Introduction
As the concept of evidence-based practice develops, the method begins distinguishing itself from other similar practices such as clinical research. Clinicians who would participate in either practice would submit their plans to the same ethics committees, which would, in turn, review them based on the same metrics. However, the two methods are noticeably different, and so the deliberations of review boards on the ethical considerations of each varied. Controversies would then arise based on differences in interpretation between various bodies. Overall, it becomes necessary to discuss the ethical issues related to evidence-based practice and their relations to general principles.
Clinical Research Ethical Safeguards and EBP
Clinical research is associated with a variety of ethical concerns due to the potential harm that may come to patients, whether intentionally or not. Much of modern medical knowledge, as well as ethical prohibitions, is based on the results of past intentionally unethical experiments. Even with safeguards in place, clinical research explores unknown aspects of healthcare, and the possibility of harm cannot be discounted. As such, informed patient consent is necessary alongside fair selection and a variety of other considerations such as investigator behavior. Independent review boards oversee adherence to all of these paradigms, and research cannot happen without their approval. The same boards also oversee evidence-based practice, as it appears to follow many of the same principles.
However, evidence-based practice is fundamentally different from clinical research in its reliance on prior findings. As such, any EBP initiative focuses on the idea that the proposed intervention is better than the current alternative. As can be seen in the cases proposed by Melnyk and Fineout-Overholt (2015), this tendency can lead review boards to exempt such proposals from some or all aspects of ethical review. However, other institutions may disagree, creating controversies and complicating the process. Besides, the practice has existed for as long as the evidence-based practice itself, and so considerable portions of past and current work have been exempt from ethics reviews for clinical research. As such, it is not feasible to consider evidence-based practice as part of clinical research and provide the same ethical demands.
At the same time, the complete exemption of EBP from ethics reviews is most likely an excessive move, as the studies and implementations still deal with patient health and carry risks. The idea that the interventions being proposed are based on evidence and therefore not dangerous is only valid if the supporting studies are sufficiently robust. Gambrill (2019) poses several questions that call the amount and types of evidence necessary to justify a treatment into question. As such, at least a review of research that serves as the foundation for the EBP intervention is necessary before a decision to expedite the ethics review process is necessary. Overall, however, it would be best if a comprehensive framework was developed from the basics.
EBQI Ethical Controversies and Principles
Health care as a whole is subject to a set of fundamental ethical guidelines that ensure that patients receive the best possible treatment. Ashcroft, Dawson, Draper, and MacMillan (2015) name the four main categories: respect for autonomy, nonmaleficence, beneficence, and justice. The first principle mandates that the patient should have the decision-making power in care if they are autonomous. The second prohibits healthcare practitioners from causing harm to the patient intentionally. The third requires that clinicians actively work to prevent harm and help the patient while balancing benefits against risks. The fourth and final principle promotes the fair and appropriate distribution of benefits among patients. Any unethical medical action can generally be traced to the breaking of one or more of these principles.
The first controversy discussed in the case study is related to the declaration by the review board that the Michigan ICU study was not clinical research and was therefore exempt from an ethics investigation. According to Melnyk and Fineout-Overholt (2015), the OHRP disagreed and maintained that the study constituted research and should have been reviewed. While the implementation carried minimal risks and was justified by evidence, its potential effects were still in question. As such, the omission of an ethics review would contradict the ethical principle of beneficence. Harm prevention requires an estimation of its probability and forms and preparation to address any issues that arise. None of the steps were taken in the study, creating grounds for the first disagreement with regards to the initiative.
The second controversy is the decision by the review board that patient consent was unnecessary as part of the broader exemption from the review. The decision contradicts the principle of respect for autonomy, as patients were not made aware of the situation or given the option of declining. Lipscomb (2016) notes that this issue, broadened into the general opposition of EBP to patient-centered care, is prevalent in the area as a whole. While the intervention took place on the care provider’s side and was based on evidence, patients should still have been given the option to refuse and demand that their assigned workers belong to the non-intervention group. However, if the evidence was strong enough, the new program could be seen as an improvement that does not require patient consent, hence the board’s actions.
The third, and final, controversy concerns the potentially broad application of the logic used by the OHRP to evidence-based practice as a whole. In doing so, it would limit the ability of clinicians to implement EBP, as it would have to undergo ethical reviews first. However, as Melnyk and Fineout-Overholt (2015) note, the studies featured in the section would likely have satisfied the requirements for an expedited review. As such, a degree of accountability would likely improve the safety of evidence-based practice, and so refusal to undergo ethics reviews contradicts the principle of beneficence. With that said, as was mentioned above, EBP initiatives would benefit from the development of a separate set of ethical requirements that would fit their nature and needs better.
Patients and Healthcare Improvement
This section discusses the concept of patients having an ethical responsibility in improving healthcare. The implication is that as EBP initiatives are created to improve care, and so patients have to accept them. As such, it is not necessary to obtain their consent, as, according to Melnyk and Fienout-Overholt (2015), it is part of their general agreement to treatment. The opposition of the approach to the principle of respect for autonomy is apparent, as they should have the ability to choose the treatment that they prefer. However, the idea may also oppose other core ethical considerations in some of its aspects.
Evidence-based practice guidelines may not necessarily consider every possible situation. As Lipscomb (2016) points out, there is a variety of viable cases for leaving patients on treatments that are supposedly inferior or do not adhere to the instructions entirely to achieve better results. As such, forcing patients to adhere to EBP can be counterproductive and violate the principle of beneficence. With regards to the other two principles, there is no intent to harm patients on the part of the guideline creators, and evidence-based practice tries to achieve a fair distribution of effort wherever possible. As such, the approach does not oppose them in the context of current evidence-based practice.
The first conflict may be resolved through the addition of a more extensive explanation about consent and the provision of choice to the patient. The explanation about consent to treatment should elaborate on the concept of evidence-based practice and mention that initiatives may be implemented during treatments. The patients should also be given the choice of agreeing or refusing to undergo the new intervention along with the information necessary for them to decide. The beneficence contradiction may be resolved through an expansion of EBP guidelines to accommodate various situations. However, clinicians should still have a degree of authority to make decisions in unique situations that are not covered by the rules.
Conclusion
The topic of ethics in evidence-based practice is complicated because the approach is still new. The same considerations as those in clinical research do not necessarily apply, creating the need to formulate a new set of ethical guidelines. Furthermore, many of the controversies surrounding EBP initiatives are rooted in the fact that they contradict core ethical principles of respect for autonomy and beneficence. The concept of patients being responsible for improving care goes against both, though the situation can be partially remedied through the introduction of patient and practitioner choice as well as the expansion of EBP guidelines.
References
Ashcroft, R., Dawson, A., Draper, H., & McMillan, J. (2015). Principles of health care ethics (2nd ed.). Chichester, Great Britain: John Wiley & Sons.
Gambrill, E. (2019). Critical thinking and the process of evidence-based practice. New York, NY: Oxford University Press.
Lipscomb, M. (ed.). (2016). Exploring evidence-based practice: Debates and challenges in nursing. New York, NY: Routledge.
Melnyk, B.M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare: A guide to best practice. Alphen aan den Rijn, Netherlands: Wolters Kluwer Health.