Discussion 10.1: Week 10 Protecting the Subjects of Your Own EBP Initiative/NUR 720

Value: 15 points (Initial Post, 9 points; Reply Posts, 6 points)
Discussion Guidelines
Initial Post
Week 10: Protecting Research Subjects

There is one lesson this week: Application of Ethics in Clinical Research. Activities include readings, learning modules, a discussion, and a written assignment. Review your course syllabus for a list of all items due this week.

This week, you will work toward preparing for your future DNP Scholarly Project by explaining how the Institutional Review Board (IRB) protects research subjects. You will begin the training you will need for your DNP Scholarly Project.

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EBP Flow Chart highlighting Step 5. Steps: 1=ID Problem; 2=Question; 3=Search; 4=Appraise; 5=Synthesize; 6=IRB Process; 7=Assess Organization; 8=ID Framework, 9=Future Coursework Design; 10=Future Coursework Implement; 11=Evaluate; 12=Disseminate.
Lesson 1: Application of Ethics in Clinical Research

In this lesson, you will learn the importance of ethical considerations in clinical research. You review historical events that led to the development of ethical codes/principles for clinical research. We introduce types of research misconduct that have been reported in clinical research and present guidelines for critiquing the ethical aspects of a research study. You also learn the Institutional Review Board (IRB) requirements for conducting clinical research.
Learning Outcomes

By the end of this lesson, you will be able to:

Discuss the importance of ethical principles in clinical research.
Explain the rights of the individual participant in clinical research.
Examine issues related to the protection of subjects and safe handling of data.
Analyze the implications of research misconduct.
Explain how the Institutional Review Board (IRB) protects research subjects.

Learning Materials

Read the following in your Evidence-based Practice in Nursing & Healthcare: A Guide to Best Practice textbook:

Chapter 23, “Ethical Implications for Evidence Implementation and Evidence Generation”

This chapter connects ethics and EBP.

Chapter 1: “Making the Case for Evidence-Based Practice and Cultivating a Spirit of Inquiry”

This chapter discusses the components of the EBP process and differentiates EBP, QI, and research.

Read the following article:

Ward-Smith, P. (2106). Evidence-based nursing: When the evidence is fraudulent. Urologic Nursing, 36(2), 98â€“99. Retrieved from BU’s Cullom-Davis LibraryLinks to an external site..

This article explains ethical principles that are relevant to clinical research and also discusses research misconduct and its relevance to nursing.

Read the following paper:

DNP projects need IRB approval (PDF)Links to an external site.

This paper explains why DNP projects need IRB approval.

Knowing that there are different views of what is defined as research; if you were to implement an EBP initiative to answer your clinical or management question:

Would an IRB define your project as QA or research?
Does this proposed project use human subjects?
How will you ensure that ethical principles are fostered?

Provide specific details for your answer to each question, including a citation to the references for the definitions you used.

Post your initial response to the Discussion Board by the end of day Thursday.
Response Post(s)

Use the RISE Model for Meaningful Feedback (PDF)Links to an external site. to provide thorough feedback to at least two classmates’ initial posts by the end of day Sunday.
Submission

Post your initial and follow up responses and review full grading criteria on the Discussion 10.1: Protecting the Subjects of Your Own EBP Initiative page.

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Protecting the Subjects of Your EBP Initiative
Ethics in research is as old as when research started. Research ethics was put to test during the early research conducted on prisoners by Nazi doctors (Sutrop et al., 2020). The incident of the ancient research was unfortunate as many people lost their lives. Various considerations were made that led to various codes to protect humans in research. The Nuremberg code required observing ethical principles including non-maleficence, beneficence, confidentiality, and informed consent when researching human subjects (Tambornino & Lanzerath, 2020). Similarly, the institution review board (IRB) upholds the ethical principles to monitor and review biomedical research involving human subjects.
Because of my proposed projects of using rest breaks to reduce burnout and improve performance among emergency room nurses, the IRB has a role in reviewing this project. Upon reviewing and conforming adherence to ethical principles, approval can of the research will follow. Fostering research ethics will be paramount to the completion of the project.
As dictated by ethics, obtaining informed consent from research participants is the initial step in conducting research. Obtaining consent is common practice in patients’ treatment including surgery and other procedures (Sutrop et al., 2020). When seeking informed consent, the researcher should explain to the participants all information including the reason for the research, risks, benefits, and consequences of the research (Tambornino & Lanzerath, 2020). The participants should be allowed to seek clarification and make informed decision for or against participating in research without intimidation or persuasion. Furthermore, participants can decide to leave the study at any time without facing negative consequences. The agreement should be signed and filed.
Apart from consent, maintaining the confidentiality of information for research participants is paramount. Participants must be assured that none of their details concerning the research will be shared with the third party without their knowledge and authority (West-McGruer, 2020). The use of locked cabinets, encryptions, and maintaining participants’ unanimity are some of the methods used to enhance confidentiality (Bell & Wynn, 2020). I will use these research ethics when researching on human subjects.
References
Bell, K., & Wynn, L. L. (2020). Research ethics committees, ethnographers, and imaginations of risk. Ethnography, 146613812098386. https://doi.org/10.1177/1466138120983862
Sutrop, M., Parder, M.-L., & Juurik, M. (2020). Research ethics codes and guidelines. In Handbook of Research Ethics and Scientific Integrity (pp. 67–89). Springer International Publishing. https://doi.org/10.1007/978-3-030-16759-2_2
Tambornino, L., & Lanzerath, D. (2020). COVID-19 human challenge trials – what research ethics committees need to consider. Research Ethics, 174701612094363. https://doi.org/10.1177/1747016120943635
West-McGruer, K. (2020). There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model. Journal of Sociology (Melbourne, Vic.), 56(2), 184–196. https://doi.org/10.1177/1440783319893523