“Many factors affected your decision to be a nurse but, for most of you, a key motivation was the desire to help others. Nursing as a profession is firmly based on the ethical principles of respect for persons, beneficence, and justice. These ethical principles that guide clinical practice must also be the standards for the conduct of nursing research (Fowler, 2017). In research, the application of ethics begins with identifying a study topic and continues through the publication of the study findings. Ethical research is essential for generating evidence for nursing practice (Lach, 2019), but what does the ethical conduct of research involve?

This question has been debated for many years by researchers, politicians, philosophers, lawyers, and even study participants. The debate continues because of the complexity of human rights issues; the focus of research in new, challenging arenas of technology, stem cells, and genomics; the complex ethical codes and regulations governing research; and the various interpretations of these codes and regulations. Unfortunately, specific standards of ethical research were developed in response to historical events in which the rights of participants were egregiously violated or the behavior of research scientists was blatantly dishonest (Grady, 2018).

To provide an understanding of the rationale for today’s human participant protection requirements, this chapter begins by reviewing five historical events, and the mandates and regulations for ethical research that were generated as a result of them. In your clinical setting, you are probably familiar with the Health Insurance Portability and Accountability Act (HIPAA) and the necessity of protecting the privacy of a person’s health information (Department of Health and Human Services [DHHS], 2003). HIPAA, which identified the elements of private health information, has had a significant impact on researchers and institutional review boards (IRBs) in universities and healthcare agencies. The chapter also discusses the actions essential for conducting research in an ethical manner through protection of the rights of human participants. This includes making an unbiased assessment of the potential benefits and risks inherent in a study and ensuring that informed consent is obtained properly.

The submission of a research proposal for institutional review is also presented. An ethical problem that has received increasing attention since the 1980s is researcher misconduct, also called scientific misconduct. Scientific misconduct is the violation of human rights during a study, including falsifying results or behaving dishonestly when disseminating the findings. Misconduct has occurred during all study phases, including reporting and publication of studies. Many disciplines, including nursing, have experienced episodes of research misconduct that have affected the quality of research evidence generated and disseminated. A discussion of current ethical issues related to research misconduct and to the use of animals in research concludes the chapter. Historical events affecting the development of ethical codes and regulations The ethical conduct of research has been a focus since the 1940s because of the mistreatment of human participants in selected studies.

Although these are not the only examples of unethical research, five historical experimental projects have been publicized for their unethical treatment of participants and will be described in the order in which the projects began: (1) the syphilis studies in Tuskegee, Alabama (1932–1972); (2) Nazi medical experiments (1941–1946) and resulting trials at Nuremberg; (3) the sexually transmitted infection study in Guatemala (1946–1948); (4) the Willowbrook State School study (1955–1970); and (5) the Jewish Chronic Disease Hospital study (1963–1965). More recent examples are included in the chapter, in relation to specific aspects of research.

Although these five projects were biomedical and the primary investigators were physicians, nurses were aware of the research, identified potential participants, delivered treatments to participants, and served as data collectors in all of them. As indicated earlier, these and other incidences of unethical treatment of participants and research misconduct were important catalysts in the formulation of the ethical codes and regulations that direct research today.

Tuskegee syphilis study In 1932, the US Public Health Service (USPHS) initiated a study of syphilis in African American men in the small, rural town of Tuskegee, Alabama (Brandt, 1978; Reverby, 2012; Rothman, 1982). The study, which continued for 40 years, was conducted to observe the natural course of syphilis in African American men. The researcher hired an African American nurse, Eunice Rivers, to recruit and retain participants.

The research participants were organized into two groups: one group consisted of 400 men who had untreated syphilis, and the other was a control group of approximately 200 men without syphilis. Most of the men who consented to participate in the study were not informed about the purpose and procedures of the research.

Assignment: Assessing and Treating Patients With Anxiety Disorders

Common

symptoms of anxiety disorders include chest pains, shortness of breath, and other physical symptoms that may be mistaken for a heart attack or other physical ailment. These manifestations often prompt patients to seek care from their primary care providers or emergency departments. Once it is determined that there is no organic basis for these symptoms, patients are typically referred to a psychiatric mental health practitioner for anxiolytic therapy. For this Assignment, as you examine the patient case study in this week’s Learning Resources, consider how you might assess and treat patients presenting with anxiety disorders.

To prepare for this Assignment:

· Review this week’s Learning Resources, including the Medication Resources indicated for this week.

· Reflect on the psychopharmacologic treatments you might recommend for the assessment and treatment of patients requiring anxiolytic therapy.

The Assignment: 5 pages

Examine Case Study: A Middle-Aged Caucasian Man With Anxiety. You will be asked to make three decisions concerning the medication to prescribe to this patient. Be sure to consider factors that might impact the patient’s pharmacokinetic and pharmacodynamic processes.

At each decision point, you should evaluate all options before selecting your decision and moving throughout the exercise. Before you make your decision, make sure that you have researched each option and that you evaluate the decision that you will select. Be sure to research each option using the primary literature.

Introduction to the case (1 page)

· Briefly explain and summarize the case for this Assignment. Be sure to include the specific patient factors that may impact your decision making when prescribing medication for this patient.

Decision #1 (1 page)

· Which decision did you select?

· Why did you select this decision? Be specific and support your response with clinically relevant and patient-specific resources, including the primary literature.

· Why did you not select the other two options provided in the exercise? Be specific and support your response with clinically relevant and patient-specific resources, including the primary literature.

· What were you hoping to achieve by making this decision? Support your response with evidence and references to the Learning Resources (including the primary literature).

· Explain how ethical considerations may impact your treatment plan and communication with patients. Be specific and provide examples.