Research Ethics
Capella University
NURS-FPX9100: Defining the Nursing Doctoral Project
Prof. Laurel Pilkington
February 17, 2024
Research Ethics
Nursing research requires researchers to uphold honesty and integrity. Ethical conduct and standards provide insights into acceptable and unacceptable practices. The goal is to avoid the falsification of data and maintain an environment of trust and respect. The IRB screening process guides nursing researchers to plan and design their projects according to the recommended standards. As such, a good project is well planned and ethically approved to achieve the intended objectives.
Overview of the Project
Inpatient falls are among the most commonly reported safety concerns. The high rates of falls expose patients to adverse clinical outcomes that jeopardize the facility’s safety and quality culture. One of the key mechanisms for reducing patient falls is through quality improvement initiatives that promote correct use of falls risk assessments, training and education programs, checklists and other interventions. For this project, the QI aligns with the need for adequate falls assessment, high completion rates of training and education on safety, and robust use of checklists to improve clinical outcomes.
The goal is to reduce length of stay, increase organizational net margins, and enhance the brand’s credibility. The fact that the facility admits many acute and sub-acute patients means that the majority are vulnerable to falls. The patients require person-centered care in the form of alternative and evidence-based options adopted to reduce the incidents of inpatient falls.
The stakeholders include the Chief Nursing Officer, the project team, patients, and the nurse educator. The group understands the challenges in the medical-surgical unit including the risk of patient falls. Successful improvements could enable the stakeholders to make significant contributions in enhancing the quality and safety of care. It is also crucial to adhere to ethical standards and conduct. Ethics enable researchers to uphold honesty and integrity throughout the project. The aim is to minimize the risk of harm to participants by upholding the principles of accountability, trust, and honesty.
History of Research Ethics
Research ethics traces its origin to the inhumane experimentation on prisoners during the Nazi regime. The experiments happened in Nazi death camps, thereby revealing the severity of the harm caused to inmates. World War II and trials associated with war crimes also reinforced the need for ethical research practices. The Nuremberg Code emerged from increased efforts to design and implement ethical principles in scientific and healthcare interventions (Gelling, 2020). The code described the need for physicians and scientists’ adherence to informed consent, proper designing of experiments, lack of coercion, and beneficence. The Helsinki Declaration of 1964 and the Belmont Report of 1979 followed the Nuremberg Code. The two focused on the need for ethical research in projects involving human subjects. This project draws insights from the various ethical aspects.
Applying the Principles of Research Ethics
The four principles identified for this project are autonomy, beneficence, nonmaleficence, and justice. The non-maleficence concept guides researchers to avoid intention and unintentional harm and discomfort. For this project, the researcher will pay attention to privacy and confidentiality to avoid exposing individuals to emotional and psychological harm. Beneficence is the principle that obliges the researcher to act in the participants’ interests (Varkey, 2021). The objective is to uphold moral and ethical standards for safeguarding the rights and freedoms of participants. It is also important to eliminate conditions that may jeopardize individuals’ wellness. For this reason, the procedures adopted for this project reflect the need to promote goodness and ensure that participants benefit from the outcomes.
Autonomy is also vital throughout the project.
The principle requires researchers to allow participants to exercise independence of thoughts when choosing to participate in the process. In this case, it is vital to acknowledge participants’ contribution and their ability to make informed decisions before agreeing to participate in the project. Autonomy encourages researchers to appreciate the need for self-determination (Varkey, 2021). The principle discourages researchers from coercing or coaxing participants to participate in the project. Justice is the other principle that encourages fairness when including participants in a project. The element also promotes equity and the right treatment of participants when allocating resources.
Human Participants in the Project
The main participants for this project are nurses in the medical-surgical unit. The team handles patients with advanced care needs and vulnerable to falls. The nurses play a key role in maintaining quality and safe care (Priyadarshini, 2020). Including the participants in this project increases the opportunity to identify operational gaps and strategies required to optimize care outcomes. The front-line roles of nurses make them ideal for contributing insights into the best ways to reduce the risk of patient falls. The nursing team brings the knowledge and skills required to address issues across departments. Including them as the main participants help strengthen the organizational commitment to delivering the best care to patients with diverse needs. Similarly, the medical-surgical unit is among the most crucial for the facility (Cuttler et al., 2017).
