The code block below illustrates how one might use # and // as comments in your logic and calculations.

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The value entered is not a valid Vanderbilt Medical Record Number (i.e. 4- to 9-digit number, excluding leading zeros). Please try again.

The value you provided must be within the suggested range

The value you provided is outside the suggested range

This value is admissible, but you may wish to double check it.

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This field must be a 5 or 9 digit U.S. ZIP Code (like 94043). Please re-enter it now.

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Required format:

3QvLn4xc2mYyjaSJFcIuZJMkKXfNx

Ascension Wisconsin IRB QI Self-Certification Tool

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.

Name of project lead/investigator

* must provide value

Project title

* must provide value

Brief description of project/goals

* must provide value

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Ascension WI facility/department through which the project will be conducted

* must provide value

Will the project involve testing an experimental drug, biologic, or device (including medical software or assay)?

* must provide value

Yes No

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Has the project received funding (e.g. industry or federal) to be conducted as a human subject research study?

* must provide value

Yes No

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Is this a multi-site project (e.g. there is a coordinating site, more than one site participating, and/or a study wide protocol)?

* must provide value

Yes No

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Does the project involve living embryos or fetus', fetal tissue or the use or study of any birth control methods?

* must provide value

Yes No

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Is this a systematic investigation designed with the intent to contribute to generalizable knowledge?
For example, does the project include: a hypothesis, randomization of subjects, comparison of case vs. control, observational research, comparative effectiveness research, etc.

* must provide value

Yes No

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

Yes No

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Will the project occur regardless of whether individuals conducting it may benefit professionally from it?

* must provide value

Yes No

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Is the project intended to improve or evaluate the practice or process within a particular institution or a specific program?

* must provide value

Yes No

reset

Date of determination

M-D-Y

STOP HERE
IRB review is likely required. See the IRB website or contact the IRB office for further guidance.

Project Lead: ______
Project Title: ______
Date of Determination: ______

You can get a copy of this completed determination below by downloading the pdf and/or entering your email address.

STOP HERE
The project does not appear to fit the definition of QI or Program Evaluation. See the IRB website or contact the IRB office for further guidance.

Project Lead: ______
Project Title: ______
Date of Determination: ______

You can get a copy of this completed determination below by downloading the pdf and/or entering your email address.

This project appears to constitute QI and/or program evaluation and does not fit the federal definition of research. Ascension Wisconsin IRB review is not required.

Project Lead: ______
Project Title: ______
Date of Determination: ______

The Project lead should ensure that anyone associated with this project are aware of the activities, including obtaining approval from the leader of the department/area(s) where the project will be conducted.

It is recommended that you refer to the project as QI/ Program Evaluation, and not research, in any future presentations/publication.

You can get a copy of this completed determination below by downloading the pdf and/or entering your email address. Please safe a copy of this determination for your records.

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.