Mm irb application revision
Institutional Review Board (IRB) Application for Improvement or Innovation Project Approval
Herzing University’s Institutional Review Board (IRB) reviews all student 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:
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This application with signatures from you and your Project Faculty |
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A copy of all questionnaires and surveys, if used |
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A copy of your CITI Certification (free certification for Herzing affiliates through Canvas) |
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A copy of the application and approval letter from any external IRB ( if applicable) |
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Letter of approval from the Program Chair of the affiliated institution ( if applicable) |
Institutional Review Board (IRB) Application for an Improvement Process or Innovation Project Approval
Step 1: Your Information
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Project Title: |
Implementation of a Nurse-Led Fall Risk Assessment and Prevention Program in an Adult Day Care Center |
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Doctorate Student Name: |
Michelle Murray |
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Check One: |
☐ XX Herzing University Student ☐ Student not affiliated with Herzing University – list institution this project is affiliated with: __________________________________
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Email: |
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Primary Phone Number: |
267-945-1706 |
Step 2: Location, Faculty, and Date Information
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Location/Sponsor: |
Caring Hands Adult Daycare Center |
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Faculty Information: |
Faculty Name: Pamela Clifton |
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Faculty Email: [email protected] |
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Faculty Phone: 715-781-7778 |
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Anticipated Start Date: |
September July 2, 2026 |
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Anticipated Completion Date: |
January 1, 2027 |
Step 3: Aim Statement Overview
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Aim Statement Construct a succinct Aim Statement for the proposed project that also includes a brief description of the selected intervention/innovation. Utilize guidance provided by the Institute for Healthcare Improvement worksheet as an aid to guide your construction.
https://www.ihi.org/sites/default/files/2023 - 11/IHITool_Aim - Statement - Worksheet.pdf |
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The aim of this quality improvement project is to reduce falls among adult day care participants over a 6-month period through a standardized, evidence-based, nurse-led fall prevention program incorporating validated risk screening, individualized prevention plans, staff education, environmental safety assessments, and participant education. The project seeks to improve participant safety, reduce fall-related incidents, and enhance adherence to evidence-based fall prevention practices. From September through December 2026, a standardized, evidence-based, nurse-led fall prevention program will be implemented among adult day care participants aimed at reducing falls and improving participant safety. |
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Project Overview Please provide a summary of the proposed 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.
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Falls remain a significant patient safety concern among older adults attending adult day care centers. Older adults frequently experience multiple chronic illnesses, impaired mobility, balance deficits, cognitive impairment, medication-related side effects, and environmental hazards that increase their risk of falls. Falls often result in fractures, traumatic brain injuries, emergency department visits, hospitalizations, increased healthcare costs, fear of falling, and reduced independence (Centers for Disease Control and Prevention [CDC], 2024). Currently, the participating adult day care center does not utilize a standardized nurse-led fall risk assessment tool or evidence-based fall prevention protocol. Assessments are completed inconsistently, resulting in missed opportunities to identify participants at increased risk and implement preventative interventions. The purpose of this quality improvement project is to reduce falls and improve participant safety. The purposed strategy is implementation of a standardized nurse-led fall prevention program. designed to improve participant safety and decrease fall rates. The intervention includes standardized fall risk screening using the Morse Fall Scale, individualized fall prevention care plans, staff education, environmental safety assessments, participant and caregiver education, and ongoing monitoring of outcomes. ***Please review the tutorial- Project Overview within the email sent with this feedback and revise section below. Project outcomes will be measured by comparing baseline and post-intervention data including: · Number of participant falls · Percentage of completed fall risk assessments · Percentage of individualized fall prevention plans completed · Staff compliance with prevention protocols · Staff knowledge before and after education · Participant education completion rates The anticipated outcome is a reduction in participant falls, improved compliance with evidence-based fall prevention practices, enhanced staff knowledge, and improved participant safety. References Agency for Healthcare Research and Quality. (2023). Preventing falls in hospitals: A toolkit for improving quality of care. https://www.ahrq.gov/patient-safety/settings/hospital/fall-prevention/index.html Centers for Disease Control and Prevention. (2024). Older adult fall prevention. https://www.cdc.gov/falls Institute for Healthcare Improvement. (2023). Science of improvement: Testing changes. https://www.ihi.org LeLaurin, J. H., & Shorr, R. I. (2019). Preventing falls in hospitalized patients: State of the science. Clinics in Geriatric Medicine, 35(2), 273–283. Morse, J. M. (2009). Preventing patient falls: Establishing a fall intervention program (2nd ed.). Springer Publishing. Montero-Odasso, M., van der Velde, N., Martin, F. C., Petrovic, M., Tan, M. P., Ryg, J., Aguilar-Navarro, S., Alexander, N. B., Becker, C., Blain, H., Bourke, R., Cameron, I. D., Clemson, L., Delbaere, K., Duque, G., Ganz, D. A., Jansen, S., Kenny, R. A., Lamb, S. E., … Task Force on Global Guidelines for Falls in Older Adults. (2022). World guidelines for falls prevention and management for older adults. Age and Ageing, 51(9), afac205. Registered Nurses’ Association of Ontario. (2024). Prevention of falls and fall injuries in older adults. https://rnao.ca This is a website only and no information about falls
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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.).