The department calls for proactive efforts to improve the quality of care. The inclusion criteria entail engaging nurses in the medical-surgical unit. The participants include nurses with over four years of working experience in advanced care settings. For the exclusion, nurses who do not consent to the study and those on medical leave are exempted from participating in this project.
Potential Ethical Risks and Action Plan
Vulnerability or Possible Concerns for Identified Project Participants
Several issues emerge that influence compliance with ethical requirements. One concern is beneficence during the recruitment and data collection processes. This project involves collecting first hand data from the selected healthcare professionals and patients. The process would require the researcher to demonstrate respect and awareness of the implication of the principle of beneficence. As such, project participants may express concerns over the distribution of benefits and the risk of harm. The group would want clear information on protection of their autonomy and desire to make informed consent when participating of withdrawing from the project (Ingham-Broomfield, 2017). In other words, the failure to objectively describe the project’s purpose may discourage many potential participants from agreeing to be part of the QI process.
Another vulnerability is confidentiality and privacy of participant’s details. Participants may express the intention to withdraw from the project if the researcher does not assure them about the confidentiality of their personal identifiable details. For instance, participants may want the researcher to conceal their names, telephone numbers, and other information that may expose them to intimidation once shared or revealed to the management (Priyadarshini, 2020). It is necessary to consider individuals’ welfare by safeguarding them from privacy and confidentiality infringement, and the emotional and mental issues arising from non-compliance with the confidentiality rules. The ethical considerations demonstrate the need for researchers to avoid disclosing sensitive information.
Strategies to Address Potential Ethical Risks Related to The Doctoral Project
The beneficence principle entails describing the risks associated with the project and the efforts made to minimize harm. The principle discourages researchers from coercing potential participants to participate in the project. In this case, the group should familiarize itself with the procedures and risks and willingly decide to participate. Several risks could arise in the course of this project. A strategy for addressing participants concern over gains of the project is to ensure that everyone included in the project is competent and understands the research purpose and net gains (Gelling, 2020). Notably, participants should be well-informed of the researchers’ intentions. Similarly, a written consent statement is crucial to demonstrate individuals’ awareness of the impact of QI project focused on addressing inpatient falls.
The other risk relates to confidentiality and privacy.
The two provide insights into the need for researchers to avoid disclosing details that may expose participants to intimidation or harm. The researcher will uphold privacy and confidentiality by excluding personal details such as email addresses, telephone numbers, and other identifiers that may limit the respondents from providing accurate and complete insights into the scenarios exposing patients to falls. Further, adherence to the autonomy principle is necessary to encourage everyone to make rational decisions. Participants will have access to details about the project and independently decide to participate or withdraw from the process. Similarly, the researcher seeks to engage individuals with the right mental, physical, and emotional capacity to understand the value of the project on patients, their families, and the organization. Thus, the project excludes those on medical leave and health conditions that limit them from exercising self-determination and actively participating in the project.
Institutional Review Board (IRB) Processes
The IRB Processes to Be Completed Prior to Starting The Data Collection Process
The Institutional Review Board is a key player in promoting compliance with ethical principles and practices. The institution monitors initiatives involving human subjects hence the need to understand guidelines and provisions for a more compliant project (Qiao, 2018). Before starting the data collection process, the IRB process will involve clarifying details of the key components of the project. The team will provide a detailed description of the problem, the project questions, data collection methods, anticipated outcomes, and the data analysis procedures (Phillips et al., 2017). The project team will also clearly define the scope of the project and the nature of data in line with the IRB approval requirements. Further, training of participants is crucial to confirm their knowledge of the provisions of the Health Insurance Portability and Accountability Act (HIPAA) or the Privacy Act (Phillips et al., 2017).
