Institutional Review Board (IRB) Approval

Institutional Review Board applications for all research and dissertations involving human subjects must be submitted to the assistant dean for research and the Ph.D. program for review after review and approval by your faculty advisor. All IRB applications must have the approval signature of the assistant dean before submission to the Office of Research Integrity. Depending upon the nature of the investigation, an application for exempt, expedited, or full review is submitted. You and your faculty advisor should determine which application is appropriate for your proposed study.

The memorandum that follows describes the process for accessing IRB information and forms via the Web.

No data can be collected until official written approval is obtained from the Institutional Review Board.
 
You also must identify and follow the procedures for study review and approval at the site(s) where your data will be collected.  You must inform the IRB when you complete your project.  If your study is conducted for more than one year, a yearly progress report must be filed with the IRB.  Also, if changes are made in the protocol or consent form, or if problems arise in the conduct of  the study, you must report them to your faculty advisor and to the IRB.
 
In consultation with your faculty advisor, your research must be determined as:

• Free of risk to human or animal subjects, and thus exempt from full review by the Institutional Review Board (IRB).
   
• Minimal risk to human or animal subjects, and thus, review by the IRB can be expedited.
   
• Risky for human or animal subjects, and thus, full review by the IRB is required.

College of Nursing procedures to prepare for each type of review are as follows:

Exempt - allow a minimum of two weeks for review and approval within the College plus an additional four weeks for receipt of written approval from the IRB.

• Submit one copy of the IRB application to the assistant dean for research and the Ph.D. program, who will forward it for review and approval by the College of Nursing representative to the IRB. If problems are noted, you and your faculty advisor will be informed, and you will be expected to make the necessary changes working with your advisor.  The representative then forwards the application to the assistant dean for research and the Ph.D. program for signature and approval.
   
• Once your application receives approval by the assistant dean for research and the Ph.D. program, you forward two copies to the IRB office at 311 Kinkead Hall and file one copy with the Office of the Assistant Dean for Research and the Ph.D. Program.
   
• You may not begin your study until you receive official, written approval from the IRB. When you receive final written approval from the IRB, file one copy of your approval letter with the assistant dean for research and the Ph.D. program.

Expedited - allow a minimum of three weeks for review and approval within the College plus an additional four weeks for receipt of written approval from the IRB.

• Submit one copy of the IRB application, including signature assurance sheet and instrument(s), to the assistant dean for research and the Ph.D. program.
   
• The assistant dean for research and the Ph.D. program refers problems to your faculty advisor, and you will be expected to make the necessary changes and resubmit to the assistant dean for re-review.
   
• Once the assistant dean for research and the Ph.D. program signs the Signature Assurance Form, submit two copies to the IRB office at 308 Kinkead Hall and file one copy with the Office of the Assistant Dean for Research and the Ph.D. Program. The IRB office will assign a reviewer to your proposal from the Medical IRB. When you receive final written approval from the IRB, file one copy of your approval letter with the assistant dean for research and the Ph.D. program.
   
• You may not begin your study until you receive official, written approval from the IRB.

FULL - allow a minimum of one month for review and approval within the College plus an additional four weeks for receipt of written approval from the IRB.

• Submit one copy of the IRB application, including signature assurance sheet and instrument(s), to the assistant dean for research and the Ph.D. program.
   
• When approved, the assistant dean signs the Signature Assurance Form. Then make 20 copies of the application and submit them to the Office of Research Integrity at 316 Kinkead Hall, and file one copy with the Office of the Assistant Dean for Research and the Ph.D. Program.
   
• Your faculty advisor should accompany you to the required meeting with the IRB.
   
• You will receive written notification from the IRB about the status of your application.  When you receive final written approval from the IRB, file one copy of your approval letter with the assistant dean for research and the Ph.D. program.
   
• You may not begin data collection until you receive official, written notice of approval from the IRB.

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