Introduction
Implementation of strict ethical principles is paramount for any research endeavor. Ethical guidelines ensure that the conducted research is authentic and accurate and that the rights, dignity, and well-being of the participants are protected. However, different types of research and implementation projects require distinct ethical guidelines. This essay will consider ethical standards and safeguards for critical research projects, evidence-based practice, and quality improvement undertakings in healthcare.
Unfeasibility of Clinical Research Ethical Safeguards for Evidence-Based Practice
Ethical safeguards designed for clinical research are not applicable for evidence-based practice. It should be noted that evidence-based practice, as well as evidence-based practice implementation projects, do not equate to clinical research. Thus, clinical research refers to a branch of healthcare science and covers all types of studies that include the recruitment and participation of human subjects (Kandi & Vadakedath, 2022). Meanwhile, evidence-based practice is the process of conscious integration and use of the best available evidence collected during clinical research in order to enable clinical decision-making (Melnyk & Fineout-Overholt, 2015). Although clinical research and evidence-based practice are closely connected, the two are distinct processes in which human participants play different roles. Therefore, it can be argued that ethical guidelines appropriate for clinical research should not be implemented during evidence-based practice.
Clinical research requires the observation of specific ethical guidelines. These standards include autonomy and individual responsibility, beneficence, nonmaleficence, justice, informed consent of the participants, privacy and confidentiality, and protection of participants’ integrity (Kandi & Vadakedath, 2022). Thus, as autonomous individuals, participants may exit any clinical research project they wish and should be aware of the study processes, results, and implications (Kandi & Vadakedath, 2022). The participants should never be intentionally harmed when taking part in a study, and the benefits and burdens of a study should be distributed fairly among the participants (Kandi & Vadakedath, 2022). However, during clinical research trials, there is a risk of participants’ health and well-being being impaired unintentionally. The privacy and confidentiality of human subjects are crucial, and researchers are limited in their ability to access information on the participants that do not directly relate to the issue under examination. In addition, it should be noted that clinical research operates on hypothesis, and researchers are ethically obliged to consider the effects of the studies on different populations and account for socioeconomic and cultural differences.
In addition, clinical research should follow specific ethical safeguards in order to ensure the accuracy and validity of collected data. Specifically, every clinical research should offer value to society, improve ways of understanding and treating disease, and strive to answer critical research questions (U.S. Department of Health and Human Services, 2021). Clinical research should follow the principles of fair subject selection, respect for the participants, and a favorable risk-benefit ratio (U.S. Department of Health and Human Services, 2021). In addition, clinical studies should be reviewed by an independent panel to ensure ethical guidelines are observed (U.S. Department of Health and Human Services, 2021). Overall, these guidelines ensure that research participants are protected and that the integrity of science is preserved.
In contrast, evidence-based practice is based on the evidence collected during clinical research and, therefore, aims to apply the best available knowledge to the treatment of a patient or a group of patients. Clinical research is limited in what information can be accessed and shared by researchers to guarantee participants’ privacy and confidentiality. However, access to information should not be limited during evidence-based practice. It is paramount to collect all relevant information to ensure the proposed intervention is beneficial and will not harm the patient. Furthermore, the ethical principles of autonomy and beneficence may conflict when employing evidence-based interventions. In particular, Melnyk and Fineout-Overholt (2015) note that it would be unethical to withhold beneficial evidence-based treatment from the patient. However, if informed consent is not obtained, medical professionals violate the beneficence principle as they do not provide the best possible care to their patients (Melnyk & Fineout-Overholt, 2015). Thus, although these principles are vital, they should not be applied in the same way in evidence-based practice as in clinical research.
In addition, the ethical principles that focus on the integrity of science being protected should not be observed during evidence-based practice. In particular, the social and clinical value of the evidence-based practice is negligible when treating specific patients as their welfare is of utmost importance. At the same time, the principles of scientific validity and fair subject selection are not applicable. As the evidence-based practice and evidence-based practice implementation projects are founded on clinical research results, it can be argued that these guidelines were already followed; consequently, there is no need for their repeat application. Therefore, ethical safeguards appropriate for clinical research are not valid for evidence-based practice.
