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HSRB 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 Human Subjects Review Board (HSRB) 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 HSRB meets once per month. Meeting times are announced each semester by the Office of Sponsored Programs. Proposals must be submitted for review by the first working Monday of each month.

HSRB Process

• The principal investigator prepares the HSRB application according to the HSRB guidelines. It is recommended that the College HSRB representative review the application before the application is sent to the Office of Sponsored Programs. To find the name of the representative for your college see a list of the members of the HSRB committee.
• The complete application packet is submitted to the Compliance Manager in the Office of Sponsored Programs.
• 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 HSRB application.
• The Compliance Coordinator conducts a Technical Review to determine that the HSRB application is complete and contains the following:
  • Completed HSRB 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), faculty sponsor (if student project), and Department Head. If the PI is a director or department head, then the PI's immediate superior should sign.

  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 HSRB 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 HSRB Chair one of the following categories:
  
  • Exempt from Review - the Compliance Coordinator provides written reasons for the exemption to the HSRB Chair
  • Expedited Review - the Compliance Coordinator provides written reasons for expedited review to the HSRB 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 HSRB 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 HSRB 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 HSRB application is forwarded to the applicant by the Human Protections Administrator 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 HSRB review.
• All Training Programs, regardless of source of funding, with a research component require HSRB review.
• All dissertation or thesis projects using human subjects require HSRB review.

Continuing 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 Sponsored Programs. The form still needs to be completed if data collection has concluded.
• The HSRB may observe the project at any time.

For further information regarding the HSRB, contact the Office of Sponsored Programs:

Compliance Coordinator : Mr. Paul Mooney , Human Protections Administrator
(270) 745-2129; Fax (270) 745-4211; E-mail: paul.mooney@wku.edu

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.