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.
The principal investigator prepares the IRB application according to the IRB guidelines.
The complete application packet is submitted through IRBNet.org. Application materials are to be found in IRBNet.org in the Forms and Templates
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;
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
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
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)
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
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.
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.
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 has
been submitted. Submit updates and revisions 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.
Financial Conflicts of Interest and Research Objectivity: The Application for Approval of Investigations Involving the Use of Human Subjects will ask investigators to determine whether they or any other person responsible
for the design, conduct, or reporting of the research has an economic interest in,
or acts as an officer of or as a director of any outside entity whose financial interests
would reasonably appear to be affected by the research.