Two Ethical Exemplars
The implementation of evidence-based quality improvement (EBQI) initiatives can be ethically controversial and contradict the four core ethical principles of healthcare. Such initiatives are necessary for healthcare, and medical facilities have an ethical responsibility to demonstrate quality improvement and how various projects affect the health and well-being of patients (Melnyk & Fineout-Overholt, 2015). Melnyk and Fineout-Overholt (2015) note that in this case, informed consent of patients is not needed as patients are viewed as responsible parties for healthcare improvement. Thus, there is an ethical controversy relating to the patients’ right to autonomy and the ability to decide whether to participate in certain activities or not. However, it should be noted that participation in EBQI initiatives can meaningfully impact patients and benefit them and the healthcare system as a whole. Therefore, there is a conflict between the principle of autonomy and the principle of beneficence. Thus, by refusing to participate in such initiatives, patients do not act in the best interest of all involved stakeholders.
Another controversy arises if the principle of nonmaleficence is considered. It can be argued that the realization of the principle of autonomy and refusal to participate in an EBQI initiative can be viewed as maleficence by omission. Therefore, if patients are given informed consent, they may choose not to benefit others and potentially cause them harm. Meanwhile, informed consent rights being withheld from the patients can be beneficial to others.
Patient’s Ethical Responsibility in Improving Healthcare and Ethical Conflicts
The healthcare system as a whole is mandated to follow four core ethical principles: autonomy, beneficence, nonmaleficence, and justice. These principles should be applied in clinical research and evidence-based practice as they ensure the safety and well-being of the research participants and patients. However, not all of these principles are compatible with the concept of patients having an ethical responsibility to improve healthcare. Patients play a crucial role within the healthcare system and can be responsible for improving the quality of care offered to them and other patients. This can be achieved through patient participation in clinical trials that focus on developing and evaluating medical, surgical, and behavioral interventions. Patient participation is invaluable as new, more efficient treatments can be advanced into practice based on the received results. Therefore, it can be argued that it is a moral responsibility of patients to participate in clinical research studies as they can improve healthcare and quality of care to other patients with the same conditions.
The concept of patients having an ethical responsibility in improving healthcare is in conflict with some of the four primary ethical standards. The principle of autonomy ensures that each patient has a right to self-determination and can make decisions concerning their health and well-being without interference from third parties, including medical professionals. Thus, patients have the right to refuse participation in clinical research or exit a clinical trial at any moment in order to ensure their own well-being (Kandi & Vadakedath, 2022). This principle conflicts with the concept of advancing healthcare as it does not consider the patients’ willingness to participate as well as how participation will impact them. The core idea of the principle suggests that patients are obliged to participate in research that will advance medical science and translate into new interventions being developed and implemented. However, the autonomy principle states that each patient has the right to decide for themselves whether participation in clinical trials is safe and valuable for them regardless of how it can affect other patients, researchers, and the healthcare system.
The principles of beneficence and nonmaleficence are not in conflict with the concept of patients improving and promoting healthcare. The ethical principle of beneficence requires persons to act in the best interest of others. Thus, medical professionals should act in favor of their patients, while researchers should ensure that individuals benefit from their participation in research in one way or another (Kandi & Vadakedath, 2022). Thus, patients who seek to improve healthcare and contribute to the development of treatment methods for specific conditions act in the best interest of others and aim to benefit other patients, medical science, and the healthcare system. The principle of nonmaleficence ensures that no harm is inflicted upon patients or persons participating in medical research (Kandi & Vadakedath, 2022). Thus, patients can ensure that no harm is caused to others by contributing to the search for more advanced and efficient treatments. Refusal to participate in clinical studies that aim to develop effective interventions can be construed as maleficence by omission, as patients do not undertake activities that can prevent others from harm.
Moreover, the principle of justice does not conflict with the concept of patients being ethically responsible for improving healthcare. The principle requires equity and fair treatment within the healthcare system (Kandi & Vadakedath, 2022). Comparative justice can be achieved through the improvement of the healthcare system as more patients can get access to the treatment they deserve based on their own merits and contributions to the system. Thus, by promoting medical science and the healthcare system as a whole, patients ensure that others can access more resources and interventions.
Conclusion
In summary, ethical guidelines and principles are critical in medical science, including clinical research and evidence-based practice implementation projects. Ethical safeguards have a profound impact on how clinical research is performed, the accuracy of data, the implications of research, as well as the health and well-being of the participants. In evidence-based practice, ethical guidelines ensure that patients have access to high-quality care while remaining in charge of their decision-making process. Although many ethical guidelines remain a recommendation, it is crucial that they are followed to benefit all the stakeholders.
References
Kandi, V., & Vadakedath, S. (2022). Ethical considerations in clinical research: A comprehensive review. American Journal of Public Health Research, 10(2), 42–52.
Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare: A guide to best practice. Lippincott Williams & Wilkins.
U.S. Department of Health and Human Services. (2021). Ethics in clinical research. Clinical Center.