Fordham University            The Jesuit University of New York
 


Frequently Asked Questions

 


How do I know if I need IRB approval?
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 if any funding that may be involved.

I am conducting research for a class project. Do I need to get IRB approval?
Research, as defined in Federal Regulations 45 CFR 46 and conducted by undergraduate and graduate students, is subject to federal regulations that require that all research protocols involving human subjects be reviewed by an Institutional Review Board. However, a number of schools and departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purposes of these course projects are to train students and to provide them with an opportunity to practice various research methods. These projects do not generally result in generalizable knowledge or publications and are not undertaken with these goals in mind. Therefore, the IRB does not consider them to be research and IRB review is not required. Such projects are considered "classroom exercises" and are typically quite limited in scope.

Please note the following restrictions:

  • Any data collected under these circumstances cannot be used for future theses or publications.  If the student might want to use these data for a future thesis or publication, the project requires IRB review and approval before the data are collected.
  • Any student-initiated and/or student-conducted research that is not a research practicum or internship, that uses human subjects, and that is undertaken with the intent to contribute to generalizable knowledge, requires IRB review and approval. This includes, but is not limited to, undergraduate and graduate honors, thesis, and dissertation research. 
  • All class research projects that involve protected groups as defined in Title 45 Code of Federal Regulations Part 46 (such as, but not limited to pregnant women, children, prisoners, institutionalized mentally ill patients) require IRB review even if there is no intention to publish results.

Please contact the IRB at irb@fordham.edu if you are still not sure whether your research requires review.


What type of review should I apply for?
The three different types of review are expedited, full board, and exempt. To determine which type of review you should submit your protocol for, review the descriptions here.

Remember that for expedited and exempt review, you must also specify the numerical category.

I have completed my Protocol. Is that all I need to submit?
Forward to 
irb@fordham.edu your completed protocol along with any informed consent letters, assent statements, etc. which are specific to your project to your project . Remember, every submission must include a copy of all research personnel's  CITI completion certificate.

Do I really need to take the CITI course?
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. Your submission will not be considered complete if it does not include certificates of completion from all participating researchers.

If you are taking the course for the first time, please take the Social/Behavioral Research basic course. Completion certificates expire after three years. If you have already taken the CITI course and it is not expired, please complete the Social/Behavioral Research refresher Course.

How long will it take me to complete the CITI course?
From the CITI website: "The average learner spends approximately 4.5 hours to complete the Basic Course site with approximately 5 logins to complete the course. The average learner requires approximately 2 hours to complete a CITI Program 'Refresher Course.'" Please note that these estimations are generous and it often takes investigators significantly less time to complete either course.

How can I utilize the student pool for my research?

In order to query the student pool for participation in your research, you must forward your IRB approved email script to Research@Fordham.edu and CC IRB@Fordham.edu. In the email body, please include the following:

  • Dates of IRB Approval.
  • The IRB Approved message to be posted (either in the email or in a Word document).
  • Indication as to which group of students in the pool you want your message sent. (undergraduates, all students, all graduate students, etc).

Please note that the student pool is updated at the beginning of each Fall semester. Requests are accepted one month after the first day of Fall semester.

 

When should an amendment be submitted to the IRB for review?

Once a study has been approved, if the investigator wishes to make a change to the approved protocol such as incorporating a different methodology of data collection, increasing the proposed number of subjects in the study, offering compensation, etc… an amendment should be submitted to the IRB.

 

The amendment form is available on our forms page. Please note, amendments should only be submitted on an approved protocol. If an application has been submitted and not yet reviewed and approved but the investigator wishes to make a change to the protocol, this is not considered an amendment. An email should be sent to irb@fordham.edu with an updated application if it has not yet been reviewed and approved, rather than submitting an amendment form.

 

 

Is the IRB “closed” over the summer?

The IRB office is open all year round, including summer time from Monday  through Friday, 9-5 (except on University Holidays and/or when the University is closed).

Full Board Submissions: There are no scheduled full board meetings for the months of June, July and August but submissions are still accepted for pre-review.

Exempt/Expedited Submissions: Are accepted and reviewed all year round as these submissions are not reviewed by the convened IRB.

How long will a review take once my application is submitted?

It varies as this depends both on the IRB and on the investigator. At certain times of the year, a large volume of protocols appear in the reviewing queue. Sometimes, the investigator needs to make modifications to the research and to the protocol as a result of the review.

Please find general times below:

Full Board Submissions: An application that requires full board review must be submitted by the submission deadline for the meeting in which the investigator would like the application to be reviewed at. The submission deadlines can be found on our Schedule of Meetings page. If the submission is complete, it will placed on the agenda for the upcoming meeting. The investigator can expect to receive a letter indicating the outcome of the review within five working days after the meeting.

Exempt/Expedited Submissions: Generally, from when an investigator receives a confirmation of receipt and completeness from the IRB, the investigator can expect to hear a response about the outcome of their review in 10-15 business days.

 

 

 

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