Frequent Sponsor Request
Summary of the contract between UW-Madison and WIRB
Payment of IRB FeesWIRB 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.
- 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.