Ethics and Evidence-Based Research
Nursing practice and the provision of quality care are greatly influenced by evidence-based practice (EBP), clinical research, and ethics. Ethics define what is wrong or right and play an important part in regulating clinical research and EBP (Ilkafah et al., 2021). While EBP entails the application of research evidence to impact decision-making and the provision of patient care, clinical research, on the other hand, focuses on generating evidence for nursing practice.
Despite ethics, EBP, and clinical practice being essential in nursing practice and patient care, some ethical guidelines have resulted in controversies that affect the accuracy and efficacy of EBP and clinical research. This current paper will discuss issues related to ethics and evidence-based research.
Why Clinical Ethical Safeguards may not be feasible for EBP
Clinical research is guided by several ethical principles that may not be applicable or feasible for EBP or an evidence-based quality initiative (EBQI) implementation. For instance, clinical research is guided by seven core ethical principles, including informed consent, independent interview, a fair selection of subjects, scientific value, scientific validity, respect for subjects, and favorable risk-benefit ratio (Melnyk & Fineout-Overholt, 2018). These principles define the foundation of clinical research, which defines the nursing practice.
Despite the importance of these principles in clinical and nursing practice, some of them are not feasible in regulating EBP. For instance, the varying nature of risks in clinical research and EP limit the application of the ethical principle of a favorable risk-benefit ratio (Ilkafah et al., 2021). Compared to low risks in EBP, the risks in clinical research range from none to very high, which requires the application of the principle of favorable risk-benefit ratio, unlike in EBP.
Additionally, ethical principles of informed consent and independent review are also applicable in clinical research with limited feasibility in EBP. Before conducting any clinical research involving human subjects, the proposed research must undergo independent review by certified independent review boards who review the study and reduce potential conflicts of interest and reduce exploitation of human subjects.
Despite independent review being paramount in clinical research, it is deemed limiting and unnecessary in EBP due to limited chances of patient exploitation (Melnyk & Fineout-Overholt, 2018). The principle of informed consent is another paramount principle in clinical research.
Individuals participating in research must be provided with relevant information, including the risks and benefits of participating in research, and be allowed to make a voluntary informed decision without intimidation. In EBP, informed consent is covered within the patient`s consent to care and may be viewed as an impediment to the smooth flow of care. Therefore, informed consent is generally limited in EBP, unlike in clinical research.
Ethical Controversies Surrounding the Implementation of EBQI Initiatives
Despite the EBQI initiative being paramount in audit and addressing quality assurance in clinical practice, implementation of EBQI is often characterized by ethical controversies. EBQI methods are used by clinicians, nurses, administrators, and staff to improve the quality of care provided to patients and families. Additionally, quality improvements are done in systematic, data-guided activities to improve the delivery of healthcare as well as advance the existing evidence-based practice.
One of the controversies plaguing the implementation of an EBQI is the over-reliance on clinical ethical regulations and lack of proper definition of clinical research. The lack of a clear line between clinical research and quality improvement has attracted heavy fines for some organizations being accused of defaulting the ethical regulations. This is evident when organizations conduct quality improvement studies that are deemed clinical research by the office of human research protection (OHRP) (Melnyk & Fineout-Overholt, 2018).
The confusing role of research administrators in differentiating between clinical research and quality improvements is another ethical controversy surrounding the implementation of EBQI. Failure of research administrators in classifying studies risks the avoidance of an ethical review or leads to the adoption of a less intensive review process.
This could result in the exploitation of human participants and attract heavy fines. Besides, the domain of research publication attracts ethical controversies in the implementation of EBP. Fear of publishing disputable findings has made many organizations publish researches which have been reviewed and authorized by independent research bodies. Such activities risk jeopardizing the quality of research as well their applicability in clinical settings.
Additionally, the four core ethical principles, including nonmaleficence, beneficence, autonomy, and justice, are related to the ethical controversies surrounding the implementation of EBQI. Advancement in the EBP has heavily stumbled of a lack of proper definition of clinical research, controversies surrounding publication, and the heavy fines imposed on an organization for alleged ethical misconduct (Melnyk & Fineout-Overholt, 2018).
Such moves demoralize organizations from conducting studies resulting in limited quality improvement programs which are aimed at limiting harm and doing good as defined by non-maleficence and beneficence, respectively. The principles of autonomy and justice are negatively affected by the confusing responsibility of research administrators, resulting in poor conduct in studies. Additionally, informed consent is also breached with improper misconduct that affects autonomy and justice.
Ethical Principles in Conflict with Patient`s Role in Improving Healthcare.
The concept of the patient`s role in improving healthcare conflicts with the ethical principles of beneficence and non-maleficence. Engagement of patients in activities improving healthcare, such as clinical research conflict with the principle of beneficence which focuses on doing good. According to Melnyk and Fineout-Overholt (2018), the principle of beneficence is conflicted when patients participate in clinical research that puts patients at risk of facing manipulation, as what is good for the research may not be good for patients.
As a result, independent review boards always review all clinical research involving human subjects to reduce the risk of patient exploitation that may jeopardize beneficence. Additionally, involving patients in clinical research conflicts with the principle of non-maleficence, as individuals are at risk of experiencing harm while helping others.
On the other hand, the principle of autonomy is a major hindrance to patients` participation in clinical research to improve healthcare. According to Yıldız (2019), the principle of autonomy allows patients to make informed decisions to take part in research voluntarily. This means patients cannot be forced to participate in research, which will be against the ethical requirements.
Furthermore, the need for individuals to give informed consent before participating in research also impedes clinical research. As a result of these impediments, most clinical research involving human subjects is either delayed, not done or not comprehensively studied, as most people fail to consent to participate in research. This impact the quality of clinical care negatively.
Overcoming the conflicts existing between clinical research, EBQI, and ethical principles requires harmonization of the regulatory framework (Yıldız, 2019). These frameworks will help provide the definition and scope of activities that differentiate clinical research from quality improvement programs to reduce the clash between these two.
This will also help to solve the conflict existing when patients are involved in clinical improvement through research. Finally, harmonizing the framework will enhance subjects’ participation in research and quality improvement while enhancing clinical care.
As presented in this paper, the importance of ethical regulations in clinical research and EBP cannot be overemphasized. Despite ethics being paramount in guiding morals and legal behavior in both research and EBP, various controversies exist in the implementation of EBQI initiatives.
There is a need to harmonize ethical regulations to define the scope of practice and differentiate between clinical research and quality improvements to address the conflicts arising when ethical principles are applied. Such a move aims at improving clinical care by enhancing patient participation in clinical research.
Ilkafah, I., Mei Tyas, A. P., & Haryanto, J. (2021). Factors related to the implementation of nursing care ethical principles in Indonesia. Journal of Public Health Research, 10(2), jphr.2021.2211. https://doi.org/10.4081/jphr.2021.2211
Melnyk, & Fineout-overholt. (2018). Evidence-based practice in nursing and healthcare, fourth edition. Lww.com. https://medicine.lww.com/Book/Show/865601#/about-this-product?groupby=learningactivity&ts=1669239627204
Yıldız, E. (2019). Ethics in nursing: A systematic review of the framework of evidence perspective. Nursing Ethics, 26(4), 1128–1148. https://doi.org/10.1177/0969733017734412