Welcome to the Lourdes University Institutional Review Board (IRB)

• What is the IRB?
• What Research Must Be Reviewed by the IRB?
• Who are the IRB Members?
• The IRB Review Process
• Meeting Schedules and Deadlines

What is the IRB?

The purpose of the Lourdes Institutional Review Board (IRB) is to protect the rights and dignity of persons who serve as research participants, and to promote excellence in research. The IRB reviews and approves all human subjects research proposals, whether conducted by Lourdes students, faculty, or staff; or by outside researchers using Lourdes as a research site, by applying human subjects. These standards include respect for autonomy, careful evaluation of the potential risks and benefits of the research, and fairness in the selection of research subjects.

What Research Must Be Reviewed by the IRB?

All research involving human subjects that is conducted by a Lourdes investigator (student, member of the faculty, staff or administration), or by an investigator from another organization who wishes to use Lourdes University as a research site, must comply with federal and college requirements for the protection of human subjects. The Lourdes University Institutional Review Board (IRB) is responsible for ensuring that all Lourdes research meets these requirements. Therefore, any investigator who plans research associated with Lourdes must first apply to the IRB for review and approval of their research. The Lourdes IRB protects the rights of human research subjects and supports excellence in research endeavors. (1.11.1.2 Institutional Review Board)

Research Conducted by Students: Students will work closely with their instructor and/or faculty advisor to develop a research application and to conduct the research. The student, faculty advisor and program director must all sign the IRB application to provide assurance that human subjects research requirements will be met.

1. Capstones, independent study, and personal scholarship: All independent research projects conducted by a student principal investigator must be submitted to the IRB for review and approval. No research activities (including, but not limited to interaction with subjects, gathering preliminary data, or pilot studies) may begin until the investigator has received an approval letter from the IRB.
2. Classroom Projects: Classroom projects or assignments that involve systematic data gathering from persons who are not members of the classroom, including surveys, interviews, focus groups and experiments must be submitted for IRB review and approval.
   At the option of the instructor, classroom projects involving only students from the class may be discussed with or submitted to the IRB.

Research Conducted by Faculty, Staff or Administration: Researchers are reminded that any project that gathers data by interacting with human subjects in order to contribute to generalizable knowledge must be submitted to the IRB for review. This includes preliminary studies as well as research applications in final form. Upon review, the IRB may determine that the project is exempt from further IRB oversight.

1. Pilot Studies, Preliminary Studies or Feasibility Studies
   Data gathering or subject interaction of any kind, even with a small group of subjects, requires IRB review and approval. The research application and informed consent process should indicate that the study is a pilot.
2. Research Involving Secondary Use of Data
   Projects that use human subjects data that has been previously gathered, whether from Lourdes or other sources, require IRB review and approval. If Lourdes data is to be used, researchers must include a Permission to Access to Lourdes University Institutional Data for Research form with their Application .
3. Research Conducted At Another Institution or Off-Campus Site
   Irrespective of the research site, any human subjects research conducted by any Lourdes student, employee, faculty or staff member requires IRB review and approval. Researchers using an outside agency as a research site should include an Agency Permission for Data Collection for a Research Project form.
   

The IRB Review Process

When a research application is received in the IRB Office, the following steps will take place.

• The IRB Office will check the application for completeness. If items are missing, the investigator will be informed and asked to submit them.
• The IRB Chair and/or designee will determine whether the application may be considered exempt from further IRB review, or whether it will be reviewed using an expedited or full IRB review process.
• Expedited reviews take 10 business days or less from the time the Application is complete.
• Full IRB Committee reviews take place on the 3rd Friday of the month. Follow up communications will be sent to the Investigator within 7 business days of the IRB meeting.
• The IRB will decide whether to approve the research without modification, require modifications prior to approval, table or disapprove the research.
• The results of the review will be communicated to the investigator (and faculty advisor, if applicable.) The investigator may respond in writing to any IRB stipulations.
• When the IRB has approved the research, the researcher will receive an approval letter and may begin the research. Under no circumstances may research begin until the IRB approval letter is received.

Meeting Schedules and Deadlines

The full IRB Committee meets on the third Friday of every month. Applications requiring full committee review must be placed in the IRB mailbox, c/o The Welcome Center in Russell J. Ebeid (formerly McAlear Hall) according to the dates listed below.

The meeting dates and deadlines for 2012-2013 are as follows:

• August 3  for the August 17 meeting
• September 7 for the September 21 meeting
• October 5 for the October 19 meeting
• November 2 for the November 16 meeting
• November 30 for the December 21 meeting
• January 4 for the January 18 meeting
• February 1 for the February 15 meeting
• March 1 for the March 15 meeting
• April 4 for the April 19 meeting
• May 3 for the May 17 meeting
• June 7 for the June 21 meeting
• July 5 for the July 19 meeting

Who are the IRB Members?

Chair

• Patrice McClellan, Ed.D., Director, Master of Organizational Leadership; Assistant Professor, Department of Business and Leadership (Non-Scientist)

Members

• LeRoy Butler, Ph.D., Director, Information Technology (Non-Scientist)
• Bob Campbell, M.A., Associate Professor, Department of Psychology (Scientist)
• Frank DiLallo, M.Ed., Ohio L.P.C., Safe/Drug Free Consultant and Diocesan Case Manager, Diocese of Toledo, Ohio; (Community Member, Non-Scientist)
• Joyce Litten, Ed.D., Chairperson and Associate Professor, Department of Social Work (Non-Scientist)
• Paul Longenecker, Ph.D., Assistant Professor, Business and Leadership Studies (Non-Scientist/Scientist)
• Nance Wilson, Ph.D., Director of Middle Childhood Education Program (Non-Scientist)
• Lynne Zajac, Ph.D., R.N., Associate Professor, Department of Nursing (Scientist) 

Ex Officio

• Deborah Schwartz, Ph.D., Dean of the Graduate School (Non-Scientist)

The Research Application Form

The required PDF Application Form is located on the left side of the main page. This form must be used for research proposals initiated in Spring Semester, 2011.

Other Forms

Sample consent forms and other documents that may be required are located on the left side of the main page.

IRB Information and Education

Links to ethical standards, federal regulations and definitions are provided on the left side of the main page.

Required Researcher Education

The link for the Collaborative Institutional Training Initiative (C.I.T.I.) is found on the left side of the IRB main page. Beginning with January, 2011 only C.I.T.I. education will be accepted.