Not Every Test Is an Experiment: Research Ethics History and the Ethical Oversight of an Evidence-Based Quality Improvement Pilot
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RN to BSN Program, Aspen University
N494: Essentials of Nursing Research
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Not Every Test Is an Experiment: Research Ethics History and the Ethical Oversight of an Evidence-Based Quality Improvement Pilot
The rules that protect people who take part in research were written in response to scandals. Today those rules shape how nurses think about any project that collects data on patients, including evidence-based practice and quality improvement projects that are not research at all. This paper describes two historical events that shaped research ethics codes and regulations, explains why the safeguards designed for research do not always fit evidence-based quality improvement, and applies that reasoning to the isopropyl alcohol triage pilot recommended in Module 6, including the ethical concerns the pilot must still address.
Two Events That Shaped Research Ethics
The first is the set of experiments conducted on concentration camp prisoners by Nazi physicians during World War II. At the Doctors' Trial in Nuremberg in 1946 and 1947, physicians were tried for experiments that included deliberate infection, freezing, and high-altitude exposure performed without consent. The judgment produced the Nuremberg Code of 1947, whose first principle is that the voluntary consent of the human subject is absolutely essential. The Code established that consent must be informed and freely given and that research must avoid unnecessary suffering and be terminated if continuing is likely to cause injury.
The second is the United States Public Health Service study of untreated syphilis in Black men in Macon County, Alabama, conducted from 1932 to 1972. Several hundred men with syphilis were followed to observe the natural course of the disease; they were not told their diagnosis, were deceived about the procedures performed on them, and were denied penicillin after it became the standard treatment in the 1940s. The study continued for decades in plain view of the medical profession, a fact historians attribute in part to racism embedded in medicine and public health (Brandt, 1978). Its exposure in 1972 led to the National Research Act of 1974, which created the commission that wrote the Belmont Report and led to federal regulations requiring institutional review of research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Nuremberg made consent the first principle; Tuskegee showed that a principle without oversight is not enough.
The Belmont Principles
The Belmont Report organized research ethics around three principles. Respect for persons requires treating individuals as autonomous agents and protecting those with diminished autonomy, which is expressed through informed consent. Beneficence requires minimizing possible harms and maximizing possible benefits, expressed through the systematic assessment of risks and benefits. Justice requires fairness in who bears the burdens and receives the benefits of research, expressed through fair selection of subjects (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). The Tuskegee study violated all three: the men were deceived, they were harmed by withheld treatment, and they were chosen because they were poor and Black.
Why Research Safeguards Do Not Always Fit Quality Improvement
Research is designed to produce generalizable knowledge, and federal regulations require that it be reviewed by an institutional review board and, in most cases, that participants give formal informed consent. Quality improvement is different. A group convened by the Hastings Center defined quality improvement as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings, and concluded that it is an intrinsic part of normal health care operations. The group found that most quality improvement is not human subjects research, should not undergo institutional review board review, and should instead receive oversight calibrated to its risk as part of the professional supervision of clinical practice (Lynn et al., 2007).
Applying research safeguards to every quality improvement project would create real problems. Requiring written consent for a change in routine care would slow or stop improvements that benefit everyone, and patients who decline would receive care that the organization has already judged inferior. Randomizing patients within a unit, a research standard, is often impractical and sometimes unethical when the change is supported by evidence. At the same time, labeling a project quality improvement cannot be a way to avoid oversight. The same Hastings Center group proposed that projects be categorized by their features, with some qualifying as both quality improvement and research and requiring a customized review (Lynn et al., 2007).
Applying the Reasoning to the Triage Pilot
The isopropyl alcohol pilot recommended in Module 6 has the features of quality improvement. Its purpose is to improve nausea care in one department, the intervention is already supported by evidence, it adds a low-risk option to standard care rather than withholding anything, and the data collected, nausea scores and time to first intervention, are part of routine documentation. Under the Hastings Center framework its oversight belongs with the emergency department's clinical leaders, the nursing practice committee and the physician medical director, rather than with an institutional review board (Lynn et al., 2007).
The Belmont principles still apply. Respect for persons means each patient is told what the pad is and why it is offered, and may decline without affecting any other care. Beneficence means standard antiemetics remain available and are not delayed, and patients with exclusions are not offered the intervention. Justice means the pad is offered to every eligible patient, including those who speak languages other than English, through an interpreter, rather than only to those easiest to approach. If the department later wishes to publish its results or compare outcomes in a way designed to produce generalizable knowledge, it should consult the institutional review board before collecting data for that purpose, because at that point the project may meet the definition of research.
Conclusion
The history of research ethics is a history of harm followed by protection. Nuremberg established that consent is essential, and Tuskegee showed that principles need oversight, leading to the Belmont Report and institutional review. Those protections were designed for research, and applying them rigidly to evidence-based quality improvement can block improvements that patients deserve. The better approach is to match oversight to the nature and risk of the project while keeping the Belmont principles at the center. For the triage pilot, that means clear information and the right to decline, no delay in standard care, fair access for every eligible patient, and a conversation with the institutional review board before the project becomes research.
References
Brandt, A. M. (1978). Racism and research: The case of the Tuskegee Syphilis Study. The Hastings Center Report, 8(6), 21-29. https://doi.org/10.2307/3561468
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.
How this N 494 Module 7 example is structured
N494 typically turns to ethics near the end of the course: the historical events that shaped research ethics codes and regulations, and why the safeguards built for clinical research may not suit evidence-based practice and quality improvement projects. Aspen does not publish module deliverables, so check your classroom for the exact questions. This example describes two events accurately and ties them to the Belmont principles, uses a named consensus framework to explain the research and quality improvement boundary, and applies both to the course's own pilot, including when to consult an institutional review board.
N494 Module 7 questions, answered
What does N494 Module 7 usually ask for?
The module commonly addresses research ethics: historical events that influenced ethical codes and regulations for research, and the ethical issues in evidence-based practice and quality improvement, including why research safeguards may not fit those projects. Aspen does not publish module deliverables, so your classroom's prompt governs.
Which historical events should I use?
The Nazi medical experiments and the Nuremberg Code, and the U.S. Public Health Service syphilis study at Tuskegee leading to the National Research Act and the Belmont Report, are the most direct links to current regulations. Other options include the Willowbrook hepatitis studies and the Jewish Chronic Disease Hospital case.
Does an evidence-based practice project need IRB approval?
Most quality improvement projects are not human subjects research and are overseen through clinical governance instead. If a project is designed to produce generalizable knowledge, such as for publication, or adds risk or randomization, consult your institutional review board before collecting data. The sample explains where that line falls for its pilot.
Write yours, or have the desk draft it
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