IRB APPLICATION INSTRUCTIONS

This document contains all forms required for submission of projects involving human subjects to the Institutional Review Board (IRB).

• Page 1&2: Investigator’s Statement of Assurance, Signature Page.  The completed pages including appropriate signatures should be submitted with the hard copy version of an application.
• Pages 3-7: Application.  These pages comprise the bulk of the application.  Each page has major headings (A-D) and several subheadings (numbered).  Each subheading is followed by a short description of what might or must be included in the application.  The principal investigator should fill out these pages by removing the short descriptions of what might be included and filling in the information as it pertains to their particular project.  If you have prior IRB approval from another institution, you do not need to fill out pages 3-7—complete pages 1&2 and submit the full application, supporting information and approval notification from the sponsoring institution. (Hard copy submission will be sufficient—see below.)
• All applications or renewals must include IRB training certificates from the IRB computer-based training course found on the following web site: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp . Please include only a copy, keeping the original for your records.  Please note:  A copy of your training certificate is part of the required documentation for each proposal.

Supplemental Information:

 All applicants should submit a copy of the information letter or signed consent form that will be  distributed to each person in the study.

All applicants should submit signed waivers or consent forms from groups or institutions who are sponsoring the project (example: a school board, hospital, etc.), if appropriate.

If an applicant is submitting a survey-based project, including a copy of the survey instrument may be required by the IRB.  It is in your best interest to submit a copy of the survey instrument with the application.

Submission:

            Please submit your application and all appropriate forms to the appropriate Sub-            Committee Chair for your college:

Or, if your college/department does not fit within the above specifications, submit your application with all appropriate forms to:

Dr. Theresa S. Kay, Chair of the IRB Committee

Weber State University

1202 University Circle

Ogden, UT 84408-1202

tkay@weber.edu

The IRB requests applicants submit their application in two different formats; an electronic file on disk and a regular paper version.  The electronic version is used to expedite approval of applications requiring a full IRB review and the hard copy, including signed forms, is maintained on file as an archive.

• Electronic Version: Either attach the completed file below to an e-mail and send it to tkay@weber.edu or include a diskette containing the document with the complete hard copy.  The IRB requests you submit your electronic file in Word Perfect format (8.0 or smaller).
  
• ***Macintosh Users:  Please submit your application using a PC disk and document format; preferably Word Perfect.  Note: We have had mixed results reading WORD files from Macintosh computers.  It is in your best interest to ensure we can read your application.

IRB APPLICATION FORMS

• Download Application Form and Instructions (Word Perfect Format)  (Save it to your computer and then open) 

• Download Application Form and Instructions (Microsoft Word Format)

• Printable Application Form and Instrucations (Adobe Acrobat)

Page Updated 20 Aug 2007