Ethics and Evidence-Based Research

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Introduction

Ethical safeguards are critical for ensuring the safety and well-being of research participants. However, they may only sometimes be appropriate or feasible for evidence-based practice (EBP) or EBP implementation projects due to different goals, dissimilar populations, and diverse types of data and regulatory requirements. The goals of clinical research and EBP implementation projects are significantly different. On the one hand, the primary objective of clinical research is to develop new knowledge by testing hypotheses (National Institutes of Health, 2022). For example, to know the effectiveness or safety of the new drug, one has to test it on patients in clinical trials. On the other hand, EBP focuses on implementing best practices based on existing evidence (Melnyk & Fineout-Overholt, 2014). Thus, the goal of EBP implementation projects is to apply the current knowledge in real-world settings to guarantee optimal health outcomes.

The populations used in clinical research and EBP implementation projects differ significantly. Clinical research often involves vulnerable populations, such as individuals with serious illnesses or children, who require special protections. For example, only patients with cancer can be used to test the effectiveness or safety of new chemotherapy drugs. Conversely, EBP implementation projects may involve a wider range of populations, which may require a different level of protection (Melnyk & Fineout-Overholt, 2014). Clinical research collects primary data, such as blood samples or imaging data, while EBP implementation projects often use secondary data sources, such as electronic health records or administrative data. Consequently, the benefits and risks associated with the data collection process differ between clinical and EBP research.

Further, regulatory requirements for clinical and EBP research are different. According to the National Institutes of Health (2022), clinical research is subjected to strict regulatory requirements, such as the need for Institutional Review Board (IRB) approval, which may not be necessary or appropriate for EBP implementation projects. Therefore, while ethical safeguards are important in all forms of research and implementation, the specific safeguards required may vary depending on the nature and goals of the project. It is imperative to consider the ethical implications of any project and ensure that appropriate safeguards are in place to protect the rights and well-being of participants.

Ethical Controversies Related To Implementing Evidence-Based Quality Improvement (EBQI) Initiatives

Evidence-Based Quality Improvement (EBQI) initiatives are programs designed to improve healthcare quality and outcomes through evidence-based practices. While these initiatives are often beneficial, several ethical controversies can arise when implementing them. The three ethical controversies related to EBQI initiatives are informed consent, equity, and confidentiality. The following sections discuss the ethical controversies and their relationship to the four core ethical principles.

The first ethical controversy related to EBQI initiatives is the issue of obtaining informed consent from patients. When implementing EBQI initiatives, clinicians may use patient data to guide their decisions and improve the quality of care (Melnyk & Fineout-Overholt, 2014). However, patients may only sometimes be fully informed about how their data will be used or may not have the opportunity to opt out of data collection. This raises concerns about respect for autonomy and non-maleficence since patients cannot decide how their data should be used. Additionally, such information may be used in malicious ways if it gets into the wrong hands causing harm to the patients. Patients have a right to be fully informed about using their data and to decide whether they wish to participate. It is important for clinicians to obtain informed consent from patients before collecting their data and to ensure that patients are fully informed about how their data will be used and protected.

The second ethical controversy related to EBQI initiatives is the issue of equity. There may be disparities in access to care or the ability to benefit from EBQI initiatives. For instance, certain populations, such as those who are socioeconomically disadvantaged, may have limited access to healthcare or cannot afford the costs associated with implementing EBQI initiatives. Such a factor raises concerns about the principle of justice and beneficence (Melnyk & Fineout-Overholt, 2014). Denying populations equal access to EBQI initiatives violates the principle of beneficence since those who would have benefited most miss that chance. It is important to ensure that EBQI initiatives are implemented in an equitable way and that all patients have access to the benefits of these initiatives regardless of their socioeconomic status or other demographic factors.

