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~ Procedures for Submitting Protocols ~

 

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GENERAL PROCEDURES

  1. Protocols should be in typewritten form, and all items of the narrative statement (page 12) need to be numbered to correspond to each specific IRB requirement.

  2. Researchers should address all issues contained within this guide, indicating “not applicable” where appropriate.

  3. While department or college level reviews are not required, researchers are strongly encouraged to have their protocols checked by colleagues, faculty mentors, or IRB staff prior to submission to the University IRB.

  4. Adequate time is a necessity for the IRB to review protocols.

  5. A full IRB review may take a month to complete. Protocols must be received in the Office of Sponsored Projects at least two weeks prior to the next scheduled meeting.

  6. Completed protocols should be submitted to:

    IRB Administrator
    Office of Sponsored Projects
    320 Sherman Hall
    1 University Circle
    Macomb, IL 61455-1390

  7. IRB meeting dates and deadlines are available by calling the Office of Sponsored Projects at (309) 298-1191or e-mail at IRB-Administrator@wiu.edu.  

 

SPECIFIC REQUIREMENTS

  1. APPLICATION FOR UNIVERSITY IRB REVIEW - Needs to include all required information and appropriate signatures.

  2. Investigator’s NARRATIVE STATEMENT (see guidelines on page 12).

  3. INFORMED CONSENT FORM to be used in the proposed project (for survey projects, a copy of the survey instrument/questionnaire must be included). If a cover letter is utilized, that too must be included.

  4. Any supporting material/appendices that the investigator believes necessary for a thorough review of the proposed research protocol.

  5. COMPLETION CERTIFICATE for the U.S. Office of Human Subjects Research Computer Based Training (CBT) tutorial. When WIU submitted a Federal Wide Assurance (FWA), in the summer of 2002, the university guaranteed that all researchers who were including human subjects in research would complete the CBT tutorial. Upon completion of this tutorial, the researchers will be able to print out a “Completion Certificate”.

    • This certificate must be included as part of the protocol or on file in the Office of Sponsored Projects to be reviewed by the IRB. No protocol will be approved without this certificate accompanying the protocol or on file in the Office of Sponsored Projects.

    • The tutorial may be accessed at http://cme.nci.nih.gov/ on the internet. This will take you to the National Cancer Institute “Learning About Clinical Trials” page. Click on “Human Participant Protections Education for Research Teams.” Click on the “New User Registration” and follow the prompts through the tutorial. Follow prompts through ALL SIX MODULES.

  6. If the project is a graduate thesis or project, the student’s Thesis Committee must review and approve the protocol PRIOR to the IRB review. This is indicated to the IRB by the signatures of Thesis Committee members and the signature of the thesis advisor on The Support of Student Use of Human Research Subjects form. In addition, all protocols related to undergraduate research should be reviewed and approved by faculty advisors prior to IRB review.

  7. WIU IRB PROGRESS REPORT FORM – If a project continues for more than 12 months from the time of IRB approval, the investigator is required to file a renewal request and send it along with any required accompanying documentation, to the Office of Sponsored Projects, 320 Sherman Hall. It is essential that this be done before the one year anniversary date of the letter from the IRB which authorized the project to commence.

  8. Modifications to the research plan, subject pool, consent form or consent procedures, or any other significant changes to the study must be reviewed by the IRB. The WIU IRB Progress Report Form may be used to communicate such changes.

  9. Research conducted in cooperation with other agencies or organizations, e.g., University of Illinois, Illinois State University, Bridgeway, etc., may require review by those organizations’ IRBs and a letter of approval from the WIU IRB. Please contact the Office of Sponsored Projects IRB-Administrator@wiu.edu for advice in such situations.