NR 516 Week 5 Research Ethics Case on Consent Example

Research Ethics Case: A Unit Proposes to Test Once-Daily Flushing Without Asking Patients Because "It Is Only Saline," Read Against Two Published Consent Paragraphs and the Federal Waiver Conditions

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College of Nursing, Chamberlain University

NR 516: Basic Research and Evidence-based Practice

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Month Day, Year

Research Ethics Case: A Unit Proposes to Test Once-Daily Flushing Without Asking Patients Because "It Is Only Saline," Read Against Two Published Consent Paragraphs and the Federal Waiver Conditions

The Scenario

After reviewing the flushing literature, my medical-surgical unit's practice council proposed a study. For three months, patients with idle peripheral catheters admitted on odd-numbered days would be flushed every 24 hours, and those admitted on even-numbered days would continue every 8 hours. Catheter failure would be recorded from the chart and compared, and the council hoped to present the results at a regional nursing conference. The unit manager suggested that patients need not be asked, because saline flushing is routine, both schedules are used in other hospitals, and the study would only change timing. This case asks whether that suggestion holds, and what consent the study would actually need.

First Question: Is This Research?

The council's plan has the features of research, not only quality improvement. It assigns patients to one of two treatments by a rule rather than by clinical judgment, it compares outcomes between groups, and it aims to present the findings to people outside the hospital. Under the federal regulations for protecting human subjects, research is a systematic investigation meant to yield knowledge that applies beyond the people studied (Protection of Human Subjects, 2018). The plan to present at a conference, and the comparison design, point toward research. That means the protocol belongs with the hospital's institutional review board, which decides whether consent is needed or may be waived. The council cannot make that decision itself.

What Two Published Studies Did

The published studies on this question are useful models because they report their consent paragraphs. In the adult pilot trial of flushing frequency, eligible patients gave written informed consent, a research nurse obtained it, non-English-speaking patients without an interpreter were excluded, and the protocol was approved by two ethics committees and registered before enrollment (Keogh et al., 2016). In a qualitative study of clinicians' adherence to a catheter care standard, all participants signed consent forms before their interviews, the data were de-identified, and approval came from two ethics committees (Xu et al., 2024).

Both studies asked each participant. The flushing trial did so even though its interventions, like the council's, were routine saline flushes at intervals already in use. Its researchers evidently did not treat routineness as a reason to skip consent.

Could Consent Be Waived?

The regulations allow an institutional review board to waive informed consent, but only when specific conditions are all met. The research must involve no more than minimal risk; it must be impracticable to carry out without the waiver; if it uses identifiable private information, it must be impracticable to carry out without that information in identifiable form; the waiver must leave subjects' rights and welfare unharmed; and, where appropriate, subjects should be given additional pertinent information after they take part (Protection of Human Subjects, 2018).

The council's study probably meets the first condition. Both schedules are in use, and the adult trial found no significant difference in failure between 6-hour and 24-hour flushing, though it was too small to prove the schedules equivalent (Keogh et al., 2016). A catheter that fails early means another insertion, which is a real if small harm, so minimal risk is a judgment the board must make rather than a given.

The study almost certainly fails the second condition. Asking patients on a medical-surgical unit for consent is entirely practicable; the adult trial did exactly that with 160 patients over four months. The manager's argument is not that consent is impracticable but that it is inconvenient, and the regulations do not recognize inconvenience as a reason.

What Each Principle Adds

The Belmont Report's three principles give the regulatory conditions their reasons (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Respect for persons means patients decide whether to take part in research, even low-risk research, because being enrolled without knowing is itself a wrong. Beneficence asks whether the study's risks are justified by its likely benefits; here the risks are small and the question is useful, which supports doing the study but says nothing about skipping consent. Justice asks who bears the burden; allocating by admission date spreads it fairly, but excluding patients who need an interpreter, as the adult trial did, would leave the unit's non-English-speaking patients out of a change that will affect them.

What a Participant Could Still Refuse

Consent is not a single signature. A patient enrolled in the council's study should be told that they may withdraw at any time, that their catheter care will continue under usual practice if they do, and that they may ask for their data not to be used. They should also be told that their catheter may be flushed on a different schedule from a neighbor's, and the reason. If a patient's catheter fails, they should know whom to ask about the study. These rights continue after enrollment, which is why the consent conversation needs a named person to return to.

Recommendation

The council should send its protocol for review by the board as research, with a plan for brief written consent obtained by a nurse not caring for the patient that day, with interpreter access so that no language group is excluded. If the council does not want to seek consent, it should redesign the project as a unit-wide practice change evaluated before and after, without random allocation and without the goal of publication, and ask the board or the hospital's quality office to confirm that it is not research. What it should not do is run a comparison on patients who do not know they are in one. Whichever route it takes, the council should also decide in advance who will look at the failure counts partway through and what result would stop the study early, for example a clear rise in failed catheters in the once-daily group. A stopping rule written before the first patient is enrolled protects patients better than a decision made after the numbers look worrying.

The board may also ask how failure will be judged and by whom, since a nurse who knows the patient's schedule could judge a borderline catheter differently. A written definition of failure, taken from the published trials, would answer that question before it is asked.

References

Keogh, S., Flynn, J., Marsh, N., Mihala, G., Davies, K., & Rickard, C. (2016). Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: A pilot, factorial randomised controlled trial in adult medical-surgical hospital patients. Trials, 17(1), Article 348. https://doi.org/10.1186/s13063-016-1470-6

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 and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/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

Xu, H., Bowdery, J., To, Y., Duff, J., Griffin, B., Ullman, A. J., Rickard, C. M., & Plummer, K. (2024). Peripheral intravenous catheter clinical care standard adherence in emergency departments: A qualitative study underpinned by the behaviour change wheel. Journal of Advanced Nursing, 81(11), 7659-7673. https://doi.org/10.1111/jan.16409