Herzing University’s Institutional Review Board (IRB) reviews all student healthcare improvement or innovation project protocol requests to determine if it is human subject research that meets definitions in The Common Rule and therefore requires review and oversight by the IRB. It is the investigator’s responsibility to give complete information regarding the planned improvement processes. After submitting the IRB application, the student will be notified in writing of IRB completed review signaling ability for the project to commence or if additional information and review relative to human subject protection is needed.

Checklist

Please make sure to submit the following items along with this application for your submission:

· This application with signatures from you and your DNP Project Faculty

· A copy of all questionnaires and surveys, if used

· A copy of your CITI Certification (free certification for Herzing affiliates through Canvas)

· A copy of the application and approval letter from any external IRB ( if applicable)

· Letter of approval from the Program Chair of the affiliated institution ( if applicable)

Institutional Review Board (IRB) Application for Healthcare Improvement or Innovation Project Approval

Step 1: Your Information

Project Title:
Doctorate Student Name:
Check One:	· Herzing University Student · Student not affiliated with Herzing University – list institution this project is affiliated with: __________________________________
Email:	Use your Herzing University email address here (not your personal one)
Primary Phone Number:

Step 2: Location, Faculty, and Date Information

Location/Sponsor:	Facility name where the project is going to be implemented – * Population Health/Community, Advocacy, Etc.
Faculty Information:	Faculty Name:
	Faculty Email:
	Faculty Phone:
Anticipated Start Date:
Anticipated Completion Date:

Step 3: Aim Statement Overview

Aim Statement

Construct the Aim Statement consistent with the guidance provided by the Institute for Healthcare Improvement accessed via link below:

https://www.ihi.org/sites/default/files/2023-11/IHITool_Aim-Statement-Worksheet.pdf

Use the IHI Aim Statement worksheet as your guide to constructing this statement. See link above.

Project Overview

Please provide a summary of the proposed healthcare improvement or innovation project including the purpose, proposed strategy to be utilized, proposed project measures that will be utilized to evaluate outcomes, and the anticipated/desired outcomes.

Open this section by providing an overview of the identified problem that is the basis for designing the student DNP/DNE project.

Provide information that demonstrates the problem exists in the project setting.

The purpose of the project is . . .

The proposed strategy that will be utilized in the project is . . .

Next you will outline the evaluative measures that will be utilized to evaluate the project outcomes.

https://www.ihi.org/resources/how-to-improve/model-for-improvement-establishing-measures

The desired outcome of the project is . . .

Below is a brief list of references that provide support for the project design of *****.

Improvement Framework

Please provide an overview of the improvement framework that will be utilized in the proposed project (e.g. KTA, PDSA, ADKAR, Lean, Six Sigma, DMAIC, etc.).

You may select a QI framework that resonates with you or that you feel is the most suitable ‘fit’ for the project.

I recommend that use of the PDSA framework as it is synonymous with IHI’s ‘Model for Improvement’ and is a very straight forward model to use. https://www.ihi.org/resources/how-to-improve

When using the PDSA framework access AHRQ’s PDSA Worksheet (see link below) and develop a narrative answer to EVERY prompt/question in the ‘Plan’ section only.

AHRQ PDSA worksheet

https://www.ahrq.gov/sites/default/files/wysiwyg/evidencenow/tools-and-materials/pdsa-worksheet.pdf

NOTE: for whatever framework/model/theory you select, you are required to provide an overview of each aspect of it and correlated that to the activities of your project.

Data Security

Please provide a description of your data security plan for both physical and electronic data that includes protected or identifying personal information. Include where the data will be stored, the security of the location or computer system, the length of retention of the data, and the method of disposition of old data.

The overwhelming majority of the student DNP projects will be designed such that Process measures will be utilized to evaluate the project outcomes. When properly designed, collection of information needed to evaluate the outcome of the project will not contain any protected or Identifying personal information.

This section will be structured to read as follows when your project design has no need to collect any personal information – in other words when the design includes only anonymous surveys.

The data collected, as a part of the project, will not include any protected or identified personal information. To avoid collection of personal identifying information, the surveys will remain anonymous and no personal identifiers will be collected on the survey.

The survey developed by the DNP student will be distributed to the project population using a Microsoft 365 Forms process.

The survey data will be stored in the DNP student’s Microsoft account, which is password protected. The data will be maintained for a minimum of 3 years after the completion of the project.

Or if your project design will result in the use of a ‘paper/printed’ copy of the survey, this section will be structured to read along the line of:

The data collected as a part of the project will not include protected or identified personal information.

The surveys developed by the DNP student will be administered with the project population using a paper copy of the survey. Participants will be asked to complete the survey and drop it into a collection box. (You will need to determine if any type of identifying information needs to be collected with your paper survey – if you need to collect data in a pre/post test fashion then you will need to include this type of information To avoid the collection of personal identifying information, the survey will ask for the participant to create a survey ID using the first initial of their mother’s maiden name and their favorite number. If there is no need for identifying information, then include the word ‘anonymous’ in the first sentence in front of the word ‘surveys’.

Data will be stored in a drawer in the DNP student’s secured filing cabinet and will be maintained for a minimum of 3 years after the completion of the project.

When there is a need to be able to compare information collected from the same individual at different points during the project, this section will be structured to read along the line of the following:

The surveys that will be utilized as a part of the project will be created using a Microsoft 365 form process.

The data collected as a part of the project will not include protected or identified personal information. To avoid the collection of personal identifying information, the survey will ask for the participant to create a survey ID using the first initial of their mother’s maiden name and their favorite number.

Information from the project survey will be exported into the spreadsheet after each time it is administered to the project participants. Examination of the information will allow the DNP student to utilized descriptive statistical analysis.

The data will be stored in the DNP student’s Microsoft account accessible which is password protected. The data will be maintained for a minimum of 3 years after the completion of the project.

Below are the links to the survey(s) that will be utilized in the project:

*** here you will insert the link(s) to the surveys you developed in Microsoft (ensure that you select to shorten the link)

Step 4: Acknowledgement of Responsibilities and Signatures

Please note that:

· Any data collected from Herzing University students, alumni, faculty and/or staff and/or any other constituents for purposes of this project is proprietary. Any publication of findings may not identify or implicate Herzing University. Any external report produced on findings generated by this study, including any presentation or publication, may not identify, reference or implicate Herzing University in any way.

· Upon completion of the project, a copy of the final deliverable will be submitted to Herzing University.

· Any additional publications or presentations produced based upon this project will be submitted to Herzing University.

I certify to the best of my knowledge the information presented is an accurate reflection of the proposed improvement project.

Doctorate Student Signature: Date:

DNP Project Faculty Signature: Date:

DNP Program Chair Signature: Date:

Bev app revision

HLC Accreditation Evidence Document Herzing University

Title: Institutional Review Board (IRB) Application for Healthcare Improvement or Innovation Project Approval

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