Training - Researcher 2
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 must be submitted for review by the 1st of each month.
- The principal investigator prepares the IRB application according to the IRB guidelines.
- The complete application packet is submitted through IRBNet.org.
- 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).
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)
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 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, 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 a report form which asks if the collection of data is complete, or if there have been any changes to the project, especially in the treatment of human subjects. The principal investigator should complete the form as soon as possible and return it to the Office of Compliance. The form still needs to be completed if data collection has concluded.
- 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.
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