IRB Application - Quality Improvement Project

Institutional Review Board

Date Date / MM / DD YYYY
1. Title of quality improvement (QI) project
2. Project Leader
Dept/University
Address Address
Street Address Address Line 2 City State / Province / Region Postal / Zip Code Country
Email
Phone Phone - ### - ### ####
PROTECTING HUMAN RESEARCH PARTICIPANTS

PROTECTING HUMAN RESEARCH PARTICIPANTS I certify that I have read the Waynesburg University IRB Guidelines and have completed PHRP or CITI training. My certificate of completion is attached here:
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3. Which of the following is the primary purpose for undertaking this QI project?

3. Which of the following is the primary purpose for undertaking this QI project? Quality improvement in local environment Discovery of new information to be generalized to multiple facilities (reconsider if research protocol application is more appropriate for this project) Publication or presentation of outcomes of this project Class project Other
4. In what facility will this QI project take place? (Upload approval letter from host facility or letter of commitment from administrative representative of the facility that indicates intent of facility to participate in and host this project).
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5. Projected Start Date 5. Projected Start Date / MM / DD YYYY

Note: No project may begin before approval by Waynesburg University's IRB.
Projected End Date Projected End Date / MM / DD YYYY
6. Problem Description
7. Available knowledge (bullet points with applicable research)
8. Purpose of Project including measurement criteria
9. Will any protected health information be accessed or collected by ANY member of this QI team? Please refer to the HIPAA Waiver form. If Yes, complete a request for IRB HIPAA Waiver of Authorization.

9. Will any protected health information be accessed or collected by ANY member of this QI team? Please refer to the HIPAA Waiver form. If Yes, complete a request for IRB HIPAA Waiver of Authorization.
No Yes
Elements of Protected Health Information to be accessed (check all that apply)

Elements of Protected Health Information to be accessed (check all that apply) Names Email addresses Social Security numbers Medical records numbers Fax numbers Health plan beneficiary numbers Account numbers Certificate/license numbers Vehicle ID & serial numbers, license plate numbers Device identifiers & serial numbers Web URL's IP Addresses Biometric ID's, including finger and voice prints Full face photographic images & comparable images All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, & their equivalent geocodes, except for the initial 3 digits of a zip code if, according to the current publicly available data from the Census Bureau All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older Any other unique identifying number, characteristic, or code, except as permitted in section immediately above
Describe why this project cannot be completed without accessing PHI or gaining consent of subject to whom PHI belongs (patient).
Describe your plan to protect the identifiers from improper use and disclosure.
PI Assurance

PI Assurance As project leader, I hereby assure that the Protected Health Information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project.
Describe alternatives/limitations to project design if access of PHI is not granted.
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10. Methods: Please provide a detailed summary of your proposed project, including consenting process and all other procedure elements.
A) Measures. Please list outcome measures. Include a description of how data will be obtained and evaluated.
B) Please list process measures. Include a description of how data will be obtained and evaluated.
C) Please list balancing measures (if applicable). Include a description of how data will be obtained and evaluated.
11. Are there any costs to the subjects for participating in this QI project (including emotional, physical, inconvenience, or monetary costs)?

11. Are there any costs to the subjects for participating in this QI project (including emotional, physical, inconvenience, or monetary costs)? No Yes (Describe costs to subjects below)
Describe all costs to subjects for participating in this project, including emotional, physical, inconvenience, or monetary costs.
12. Why do you think this project is quality improvement and not research?
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