Institutional Review Board

Students and faculty planning to conduct research with human subjects must receive approval from the Le Moyne College Institutional Review Board (IRB). Information on the College’s Policies and Procedures and the guidelines for preparing the forms that must be submitted with an application can be found at the links located on the right side of this page under Resources for Researchers.

When planning your research project, please allow a minimum of 6-8 weeks between the date that you first submit your application to the IRB and the date that you plan to begin recruiting participants for your study. Getting IRB approval for a project takes time and involves a number of steps. These include an initial review of the application, soliciting revisions – which are almost always necessary, with many applications (especially from first-time applicants) requiring more than one round of revisions – and review of the revised application(s) before an approval can be issued. The time required for approval depends on a variety of factors, including the extent to which revisions are required, the time needed by researchers to make the necessary revisions, and the number of applications that are pending before the IRB. Final approval, even for exempt studies, must be received before researchers can begin to recruit participants and collect data.

CITI Training

The IRB will only accept applications from faculty, student, and administrative researchers who have successfully completed the Collaborative Institutional Training Initiative (CITI) Program online training course on human research participants protection. Faculty sponsors of student researchers must also complete the relevant CITI Program course. All researchers and sponsors must include a copy of the completion report for their course when submitting their application.

The purpose of CITI training is to help new and continuing researchers prepare applications that are in compliance with the College’s policies and procedures and the federal government’s guidelines for working with human research participants. This compliance is required by the College’s Board of Trustees and the New York State IRB. The CITI course modules define and explain the factors that must be taken into account when preparing an application (e.g., identifying potential risks, developing safeguards to minimize risks; providing the necessary information for obtaining valid consent from participants; distinguishing between privacy, confidentiality, and anonymity, etc.). The modules also provide numerous examples of how to apply the rules when developing research protocols, consent forms, and experimental interactions with research participants. Therefore, researchers and their sponsors should complete CITI training before they begin to prepare their IRB application. Finally, as researchers adopt new technologies for interacting with participants and analyzing their information, the guidelines are updated. The resources provided by the CITI program are therefore valuable in helping researchers stay current on the latest developments.

Instructions for registering for the appropriate CITI program course can be found here: CITI Instructions; please follow these instructions carefully as you complete the registration process. The instruction document takes you through Step seven of the CITI registration process, which contains 10 questions related to the particular CITI course(s) that you wish to register for; these questions contain all the courses currently available through the Le Moyne College subscription. The IRB requires only that researchers complete the relevant basic course in their field (Question 1 in Step 7). The remaining questions in Step 7 may be skipped (or you may respond “no” / “not at this time”) as long as: (i) your department / program does not require any additional training; (ii) you are not renewing CITI certification via a refresher course; and (iii) you do not have any other role on the IRB. PLEASE NOTE:

• If you are completing CITI training for the first time, you must take the basic course in your research field--that is, the basic course for Biomedical Research Investigators, Social & Behavioral Research Investigators, or Educational Researchers (Question 1 in Step 7 of the registration process). Do not register for a refresher course (Question 2) if you are completing CITI training for the first time.
• The refresher CITI course  (Question 2) is reserved for those researchers who completed a CITI basic course in the past and whose certification is set to expire or recently expired. The IRB will not accept completion certificates for refresher courses from researchers completing CITI training for the first time.
• The Responsible Conduct of Research course is an optional course that a researcher may take in addition to the basic course. The IRB will not accept completion certificates for the Responsible Conduct of Research course in lieu of the basic CITI course.

Contact the IRB at irb@lemoyne.edu

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