Projects that do not meet the federal definition of research do not require IRB review. This tool was developed to assist the Ascension Wisconsin community in determining when a project falls outside of the IRB's purview because it does not constitute research, but does qualify as a Quality Improvement (QI) or Program Evaluation project.

NOTE: This tool is not designed to determine all cases when a project falls outside of the IRB's purview. This tool is only for determining if a project is QI/Program Evaluation. The Ascension Wisconsin IRB Office has additional resources that can help determine the need for IRB review and guidance on types of review and IRB submissions.

FOR RESIDENTS and STUDENTS: If you are a Resident at Ascension Wisconsin, check with your Resident Program Director before using this tool. Many programs require submission directly to the IRB as a training exercise. Additionally, colleges or universities may have additional requirements for students, check with your school to ensure you meet all applicable requirements.

Instructions:

  • Complete the requested project information in the questions below.
  • Select the appropriate answers to each question in the order they appear. Additional questions may appear based on your answers.
  • If you receive a STOP HERE message, the project will not qualify for the Self- Certification, follow the provided direction to contact the AW IRB for additional information and guidance.
  • If you do not receive a STOP HERE message, the completed questionnaire may be printed as certification that the project is "not research", and does not require IRB review. The AW IRB Office will not review your responses as part of the self-certification process. Responses are, however, maintained for quality assurance/improvement purposes.
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