Prior to submitting any research proposal to the Aurora IRB or the Wisconsin IRB Consortium (WIC), you are required to obtain administrative approval from the Patient-Centered Research Office. This approval is necessary prior to accessing Aurora data or specimens for research purposes, or conducting any research activities at Aurora. This administrative approval, allowing the research activities to take place at Aurora, should not be misinterpreted as IRB approval. You may only begin research activities upon receipt of a letter of Aurora IRB approval, or an appropriate written IRB deferral agreement from the Aurora IRB Manager.
The Aurora Research Subject Protection Program (RSPP) office will require written acknowledgement of this administrative approval be included with the IRB submission packet in order to begin the IRB review process. Please contact Vicki Soerens, Executive Assistant to the Vice President of Research & Academic Relations with questions or for assistance obtaining this approval. Vicki can be reached via e-mail or by phone at (414) 219-7328.
If your proposal is managed through Patient-Centered Research, the Director or Manager will be responsible for obtaining this administrative approval. A statement from the Manager or Director will be acceptable for this purpose and should be included with the submission of your research proposal.
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- Addition of Aurora Facility Form
- Application for Continuing Review/Final Report
- Unanticipated Problems Reporting Spreadsheet for Continuing Review
- Violation Spreadsheet for Continuing Review
- Protocol Exceptions Since Last Continuing Review
- Protocol Exceptions Flow Chart
- Delegation of authority log
- Exempt Protocol Submission Application
- External Unanticipated or Adverse Event Reporting Form
- Investigator/Key Personnel Conflict of Interest Statement
- IRB Protocol Submission Application
- A complete protocol is required for each submission. If the Sponsor has created a protocol please send with submission. If the study is investigator initiated, sample protocol templates are below.
- Local Unanticipated or Adverse Event Reporting Form
- Memo to Sponsors Regarding Aurora IRB's AE Reporting Policy
- Modification Form
- Urgent Modification Review Request Form
- Review Preparatory to Research and HIPAA Waiver Requests (502-A)
- Application for Review of Medical Records and/or Databases for Research Purposes
- Significant New Findings Reporting Form
- Significant Deviation/Violation Form
- Local Event Reporting Summary Memo
- External Event Reporting Summary Memo