IRB Request and Approval Process

IRB Request and Approval Process For Western Carolina University

Step 1:
  Take the Collaborative Institutional Training Initiative (CITI) online course.

You may not conduct research at WCU without CITI training.  . Take the “Social/Behavioral Research Basic Course” or the "Biomedical Research - Basic Course" ONLY.  If you have previously completed the Basic Course, you may enroll in a Refresher Course.

Keep a copy of your completion certificate for your records.  DO NOT send the certificate to the IRB committee unless requested.  Your completion will be automatically noted in the system.

Step 2:  Consult the IRB meeting schedule.
Plan carefully to reduce the time required for a decision.  Turn your application at least ten days prior to an IRB meeting to be considered at that meeting.

For example, for a meeting scheduled for October 25, you should submit your application to the committee chair by October 15.
Because of the high volume of requests processed by the committee, any late submissions that require full board review will be considered at the next monthly meeting.

Step 3. Fill out a Request for Review of Human Subjects Research.

Follow all directions carefully.

Complete all items.  Failure to answer all questions fully will result in the delay of the approval of your application.

Your application must be written in a language understandable to members of the IRB from diverse disciplines and to the member from the community who sits on the IRB.  Assume no familiarity with your measures or methods on the part of reviewers.

Do NOT respond “see attached” to any of the questions on the application.  Attachments are not a substitute for answering any question in the IRB request.  Such applications will be returned to you asking for clarification, thus delaying approval.

Step 4:  Submit your IRB request and supporting documents to the office of research administration.

You may send the application with attachments and measures electronically to or via intra campus mail to “Research Administration, Cordelia Camp Building, Room 110, Western Carolina University, Cullowhee, NC 28723.

If you do not receive an e-mail message acknowledging receipt of your request within 3 to 5 business days, please contact our office at 828-227-7212. (Note: All requests sent by e-mail should be sent through WCU e-mail accounts only. Sending requests through other e-mail accounts such as yahoo or g-mail will cause the institution's spam filters to block them.)

The office of research administration will forward your application to the respective IRB liaison for your department. The IRB liaison will communicate with the Principal Investigator (PI) notifying him or her of any clarifications, and determine the type of review that the application will undergo (e.g. expedited versus full board).  A smaller proportion of requests will require a full board review; those requests will be considered at the next IRB meeting.
The board may approve your request, ask for more information, or request changes to be submitted to the chair or departmental liaison.  It is also possible that your request will be denied.  In that case, a full explanation will be provided.

A larger proportion of requests require only an expedited review.  In that case, the chair or your departmental liaison will return any comments to you via e-mail.  Concerns should be addressed and returned to the liaison for approval. The determination whether the review is expedited or full board, can ONLY be me made by an IRB member not the researcher.

Step 5:  After receiving final approval, the departmental liaison or chair will copy the PI and to archive the proposal.
Step 6:  Collect data. Studies may only be conducted after receiving final IRB approval. 


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