Frequent Sponsor Request
Institutionally Required Consent Form Language
Summary of the contract between UW-Madison and WIRB
The University of Wisconsin - Madison, with cooperation of the Western IRB, has developed standardized language blocks that are institutionally required, UW/WIRB Template Language. The Western IRB will insert the institutionally required language in the consent form as appropriate.
Payment of IRB Fees
WIRB will directly bill sponsors for all studies submitted to WIRB on or after September 1, 2015. Please see https://kb.wisc.edu/hsirbs/17762 for more information.
Institutional Required Standards for Consent Document
- 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
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 Purview
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
- Institutional templates must be followed. Please see HIPAA Form Templates or contact a WIRB Gateway Team member for tissue banking templates.
- 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.
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
Please forward changes or documents to the research staff. The UW has an institutional hold for approval of all 'On Behalf" changes submitted to WIRB.