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NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Assessment 1: Protecting Human Research Participants


Capella University

Prof. Name

June 14th 2024

Protecting Human Research Participants

The Collaborative Institutional Training Initiative explores the historical progression, ethical duties, and legal factors essential to research projects that involve human participants. Historical ethical breaches have necessitated the formulation of stringent ethical standards and legal frameworks to protect human subjects in research (Khosravani et al., 2024). This report offers a comprehensive overview of the evolution of ethical standards, the necessity of participants, and the application of these principles in contemporary research. The assessment highlights critical measures ensuring researchers are well-equipped to conduct studies with ethical integrity and legal compliance.

History and Evolution of Human Subjects Protection

The imperative to protect human subjects in research has evolved from significant historical lessons (Asare et al., 2022). Crucially, the Nuremberg Code emerged in response to the unethical research practices during World War II, establishing the necessity of informed consent. The Declaration of Helsinki built on this foundation, emphasizing safeguarding participants’ well-being (Gordon, 2020). At. the same time, the Belmont Report introduced the principles of respect, beneficence, and justice into research practices (Bolado et al., 2024). These documents underscore the vital role of ethical standards in research involving human subjects, highlighted in the CITI training materials.

The CITI training further explores cases like the Public Health Service Syphilis Study at Tuskegee, underscoring the need for transparency and ethical engagement with research participants (Alshawish & Benbenishty, 2023). It also discusses recent advancements, such as incorporating electronic informed consent, demonstrating ongoing innovations in how participant protections can adapt to new technological and ethical challenges (Godskesen et al., 2023). These examples from the training illustrate both the historical context and the dynamic, evolving nature of human subject protection, reinforcing its critical importance in contemporary research practices.

Research Activities Involving Human Subjects and Impact on Nursing

Research involving human subjects is essential for advancing healthcare and improving nursing practice (Chimonas et al., 2023). Various research activities require the participation of human subjects, each contributing uniquely to the body of medical and nursing knowledge (Gordon, 2020). Clinical studies evaluate the safety and effectiveness of new therapies, medications, or medical equipment. For example, a clinical trial might investigate a new chemotherapy regimen for cancer patients, directly involving them to evaluate outcomes and side effects (Resnik, 2021). Behavioral studies explore psychological and behavioral responses through surveys, interviews, and observations (Bolado et al., 2024). An example includes research on patient adherence to medication regimens, which can identify factors influencing compliance and guide interventions to improve it. Epidemiological research examines the spread and factors influencing population health and disease states (Chimonas et al., 2023). Studies involving human subjects might investigate the prevalence of hypertension in a community, providing data that can inform public health strategies and preventive measures (Khosravani et al., 2024). Qualitative research by Giannetta et al. (2021) utilizes detailed interviews, focus groups, and case studies to explore individual experiences and societal phenomena. For instance, qualitative studies might explore the experiences of end-of-life care among terminally ill patients, offering insights into their needs and improving palliative care practices.

These research activities significantly impact nursing practice by providing evidence-based insights that inform clinical decisions and care strategies. Clinical trials help identify effective treatments and interventions, shaping clinical guidelines and protocols (Godskesen et al., 2023). Behavioral studies offer valuable insights into patient behaviors and attitudes, enabling nurses to develop more effective patient education and support programs (Li et al., 2022). Epidemiological research provides critical data on health trends and risk factors, guiding public health initiatives and preventive care strategies (Zhang et al., 2024). Qualitative research enriches understanding of patient experiences and needs, fostering a more patient-centered approach to nursing care (Asare et al., 2022). Integrating these diverse research findings enhances nursing practice, improving care standards and patient outcomes.

Strategies to Minimize Potential Risks to Research Participants

Minimizing possible hazards associated with research participants is crucial for ethical research (Li et al., 2022). One effective strategy is obtaining informed consent, guaranteeing that participants comprehend the study’s purpose, possible dangers, and advantages before participation. Implementing rigorous data protection measures, such as encryption and secure storage, protects participants’ confidentiality and privacy (Gordon, 2020). Using non-invasive techniques, like surveys or observational methods, can significantly reduce physical and psychological risks (Resnik, 2021). Regular monitoring and reporting of adverse events allow prompt action to mitigate emerging risks. Conducting a thorough risk assessment during the study design phase helps identify and address potential hazards in advance (Egry et al., 2021). An independent Institutional Review Board (IRB) review meets all ethical considerations (Godskesen et al., 2023). Providing participants access to counseling and support services during and after the study can help mitigate any psychological or emotional impacts. These strategies collectively help create a safer and ethically sound research environment while preserving the robustness of the research framework.

Protections for Vulnerable Research Populations

Federal regulations mandate enhanced safeguards for vulnerable research groups, including children, pregnant women, prisoners, and those with cognitive disabilities, to ensure their safety and ethical treatment in research (Alshawish & Benbenishty, 2023). For these groups, obtaining informed consent must involve additional steps, such as obtaining consent from legal guardians or advocates and providing information in an accessible and understandable manner. Studies involving these populations undergo more stringent review processes by Institutional Review Boards (IRBs) to ensure that the benefits justify the risks. Assent and consent are particularly important for populations like children, where the child’s agreement is sought in addition to parental consent (Asare et al., 2022). Personalizing the research design to minimize potential harm and ensure the well-being of participants is crucial. Extra monitoring and support throughout the study help promptly address any emerging issues (Bolado et al., 2024). These enhanced protections help safeguard the rights and welfare of vulnerable populations while enabling valuable research to proceed ethically.

