Why are ethical principles important when conducting research on human subjects?

And whatever you do, in word or deed, do everything in the name of the Lord Jesus, giving thanks to God the father through Him —Colossians 3:17 (English Standard Version)

Essential Questions

· Why are ethical principles important when conducting research on human subjects?

· What is the focus of qualitative nursing research in professional nursing practice?

· What methodologies are used to conduct qualitative research?

· Why should the BSN-prepared nurse critically appraise published research studies?

· How does the BSN-prepared nurse critically appraise published research studies?

Introduction

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One of the hallmarks of any profession is a scientific research base. The nursing profession bases its practice on a solid foundation of evidence developed through research by nurses and results gleaned from multiple disciplines, such as psychology, social work, and medicine. Nurses are called upon to develop a safe practice that is grounded in evidence to promote positive health outcomes in the populations served.Nurses are called upon to develop a safe practice that is grounded in evidence to promote positive health outcomes in the populations served. The continued advancement of nursing research is critical for further development of the nursing profession. The process of conducting nursing research must be grounded in  ethics  and provide fair treatment of  human subjects . A proficient registered nurse must be knowledgeable about ethical principles that are required when conducting nursing research. 

Through a variety of methodologies, nurse researchers study phenomena of interest to the profession. For example, a nurse wishing to determine the  causative factors  related to increased infection rates in patients with urinary catheters may study nursing care procedures for these patients. Likewise, a nurse may desire a deeper understanding of culture on health practices and design a study to learn about these influences. 

Nursing is considered to be both an art and a science. The science component requires nurses to seek methodical, logical methods for choosing nursing process actions. In addition, nurses seek answers to practice questions through application of scientific inquiry or research. Researchers may design studies that are  quantitative  or  qualitative  in nature. Quantitative design is based on the traditional scientific research design and the science aspect of nursing. Through quantitative design, researchers are able to quantify findings easily. For example, a quantitative study designed to address infection rates will provide factual data about the number of infections occurring and other statistical data. 

Through qualitative research methodologies, nurseresearchers study aspects of the art of nursing. These may include lived experiences, feelings, and perceptions among other facets of the human experience. For example, the nurse researcher may design a study to learn more about the lived experiences of breast cancer survivors. This information can then be used to prepare the registered nurse to provide care to this population of patients. The baccalaureate-prepared nurse is a consumer of nursing research. In this role, the nurse accesses, appraises, and may participate in clinical research. This chapter will provide an overview of the ethical implications for qualitative nursing research as well as discussion about qualitative nursing research methodologies. 

Nursing and Codes of Ethics

Nursing is a profession grounded in ethical practice. Historical foundations of the nursing profession are deeply intertwined with ethical actions by those called to provide care for the sick, needy, and poor. Historically, nursing education curricula have included focus on the foundations of ethics, nursing codes of ethics from the American Nurses Association (ANA) and the International Council of Nursing, as well as the development of professional values as part of the essential elements of baccalaureate nursing education (American Association of Colleges of Nursing, 2008). The codes of ethics are used to guide professional nursing practice and role performance, including qualitative research. Nurse researchers are also guided by the Nuremburg Code, the Declaration of Helsinki, and the Universal Declaration of Human Rights in pursuit of ethical and safe nursing research (Kawar, Pugh, & Scruth, 2016; Schuster, 1997; United Nations, n.d.; World Medical Association, 2017). In addition to these guiding principles,  nurse scientists  are also responsible for adhering to federal, state, and local laws pertaining to research on human subjects (Mallari & Tariman, 2017).

As part of the professional role responsibility, the BSN-prepared nurse should engage in the examination of emerging ethical issues in practice and take an active role in solving these dilemmas. The process of  ethical problem solving  is complex; the nurse must understand basic ethical principles in order to aid in principled decision making. The use of ethical frameworks and decision-making models can guide the nurse through ethical dilemmas. An approach to ethical dilemmas and nursing research that is evidence-based may contribute to patient safety and improved outcomes (Mallari & Tariman, 2017). To fulfill professional role responsibilities, the BSN-prepared nurse should be familiar with both the ANA Code of Ethics and the International Code of Ethics. 

