QI Determination Submission

"*" indicates required fields

Is the goal of the project to identify a new risk factor or to quantify an association between two factors that has not been previously reported in the literature?*

Yes

Unsure

Does the project aim to implement or increase compliance with a practice that falls within the current standard of care?*

Yes

Unsure

Is the project based on enough published evidence that other institutions are likely to independently implement a similar intervention?*

Yes

Unsure

Is this project specifically tailored to UCM/BSD so that knowledge from the outcome of the project is unlikely to be generalizable to other health systems?*

Yes

Unsure

Determination of Quality Improvement Application

Name*

First Last

Role*

Email*

Department*

Please specify department*

Are you a fellow or resident?

Fellow

Resident

Are you a student?*

Yes

What school?*

Who is your preceptor or mentor? Please discuss with them before submitting this form.*

What is your preceptor or mentor's email address?*

Does your project team contain a fellow, resident, or student?

Yes

What type?*

(i.e. resident, fellow, nursing student)

Is your team interprofessional?

Yes

Check all that apply:*

Medicine

Nursing

Pharmacy

Physical Therapy

Other

Other Team:*

Where is the Primary Location of the Project?*

Hyde Park

Ingalls

Other

All (enterprise-wide)

Other Location

Project Title*

Project description:*

(detailed enough to understand the major points of the project)

Describe why you believe this project is quality improvement and not human subjects research.*

Please include a few reasonably related references:

If you could not disseminate these results outside of UCM/BSD, would you conduct the work? How would it differ from what you plan now?*

Optional File Attachment

Max. file size: 2 MB.

The goal of this project is to improve care. All patients will receive the standard of care.*

Agree

Disagree

This project involves implementing care practices that are evidence- or consensus-based. It does not test an intervention that is beyond current science and experience.*

Agree

Disagree

If publishing or presenting your work, you are comfortable with the following statements in your methods section: “This project received a formal Determination of Quality Improvement status according to University of Chicago Medicine institutional policy. As such, this initiative was deemed not human subjects research and was therefore not reviewed by the Institutional Review Board.”

Agree

Disagree

Attestations:

Attestations 1*

I have provided correct, accurate, and truthful information above.

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Attestations 2

A member of my project team has completed the institution's required Human Subjects Research training (i.e. CITI program, NIH training)

Attestations 3*

If I have any further questions, I will reach out to the IRB and/or my department Quality Chief.

Attestations 4*

I understand that this process does not provide approval for resources to perform quality improvement projects or data extraction.

Attestations 5*

In all cases, I will follow institutional guidelines for information security and HIPAA guidelines. If I do not understand them, I will reach out to the Privacy office and to the Office of the Chief Information Security Officer for clarification.

Attestations 6*

I attest that I have read this policy in its entirety.

Attestations 7*

I agree to resubmit my project to this process should the procedures change.

Attestations 8*

I will not use data associated with this QI project for any other purpose.

Attestations 9*

A member of our team will be responsive to a 1-year check in

Signature

Signature attesting that all of the above information is accurate.

First Last

Date

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First Level Reviewer Status

I believe this project is quality improvement

I believe this project is human subjects research and should go to IRB

This project should not proceed through QI Determination for another reason

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First Level Reviewer Comments

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First Level Reviewer Name

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Second Level Reviewer Status

I believe this project is quality improvement

I believe this project is human subjects research and should go to IRB

This project should not proceed through QI Determination for another reason

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Second Level Reviewer Comments

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Second Level Reviewer Name

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Third Level Reviewer Status

I believe this project is quality improvement

I believe this project is human subjects research and should go to IRB

This project should not proceed through QI Determination for another reason

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Third Level Reviewer Comments

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Third Level Reviewer Name

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Avery Tung, MD

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Andy Davis, MD

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Ali Mansour, MD

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Margaret DeKoning

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Sara Wallace, MD

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Abbe Kordik, MD

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Julia Simon, MD

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Margaret Mueller, MD

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Peter Veldman, MD

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Melissa Pessin, MD

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Allison Bartlett, MD

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Randall Knoebel, PharmD, BCOP

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Royce Lee, MD

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Stanley Liauw, MD

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Jonathan Chung, MD

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Vivek Prachand, MD

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Judy Holleman

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Nicole Pierce

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Anne Pohlman

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Denise Scarpelli

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Heather Himelhoch

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Ryan Merkow

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Monica Gonzalez

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Peleg Horowitz

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HDSI

Determination of Quality Improvement Application

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