The third ethical controversy related to EBQI initiatives is the issue of confidentiality. Patient data is often collected and analyzed in the context of these initiatives, which raises concerns about protecting patient privacy and confidentiality. The latter is particularly important when dealing with sensitive information, such as mental health or reproductive health data. The principle of confidentiality is an important aspect of respect for autonomy, as patients have a right to expect that their personal information will be kept confidential (Melnyk & Fineout-Overholt, 2014). Clinicians and researchers must ensure that patient data is protected and that all necessary safeguards are in place to protect patient privacy and confidentiality.

In summary, implementing EBQI initiatives can raise several ethical controversies, including informed consent, equity, and confidentiality issues. These controversies are linked to the four core ethical principles of respect for autonomy, beneficence, non-maleficence, and justice. To ensure that these principles are upheld, obtaining informed consent from patients, ensuring that EBQI initiatives are implemented equitably, and protecting patient privacy and confidentiality is important.

Conflict of Ethical Principles with the Concept of “Patients Having an Ethical Responsibility in Improving Healthcare”

The concept of “patients having an ethical responsibility in improving healthcare” suggests that patients have a role in ensuring they receive high-quality care. Additionally, they contribute to the improvement of the healthcare system. For instance, patients are responsible for being truthful, expressing concerns to their healthcare providers early, and cooperating with agreed-upon appointments and treatment plans. Similarly, they must take personal responsibility when necessary to prevent the development of diseases. According to De Marco et al. (2021), patients are accountable for their health-relevant behaviors and choices. While this concept has some merits, it can also raise ethical concerns, particularly concerning the principles of autonomy and non-maleficence.

The principle of autonomy holds that individuals have the right to make decisions about their healthcare without interference from others. Therefore, it can be seen as an infringement on patients’ autonomy when asked to have an ethical responsibility to enhance healthcare. For instance, patients may be asked to change their lifestyle and behaviors to prevent illnesses or facilitate quick recovery from certain health conditions. However, some patients may feel that policies that hold them accountable for their health outcomes are unjustifiable (De Marco et al., 2021). Patients may feel pressured or obligated to take actions they are uncomfortable with to fulfill their perceived ethical responsibility. Interfering with patients’ decisions may make them feel disempowered and vulnerable to external influences, which can be detrimental to their well-being.

The principle of non-maleficence requires healthcare professionals to act in a way that does not cause harm to their patients. The principle supports various moral values, such as not causing suffering, incapacitating, and depriving others good life (Varkey, 2020). Therefore, healthcare providers should weigh all interventions and treatments and select the best course of action for the patients. However, asking patients to have an ethical responsibility to improve healthcare is associated with risks that may inadvertently cause harm to themselves and others. For instance, if physicians or nurses ask patients to self-diagnose or self-treat, they are likely to harm themselves or individuals close to them by taking ineffective or inappropriate treatments.

Conclusion

It is imperative to balance the concept of patient responsibility with the principles of autonomy and non-maleficence to address these conflicts. Patients should be empowered to take an active role in their healthcare while at the same time being supported in making informed decisions that align with their values and preferences. This approach is achievable through patient education, shared decision-making, and clear communication between patients and their healthcare providers. Moreover, it is crucial to encourage patients to ask questions and seek clarification when unsure about their role in improving healthcare. Further, healthcare providers should consider patients as partners in care delivery rather than dictating their responsibilities or expectations. Thus, there should be clear and effective communication between healthcare providers and their patients.

References

De Marco, G., Douglas, T., & Savulescu, J. (2021). Healthcare, responsibility and Golden Opportunities. Ethical Theory and Moral Practice, 24(3), 817–831. Web.

Melnyk, B. M., & Fineout-Overholt, E. (2014). Evidence-based practice in Nursing & Healthcare: A guide to best practice (3rd Ed.). Lippincott Williams & Wilkins.

National Institutes of Health. (2022). The basics: The NIH Clinical Trials and You. NIH. Web.

Varkey, B. (2020). Principles of clinical ethics and their application to practice. Medical Principles and Practice, 30(1), 17–28. Web.

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Ethics and Evidence-Based Research

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