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(Michelle Murray- Student Investigator)
***Please review the tutorial- Improvement Framework within the email sent with this feedback and revise section below. Plan: Student investigator will collaborate with the adult day care nurse, facility leadership, and designated staff to prepare for implementation of the nurse-led fall prevention program. Before implementation, the student investigator will review and collect baseline fall data from the previous three months using existing facility incident reports and will enter de-identified aggregate data into a project tracking spreadsheet. The student investigator will also develop staff education materials, a fall-prevention compliance checklist, a participant education log, and a standardized tracking sheet for project measures. Nursing staff will be oriented to use of the Morse Fall Scale and individualized fall-prevention interventions. Facility leadership will assist with staff scheduling, access to existing fall data, and communication regarding project implementation. The prediction is that standardizing fall-risk assessment and prevention practices will increase identification of high-risk participants, improve staff compliance with fall-prevention interventions, and ultimately decrease participant falls. Do: During the implementation period, designated nursing staff will complete the Morse Fall Scale for eligible adult day care participants according to the project protocol. Nurses will develop individualized fall-prevention plans for participants identified as being at increased risk and document completion on the project tracking sheet. Trained staff (Program Aides/Nurses) will conduct environmental safety checks and address identified hazards according to facility procedures. Nursing staff will provide fall-prevention education to participants and caregivers and document completion on the education log. The student investigator will provide staff education before implementation and will conduct periodic compliance reviews during the project. The student investigator will collect de-identified project data from the tracking sheets, education logs, environmental checklists, and facility incident reports. Study: The student investigator will review and analyze project data at predetermined intervals and at completion of the intervention period. Data will include the number of participant falls, percentage of completed fall-risk assessments, percentage of individualized prevention plans completed, staff compliance with the fall-prevention protocol, staff pre- and post-education knowledge scores, and participant/caregiver education completion rates. These are consistent with the outcome measures already identified in the application. IRB Application Quality (week 9).pdf Data will be entered into a password-protected spreadsheet and summarized using frequencies, percentages, and comparisons between baseline and postimplementation results. The student investigator will review findings with the project faculty mentor and appropriate facility leadership to determine whether the intervention produced the anticipated improvements. Act: Student investigator, in collaboration with nursing staff and facility leadership, will identify which components of the intervention were successful and which require modification. Strategies associated with improved assessment completion, staff compliance, participant education, and reduced falls will be recommended for integration into routine practice. Barriers identified through staff feedback, compliance audits, or project data will be reviewed and addressed. If goals are not achieved, the student investigator and project team will revise the affected component and recommend an additional PDSA cycle. Facility leadership will determine which successful practices can be incorporated into ongoing organizational policies and procedures to support sustainability.
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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.
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(This most likely will require revision was the above sections are completed) This project is a quality improvement initiative and will utilize de-identified aggregate data whenever possible. No participant names, dates of birth, medical record numbers, or other direct identifiers will be included in project reports or presentations.
Physical documents, if utilized, will be stored in a locked file cabinet within a secured office accessible only to authorized personnel. Electronic data will be maintained on a password-protected computer with encrypted storage. Access to project data will be limited to the student investigator, project faculty, and approved organizational leadership as necessary.
Data will be retained in accordance with organizational and university policies for a minimum of three years following project completion. Upon completion of the retention period, paper records will be shredded and electronic files will be permanently deleted using secure data destruction methods. No identifying information will be shared in publications, presentations, or project reports.
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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.
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Doctorate Student Signature: Michelle Murray
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Date: July 6, 2026 |
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Project Faculty Signature: Ikisha Jackson
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Date: July 6, 2026 |
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Program Chair Signature: |
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Date: |
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