This project meets the conditions on a design, evaluation, and net gains that portray adherence to the IRB’s review requirements. The selected site has an IRB based on the administration’s awareness of the need to utilize evidence-based findings derived through ethical research practices. Thus, the site encourages the workforce and patients to understand ethical standards that help minimize harm among human subjects. The site requires submission of the consent documents, permits, and recruitment processes adopted throughout the project. The focus on human subjects means that it is vital to attach details of the conversations with participants informing them about the value of the project from a personal, career, and organizational perspective. One month is the identified duration to acquire the relevant approvals for the project. The review team will have enough time to scrutinize the documents and make the right decision on whether the project meets the requirements.
Possible Future Changes That Would Require IRB Approval
The proposed intervention is training and education on patient falls risk assessment tools, use of checklists, and the need for increased care coordination. However, changes to the data collection tool may be necessary to include additional questions that match inpatient falls. For the reason of a change to the questionnaire, it is necessary to seek IRB approval. In this project, the review will involve effective planning for the changes characterized by accurate and complete insights into the robustness questions and their compliance with ethical guidelines involving human participants. The priority for the project team is to adhere to the scope and guidelines set by IRB in terms of minimizing psychological, emotional, and physical harm triggered by the questions. A comprehensive work breakdown structure (WBS) is necessary at this point to track tasks and minimize deviations. In this case, the team will have a detailed plan to contextualize objectivity of new questions and how they match the project goals.
Conclusion
A project on patient falls in advanced care settings is vital to enhance the culture of safety and quality care. However, the success of the initiative depends on the project team’s commitment to upholding ethical standards and requirements set by the IRB. It is vital to adhere to the principles of autonomy, beneficence, justice, and nonmaleficence to achieve the intended outcomes. Thus, a takeaway from the process is the need for a well-designed project characterized by appropriate participants’ recruitment, data collection, analysis, and reporting of findings. It is also crucial to enhance the quality of data collected by engaging participants with the mental, emotional, and physical capacity to make informed decisions. The aim is to minimize the risk of engaging individuals who lack the self-determination to actively contribute towards reducing patient falls in the medical-surgical unit.
References
Cuttler, S., Barr-Walker, J., & Cuttler, L. (2017). Reducing medical-surgical inpatient falls and injuries with videos, icons and alarms. BMJ Open Quality, 6, 1-8. https://bmjopenquality.bmj.com/content/6/2/e000119
Ingham-Broomfield, R. (2017). A nurses’ guide to ethical considerations and the process for ethical approval of nursing research. Australian Journal of Advanced Nursing, 35(1), 40-47, https://www.ajan.com.au/archive/Vol35/Issue1/5Broomfield.pdf
Gelling, L. (2020). Research ethics in real-world research. Journal of Clinical Nursing, 29, 1019–1022. https://onlinelibrary.wiley.com/doi/epdf/10.1111/jocn.15083
Phillips, M., Abdelghany, O., Johnston, S., Rarus, R., Austin-Szwak, J., & Kirkwood, C. (2017). Hospital Pharmacy, 5(2), 105-116. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5345908/
Priyadarshini, P. (2020). Ethics in nursing research. European Journal of Molecular & Clinical Medicine, 7(7), 6080-6086. https://ejmcm.com/article_6005_21f5f1614485918666042bdb6cc01468.pdf
Qiao, H. (2018). A brief introduction to institutional review boards in the United States. Pediatric Investigation, 2(1), 46-51. https://www.researchgate.net/publication/325096564_A_brief_introduction_to_institutional_review_boards_in_the_United_States
Varkey, B. (2021). Principles of clinical ethics and their application to practice. Medical Principles and Practice, 30, 17–28. https://www.karger.com/Article/FullText/509119
Wu, Y., Howarth, M., Zhou, C., Hu, M., & Cong, W. (2019). Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: A retrospective observational study. BMC Medical Ethics, 20(94), 1-9. https://bmcmedethics.biomedcentral.com/track/pdf/10.1186/s12910-019-0431-5.