Institutional Review Board - Policy and Procedures

Introduction 

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.

Valparaiso University IRB Policy

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.  

For more information on Informed Consent, review the full IRB policy.

Ethics Training 

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:

http://phrp.nihtraining.com/users/login.php

Application Submission Information

Only paper copies will be accepted.  Please make sure all necessary signatures are included in the documents.

  • For exempt projects, provide the original documents
  • For expedited projects, provide the original documents, plus 2 copies
  • For full review projects, provide the original documents, plus 10 copies

Forward all required materials and questions to:

IRB

c/o Rasha Abed

Office of Sponsored Research

Arts & Sciences Building, Room 212

1400 Chapel Drive

Valparaiso University

Valparaiso, IN 46383

valpoirb@valpo.edu

Time Frame for Review 

An application may be filed at any time, and a response will be sent back as soon as possible. Please allow the following amounts of time for review during the main academic calendar:

Exempt review - 2 weeks
Expedited review - 3 weeks
Full review - 4-6 weeks

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 

  1. Sponsoring faculty members are required to educate students on the IRB process.
  2. Sponsoring faculty are required to help and guide students in completing their IRB applications.
  3. Sponsoring faculty members must sign off on the completed application prior to a student application being submitted to the IRB.  By signing off on the application, faculty members are acknowledging that they have educated students about the IRB process, have guided them through the application process, and have read students’ completed application and deemed it acceptable prior to submission to the IRB.
  4. IRB regulations do not differentiate between students and more experienced investigators.  Therefore, student applications will be reviewed with the same scrutiny as other applications.  Student applications that are lacking may result in additional review time and a student not being able to complete a project within an academic semester.

Short Summary of the IRB Process

  1. Investigators should use the IRB Questionnaire Form as guidance in determining if their project is subject to the IRB, and if so, which application form to file with the IRB.
  2. After completing the IRB Questionnaire Form, Investigators should fill out the proper application with complete information and required materials.  Investigators should include proof of ethics training for themselves and any co-investigators.
  3. Investigators should submit a completed application to the IRB and allow for sufficient time for review as described in Section VIII of the policy. Sponsoring faculty members should sign off on the applications for student investigators prior to submission.
  4. When requesting changes and/or continuing review, investigators should file a Request for Changes and Continuing Review Form with the IRB.
  5. When investigators complete their research projects, they should file an IRB Project Closure Form with the IRB.
  6. For research subject to expedited review or full IRB review, investigators should keep all signed Informed Consent documents (if applicable) for a minimum of three years after completion of their projects.

 

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.