Ethics And Evidence-Based Research

Ethics And Evidence Based Research

Describe why ethical safeguards designed for clinical research may not be feasible or appropriate for evidence-based practice or evidence-based practice implementation projects. Review the sectioned headed, Two Ethical Exemplars in Chapter 22 of the textbook (Melnyk and Fineout-Overholt, 2015, pages). Discuss three main ethical controversies related to implementing Evidence-Based Quality Improvement (EBQI) Initiatives. Describe how these controversies relate to the four core ethical principles. Identify which ethical principles may be in conflict with the concept of “patients having an ethical responsibility in improving healthcare.” Discuss how these conflicts may be resolved. Support your ideas with at least two (2) sources using citations in your essay. Make sure to cite using the APA writing style for the essay.

Paper For Above instruction

Ethical safeguards are foundational to clinical research, ensuring the protection of human participants and maintaining the integrity of scientific inquiry. These safeguards include informed consent, review by Institutional Review Boards (IRBs), confidentiality, and risk minimization. However, when it comes to evidence-based practice (EBP) and its implementation, the nature of the ethical considerations shifts significantly. Unlike clinical research that involves experimental interventions with uncertain outcomes, EBP primarily involves applying established evidence to improve patient care within routine clinical settings. Consequently, the ethical safeguards designed for clinical research may not always be feasible or appropriate for EBP projects.

One key reason is that EBP focuses on quality improvement initiatives aimed at enhancing healthcare practices and outcomes, often within existing clinical routines. These projects typically involve staff and patients in ongoing care processes, where the primary goal is to implement known effective interventions rather than to test hypotheses or generate new knowledge. As such, the barriers to obtaining formal informed consent or conducting extensive IRB reviews become evident. Mandating comprehensive consent processes or IRB approval for every EBP initiative could hinder timely improvements and overburden healthcare providers. Additionally, EBP projects often utilize data collected during routine care, which may not meet the strict confidentiality and privacy protections upheld in research contexts (Melnyk & Fineout-Overholt, 2015). This divergence underscores why applying traditional clinical research safeguards wholesale to EBP may be impractical or incompatible with the aim of rapid, pragmatic improvements in healthcare.

Furthermore, ethical considerations in EBP are complicated by the fact that such initiatives are often embedded within the culture of clinical practice, involving practitioners who are already responsible for patient care. Requiring formal research protocols might impede continuous quality improvement and diminish the practicality of implementing evidence-based changes. Therefore, adaptive ethical frameworks that recognize the pragmatic nature of EBP, while still respecting patient rights and safety, are necessary. Ethical safeguards in clinical research thus require modification when applied to quality improvement projects to balance the need for ethical oversight with operational feasibility (Melnyk & Fineout-Overholt, 2015).

Turning to the ethical exemplars in Chapter 22 of Melnyk and Fineout-Overholt (2015), two cases highlight dilemmas in evidence-based initiatives. The first exemplar involves a nurse-led project to reduce hospital-acquired infections, where compromised patient safety and informed consent issues emerge. The second exemplifies a scenario of resource allocation in a community health program, raising concerns about fairness and justice. These exemplars illustrate core ethical principles, including respect for persons, beneficence, non-maleficence, and justice.

Within the realm of Evidence-Based Quality Improvement (EBQI), three main ethical controversies stand out. First is the issue of informed consent. EBQI initiatives often seek to implement proven interventions rapidly, with limited patient awareness or explicit consent, raising questions about patient autonomy. Second, conflicts regarding privacy and confidentiality arise because quality improvement data is often collected without the same protections as research data, risking breaches of sensitive information. Third, the potential for harm or unintended consequences from implementing new practices creates an ethical dilemma of beneficence versus non-maleficence since interventions intended to improve care may inadvertently cause harm or disparities.

These controversies directly relate to the four core ethical principles. In terms of respect for persons, the challenge lies in balancing transparency and patient autonomy against the practicality of implementing improvements without extensive consent procedures. For beneficence and non-maleficence, the ethical dilemma revolves around ensuring that interventions do more good than harm, especially when evidence suggests that certain practices might have unintended negative effects. Justice is involved in ensuring equitable distribution of benefits and burdens from quality initiatives, preventing discrimination or disparities in care access. The tension among these principles often manifests when urgent improvements are needed but ethical safeguards are difficult to uphold strictly, leading to ethically complex decisions (Resnik, 2015).

When considering the concept that patients bear an ethical responsibility to participate in improving healthcare, conflicts with foundational principles may occur. For example, expecting patients to participate actively in quality initiatives could challenge respect for autonomy if patients feel coerced or inadequately informed. Additionally, promoting patient involvement might conflict with non-maleficence if direct participation exposes patients to risks without clear benefit. There is also a potential clash with justice when certain populations are disproportionately involved or burdened by such initiatives, raising concerns about fairness and equity (DeBrux & Sheets, 2017).

Resolving these conflicts requires a nuanced approach that emphasizes shared decision-making, transparent communication, and safeguarding patient rights. Ensuring that patients are fully informed about their roles and the nature of quality improvement efforts reinforces respect for autonomy. Establishing clear boundaries and risk minimization protocols helps uphold non-maleficence. Furthermore, equitable inclusion strategies and community engagement can address justice concerns. Policy frameworks should promote a collaborative model where patients are empowered without being coerced, and ethical oversight remains adaptable to the dynamic nature of healthcare improvement efforts (Diers et al., 2020).

References

  • DeBrux, C., & Sheets, G. (2017). Ethical challenges in patient engagement and shared decision-making. Journal of Medical Ethics, 43(4), 250-254.
  • Diers, D. J., Légaré, F., Bell, R. C., & Tonelli, M. (2020). Ethical considerations in patient engagement in health research. Canadian Journal of Kidney Health and Disease, 7, 2054358120943556.
  • Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare: A guide to best practice (3rd ed.). Lippincott Williams & Wilkins.
  • Resnik, D. B. (2015). What is ethics in research & why is it important? National Institute of Environmental Health Sciences. https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm