New Information about IRB approval
Federalwide Assurance (FWA): FWA00012669
About UI&U's Institutional Review Board
Union Institute & University’s Institutional Review Board (IRB) is an institution-wide committee responsible for reviewing and approving (or denying) research involving human subjects conducted under the auspices of the university. IRB guidelines and requirements apply to all research projects involving human subjects for which data collection began after November 1, 2003. All proposed research projects involving humans as subjects must have IRB approval prior to implementation.
The IRB is authorized to:
- approve proposed research activities;
- require modification to research activities;
- disapprove research activities;
- and conduct regular reviews of ongoing research.
Who is required to obtain IRB approval?
Anyone affiliated with UI&U—learners, faculty, staff, and others—who propose to conduct research that involves human participants is required to secure approval from the IRB prior to beginning their study. The requirement for IRB review and approval applies to all types of social and behavioral research projects and to registered learners in all degree programs. Research studies conducted as part of a course, seminar, or internship also need IRB review and approval if interaction with human subjects will be involved. Contact the IRB Coordinator to determine whether a specific research project needs IRB review and approval.
All academic approvals must be completed prior to submitting an IRB application and research proposal. Doctoral learners must have their doctoral committees', faculty advisors' or dissertation chairs', and Dean's approval of their culminating research proposals (dissertation) before the IRB will consider their IRB applications. Master's and Bachelor's learners need their faculty advisor's approval.
How were IRB criteria developed?
The IRB's criteria for research with human subjects stem from national standards, primarily The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (pdf), developed in 1979 by a national commission, and the Code of Federal Regulations Title 45 CFR Part 46 (Protection of Human Subjects) of the Department of Health and Human Services, Office for Human Research Protections (OHRP).
Who is on UI&U's IRB and how does it operate?
IRB members are appointed by the Provost. IRB members are faculty members who are committed to the ethical conduct of research and the safety of human participants in research studies. The IRB also includes one member external to UI&U and two non-scientist members. The IRB is cross-institutional (i.e., not college- or program-specific). The IRB meets or exceeds standards established by the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services. The IRB is registered with OHRP, and the Federalwide Assurance (AWA) number is FWA00012669.
The IRB's organizational structure and review processes are designed to ensure timely and consistent review of applications. The ten-member IRB meets monthly and reviews and approves proposed research studies during the monthly meetings.
2008 IRB Meetings – July to December: 3d Thursday of each month:
July 17 – Submit applications for Full Review by June 17
August 21 – Submit applications for Full Review by July 21
September 18 – Submit applications for Full Review by August 18
October 16 – Submit applications for Full Review by September 16
November 20 – Submit applications for Full Review by October 20
December 18 – Submit applications for Full Review by November 18
The IRB process is coordinated by Mary Ginn, Coordinator, Institutional Review Board. Contact the IRB.
How do I apply for IRB approval?
Before preparing an application for IRB review, become familiar with the criteria for IRB approval and the application requirements. Two key resources are available to help you: the CITI Course for the Protection of Human Research Subjects and the IRB's Handbook for Research With Human Subjects (pdf).
All IRB application research proposals are to be prepared according to the IRB Application Research Proposal Outline (FORM 540). This outline is available in a Word document and may be downloaded through the link below.
IRB approval is required for a Pilot Study or Test involving human subjects that will precede a full study. Approval for studies involving a pilot study and a full study is a two-step process: (1) Obtain approval for the pilot study. After the pilot study is completed, incorporate any changes resulting from the pilot study, such as changes to interview questions, and (2) Obtain approval for the full study.
Steps for preparing an IRB application:
- Complete the CITI Course for the Protection of Human Research Subjects. A completion report will be automatically sent to the IRB Coordinator. (Required)
- Review the IRB Handbook (available on the IRB Web site, or contact the IRB Coordinator to request a paper copy).
- Prepare your proposal using FORM 540 IRB Application and Research Proposal Outline. Follow the outline carefully to assure that your proposal incorporates all information the IRB needs to review and approve your study.
- Attach interview questions and/or surveys that you propose to use.
- Provide a link to any online surveys or questionnaires.
- Attach consent form(s) and other materials related to the informed consent process such as presentation scripts and translated documents. An outline recommended for preparing the informed consent form is available on the IRB Web site. (See FORM 495.)
- See the Informed Consent Web page for more information on the informed consent process, particularly regarding minor children (under age 18).
- Attach all recruitment materials (e.g., flyers, ads, letters, e-mail messages, Web site notices, etc.).
- Send the completed proposal to your faculty advisor, dissertation chair, or supervisor for review and approval. Your advisor, disssertation chair, or supervisor needs to sign the signature page or send a separate approval by e-mail, pdf with electronic signature, or regular mail.
- Undergraduate learners' faculty advisors will submit undergraduate learners' IRB applications to the IRB Coordinator. Graduate learners submit their applications and research proposals directly to the IRB Coordinator, preferably by e-mail to irb@tui.edu. Regular mail is also acceptable.
- Handwritten applications will not be accepted.
How do I contact the IRB?
Questions about the IRB may be directed to Mary Ginn, IRB Coordinator (irb@tui.edu).
Find out more:
- IRB Handbook for Research with Human Subjects – PDF
- Ethical Practice in Research
- Handbook and Forms
- IRB Application Research Proposal Outline Word format or PDF file
- Informed Consent form Word format or PDF file
- Extension Request form Word format or PDF file
- CITI Course for the Protection of Human Research Subjects
- Other Resources
