Ethics and Evidence-Based Research

Part 1 

Ethical Issues in Clinical research 

Clinical research aims to ascertain if a particular medical practice is better than the other, the magnitude of its clinical merits and if it has minimal risks. A code of ethics that the researcher and other clinical research stakeholders are required to abide by when conducting their duties has been set in place globally. The ethical guidelines are meant to protect research accomplices’ rights and ensure their safety. 

It should be noted that without the participants and the data they provide, research wouldn't be possible. To ensure that the guidelines get followed to the latter, the research activities should be monitored and reviewed regularly. Due to advancements in technology, a broad scope of research undertakings, and clinical research globalization, the ethical concerns that need working on keep accumulating. Possible threats that face research participants are alike globally, thus the need to keep updating the guidelines. Their constant update helps to ensure that participants of research and the community are safe when conducting research. 

Evidence-Based Practice 

Evidence-based practice informs decisions and guidance based on scientific evidence. In 1992, evidence-based medicine was introduced, which later spread to other professions. The evidence-based practice encourages and sometimes forces professionals to make decisions based on evidence. The practice shifts decisions making basis from traditions and random practices to firm research scientifically. Thus, outdated practices get replaced by more operative ones. The quality of scientific research is improved by evidence-based practices. It facilitates the use of up-to-date methods that get arrived at through high-quality research outcomes. 

Barriers of Ethical Safeguards on Evidence-Based Practice 

In evidence-based practice, ethical principles are as important as in the employment of evidence-based practice projects. According to Balas et al., (2015), if clinical research gets carried out diligently, there would be a minimal scope of conflict between ethics and evidence-based practice. However, conflicts may arise since the two operate differently. When patients’ involvement is viewed as an option in research, the evidence-based practice offers patients the same treatment in its care routine. Research activities seek to make its findings general to a wider population than its subjects. 

On the other hand, evidence-based practices aim at improving patients care in a particular setting. Research activities aim at giving findings to be used beyond the organization, while evidence-based practice aims at providing data to be used internally to improve the practice changes. If the implementation of evidence-based practice projects does not improve the quality, the patients' principle, and the principle of do no harm will become violated. If patients' are not offered equal treatment, the principle of Justice will get violated where a patient was not consulted. 

Part 2 

Review of Two Ethical Exemplars 

Two ethical exemplars in clinical research have been identified. "Fair subject selection and "Favorable risk-benefit ratio." "Fair subject selection" puts emphasis on the need for inclusion and exclusion methods to be used in the recruitment of research partakers to be scientifically based. Not how convenient or vulnerable they are. The number of patients served by an organization should be the determining factor of patients being involved in EBP and EBQI projects. The "Favorable Risk-benefit Ratio" puts emphasis on the minimization of risks and maximization of gains derived from research, EBP, and EBQI studies and initiatives. 

Ethical Controversies in Implementation of Evidence-Based Quality Initiatives 

When research is directed towards coming up with evidence for practice, EBQI is meant to implement evidence in practice. Research brings about risk often, but EBQI encounters very low-risk levels. EBQI is a vital part of the management of evidence-based practice when research is not. When implementing evidence-based practices and evidence-based quality initiatives, ethical values becomes very crucial (Mackey & Gass, 2015). However, it is not clear whether all the necessities for clinical research need to be incorporated into EBQI initiatives. The current controversies in application of evidence-based quality initiatives are: the inquiry of if EBQIs require equal application of consultation of patients as in clinical research, whether implementing EBP on one part while the other continues with traditional practice, which could be substandard is ethical, and whether patients receiving traditional care should be consulted in implementation of EBQI. 

Relationship of the Controversies to the Four Core Principles 

There is a notable and robust relationship between ethical disagreements when implementing Evidence-Based Quality Initiatives and the four core principles of clinical research. The link is in "Social or Scientific Value" and "Scientific Validity." In "scientific value," research, evidence-based practice, and evidence-based quality initiatives all require to be worth doing for them to be ethical. “Scientific Validity” requires research initiatives to be systematically comprehensive to ensure they are valid and offer generalized results. If evidence-based practice and evidence-based quality initiatives are constructed and implemented poorly, there will be wastage of both resources and time of the participants. 

Part 3 

Ethical Principles in Clinical Research 

Ethical principles help research participants in decision making on issues that concern each individual. They provide a means of avoiding abuse in human processes. Principles on ethics when conducting clinical research, helps in minimizing the possible exploitation of human rights. Thus, it facilitates respect and ensures the protection of human rights. The morality of all involved should be observed. Four main ethical principles uphold the practice of healthcare. The principles are beneficence, Justice, autonomy, and nonmaleficence. Beneficence puts emphasize on the importance of doing good to the patients. Justice delves into an equal and fair distribution of resources to people without showing fairness to one side. Autonomy emphasizes that patients should be accorded a right to make decisions on issues pertaining to the health of their lives and bodies. Nonmaleficence stresses that patients should not be harmed. Ethical principles are very crucial factors to consider when implementing EBQI initiatives. For ethical principles to be complied with, researchers and their subjects should be closely supervised. 

Patients’ Ethical Responsibility of Improving Healthcare 

Patients owe their physicians various obligations. They should honestly communicate with doctors about matters pertaining to their health. They are required to follow the doctor's orders to the latter, and they should see doctors early as this enables the doctors to plan their days early. Treatment regimens should be keenly observed by the patients. The patients are also not supposed to tire the physicians with issues not pertaining to their health. After recovery, patients are supposed to give a just judgment of the value of services rendered them by their physicians. It is also the responsibility of patients to adapt to healthy lifestyles. Patients are required to take part in the determination and implementation of schemes meant to curb the costs of health care. 

There are notable conflicts between the ethical principles of healthcare and patients' responsibilities in the advancement of healthcare practices. The principle of autonomy offers patients the right to be involved in decisions pertaining to their health but does not explain the foundation of such obligations. All the principles of ethics are related to patients individually but not collectively (Koo & Li, 2016). Their adherence does not mean that patients and physicians will put into considerations how their decisions and actions affect others. In as much as the principle of Justice draws attention to other principles, it is only considered when resources are scarce or when making decisions on policies. A conflict arises because when physicians and patients do not consider others when making routine decisions on treatment. 

Solving the Conflicts 

There is a great need to incorporate possible ways of resolving possible conflicts. One way is to ensure that all research participants are educated on the essential ethical principles. Ethical behaviors should be promoted to facilitate the easy adoption of policies set regarding people’s beliefs and behavior. Patients and physicians should put into consideration others and the community at large when making decisions on healthcare. The principles need to be clearly defined to be easily understood by all. The efforts to amend the principles should be explained clearly to eliminate conflicts. It should be clearly explained why specific responsibilities are vested on autonomous individuals. A moral responsibility virtue should be demonstrated by all involved in health care, not only patients. The obligation of fostering it should be vested on physicians and ethicists of health care. Thus, a significant transformation in decision making in the health care sector. 

References 

Balas, A., Vernon, M., Magrabi, F., Gordon, L. & Sexton, J. (2015) “Big Data Clinical Research: Validity, Ethics, and Regulation . ” MedInfo. 

Mackey, A. & Gass, S. (2015) “Second Language Research: Methodology and Design.” content.taylorfrancis.com 

Koo, T & Li, M. (2016) “A Guideline of Selecting and Reporting Interclass Correlation Coefficients for Reliability Research.” Journal of chiropractic medicine .