Frequent Sponsor Request

Summary of the contract between UW-Madison and WIRB

Payment of IRB Fees

WIRB will directly bill sponsors for all studies submitted to WIRB on or after September 1, 2015. Please see the IRB Fee Policy for more information.

Institutional Requirements

  • Consent Form Language

    The University of Wisconsin - Madison, with cooperation of the Western IRB, has developed standardized language blocks that are institutionally required, as described on the Initial Review page. The Western IRB will insert the institutionally required language in the consent form as appropriate. This language includes:
    • Removal of all 'I understand' and 'Subject's responsibility' language if it is in the template informed consent document. The institution requires that these sections be re-worded, re-organized as a paragraph and/or removed from the consent document.
    • For all consent documents being sent to the WIRB, all authorization language and signature blocks for authorization will be removed from the consent document. UW-Madison is retaining purview of HIPAA authorization forms, WIRB will not have purview for this review. The institution requires that every consent form have a separate stand alone HIPAA authorization form.
    • Voluntary participation/no loss of benefits to which the subject is otherwise entitled language is present.
    • The number of visits, visit duration and the duration the subject will be enrolled must be present.
    • Sub-studies that are optional have opt in/out language and check boxes in the combined consent document.

  • Tissue Banking

    UW-Madison requires the disclosure of who will be maintaining the tissue bank, what the name of the bank will be, how long the tissue will be banked for, what type of testing will be done to the tissue and how the tissue will be destroyed. If your protocol or consent document does not provide this information the UW research team will request this information. This information is necessary to properly prepare the HIPAA authorization form that is required by the institution.
  • HIPAA Authorization

    UW-Madison is retaining purview of HIPAA authorization forms; WIRB will not have purview for this review. UW-Madison HS-IRBs Office will review and accept all HIPAA forms. WIRB will not review or have the HIPAA Authorization listed on their Certificate of Approval (COA). Institutional requirements for standalone HIPAA Authorizations include:

    • Institutional templates must be followed.
    • Combined authorization forms which include optional sub-studies are required to have opt in/out language and check boxes. These check boxes maybe located in either Section A or the Authorization Signature section of the document.

Initial Post Approval Review Service from WIRB

The Western IRB offers initial post approval document review to sponsors/CROs prior to release to UW-Madison. If you would like to take advantage of this service, please contact WIRB Client Services at 1-800-562-4789.

"On Behalf" of the PI Changes

Sponsors should forward changes or documents directly to the research team staff. The UW has an institutional hold for approval of all "On Behalf" changes submitted to WIRB.

Keywords:WIRB, sponsor, industry   Doc ID:18809
Owner:Mike B.Group:Western Institutional Review Boards
Created:2011-06-13 18:00 CSTUpdated:2017-10-19 14:32 CST
Sites:Western Institutional Review Boards
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