Order ID | 53563633773 |
Type | Essay |
Writer Level | Masters |
Style | APA |
Sources/References | 4 |
Perfect Number of Pages to Order | 5-10 Pages |
Quality Improvement Using DNP Project
Quality, Improvement, Using, DNP, Project
DNP Project Team Determination: Quality Improvement Project or Research
This form is to be filled out by the student at the time the IRB application is filled out. All
students will fill out the IRB application as this experience will provide insight into the
IRB process. This decision form will then be used to guide the student and the project
team as to whether the IRB application should be submitted to IRB.
Although all IRB applications should be submitted to the course drop-box, IRB
applications are only submitted to the IRB for review when they are determined to be
research (not quality improvement) and involve human subjects.
All DNP Projects regardless of methodology must uphold the highest standards of
ethical practice including confidentiality and privacy as described in the ANA Code of
Ethics. Accordingly, basic principles of ethics, confidentiality and privacy must be
addressed and maintained in each phase of the DNP Project implementation. Methods
for maintaining such should be described in full detail within body of the DNP Project
Paper.
If the determination is made that the DNP Project is a “Quality Improvement Project”,
then the project should be referred to as such in all future communications both in
writing and verbally.
“Quality Improvement Projects” should not be referred to as research or research
projects. In addition, these projects are not subject to any form of IRB review.
Additionally, the student should not make any claim in writing or verbally of IRB
exemption status, acceptance, or review in such projects.
Section A should be completed and submitted by the student. Section B should be
completed by the faculty.
SECTION A:
Student Name:
______________________________________________________________________
DNP Project Title:
____________________________________________________________________
DNP Project Instructor:
_______________________________________________________________
Academic Mentor:
___________________________________________________________________
Quality Improvement or Research Worksheet
Rachel Nosowsky, Esq.
ITE
M Issue and Guidance Rati
ng
1
Are participants randomized into different intervention groups in order to
enhance confidence in differences that might be obscured by nonrandom
selection? Randomization done to achieve equitable allocation of a scarce
resource need not be considered and would not result in a “yes” here.
___
_
YES
___
_
NO
2
Does the project seek to test issues that are beyond current science and
experience, such as new treatments (i.e., is there much controversy about
whether the intervention will be beneficial to actual patients – or is it designed
simply to move existing evidence into practice?). If the project is performed to
implement existing knowledge to improve care – rather than to develop new
knowledge – answer “no”.
___
_
YES
___
_
NO
3 Are there any potential conflicts of interest (financial or otherwise) among any
researchers involved in the project? If so, please attach a description of such
in an attachment to this form.
___
_
YES
___
_
NO
4 Is the protocol fixed with a fixed goal, methodology, population, and time
period? If frequent adjustments are made in the intervention, the
measurement, and even the goal over time as experience accumulates, the
answer is more likely “no.”
___
_
YES
___
_
NO
5 Will data collection occur in stages with an effort to remove potential bias? If
so is there any potential for data skewing from this process?
___
_
YES
___
_
NO
6
Is the project funded by an outside organization with a commercial interest in
the use of the results? If the answer to this question is “Yes” please also
answer question 6a and 6b. If the project is funded by third-party payors
through clinical reimbursement incentives, or through internal
clinical/operations funds vs. research funds, the answer to this question is
more likely to be “no.”
___
_
YES
___
_
NO
6a Is the sponsor a manufacturer with an interest in the outcome of the project
relevant to its products?
___
_
YES
___
_
NO
6b Is it a non-profit foundation that typically funds research, or internal research
accounts?
___
_
YES
___
_
NO
Adapted from Hastings Center, “The Ethics of Using Quality Improvement Methods to
Improve Health Care Quality and Safety” (June 2006) If the weight of the answers tends
toward “yes” overall, the project should be considered “research” and approved by an
IRB prior to implementation.
If the weight of the answers tends toward “no,” the project is not “research” and is not
subject to IRB oversight unless local institutional policies differ. Answering “yes” to
sequence #1 or #2 – even if all other answers are “no” – typically will result in a finding
that the project constitutes research.
It is important to consult with your local IRB if you are unsure how they would handle a
particular case, as the analysis of the above issues cannot always be entirely objective
and IRB policies and approaches vary significantly.
Obtained
from: https://irb.research.chop.edu/sites/default/files/documents/quality_improvement_o
r_research_worksheet.pdf
Additional resources:
http://humansubjects.stanford.edu/research/documents/qa_qi_faqs_AID03H16.pdf
https://irb.research.chop.edu/quality-improvement-vs-research
SECTION B:
Project Classification Decision:
The project team consisting of a minimum of two faculty members will select one of the
three classifications listed below.
_____ This DNP Project is a quality improvement project. Do not submit to IRB for
review.
_____ This DNP Project contains research methodology and an IRB application should
be submitted to the TUN IRB committee for exemption determination and/or full IRB
review.
_____ This DNP Project is not clearly delineated as quality improvement or research of
discovery. Additional consultation will be obtained from the IRB committee by the
project team. The advice of the IRB committee regarding the need for review will be
noted in writing and the student will be informed of such (Please attach any pertinent
documentation from IRB review as an Appendix to this document.)
By signing below, each member of the project team indicates that they agree with the
above selection.
Printed Name of Project Team Member 1:
__________________________________________________
Signature of Project Team Member 1:
_____________________________________________________
Printed Name of Project Team Member 2:
__________________________________________________
Signature of Project Team Member 2:
______________________________________________________
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