DNP 850B Module 7 Ethics, Human Subjects Training and Review Example

Improvement With Protection: Ethical Safeguards, Human Subjects Training and Review for a Home Blood Pressure Project

Student Name

Doctor of Nursing Practice Program, Aspen University

DNP 850B: Project Proposal

Instructor Name

Month Day, Year

Improvement With Protection: Ethical Safeguards, Human Subjects Training and Review for a Home Blood Pressure Project

Quality improvement projects are sometimes treated as exempt from ethical scrutiny because they are not research. That view is too simple. A project that changes how patients' medications are adjusted, and that collects and reports their data, carries real risks and owes patients real protections, whatever its label. This paper sets out the ethical protections for my DNP project, a 12-week effort in which clinic nurses use patients' home readings to adjust treatment within a signed protocol. It considers whether the project is research, applies the Belmont principles, reports the human subjects training completed, describes the review process and privacy safeguards, and addresses protections for vulnerable patients and the author's own role.

Is the Project Research?

Casarett et al. (2000) proposed two tests for deciding when a quality improvement activity should be treated as research. The first asks whether most participants are expected to benefit directly from the knowledge gained; the second asks whether participants are exposed to risks or burdens beyond usual care in order to make the results generalizable. The project passes both tests as improvement work. Enrolled patients are the intended beneficiaries of the change, and the intervention delivers care recommended by national guidelines rather than an experimental treatment. The project adds no procedures solely to produce knowledge: office readings and laboratory tests are those that good care requires.

Lynn et al. (2007) argue that improvement work should nonetheless receive ethical oversight in proportion to its risks, integrated with the organization's normal accountability for care. The project follows that advice. Its plan will be reviewed by the health center's quality committee, and, because Aspen requires it for DNP projects, an application will be submitted to the university's institutional review board, which will decide on the level of review.

Applying the Belmont Principles

The Belmont Report's three principles frame the protections (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Respect for persons requires that participation be voluntary and informed. Although the program is offered as clinical care, each patient will receive a plain-language explanation, in English or Spanish, of what enrollment involves, what data will be used for the project report and the right to decline or withdraw without any change in usual care, and will give written agreement. Beneficence asks that harm be kept as small as possible and outweighed by the good expected. The main clinical risks, low blood pressure and changes in potassium or kidney function after medication changes, are addressed by protocol thresholds, laboratory checks and same-day escalation rules. Justice requires a fair distribution of burdens and benefits. The project deliberately enrolls the patients most affected by the clinic's gap, including uninsured and Spanish-speaking patients, and provides cuffs at no cost so that ability to pay does not decide who benefits.

Human Subjects Training

Before any data are collected, the project lead has completed the CITI Program basic course in human subjects protection and its module on privacy and confidentiality, as the course requires, and the nurse care managers have completed the health center's annual privacy training. Certificates are held in the project file and will be attached to the review applications.

Review and Approval Sequence

Approvals will be obtained in a fixed order. The site letter of support has been signed. After the committee approves the proposal at the defense, the health center's quality committee will review the protocol and data plan. The application to Aspen's institutional review board will then be submitted with the site approvals attached. No patient will be approached, and no data extracted, until every approval is in hand. If any reviewer requires changes, the proposal will be amended and the committee informed before implementation.

Privacy and Data Handling

Data will be handled under the minimum necessary standard. The project data set will include only the variables defined in the data dictionary, with each patient identified by a study code. The key linking codes to medical record numbers will be kept by the clinic manager on the health center's secure drive, not by the project lead. The data set will be stored on an encrypted, password-protected device, will never be sent by email, and will be destroyed after the retention period set by the university. Historical comparison data will be extracted under a data use agreement and de-identified before leaving the clinic. Only group totals will be published, and any cell under 10 patients will be withheld.

Protecting Vulnerable Patients and the Author's Role

Many enrolled patients will be uninsured, and some will have limited English proficiency, which raises the risk that they feel unable to refuse. Invitations will therefore come from nurse care managers in the patient's preferred language, with the community health worker available, and the project lead will not approach patients. The project lead is employed by the health center in a nonclinical quality role, and that dual role will be disclosed to the committee and the review board. The lead will not provide care to enrolled patients or have access to identified data after extraction.

Risks and Safeguards

The table summarizes the main risks and the safeguards for each.

Conclusion

The project meets published criteria for quality improvement rather than research, yet it will receive proportionate oversight from the site and the university. Its protections follow the Belmont principles, rest on completed training, and address privacy, the needs of vulnerable patients and the author's dual role. With these safeguards in place, the project can improve care without asking patients to bear avoidable risk.

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.