Procedures For Research Approval And Human Participant Prote

Procedures for Research Approval and Human Participant Protection

In a healthcare setting, particularly within a practicum environment, understanding the procedures for research approval and the ethical considerations for protecting human research participants are paramount. This essay explores the typical processes required at a practicum site to obtain research approval, emphasizing the role of Institutional Review Boards (IRBs) and certifications such as NIH compliance. Additionally, it discusses key factors nurses and informaticists must consider to safeguard participants' rights and well-being, including confidentiality, anonymity, and informed consent.

At the practicum site, the procedure for obtaining research approval begins with submission to the hospital’s Institutional Review Board (IRB). The IRB is responsible for reviewing research protocols to ensure the protection of human subjects involved in the study. The IRB evaluates whether the research is exempt from ongoing review or if it requires continuous oversight. This process involves detailed documentation of the study’s objectives, methodology, potential risks, and benefits. Once submitted, the research proposal must be approved by a designated committee member, often the director for professional practice in nursing. This structured review process ensures that ethical standards are maintained and participant protections are in place. Additionally, researchers must be NIH certified, which involves completing an online training course focused on human research protections. The certificate obtained from this course must be submitted with the IRB application to demonstrate that the researcher understands and adheres to ethical principles outlined in the Belmont Report, including respect for persons, beneficence, and justice (NIH Office of External Research, 2011).

As a nurse informaticist, it is crucial to remain cognizant of situations where protecting human research participants becomes essential. These scenarios can arise in various contexts, such as data collection, quality improvement projects, or clinical trials involving patient data. Ensuring confidentiality involves safeguarding personal health information (PHI) and restricting access to authorized personnel only. Maintaining anonymity further protects participants by removing identifiers from data sets, thereby reducing risks of personal identification. Informed consent is another critical facet; it requires that participants be fully aware of the study’s purpose, procedures, potential risks, and benefits before agreeing to participate. As a nurse informaticist, one must ensure that electronic systems managing research data are secure, that data is de-identified when appropriate, and that consent processes comply with regulatory standards such as HIPAA. Moreover, ongoing monitoring and reporting of adverse events or breaches in confidentiality are vital responsibilities to uphold ethical standards and protect participants throughout the research process.

Scholarly Article Summary

Ongenae et al. (2014) discuss the importance of ambient-aware continuous care through semantic context dissemination. The study highlights how integrating semantic data in healthcare environments can enhance patient care by providing real-time, context-aware information to clinicians and systems. The authors propose a framework that utilizes ambient sensors and semantic web technologies to deliver continuous, personalized care. Findings suggest that such systems can improve decision-making efficiency, support timely interventions, and foster a more holistic approach to patient management. This research underscores the evolving role of health informatics in creating smarter, adaptive healthcare environments that respond dynamically to patient needs, ultimately contributing to better health outcomes.

Reference: Ongenae, F., Famaey, J., Verstichel, S., De Zutter, S., Latré, S., Ackaert, A., & De Turck, F. (2014). Ambient-aware continuous care through semantic context dissemination. BMC Medical Informatics and Decision Making, 14, 97. https://doi.org/10.1186/1472-6947-14-97

Practicum Onsite Visits Summary

This week, I participated in a meeting focused on the implementation of a new nurse call system in the emergency department. During the session, we discussed the various visual indicators, including different colored lights representing specific types of patient calls. For example, a blinking purple light outside a patient’s room indicates that the patient is receiving respiratory treatment. My role involved observing the decision-making process and understanding how technological changes can streamline communication among staff. Additionally, I worked on developing my flowchart, which will serve as a visual aid for understanding process workflows and ensuring smooth integration of new systems. This experience provided practical insight into the interdisciplinary collaboration needed for successful health technology implementation, emphasizing the importance of clear communication, stakeholder engagement, and workflow analysis in advancing patient safety and operational efficiency.

References

• National Institutes of Health Office of External Research. (2011). Protecting human research participants. Retrieved from https://phrp.nihtraining.com
• Ongenae, F., Famaey, J., Verstichel, S., De Zutter, S., Latré, S., Ackaert, A., & De Turck, F. (2014). Ambient-aware continuous care through semantic context dissemination. BMC Medical Informatics and Decision Making, 14, 97. https://doi.org/10.1186/1472-6947-14-97
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. U.S. Department of Health & Human Services.
• Resnik, D. B. (2015). Protecting research participants: A review of challenges and solutions. Accountability in Research, 22(3), 145–153.
• Faden, R. R., Beauchamp, T. L., & King, N. M. (2013). A history and theory of informed consent. Oxford University Press.
• Bell, J. A., & Norman, W. V. (2017). Ethical considerations in health informatics research. Journal of Health Informatics, 9(2), 123–130.
• Kohli, R., & Tan, S. (2015). Transforming health systems with health information technology. Health Affairs, 34(4), 434–439.
• Paul, D., & Duerden, M. (2014). Ethical challenges in clinical research. British Journal of Nursing, 23(12), 644–648.
• Spina, S., & De Domenico, S. (2019). Data security in healthcare research. Health Informatics Journal, 25(3), 927–938.
• Schroeder, R., & Montague, E. (2020). Improving patient safety through health IT implementation strategies. Healthcare Management Review, 45(2), 123–134.