NUR 675 Module 8 Ethics Paper Example

Quality Improvement or Research? Ethics Review and Protections for a Practicum Falls Project

[Student Name]

Southern New Hampshire University

NUR 675: MSN Seminar: Preparation for Practicum

Module Eight Ethics Paper

[Instructor Name]

[Date]

Quality Improvement or Research? Ethics Review and Protections for a Practicum Falls Project

Practicum projects sit in an ethical gray zone. They are meant to improve care at a site, which makes them look like quality improvement, but students often collect data, analyze it and hope to share results beyond the site, which makes them look like research. The distinction matters because research with human participants generally requires review by an institutional review board and, often, informed consent, while quality improvement is usually overseen through the organization's normal operations. This student plans to test a night-shift toileting and medication review program to reduce falls, collect data on round completion and falls, ask a small number of patients about sleep disruption and hopes to present a poster at a regional conference. This paper determines whether the project is research and what protections it needs. It argues that the answer depends on the project's purpose, risks and burdens rather than on whether results will be shared, and that improvement work carries ethical obligations of its own.

When Improvement Becomes Research

Casarett et al. (2000) proposed two criteria for deciding when a quality improvement initiative should be considered research and reviewed as such. The first asks whether the people taking part will themselves gain from what is learned; improvement work is designed to benefit the patients and the institution where it occurs, whereas research aims mainly at generalizable knowledge for others. The second asks whether patients are exposed to additional risks or burdens beyond usual clinical practice in order to make the results generalizable, such as randomization, extra tests or procedures done only for data collection. If either condition holds, the initiative should be reviewed as research.

Applied to the falls project, the intended beneficiaries are patients on the unit, who are exposed to a change in routine care, scheduled toileting and medication review, that is itself standard practice supported by evidence. Patients are not randomized, and no tests are added for research purposes. The brief sleep question is a minimal burden that serves to monitor a possible harm of the change. By these criteria, the project is quality improvement rather than research.

The Ethics of Improvement Work Itself

Concluding that a project is not research does not end the ethical analysis. Lynn et al. (2007), writing for a group convened by the Hastings Center, described improvement work as woven into the everyday running of health care and set out the ethical standards it must still meet. These include that the work have social value and a sound design, that participants be selected fairly, that risks be minimized and justified by potential benefits, that patients' rights and interests be respected, including through consent when risks exceed the minimal, and that there be review and supervision proportionate to the risk. They also suggested that patients have some obligation to participate in low-risk improvement work that benefits them and others, since such work is how care gets better, and that organizations have an obligation to conduct improvement responsibly.

Applying Ethical Principles

The Belmont Report identified respect for persons, beneficence and justice as the core principles for research involving human participants (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979), and they translate readily into protections for this project. Respect for persons means that patients can decline toileting rounds or ask not to be woken; nurses will offer rather than impose rounds, document refusals and respect them, and the sleep question will be voluntary. Beneficence means monitoring for harm; the balancing measure on sleep exists because interrupted sleep could increase delirium and falls, and the project will stop or adjust the schedule if sleep disruption rises. Justice means that the change should be offered to all patients at high risk, not only those easiest to reach, and that burdens should not fall disproportionately on some patients or staff.

Staff Data and Privacy

The project also collects data about nurses, since round completion sheets show which nurses completed rounds. These data could be misused to judge individual performance, which would undermine trust in the project and in the hospital's just culture. The student and preceptor agreed that completion data will be reported only in aggregate by shift, that no individual nurse will be identified in any report or presentation and that the sheets will be destroyed after data entry. Patient data will be accessed only through the hospital's quality department, stored on hospital systems rather than personal devices and reported in aggregate. The poster will include no patient or staff identifiers and will describe the unit only as a medical-surgical unit in a community hospital.

The student also considered her dual role. Because she works at the same hospital, colleagues might feel pressure to take part or to report favorable results to help her. She will remind staff that participation in the project's feedback is voluntary, collect staff views anonymously and avoid supervising any nurse in her practicum role whom she supervises as charge nurse.

The Determination and Presenting Results

The student submitted a brief description of the project to the hospital's nursing research council, which follows the hospital's policy of having a designated reviewer decide whether projects require review by the institutional review board. The reviewer determined that the project was quality improvement and not human subjects research, noting that intent to present at a conference does not by itself make a project research, and issued a written determination the student will keep with her practicum records. The determination also recommended that any future plan to test the change against a control group or to publish in a journal be resubmitted for review. The student's university was informed of the determination through her faculty member.

Conclusion

The falls project is quality improvement by the criteria Casarett and colleagues proposed: it aims to benefit the unit's patients and adds no research-driven risks or burdens. It still carries ethical obligations, as the Hastings Center framework makes clear, which the project meets by respecting patient choice, monitoring for harm, treating staff data carefully and protecting privacy. A written determination from the hospital settles the review question and guides how results can be shared.

References

Casarett, D., Karlawish, J. H. T., & Sugarman, J. (2000). Determining when quality improvement initiatives should be considered research: Proposed criteria and potential implications. JAMA, 283(17), 2275-2280. https://doi.org/10.1001/jama.283.17.2275

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., . . . 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

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health, Education, and Welfare.