Ethics and Evidence-Based Research

Ethics and Evidence-Based Research

Introduction

Ethical values are rules of conduct that guide the intentions, motives, and values of healthcare researchers and healthcare professionals (Rasoal et al., 2017). In specific scenarios, ethical values are not aligned with evidence-based research since the ethical values may not be supported by scientific knowledge. Ethical safeguards are essential in the design of clinical research and the implementation of evidence-based research. There are also ethical controversies that may arise when implementing evidence-based quality improvement (EBQI) initiatives.

Part 1

Ethical safeguards are critical since they guide the conduct of clinical research, and they also observe ethics and protect the participants in the clinical research. Ethical safeguards guide subjects’ enrollment, participation, and decision-making in clinical research. Ethical safeguards in clinical research include institutional review boards, informed consent, confidentiality practices, and alternative decision-making. These safeguards aim to protect research participants and ensure their rights are protected. The safeguards ensure that study researchers do not influence participants when enrolling for clinical research (Gordon, 2020).

Researchers must ensure their clinical research is aligned with ethical safeguards to reduce the chances of not following these guidelines. They must strive to protect vulnerable patients, such as individuals from low socioeconomic status and mental conditions (Gordon, 2020). Informed consent ensures that researchers inform the study participants of the study’s objectives, requirements, possible outcomes, and impact on the participant’s health status (Gordon, 2020). Healthcare professionals can obtain evidence for practice and decision-making through various sources. It may, however, be challenging since the evidence depends on data collected to improve the quality of care, patient outcomes, and healthcare outcomes.

Information for evidence-based can be obtained from a patient’s personal information and history. However, this requires consent since there are limits on what information can be accessed, for how long, and by whom. It may thus be hard to use this ethical safeguard when implementing an evidence-based project. In addition, ethical safety guidelines require institutional review boards to seek approval before conducting clinical research. However, this may not be possible in implementing EBPs since these initiatives are done at the hospital level; hence, this safeguard may not be implemented.

Ethical safeguards also protect vulnerable individuals, such as those with cognitive disabilities, mental health issues, and economic vulnerabilities. However, these safeguards may not be applicable in implementing EBP initiatives to improve healthcare practices. Some EBP initiatives may be meant to improve service delivery in healthcare organizations; hence, the project leads may not seek informed consent before involving them in the EBP initiatives. They may issue survey forms that participants, such as patients and healthcare professionals, may be asked to fill out. The project leads may not reveal the whole nature or details of the EBP to the participants.

The ethical principle of beneficence demands that the project is for the benefit of the participants (Gordon, 2020). This may not necessarily be the case when implementing evidence-based practice initiatives, and individuals involved in the EBP practice may not necessarily benefit from these initiatives. These initiatives may improve the quality of care and nurses’ job satisfaction or reduce healthcare costs, and this may only benefit a group of participants and not all of them. An initiative to enhance nurses’ job satisfaction may only benefit the nurses and not the patients. EBP initiatives may also pose a conflict of interest since the nurse may be torn between organizational interests and patient interests

Part 2

Any healthcare practices done in healthcare settings must be carefully evaluated to ensure that the well-being and rights of patients are protected. It is critical to differentiate evidence-based implementation initiatives and clinical research to help implement ethical safeguards and utilize ethical principles in healthcare settings. Clinical research involves the use of human subjects in research. Evidence-based quality improvement initiatives are activities done to improve the delivery of quality healthcare services in specific settings (Abou Hashish & Alsayed, 2020). All of these activities require a clinical appraisal to protect patient rights.

Several controversies are present in the course textbook’s “Two ethical exemplars” section. The first controversy in the “Michigan ICU Study” was no informed consent. The study was submitted to the review board, which ruled that it was an EBP quality improvement initiative and not clinical research, and hence, there was no need for informed consent (Melnyk & Fineout-Overholt, 2015). John Hopkins Institutional Review Board exempted informed consent from this study. However, the Office for Human Research Protections (OHRP) disagreed and stated that informed consent should have been sought since it was clinical research. This controversy concerns the ethical principle of informed consent, in which study participants must be given complete information about the study to allow them to make an informed choice of participating (Melnyk & Fineout-Overholt, 2015). This controversy is also related to the ethical principles of beneficence and nonmaleficence. The EBP initiative tested an educational intervention with an unknown efficacy, which violated the ethical principles of beneficence and nonmaleficence. There was indecisiveness in obtaining informed consent from participants before the study since it was considered an EBPQI, which was a violation of the patient’s autonomy. It is essential to obtain patient consent regardless of the category of the study.

