NU802 Unit 7 QI Ethics Determination Paper Example

Not Research, Still an Ethics Question: A Unit 7 Ethics Determination Paper for an Insulin Discharge Readiness Project

[Student Name]

Purdue University Global

NU802: DNP Project I

Unit 7 Ethics Determination Paper

[Instructor Name]

[Date]

The hospital, its review process and the project are composite and illustrative; the regulations and sources cited are real.

Why the Question Matters

A DNP project that counts as research needs a review board's approval before the first patient's data are touched, and most projects that collect patient data without consent could not go forward as research without a waiver. A project that is quality improvement is reviewed through the organization's own processes. Getting the classification wrong in either direction causes harm: calling research improvement exposes patients to unreviewed risk, while calling improvement research delays useful changes and can discourage staff from improving care at all. Lynn et al. (2007), reporting the conclusions of a national ethics project on improvement work, argue that improvement work carries its own ethical obligations and needs its own form of oversight, proportionate to its risk, rather than being forced into research review or left with none.

The Federal Definition

The Common Rule (Protection of Human Subjects, 2018) asks two things of a possible research project at this hospital: is the work systematic, and was it built to yield findings meant to hold for patients and hospitals well beyond Dubuque? The project is systematic, since it measures outcomes monthly with defined methods. The decisive question is design and intent. The bundle is being introduced because the hospital has decided it should be standard care on all adult units, based on its own pilot results and the evidence synthesized in Unit 3. Its purpose is to improve care at this hospital and to learn whether the spread works here. Units start in an order set by readiness, not by assignment for comparison, and no patient receives a different standard of care for the sake of a comparison.

The federal Office for Human Research Protections has addressed the question directly in its guidance on quality improvement. It explains that implementing a practice to improve care and collecting data on it for clinical, practical or administrative purposes does not by itself make an activity research, and that an intention to publish does not, on its own, turn improvement into research (Office for Human Research Protections, n.d.). What would change the classification is a design aimed at producing knowledge beyond the setting, such as randomizing patients to bundle and no bundle or adding procedures done only to answer a scientific question.

Wanting to share what we learned does not change what we are doing; designing the work to answer a question for everyone else would.

The Hospital's Determination

The hospital requires a quality improvement determination form, reviewed by the chair of its research review board, for any project that collects data and may be shared outside the hospital. The form asks seven questions: whether the main aim is to improve local care; whether the change is supported by existing evidence; whether patients are assigned to different care for comparison; whether data collection adds burden or risk beyond usual care; whether any data are collected only for the project; whether results will be shared outside; and who is accountable for the work.

The project's answers were that the aim is local improvement; the bundle is supported by moderate evidence and the hospital's pilot; no patient is assigned to a comparison; data come almost entirely from routine records; the only items gathered for the project are three day-seven questions about how sure patients feel and what being on insulin means to them, asked during the day-seven contact as part of follow-up care and answerable or skipped as the patient wishes; results may be presented and published; and the chief nursing officer is accountable. The chair found that the project falls outside the definition of research with human subjects and needs no board review, and the determination letter is filed with the proposal. Purdue Global's DNP program also requires its own review of the project, and that form was submitted with the hospital's letter attached.

Protections That Still Apply

Not needing research review does not mean ethics no longer apply. Lynn et al. (2007) list obligations for improvement work that include respecting patients' rights, making sure the change is likely to be beneficial, protecting privacy and distributing burdens and benefits fairly. Each is addressed in the proposal.

Benefit and risk. The bundle's components are already recommended in national hospital standards, and none adds physical risk. The one plausible harm is that teaching or pen dispensing could delay discharge, so time from discharge order to departure is monitored as a balancing measure. A rise in lows after discharge would pause the spread under the charter's safety rule.

Respect for patients. Patients can decline any component, as they can decline any teaching, and the nurse documents the choice without pressure. The transition questions are optional, and patients are told they are part of follow-up and that their answers help the hospital improve the program.

Privacy. Patient data are used within the hospital for health care operations, which the federal privacy rule permits without individual authorization. The student receives only data with identifiers removed, stored in the hospital's secure system, and no project data leave the hospital in identifiable form.

Fairness. The bundle reaches every eligible patient on each unit once that unit starts, and results are stratified by payer, age and distance so that groups who benefit less are seen. The order of units follows readiness, and the last units start within the project period.

Staff. Staff take part in training and audits as part of their normal work. Audit findings are used to improve the process and are not used to discipline individual nurses, a commitment the chief nursing officer has put in writing.

Conditions That Would Change the Determination

The determination applies to the project as described. If the student later wished to randomize units or patients, add interviews or surveys beyond follow-up care or use the data to answer a question unrelated to the bundle, the project would return to the review board chair for a new determination before any change. Any manuscript will say that the hospital classified the work as quality improvement and will not call it research.

Conclusion

The insulin discharge project is quality improvement under the Common Rule and federal guidance: it introduces a supported practice as standard care, measures it with routine data and assigns no patient to a comparison. The hospital's chair has made that determination, and the university's review has been requested. The project still carries ethical duties to patients and staff, and the proposal meets them through monitoring for harm, optional participation in added questions, protected data, fair distribution and a commitment that audits will not be used to punish.

References

Lynn, J., Baily, M. A., Bottrell, M., Jennings, B., Levine, R. J., Davidoff, F., Casarett, D., Corrigan, J., Fox, E., Wynia, M. K., Agich, G. J., O'Kane, M., Speroff, T., Schyve, P., Batalden, P., Tunis, S., Berlinger, N., Cronenwett, L., Fitzmaurice, J. M., Dubler, N. N., & James, B. (2007). The ethics of using quality improvement methods in health care. Annals of Internal Medicine, 146(9), 666-673. https://doi.org/10.7326/0003-4819-146-9-200705010-00155

Office for Human Research Protections. (n.d.). Quality improvement activities FAQs. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/index.html

Protection of Human Subjects, 45 C.F.R. pt. 46 (2018). https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46