P C 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

P C 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.

ITEM

Issue and Guidance

Rating

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_or_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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