Initial Review Guidance for WIRB Submission


Submission Process

See Eligibility for how to determine when a study is eligible for review by WIRB. Completing the eligibility process is required and generates the UW Tracking number necessary for an initial submission.

  1. The UW research team contacts WIRB Client Services at 1-800-562-4789 to determine type of initial application to submit. There are two types of applications:

    1. Submit New Investigator Site (protocol was previously reviewed by WIRB, and WIRB will give research team the WIRB study number)
    2. Submit New Study (protocol has never been reviewed by WIRB)

  2. You will be prompted to provide a name for the new submission. For the "Submission Name" include the UW tracking number first, followed by date of the initial application upload (e.g., 2015-5089, 9/14/2015). Note: The WIRB institution number for UW-Madison is 63182.
  3. The research team uploads a New Submission into WIRB Connexus which includes:

    • WIRB Initial Review Application
    • Billing Verification Form
    • Institutional Compliance Review Sheet
    • UW COI Form
    • UW CTA Form
    • Consent Form(s)
    • Shared Checklist
    • WIRB Consent Checklist
    • HIPAA Authorization form(s)
    • Protocol and supporting documentation

    See below for the copies of the required forms.

    NOTE: The UW Reliance Team will remove the HIPAA Authorization form(s), UW CTA, UW COI, UW-Madison Institutional Compliance Review Sheet, and Shared Checklist from Connexus before submitting to WIRB because they are for institutional review only.
  4. Click "Save and Submit Later."
  5. Research team invites study team key personnel who have WIRB Connexus submission privileges for the study. Please include the PI and any key personnel listed (e.g., manager(s) and/or back-up).
  6. Research team invites submitwirb@medicine.wisc.edu as participants to the study.
    •   Click for instructions on doing this in Connexus.

      1. In Connexus 3.0, go to "My Investigators" Page.
      2. Select the Investigator's name displayed under the "Get Investigator" button.
      3. In section 2, "Select Study," select the study for which you are looking to provide access.
      4. Click "Search" and scroll down.
      5. The "Submissions" tab will list the Connexus submission.
      6. If you select the "Submission ID" you will be directed to the submission profile where you can edit the unsubmitted submission.
      7. Select the "Manage Access" tab.
      8. Select your Investigator's name and then select the Manage Access Link.
      9. Please put "submitwirb@medicine.wisc.edu" in the email field, and select "Institution" for the Represents Field and "Manager" in the Access Level Field.
      10. This will prompt WIRB Connexus to notify the submitwirb emHorizontal ruleail inbox of the submission (and provides access for the Reliance Team to review the pre-submission). Please note that after this invitation has been made, no modifications should be made to any documents within the site workspace, except by the Reliance Team.

  7. The Reliance Team will review the submission to ensure institutional requirements are fulfilled prior to submitting to WIRB. Revisions may be requested via email by the Reliance Team to bring the submission in line with institutional requirements before it can be released to WIRB.
  8. The Reliance Team will release the research documents to WIRB for review when the submission is considered ready.


Submission Tips

  • The UW Tracking Number (e.g., 2015-5000) can be used as the "New Research" Submission Name.
  • Please upload the most recent version of your protocol with your WIRB Connexus submission.
  • Check WIRB Connexus for finalization of application submission.
  • If you have more than one consent and HIPAA authorization document for the study, please designate the difference between them.
    • Example: 2015-5000ICFPrimary.doc/2015-5000HIPAAPrimary.doc
    • Example: 2015-5000ICFSecondary.doc/2015-5000HIPAASecondary.doc

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Required Forms

  • Conflict of Interest (COI) Form - Assessment form for potential conflicts of interest for research involving human subjects.
  • HIPAA Authorization Form - UW-Madison retains purview of the HIPAA authorization. All HIPAA language must be removed from the consent form, and placed into a separate, stand-alone document.
  • Institutional Compliance Review Form - Please complete this form and upload in WIRB Connexus as part of your initial review submission.
  • Shared Checklist - A checklist that is utilized by the research team and the UW Reliance Team for guidance on institutional policies required by the UW for inclusion with all protocols. This document does NOT go to WIRB and is removed from Connexus by the UW Reliance Team during institutional review.
  • UW Clinical Trials Agreement (CTA) Form - The research team is required to review and certify that the consent form compensation for injury language is in line with the signed CTA. This form documents the PI's acceptance of this UW requirement.
  • WIRB Billing Verification Form - WIRB requires this form to be completed in order to bill industry sponsors. Please complete this form and upload in WIRB Connexus as part of your initial review submission.
    • NOTE: Please indicate "to be assigned" in the WIRB Study # and Work Order # fields.

  • WIRB Consent Form Checklist - A checklist that provides verification to WIRB regarding language specific to protocol activities that should be used within study consent document(s). This document is included in the submission to WIRB in Connexus. Please see the WIRB Consent Language Template as well.
  • Site Delegation Log - UW must sign-off on human subjects training for all key personnel. Please complete the site delegation log and attach in WIRB Connexus as part of the initial review submission.

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Training

Anyone listed as a study team member on the WIRB application who is engaged in human subjects research must complete human subjects protection and HIPAA Privacy Rule training for researchers. Prior to submitting the Initial WIRB submission, study teams must verify all study team members have completed required training:

  • CITI Human Subjects Training - The UW-Madison requires CITI training for UW personnel engaged in human subjects research.
    • Search the Research Certification Course Completion Database to review and print training certificates. NOTE: This requires a UW-Madison NetID.
    • Did you complete UW-Madison CITI training without a NetID? Here's how to request a merger of your new NetID account with your completed training account.
    • Did you previously take CITI human subjects training at another institution? Here's to get credit against the UW-Madison CITI human subjects training for training you previously took at another institution.

  • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Training - The UW-Madison requires HIPAA Privacy Rule training for those who are within the Health Care Component of the university or part of the Affiliated Covered Entity (UW-Madison and UW Health).
    • If a study team member's HIPAA Privacy Rule training cannot be verified in Research Certification Course Completion Database, please contact the Reliance Team.

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CVs and Licenses

WIRB requires the license and CV of the PI. WIRB requests the CV of all the Sub-Investigators. If any of this information is already on file with WIRB for these individuals, the license or CV is only needed if it is an updated version. Sponsor requirements may require license and/or CV submission of additional personnel.

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Keywords:WIRB, uw forms, connexus, WIRB connexus, naming conventions, cv's, cvs, license, licenses, training, citi, hipaa, application, submission, tips, help, help with initial, initial application, certificate look up, understand, WIRB Cover sheet, coversheet   Doc ID:18816
Owner:Mike B.Group:Western Institutional Review Boards
Created:2011-06-13 18:00 CSTUpdated:2017-10-23 09:16 CST
Sites:Western Institutional Review Boards
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