Institutional Review Board
About the Institutional Review Board
The Institutional Review Board (IRB) is charged by the Le Moyne College Board of Trustees and the Vice-President for Academic Affairs with approving all research conducted under the auspices of the College that involves human research participants (or subjects). The IRB must assure that all research complies with the College’s policies and procedures regarding the ethical treatment of research participants. This includes the minimization of risks, implementation of the proper safeguards to protect participants, and requirement that the informed consent process complies with the standards established in College and federal government guidelines. Students and faculty planning to conduct research with human subjects must receive approval from the Le Moyne College IRB before they begin to recruit participants and carry out their research.
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
All researchers and faculty sponsors must complete a CITI course before applying for IRB approval.
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. Researchers should complete CITI training BEFORE they begin to prepare their IRB 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.
All researchers and faculty sponsors must complete the relevant CITI Program course. In addition, anyone who will interact with the research participants and/or their data (e.g., outside collaborators, lab assistants) are considered researchers from an IRB perspective and must complete CITI training. Applicants must include a copy of the CITI basic course completion report for all individuals identified above when submitting their application.
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. Researchers should complete CITI training BEFORE they begin to prepare their IRB 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.
All researchers and faculty sponsors must complete the relevant CITI Program course. In addition, anyone who will interact with the research participants and/or their data (e.g., outside collaborators, lab assistants) are considered researchers from an IRB perspective and must complete CITI training. Applicants must include a copy of the CITI basic course completion report for all individuals identified above when submitting their application.
- 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.
- 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.
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. The homepage for the CITI program can be found here.
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. The homepage for the CITI program can be found here.
Membership
Co-Chairs 2024-25
Dr. Gina Myers, Ph.D., RN, Dept. of Nursing
Dr. Matthew Loveland, Ph.D., Dept. of Political Science
Institutional Review Board Members 2024-25
Dr. Mitchell Franklin, Dept. of Accounting
Mr. Mark Godleski, Assistant Dean for Student Development
Brian Linnane, S.J., Dept. of Religious Studies
Michele O’Brien, Trinity Health (outside member)
Dr. Mounika Ragula (Information Technology)
Dr. Samantha Sassone, Dept. of Nursing
Patrick Witmer, student representative
IRB Fall Meetings
October 10
November 7
December 5
Form Cs must be submitted one week prior to the meeting dates in order to be considered at that meeting. Forms A and B have no deadline; they are accepted on a rolling basis and reviewed in the order received.
In order to have their application reviewed, researchers must submit all of the following materials (see the links on the right above for all IRB resources and forms):
- The signed Form A/B/C
- Research Outline
- All recruitment materials in their final form (e.g., fliers, emails/letters to be sent to potential participants, announcements to be posted on social media sites)
- All consent forms in their final form
- All surveys in their final form or a list of initial questions for semi-structured interviews (if applicable)
- A clickable link to online consent forms and surveys (if applicable)
- Signed administrative consent letters for projects that intend to recruit subjects and/or collect data at a site outside the College (if applicable)
Send all application materials as an email attachment in either Word or pdf format, including a copy of the signed Form A/B/C, to irb@lemoyne.edu. Unsigned forms will not be accepted. Because the IRB is required to maintain a copy of all application materials, they must be sent as email attachments. The IRB will not review documents that are shared through Google Docs or a similar platform.
