Valparaiso University’s Institutional Review Board (IRB) is an official committee of the University whose purpose is to protect the human subjects who are participating in research conducted by the faculty, staff, students, and other professionals affiliated with Valparaiso University.
Every university that has community members who perform research involving human subjects is required by law to have an Institutional Review Board. The processes used by the IRB are in accordance with the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46), the Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) regulations. The IRB functions to assess the scientific merit of research and its methods, to promote fully informed and voluntary participation by potential subjects, and to maximize the safety of subjects once they are enrolled in a project.
Investigators are responsible for understanding this policy and how it applies to their research projects.
Summarized information is included below regarding the IRB process. However, it is necessary to review the complete policy prior to submitting your application.
Authority of the IRB
When a research project application is submitted, the Valparaiso University IRB holds the authority to:
1. Determine if the IRB is applicable to the proposed research project;
2. Determine if the project is exempt from further review, subject to expedited review, or if it requires full IRB review;
3. Ask persons submitting an application to make revisions to the documents, procedures, and/or other materials related to the application;
4. Reject a submitted application entirely. In this case, the researcher may not conduct the proposed research project.
Researchers may not proceed with their research until given final approval by the IRB.
Does the IRB Process Apply to My Research Project?
For this IRB process to be applicable, the project must be “research” on a “human subject” (as these terms are defined in the Code of Federal Regulations).
“Research” is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
“Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains (a) data through interventions or interaction with the individual, or (b) identifiable private information.
If an investigator’s project does not meet both of these definitions, it is not subject to IRB review and no application needs to be filed with the IRB.
Categories of Review
Federal regulations categorize planned human subjects research into three categories:
1. Research that is exempt from further IRB review
2. Research subject to expedited review
3. Research requiring full IRB review
The three categories are described in detail in the full IRB policy. All protocols must be reviewed by the IRB Chair who establishes the appropriate category of review. Only the IRB can determine if a project is exempt or expedited research.
Investigators can use this IRB Decision Questionnaire Form to help them determine if their projects are not applicable to the IRB, are exempt, can be expedited, or require full review. For projects requiring expedited review or full IRB review, the regulations obligate the IRB to use certain criteria when determining if a project is approved or not.
Informed Consent (for Projects subject to Expedited Review or Full IRB Review)
Projects that require expedited review or full IRB review have higher levels of risk that vary from project to project. Because there are higher levels of risk involved, in most cases the law requires that Informed Consent be obtained from the participants. Exempt research projects do not require informed consent.
ALL submissions to the IRB must include documentation of investigators and co-investigators successfully completing human subjects’ ethics training. A link to the approved NIH training site is available here:
Application Submission Information
Only paper copies will be accepted. Please make sure all necessary signatures are included in the documents.
Forward all required materials and questions to:
c/o Rasha Abed
Office of Sponsored Research
Arts & Sciences Building, Room 212
1400 Chapel Drive
Valparaiso, IN 46383
Time Frame for Review
An application may be filed at any time. Please allow the following amounts of time for review during the main academic calendar:
Exempt review - 2 weeks
Expedited review - 3 weeks
Full review - Complete application materials are due by the 1st of each month to be reviewed during that month's IRB meeting. Allow 4-6 weeks for review and approval.
Investigators are responsible for giving the IRB adequate time to review proposals. Additional time may be required for review of IRB applications during the summer months. Not filing the proper application may also result in additional review time because the investigator will be required to re-file the correct application or make modifications to the current application.
Faculty Role in Projects with Student Investigators
Short Summary of the IRB Process
Full Policy and Forms
Investigators are responsible for reviewing the entire IRB policy. The following list includes more detailed information about the federal regulations, the levels of review, and appropriate forms.