2.  The IRB application  The Review Process  Summary of Protocol  Appendixes  Informed Consent  Recruiting materials  Research Instruments  Other documents as needed

3.  The IRB application can be found on our website www.xavier.edu/irb/forms.cfmwww.xavier.edu/irb/forms.cfm  Make sure all of the information is complete.  Check all boxes pertaining to the training and make sure to include a copy of the certificate of completion if there is not one on file in the IRB office.  Use the check sheet provided.

4.  The Principal Investigator prepares and submits the application packet.  A Technical Review is conducted.  The IRB chair or designee determines if the protocol has been submitted in the appropriate category for review.  There are three levels of review:  Exempt  Expedited  Full Board

5.  The Exempt review  Exempt review does not require further review by the IRB, however you must submit a protocol so that it can be reviewed to verify that it is an exempt protocol.  The Expedited review  Expedited review does not involve the whole IRB and thus can be completed in a shorter period of time than full board review. The rigor of this review is as comprehensive as a full board review. A letter granting approval or recommendations leading to approval usually will be sent within seven working days of receipt.  The Full Board review  If materials are received ten days before the next IRB meeting, the protocol will be discussed at the meeting and approval or recommendations leading to approval will be sent within two working days of the full meeting of the IRB

6.  Statement of the research, purpose and significance of the study  Research methodology and procedures including sample selection and size, recruitment of subjects (who and why, total number, inclusion/exclusion criteria, source, initial contact method), and data collection, analysis, and storage/destruction procedure (less detail required for exempt studies than expedited or full review studies)  Informed consent procedures. Informed consent is a process, not just a form. Potential subjects must be given information they need to make an informed decision to participate in this research

7.  Informed Consent  A sample informed consent is available on our website at www.xavier.edu/irb/forms.cfmwww.xavier.edu/irb/forms.cfm  Make sure that you include all of the requested information.  Recruiting materials  Research Instruments  Other documents  Debriefing form  HIPPA form  Letter of permission from study/recruitment site or data source