Fillable IRB Application for Human Research (Evidence-Based Practice) York (York College of Pennsylvania)

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IRB Application for Human Research (Evidence-Based Practice) York (York College of Pennsylvania)

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IRB Application for Human Research
(Evidence-Based Practice)
York College of Pennsylvania
Name of Primary Investigator
Date
Format:12/22/2014
IRB Number (for previous applications) Date of Original Application (if appropriate)
Title of Project
Names of Academic Advisors
Names of Co-Investigators (include institutional affiliations and contact information)
Email Phone Number
Please provide sufficient detail to allow readers who are not experts in your field to get a sufficient
idea of the risks your project may pose to those involved (patients, coworkers, etc.).
(1) What type of project do you wish to pursue? Check as many as apply.
(Note that the presence of a project type on this list does not warrant that such a project will
be acceptable in meeting York College's DNP Scholarly Project requirement.)
Administrative Practice Change Quality Improvement
Synthesis System Change Translational Research
Other
(2) At what site(s) will your project be conducted? Please be as specific as possible (for
example, specify the particular hospital, department, and/or unit.) If you are affiliated with this
site, describe your title and role.
(3) What is the goal of your project? What means will you use to achieve it?
What question are you seeking to answer, what intervention will you be examining, what subject
population are you examining, etc.?
(4) Special Considerations
If you will be doing any of the following in the course of your project, please describe:
randomizing subjects into different intervention groups; providing any intervention (including but
not limited to treatments, treatment regimens, pharmaceuticals, or medical devices) not normally
provided to patients at your project site; engaging in any practice that requires special approval
from site administrators or federal, state, or local government agencies; or delaying the analysis
of data or providing feedback to patients because they are part of your project.
(5) What previously collected data sources will you be relying on?
If you are relying on data previously collected at your project location, describe their nature and
scope. Examples may include (but are not limited to): patient charts, data collected at the site
from previous research projects, staffing data, data on usage of facilities, billing data.
As appropriate, it may prove helpful to identify particular data fields (e.g., if billing data includes
social security numbers).
(6) What new data will you be collecting?
(7) What kinds of confidential information will you be using?
This includes but is not limited to data that may be used to identify individuals, protected health
information, information about actual or expected criminal acts, information that could damage a
patient's professional prospects or personal relationships.
(a) If possible, please list the data fields, or else describe the types of confidential data you
reasonably expect to receive.
(b) How will data be protected during your project work and afterwards? Routine information
safeguards in place at your practical site need not be described here: focus instead on data you
will be collecting or that will be in your possession (on your computer or paper notes, placed by
you on external servers or analyzed using cloud-based systems, shared with third parties, etc.).
(8) What physical or health risks will your project impose on people?
Focus on risks to which people would not be subject if you were not engaging in this project, but
briefly describe routine risks involved in any procedures or actions involved in the study.
(9) Briefly describe the evidence that supports the change or intervention that you will
be implementing. Provide citations of the key literature (including anything cited
elsewhere in this application).
(10) If you be making use of any funding or resources not provided by your project site
or York College, please explain.
When submitting this application, please include any additional documentation that is required by
the nature of your project (e.g., informed consent documents, correspondence seeking
participation, etc.) or that will help the Board understand the relevant implications of your project.
Version Date: 8-8-16
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IRB Application for Human Research (Evidence-Based Practice) York (York College of Pennsylvania)

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Completed 25 July 2020

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