The second controversy was that this study was exempted from the IRB review since it was not considered clinical research. All clinical studies must be subjected to the IRB since the boards will be able to determine the safety and protection of research participants. The Johns Hopkins Review Board should have determined the need for informed consent, the risk to patients, and the efficacy of the study. Nonmaleficence and justice may have been violated since the outcomes of educational interventions were unknown, and hence, some patients may have been negatively impacted by this study.

The third ethical controversy about these two exemplars was categorizing whether the projects were EBQIs or clinical research. EBQIs and clinical research have different ethical safeguards. There is tighter control of clinical research, and they must go under the IRBs to determine their safety, efficacy, informed consent, and protection of patient rights. Many researchers may thus want to bypass these regulations by claiming that their studies are EBQIs and not clinical research, which may expose the patients to unnecessary harm.

Part 3

Several ethical principles can cause conflicts with patients’ moral rights to enhance healthcare. The selection of patients should be fair with the use of exclusion and inclusion criteria using scientific rationale and not vulnerability and convenience (Melnyk & Fineout-Overholt, 2015). Participation of human subjects should be voluntary since a lack of knowledge in improving healthcare may impact the results. It is critical to educate the patients on what is expected of them to meet improvement objectives, which will benefit everyone involved.

The concept of “patients have an ethical responsibility in improving healthcare” conflicts with three ethical principles: justice, benevolence, and nonmaleficence. These three principles do not include the patient in the decision-making plans to improve healthcare. One of the principles is that if patients are well-managed, asking for them is unnecessary. Nonmaleficence ensures that no harm befalls the patient. So, if no harm befalls the patient, letting them decide the healthcare activities to implement is unnecessary. The principle of justice is that if healthcare resources are justly divided, patients should be satisfied and allow healthcare activities to be implemented without seeking their consent.

These principles opine that effective implementation of evidence-based activity is better than seeking consent from patients who may oppose the implementation. These conflicts can be resolved by connecting all the principles and ensuring their application to all patients is consistent. Seeking patients’ opinions is critical since it allows them to voice their preferences and needs. Patients being part of the decision-making process will help to improve healthcare. In addition to this, there should be an equitable distribution of resources. Patients should also be protected from intentional and unintentional harm. No healthcare activities should be implemented if ethical principles are not observed.

Conclusion

Healthcare professionals and researchers must observe ethical safeguards protecting human research subjects. It is critical to gain informed consent from patients to ensure they are protected in the project. It is also critical to analyze the difference between EBPQIs and clinical research to ensure that some ethical safeguards are bypassed. Ethical principles help to protect patients, study participants, and the validity of research studies.

References

Abou Hashish, E. A., & Alsayed, S. (2020). Evidence-based practice and its relationship to quality improvement: A cross-sectional study among ‎Egyptian nurses. The Open Nursing Journal, 14(1), 254-262. https://doi.org/10.2174/1874434602014010254

Gordon, B. G. (2020). Vulnerability in research: Basic ethical concepts and general approach to review. Ochsner Journal, 20(1), 34-38. https://doi.org/10.31486/toj.19.0079

Melnyk, B. M. & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare: A guide to best practice (3rd ed.) Philadelphia, PA: Wolters Kluwer Health.

Rasoal, D., Skovdahl, K., Gifford, M., & Kihlgren, A. (2017). Clinical ethics support for healthcare personnel: An integrative literature review. HEC Forum, 29(4), 313-346. https://doi.org/10.1007/s10730-017-9325-4

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Write a 1250-1500 word essay addressing the following points/questions. Be sure to answer all the questions for each bullet point completely. There should be three main sections, one for each bullet below. Separate each section in your paper with a clear heading that allows your professor to know which bullet you are addressing in that section of your paper. Support your ideas with at least two (2) sources using citations in your essay. Make sure to cite using the APA writing style for the essay. The cover and reference pages in the correct APA do not count toward the minimum word amount. Review the rubric criteria for this assignment.

Part 1: Describe why ethical safeguards designed for clinical research may not be feasible or appropriate for evidence-based practice or evidence-based practice implementation projects.

Part 2: Review the section headed, Two Ethical Exemplars, in Chapter 22 of the textbook (Melnyk and Fineout-Overholt, 2015, pages 518-519). Discuss three ethical controversies about implementing Evidence-Based Quality Improvement (EBQI) Initiatives. Describe how these controversies relate to the four core ethical principles.

Part 3: Identify which ethical principles may conflict with “patients having an ethical responsibility in improving healthcare.” Discuss how these conflicts may be resolved.