Levels of Review | Western Kentucky University

Human Subjects Regulations Decision Charts

IRB Procedure

Western Kentucky University is committed to excellence in teaching, research, and public service. Concomitantly, the University is committed to the conduct of these activities with the highest possible ethical standards. The Institutional Review Board (IRB) of Western Kentucky University is responsible for reviewing all research and training projects proposed by faculty, staff, and students which involve humans as subjects. The IRB meets once per month.

Proposals seeking participants from vulnerable populations (minor, pregnant women, or prisoners) must be submitted for review by the 1st of each month by a WKU Faculty or Staff member.

IRB Process

The principal investigator prepares the IRB application according to the IRB guidelines.

The complete application packet is submitted through IRBNet.org. Once registered with IRBNet.org, application materials are to be found in the Forms and Templates section.

The application is logged in and receives a unique identification number. The principal investigator is notified via e-mail of the number and receipt of the IRB application.

The Compliance Coordinator conducts a Technical Review to determine that the IRB application is complete and contains the following:

Completed IRB application form;

Informed consent documentation (if informed consent is not required, verification of a request to waive informed consent is necessary);

A copy of the actual survey instrument, questionnaire, or data record form to be used in the project; and,

Signatures of the principal investigator (PI), co-investigators, and faculty sponsor (if student project) through electronic means in IRBNet.org.

Incomplete application packets will be returned to the principal investigator, with a memo stating deficiencies. Once corrected, these applications may be resubmitted for review.

Complete IRB applications will receive an Initial Evaluation by the Compliance Coordinator to determine content and impact of the project on human subjects. The Compliance Coordinator recommends to the IRB Chair one of the following categories:

Exempt from Review - the Compliance Coordinator provides written reasons for the exemption to the IRB Chair;

Expedited Review - the Compliance Coordinator provides written reasons for expedited review to the IRB Chair (only recommended if there is minimal risk to human subjects); or,

Full Board Review Required - the Human Protections Administrator and Compliance Coordinator provide copies of the application to all members of the IRB for review at the next Human Subjects Review Board meeting.

The full board meets once per month. If an application requires full board review, the principal investigator will be asked to make a brief verbal presentation of the application at the meeting, and to respond to IRB inquiries. A summary of projects approved for exempted or expedited review is reviewed by the full board at the monthly meeting and recorded in the minutes.

In all cases, disposition of the IRB application is forwarded to the applicant by the Compliance Manager within two weeks following the decision. Depending upon the type of review required, and whether or not any revisions must be made by the principal investigator, the decision may take from one day to one month or more.

Special Considerations

All student-initiated research projects, which are conducted outside of the classroom, require IRB review.

All Training Programs, regardless of source of funding (or unfunded), with a research component require IRB review.

All dissertation or thesis projects using human subjects require IRB review.

Continuing Review

Within a year following approval, the principal investigator will receive an email from IRBNet.org at 60, 30, and at the day of expiration. The principal investigator should complete the Continuing Review Form as soon as possible and return it to the Office of Research Integrity.
If changes (other than an extension of time) need to occur the principal investigator should complete the Continuing Review Form as soon as possible and return it to the Office of Research Integrity.

Revisions, Updates, or Modifications to the study after the initial application: Any and all changes require submission by clicking on the Project History button in the IRBNet.org submission to add new documents. This creates a -2 (and so on) to the previous submission IRBNet ID, and the WKU IRB will get everything verified. Modifications and requests for additional time to collect data require the use of the Continuing Review Form found in the Forms & Templates section of IRBNet.org.

The IRB may observe the project at any time.