Ethics and Evidence-Based Research

Introduction

Ethics refers to professional values that every human being is supposed to observe in the in daily activities. It should be followed in all professions including business, teaching, law, and in the healthcare sector too in medical, dental, and all other occupations. Researchers are also supposed to observe ethical values since they are also professionals by training. Clinical research refers to all kinds of research carried out on human beings to improve patient care, and ethics thus guides it.  Conversely, evidence-based practice (EBP) is the use of existing best evidence in making decisions concerning patient’s care. Critics suggest that EBP is guided by a vague definition of evidence and knowledge, and thus, the evidence is insufficient and does not give the objectives that action requires thus, making it unsuitable for use in practice.

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Reasons why ethical safeguards designed for clinical research may not be appropriate for EBP

The ethical safeguards for clinical research all stem up from the basic principles of research ethics. The laws aim at protecting the welfare of humans beings used in the research process, unlike EBP, which focuses on finding results using the best evidence available. One of the ethical safeguards for clinical research involves minimizing the possibility of harm (Wainwright et al., 2018). Some of the damages that a participant can be subjected to include physical injury, social disadvantages, psychological distress and comfort, and invasion of the participants’ privacy. A second component of the ethical safeguards requires that participants should volunteer and not be coerced, unless under special conditions, into participating in the research. Protecting the confidentiality of the research participants is also another requirement of research ethics. This helps to motivate the participant to volunteer the needed information that might be too personal. Avoiding deceptive practices is another ethical safeguard of clinical research. The participants have a right to know the proceedings of the investigation even though some information might be withheld at times. Finally, all participants should have the right to withdraw at any time during the research process. Furthermore, a participant who wishes to retire should not be coerced to stay by any means. 

Conversely, unlike ethical safeguards of clinical research, EBP aims at replacing the usual practice with a practice that is based on rigorous results-oriented research. Furthermore, it seeks to make the exercise less subjective and increase the level of accountability of the exercise (Ramira et al., 2016). The training focuses on identifying the best performances in various disciplines, including nursing. 

Ethical controversies related to implementing evidence-based quality improvement (EBQI)

The examples of main ethical issues that are related to implementing EBQI include ethical issues that arise during attempts to improve healthcare quality that may end up causing harm to the patient. In the first case, the authors conducted evidence-based research to help reduce the rate of bloodstream infections related to catheters, which cause patients to overstay in intensive care units (ICU). Despite saving 1800 lives within the 18 months, the project was criticized for not obtaining the consent of the participants and thus, failing to observe the principle of autonomy. The IRB viewed the project as an evidence-based practice and not clinical research and therefore, did not require the consent of the participants since the project could serve as any standard practice, which covered the patient’s general consent to treatment. Conversely, the OHRP viewed the project as clinical research, which could mean critical works of patient care in hospitals either stopped or reduced and thus, causing harm to the patients.

In the case of the Spanish ICU study, the results proved capable of saving 490 lives yearly. The program thus appeared to promote the principle of beneficence and nonmaleficence. However, the plan was criticized for failing to obtain the consent of the participants and therefore, was against the principle of autonomy. In their defense, the authors claimed that the project was an evidence-based quality improvement program and clinical research.

 The principle of nonmaleficence of clinical research requires that participants should be safe (Briner, 2019). According to the OHRP, in the case in Michigan, the program placed the patients at risks. An individual should not be put into any harm in the process of research. Evidence-based quality improvement initiatives may also involve activities that better suit being classified as clinical research but which are declared as quality improvement programs and thus, lead to controversies (Huyhn et al, 2016). 

Other controversies involved in social protection in relation to evidence-based quality implementation include the dilemma at whether the quality improvements need consent from the participants before researching like in the case of the clinical research (Meredith, 2018). More controversies arise on the issue of whether participants being treated under routine care should also be asked for consent. 

Ethical principles that may conflict with the concept of “patients having a moral responsibility in Improving health care

Principle of Beneficence

Failure to implement efforts that enhance quality through evidence-based quality implementation leads to the violation of the law of beneficence (Briner, 2019). The principle of beneficence is an ethical principle that emphasizes that the actions of a healthcare giver should be aimed at promoting good. The principle requires that researchers act with the intention to increase the potential benefits to the participants while reducing any losses or risks that may harm the participants (Huyhn, 2016).  The principle is built upon the fact that there exists a lot of uncertainty in the level of risks and benefits involved when an individual is subjected to medical conditions during clinical research.

Principle of autonomy

The failure of the evidence-based quality implementation to provide equal treatment to all participants violates the principle of autonomy (Ontgomery, 2018). The principle of autonomy requires that each participant be handled like an autonomous agent. For instance, the researching organization has to obtain the consent for participation of each participant before the research.  It also emphasizes that personal dignity and individual worth of the participants be observed. The select members, for example, children and persons with disability should be accorded special conditions. The principles also call for the respect of the right of an individual to change their mind concerning participating in the research and opting out. The participants also have a right to know about the findings of the study.

Principle of justice

If the evidence-based quality implementation fails to treat the participants equally, then it is in violation of the principle of justice. The principle demands the fair distribution of potential benefits and risks (Meredith, 2018). Therefore, it requires that vulnerable people be included in research only when necessary. However, it is critical to involve all kinds of people in research activities without discrimination.

Conclusion

The question as to whether there exists a conflict between ethics and evidence-based practice remains open despite numerous explanations. Evidence-based practices do not conform to all the ethical principles of clinical research. The principles help to protect the participants of a study from any harm, ensure that they participate in a study willingly, and they receive equal treatment such as the vulnerable groups like the disabled get special treatment. The principles also ensure that participants’ right to know the results of the research is observed.   All professions have some set of standards of ethics, which guide how they operate in their daily jobs. Adhering to the guidelines is a crucial element for conducting clinical research since it maximizes the benefits of the study to the participant while observing the welfare of the participants. Therefore, it is important for professionals and organizations to prove whether evidence-based initiatives demonstrate sustainable improvement in outcomes.

References

Briner, R. (2019). The Basics of Evidence-Based Practice. People & Strategy, 42(1), 1–7.

Huynh, A. K., Lee, M. L., Farmer, M. M., & Rubenstein, L. V. (2016). Application of a nonrandomized stepped wedge design to evaluate an evidence-based quality improvement intervention: a proof of concept using simulated data on patient-centered medical homes. BMC Medical Research Methodology, 16, 1–11

Meredith, L. S., Batorsky, B., Cefalu, M., Darling, J. E., Stockdale, S. E., Yano, E. M., & Rubenstein, L. V. (2018). Long-term impact of evidence-based quality improvement for facilitating medical home implementation on primary care health professional morale. BMC Family Practice, 19(1), N.PAG.

Ontgomery, A. (2018). Effect of an evidence-based quality improvement framework on patient safety. Australian Journal of Advanced Nursing, 35(4), 6–16.

Ramira, M. L., Instone, S., & Clark, M. J. (2016). Quality Improvement. Pediatric Pain Management: An Evidence-Based Approach. Pediatric Nursing, 42(1), 39–49.Wainwright, D. W., Oates, B. J., Edwards, H. M., & Childs, S. (2018). Evidence-Based Information Systems: A New Perspective and a Road Map for Research-Informed Practice. Journal of the Association for Information Systems, 19(11), 1035–1063.

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