The Institutional Review Board (IRB) at Fordham University works cooperatively with researchers in the Fordham community to assure that standards are met for the conduct of research with human subjects. We work with investigators to modify projects so that adequate protection is ensured for its subjects' welfare and right of self-determination.
What We Review:
All research conducted by members of the Fordham community involving human subjects is subject to review and approval by the IRB. All external research which hopes to use the Fordham body for the recruitment of subjects is also subject to IRB review and approval. These statements remain true whether you are a member of Fordham's faculty, staff, or student body, and regardless of where the research is conducted, or of any funding that may be involved.
Why We Review:
The IRB reviews research projects which involve human subjects to ensure that two broad standards are upheld:
(1) that subjects are not placed at undue risk;
(2) that subjects provide uncoerced, informed consent to participate.
These principles are helpful to investigators as well, in that they also protect the validity of the researcher's findings.
(1) An application should be submitted at the research proposal stage: before any human subjects are recruited. Please see IRB Forms page for Initial Review Form.
As of 1/1/13, all faculty, staff, students conducting or overseeing human subjects research, must complete the required online CITI program and submit a completion certificate with new or continuing application.
Instructions for Registering and Completing CITI Course
(2) After approval: if you plan on making any changes to your approved study. Investigators are responsible for reporting any proposed changes to the IRB via email, 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. Click here for the Amendment Request Form.
(3) After approval: one month prior to your expiration, if additional data collection is necessary or if you need to close your study at completion. Initial approvals are issued for one year. All studies requiring additional time for data collection should be submitted to the IRB office for "continuing approval," which is an application for extension of an additional year. If your research is complete, a study closure should be submitted. When submitting a continuation, please email your continuation protocol and current consent form(s) (if you are continuing to collect data with human subjects) in MS Word format (not a pdf document) one month prior to your study's current expiration date. Please see IRB Forms page for Annual Review form.
This website provides information about the IRB process and its requirements for preparing and submitting a protocol for review by the IRB. You may use the links to the left to help navigate through this site, or the hyperlinks featured throughout.
If you have any comments or questions for us, you may email us at IRB@fordham.edu.
At the IRB, we are guided by the principles outlined in The Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The IRB policies and procedures comply with the rules and regulations of The Federal Policy for the Protection of Human Subjects as stated by the Department of Health and Human Services (DHHS) in the Federal Code, 45 CFR Part 46.
FWA Number: FWA00000067
Approved for use through 07/27/2016
IORG Number: IORG0000353
Approved for use through 09/26/2017
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).