NUR 720 Discussion 10.1: 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

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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Lesson 1: Application of Ethics in Clinical Research

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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), 98–99. 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.

DNP Projects and Research

DNP projects should not be research; these are projects that change systems and are based on research. However, DNP projects commonly go through an IRB process. IRBs have a broad definition of research, and sometimes this definition includes EBP projects. Please examine their definition of research in the learning materials. Think about your NUR720 project, does it call for the use of human subjects?

Ethics in Clinical Research

The following presentation gives you additional information regarding ethical issues to be aware of while conducting clinical research.

Ethics in Clinical Research Transcript (PDF)Links to an external site.

Your DNP Project: Conducting Ethical Research Driven by Strong Sufficient Evidence

The following infographic shows the juxtaposition of the view of projects from academia and IRBs. Reflect on where your project will be located in the two viewpoints.

Alternate Version of Your DNP ProjectLinks to an external site.

You Don’t Want to Do It Like That: Infamous Cases of Ethical Misconduct

These are some (in)famous examples of research misconduct from Chris Willmott.Links to an external site.

This presentation was created by Dr. Chris Willmott of the University of Leicester. It reviews famous cases of research misconduct.

Additional Resources

For additional information related to ethics in clinical research, view and save the links to these sources:

Bradley University Resources

Committee on the Use of Human Subjects in Research (CUHSR)Links to an external site.

Reviews all research and EBP projects conducted at BU
Determines whether research is exemptLinks to an external site., expeditable,Links to an external site. or requires a full review.
Administers guidelines for informed consentLinks to an external site.

National Institutes of Health (NIH)

Using Patient Information from Electronic Health Records (EHRs)

These links provide you with supportive references when questions regarding responsible research arise.

Value: 15 points (Initial Post, 9 points; Reply Posts, 6 points)

Discussion Guidelines

Initial Post

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.