IRB review and approval before they are introduced into the research. Please visit Mentor IRB, download and complete the amendment summary form. Instructions on how to submit your amendment for review can be found on the Info Page on Mentor IRB.
You will receive notice when your study approval is going to expire. If you will be continuing your study, you must apply for renewal. Instructions for completing and submitting your continuing application and documentation, can be found on the Info Page on Mentor IRB.