Eligibility


What Research is Eligible for WIRB Review?

What research is eligible?

  • Studies initiated by a for-profit industry sponsor, including studies that are observational and/or minimal risk
  • Research designed to evaluate, prospectively, the safety and/or effectiveness of new drugs, dietary supplements, devices or behavioral interventions
  • Research using a protocol designed and written by the study sponsor
  • Studies involving the testing or evaluation of devices in which the industry sponsor holds any applicable IDE
  • Studies involving the testing or evaluation of drugs or biologics in which the industry sponsor holds any applicable IND
  • Research involving Meriter facilities, records, or patients when both Meriter and the UW defer the study to WIRB

NOTE: The UW reserves the right to withhold any new research protocol regardless of industry sponsorship from being sent to WIRB for review.

What research is NOT eligible?

  • Investigator-initiated research
  • Research where a potential financial conflict of interest exists for any of the study team members as defined by UW-Madison policy
  • Unfunded or non-industry funded research, such as federal or private foundation support
  • Research involving the VA
  • Research wherein UW personnel use Meriter Hospital or Dean Clinics facilities, records or patients, unless those sites will defer review to WIRB as well
  • Research involving embryonic stem cells, gene transfer, or xenotransplantation
  • Research requiring review by the Institutional Biosafety Committee (e.g. recombinant DNA research and investigations that involve biohazardous materials)
  • Research intending to include prisoners as part of the target population
  • Non-therapeutic interventional studies

NOTE: In order for a study team to use WIRB, they must receive a UW tracking number from the UW Reliance Team. Please see "Step-By-Step Process" below.

Return to top


Training

Please note that WIRB Training is required for all new users and all new employees of study teams who will be engaged in WIRB regulatory processes. This training must be completed before you can begin any process involving a WIRB submission.

Please see Training for additional information on training.

Return to top


Step-By-Step Process

  1. The research team is contacted by an industry sponsor and receives the sponsor protocol and consent form(s).
  2. The research team fills out the WIRB Eligibility Worksheet to determine if the study qualifies for WIRB review.

    If you are having problems opening the WIRB Eligibility Worksheet in Mozilla Firefox or Google Chrome (NOTE: Internet Explorer does not appear to have issues opening the form), please contact your departmental IT to assist in changing your browser settings or click below.

    •   Instructions to Troubleshoot Opening WIRB Eligibility Worksheet

      • Mozilla Firefox Google Chrome
        1. Open browser
        2. Click "Tools"
        3. Click "Options"
        4. Select the "Applications" tab
        5. Under "Content Type", scroll down to "Portable Document Format"
        6. In the drop-down box to the right, select "Use Adobe Acrobat (in Firefox)"
        7. Click "Ok"
        1. Open Browser
        2. Enter "chrome:plugins" into the address bar
        3. Scroll to "Adobe Reader" (most likely greyed out)
        4. Click "Enable" (will no longer be greyed out)
        5. "Chrome PDF Viewer" should automatically disable

  3. The research team submits the WIRB Eligibility Worksheet and protocol to the Reliance Team via email (submitwirb@medicine.wisc.edu) when ready to submit the protocol for WIRB review.
  4. The Reliance Team forwards the WIRB Eligibility Worksheet and protocol received from the research team to the Pharmaceutical Research Center (PRC), which acts as an agent for the UW Hospital and Clinics, for review.
  5. If the PRC agrees the protocol can be sent to WIRB, the Reliance Team will email the identified point of contact for the research team to provide the required UW Tracking Number and indicate they can proceed with an initial review submission to the Reliance Team. For more information about the UW Tracking Number, see below.

NOTE: The Reliance Team does not review eligibility until initial review. To avoid being denied after consent and application submission, please ensure all questions on the WIRB Eligibility Worksheet are answered correctly. If you have questions about eligibility, please contact the Reliance Team.

Return to top


Assignment of UW Tracking Number

Protocols sent to WIRB are assigned a tracking number by the UW because the UW needs a way of tracking the study internally. This number should be used in communications with the UW Reliance Team.

  • Examples of tracking numbers:
    • 2015-5061
    • 2015-5021CPU

The tracking number contains the following information:

  • The first set of numbers reflect the year of initial review
  • The second set of numbers will always begin with 5XXX
  • Phase 1 studies will be identified with an additional suffix (CPU)

NOTE: Effective September 1, 2015, no "A" or "B" prefix will be included with a newly assigned tracking number. Already existing tracking numbers will not be impacted by this change.

Return to top


Deadline for Submission

There are NO deadlines for submission - you may submit any day of the week - and the HS IRBs office generally processes eligibility submissions within 7 business days from receipt.

NOTE: The submitwirb@medicine.wisc.edu email is not monitored on holidays or weekends.

Return to top


Contact for Questions

For general inquires, contact: submitwirb@medicine.wisc.edu.

For specific inquires, contact:

Elizabeth Jach, MA
IRB Facilitator
608-262-7564
ejach@wisc.edu

Mike Bingham, JD
IRB Facilitator
608-265-9792
mbingham@medicine.wisc.edu

Return to top




Keywords:new, confirmation, eligibility, submission, new application, new protocol, industry protocol, WIRB, wirb worksheet, qualify, COI   Doc ID:22374
Owner:Mike B.Group:Western Institutional Review Boards
Created:2012-01-24 13:46 CSTUpdated:2017-10-12 15:19 CST
Sites:Health Sciences IRBs, Western Institutional Review Boards
Feedback:  22   22