UW-Green Bay QI Program Self-Certification Tool

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Survey Completion
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Name of Principal Investigator/Researcher

Project Title

Brief Description of Project and Goals for Research

College/Department through which the project will be conducted

Does the project you are conducting involve the testing of an experimental drug, device (this includes medical software or assays), or biologic?

Yes
No

STOP HERE. IRB review is necessary to address FDA requirements. Please contact the IRB via email at irb@uwgb.edu for more information.

The IRB website: https://www.uwgb.edu/institutional-review-board/

What does this mean?
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. For additional guidance review the official IRB website at www.uwgb.edu/institutional-review-board/ for more information.

Has this project received funding (Federal, or industrial) to be conducted as a human subjects research study? (If you are unsure, select Yes)

Yes
No

STOP HERE. IRB review is necessary to address FDA requirements. Please contact the IRB via email at irb@uwgb.edu for more information.

The IRB website: https://www.uwgb.edu/institutional-review-board/

What does this mean?
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. For additional guidance review the official IRB website at www.uwgb.edu/institutional-review-board/ for more information.

Is this a multi-site project? (Are multiple campuses participating? Is there a lead center or coordinating business? Is there a study-wide protocol?)

Yes
No

STOP HERE. IRB review is necessary to address FDA requirements. Please contact the IRB via email at irb@uwgb.edu for more information.

The IRB website: https://www.uwgb.edu/institutional-review-board/

What does this mean?
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. For additional guidance review the official IRB website at www.uwgb.edu/institutional-review-board/ for more information.

Is this an investigation designed to contribute to general knowledge (e.g. testing a hypothesis; randomization of subjects; comparison of case vs. control; observational research; comparative effectiveness research; or comparable criteria in alternative research paradigms)?

Yes
No

STOP HERE. IRB review is necessary to address FDA requirements. Please contact the IRB via email at irb@uwgb.edu for more information.

The IRB website: https://www.uwgb.edu/institutional-review-board/

What does this mean?
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. For additional guidance review the official IRB website at www.uwgb.edu/institutional-review-board/ for more information.

Will the results of this project be published, presented or disseminated outside of the institution conducting it?

Yes
No

STOP HERE. IRB review is necessary to address FDA requirements. Please contact the IRB via email at irb@uwgb.edu for more information.

The IRB website: https://www.uwgb.edu/institutional-review-board/

What does this mean?
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. For additional guidance review the official IRB website at www.uwgb.edu/institutional-review-board/ for more information.

The project appears to constitute QI and/or Program Evaluation and IRB review is not required
because, in accordance with federal regulations, your project does not constitute research as defined under 45 CFR 46.102(d). If the project results are disseminated, they should be characterized as QI and/or Program Evaluation findings. Finally, if the project changes in any way that might affect the intent or design, please complete this self-certification again to ensure that IRB review is still not required. Click the button below to view a printable version of this form to save with your files, as it serves as documentation that IRB review is not required for this project.

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