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Institutional Review Board

Institutional Review Board

Institutional Review Board

The Institutional Review Board (IRB) is the formal structure to review, approve, and monitor research conducted at St. Mary’s Medical Center by physicians, nurses, or students.

There are three categories of IRB reviews: exempt, expedited, or full board. Here at St. Mary's, each principal investigator (PI) of a new application is required to introduce the study or project under review. The introduction of the study needs to be 5 minutes or less.

The IRB meets every other month. New applications and annual reports are due 2 weeks prior to the meeting.

All student projects, research or non-research, that are conducted on any of the St. Mary’s campuses must have IRB approval before any data collection can be done. This includes collecting information from nurses, physicians, patients, medical records, or medical center databases.

Contact us:

IRB Chair                              Michael Klueh PhD EJD CPA FACHE FHFMA          812 485-6500
Administrative Asst.            Sheila Hawes                                                                 812-485-6500
Liaison                                  Rebecca P Winsett PhD RN                                        812-485-7134

 

IRB Meeting Date                                                            Meeting Packet Deadline

April 11, 2014                                                                   March 21
June 13, 2014                                                                  May 23
August 8, 2014                                                                 July 18
October 10, 2014                                                             September 19
December 12, 2014                                                        November 21

 

Steps for approval

  1. Understand the IRB guidelines by reading the St. Mary’s IRB policy
  2. After your research plan is complete or your student project is written and has faculty approval, submit the appropriate application form.
  3. All Principal Investigators and Student Project Leaders must complete a human subject protection course and submit copies documenting completion of the course. If you need assistance in finding a course, contact Rebecca P. Winsett PhD RN.
  4. Submit your completed application in one single document.  The order of the document is as follows:
    1. Cover letter
    2. Face page of IRB application with all appropriate signatures
    3. IRB application
    4. Reference Page
    5. Appendices
      i.    Appendix 1 should be the copies of all human subject protection certificates of all personnel listed on the Face page.
  5. If your study is supported by a grant or a multi-center study, submit a copy of the grant application, or a copy of the multi-center study protocol. The multi-center study protocol is NOT your IRB application.
  6. Submit the application in a single document to the IRB via email. The document can be emailed to Sheila Hawes
  7. Once notified that you are on the IRB agenda, please attend the meeting to describe your study and answer questions of the IRB.
  8. Once approval is received, you may start your study.
  9. During the first year of the study, the PI or project leader must submit a report at 6 and 12 month. To continue at study, an annual report must be submitted. No study may continue without annual IRB review.
  10. A closure form and an abstract of findings is submitted to close the study.

 

The following links are forms used to complete an IRB application. The IRB policy is included below for additional reference.  If you need any assistance, contact Rebecca P. Winsett RN PhD.

 

 

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