Impact of Protections on Research Design

Enhanced protections for vulnerable research populations significantly impact research design (Egry et al., 2021). Researchers must incorporate additional consent procedures, such as obtaining legal guardian consent and providing information in accessible formats (Asare et al., 2022). The need for more stringent IRB reviews means that study protocols are often adjusted to ensure minimal risk and maximal benefit to participants (Chimonas et al., 2023). Designing studies to include extra monitoring and support mechanisms can also be necessary, which may increase the complexity and cost of the research. Assent procedures, particularly for children, require developing age-appropriate materials and methods (Giannetta et al., 2021). These considerations ensure ethical compliance but often require more detailed planning and resources, ultimately shaping the research design to prioritize participant safety and ethical standards.

Ethical Standards in Research and Their Impact on Research Design

Ethical standards in research are foundational principles that guide the conduct of studies involving human subjects (Zhang et al., 2024). Key standards include respect for persons, which mandates informed consent and the protection of participants’ autonomy; beneficence, which requires maximizing benefits while minimizing harm; and justice, which ensures fair distribution of the research’s benefits and burdens (Khosravani et al., 2024). Compliance with standards necessitates thorough informed consent procedures, ensuring that participants completely grasp the study and its potential risks and advantages (Alshawish & Benbenishty, 2023). Research designs must incorporate measures to protect participants from harm, such as rigorous risk assessments and ongoing monitoring (Egry et al., 2021). Fair selection criteria must also be implemented to prevent the exploitation of vulnerable populations. These ethical requirements often lead to more detailed and carefully considered research protocols, potentially increasing complexity and cost but ultimately ensuring that the research is conducted in a manner that is respectful, safe, and just for all participants.

NURS FPX 5005 Assessment 1 Protecting Human Research Participants Conclusion

Protecting human subjects in research is paramount to advancing scientific knowledge while safeguarding the dignity and welfare of individuals, guided by historical documents such as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. These frameworks emphasize informed consent, participant well-being, and ethical integrity. Research activities, including clinical trials and qualitative studies, rely on human subjects to advance healthcare and nursing practice (Godskesen et al., 2023). Implementing strategies to minimize risks and providing additional protections for vulnerable populations ensure ethical compliance and participant safety (Giannetta et al., 2021). Adhering to these ethical standards ultimately leads to more reliable, respectful, and impactful research, fostering advancements in medical knowledge and improved patient outcomes.

NURS FPX 5005 Assessment 1 Protecting Human Research Participants References

Alshawish, E., & Benbenishty, J. (2023). Global nurse involvement in ethical decision-making during pandemics: A concept analysis. Journal of Research in Nursing, 28(2), 92–101. 

Asare, P., Ansah, E. W., & Sambah, F. (2022). Ethics in healthcare: Knowledge, attitude, and practices of nurses in the Cape Coast metropolis of Ghana. PloS One, 17(2), e0263557. 

Bolado, G. N., Ataro, B. A., Feleke, M. G., Gadabo, C. K., Kebamo, T. E., & Minuta, W. M. (2024). Informed consent practice and associated factors among healthcare professionals in public hospitals of Southern Ethiopia, 2023: A mixed-method study. Nursing, 23(1), 77. 

Chimonas, S., Lipitz, A., Matsoukas, K., & Kuperman, G. (2023). Electronic consent in clinical care: An international scoping review. Health & Care Informatics, 30(1), e100726. 

Egry, E. Y., Fornari, L. F., Taminato, M., Vigeta, S. M. G., & Fonseca, R. D. (2021). Indicators of good nursing practices for vulnerable groups in primary health care: A scoping review. Revista Latino-Americana De Enfermagem, 29, e3488. 

Giannetta, N., Villa, G., Pennestrì, F., Sala, R., Mordacci, R., & Manara, D. F. (2021). Ethical problems and moral distress in primary care: A scoping review. International Journal of Environmental Research and Public Health, 18(14), 7565. 

Gordon B. G. (2020). Vulnerability in research: Basic ethical concepts and general approach to review. Ochsner Journal, 20(1), 34–38. 

Godskesen, T., Björk, J., & Juth, N. (2023). Challenges regarding informed consent in recruitment to clinical research: A qualitative study of clinical research nurses’ experiences. Trials, 24(1), 801. 

Khosravani, M., Taheri, M., Amini, N., Babaeian, N., Lak, S., & Nejat, N. (2024). Explaining ethical challenges and practical solutions from a nursing management perspective: A phenomenological study. Journal of Family Medicine and Primary Care, 13(2), 681–690. 

Li, D., Liu, Y., Pan, M., & Zhao, L. (2022). Application and effect evaluation of nursing risk management in nursing of cardiovascular medicine. Contrast Media & Molecular Imaging, 2022, 9253868. 

Resnik D. B. (2021). Standards of evidence for institutional review board decision-making. Accountability in Research, 28(7), 428–455. 

Zhang, Y., Fu, J., Lai, J., Deng, S., Guo, Z., Zhong, C., Tang, J., Cao, W., & Wu, Y. (2024). Reporting of ethical considerations in qualitative research utilizing social media data on public health care: A scoping review. Journal of Medical Internet Research, 26, e51496.

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