ANA Code of Ethics

The first official nursing Code of Ethics was developed by the ANA in 1950 (Epstein & Turner, 2015). The purpose of the original ANA Code of Ethics was to provide a framework to guide professional nursing practice through competence and ethical behaviors. The current ANA Code of Ethics has been through multiple revisions since origination, with the most current version approved by the ANA in 2015. The modern ANA Code of Ethics describes the profession’s “values, obligations, duties, and professional ideals” (Epstein & Turner, 2015, para. 21). The ANA Code of Ethics is an important framework for the registered nurse to use when navigating complex situations and ethical dilemmas in the health care setting. The document is also used as a guiding framework when conducting qualitative nursing research. Provisions 1–3 address nurse and patient relationships, Provisions 4–6 address nurse boundaries of duty and loyalty, and Provisions 7–9 address professional commitments beyond patient encounters. The registered nurse must utilize this framework to develop a professional moral compass and deliver high quality, safe nursing care. In addition, the nurse researcher must apply principles from the ANA Code of Ethics when conducting any type of research. For example, Provision 1, human dignity, compels qualitative nursing researchers to adhere to the patient’s right to self-determination (see Table 2.1). Likewise, Provision 4, ethics encompassing duty and loyalty, fosters accountability expectations for the researcher.

Table 2.1

Overview of the ANA Code of Ethics Applied in Qualitative Nursing Research

ANA Code of Ethics Provision	Application to Qualitative Nursing Research
Provision 1: The nurse practices with compassion and respect for inherent dignity, worth, and unique attributes of every person.	· Researchers must respect human dignity, relationships with patients, the nature of health, the patient’s right to self-determination.
Provision 2: The nurses’ primary commitment is to the patient, whether an individual, family, group, or community.	· Areas addressed include primacy of the patient’s interests, conflict of interest for nurses, collaboration, and professional boundaries. · The researcher’s commitment is to the subject. · Example: The nurse researcher should ensure a subject is comfortable when discussing the death of a child in a study focused on parental grieving. A private room and tissues would be provided by the researcher.
Provision 3: The nurse promotes, advocates for, and protects the rights, health, and safety of the patient.	· Areas addressed include protection or privacy and confidentiality for human participants in research, performance standards and review mechanisms, promoting culture of safety, and questioning unsafe and impaired practice. · The researcher is a patient advocate. · Example: The nurse researcher advocates for long-term counseling services to be made available to subjects in a study focused on surviving physical abuse after the study’s conclusion.
Provision 4: The nurse has authority, responsibility, and accountability for nursing practice; makes decisions; and takes action consistent with the obligation to promote health and to provide optimal care.	· Areas addressed include authority, accountability, responsibility, nursing judgments/decisions/actions, assessment, and delegation. · The researcher is responsible and accountable. · Example: The nurse researcher determines that music therapy helped research subjects without improved mental health during chemotherapy treatment. To promote health, the nurse disseminates research findings in an appropriate manner.
Provision 5: The nurse owes the same duties to self as to others, including the responsibility to promote health and safety, preserve wholeness of character and integrity, maintain competence, and continue personal and professional growth.	· Areas addressed include duties to self and others, promotion of personal health/safety/well-being, preservation of wholeness of character, preservation of integrity, maintenance of competency, and continuation of professional and personal growth.  · The researcher must take care of self. · Example: The nurse researcher takes time to self-reflect after interviews with subjects who have reported being perpetrators of crimes.
Provision 6: The nurse, through individual and collective effort, establishes, maintains, and improves the ethical environment of the work settings and conditions of employment that are conducive to safe, quality health care.	· Areas addressed include environment and moral virtue, environment and ethical obligation, and responsibility for health care environment. · Researcher promotes an ethical environment. · Example: The nurse researcher ensures that he or she is truthful in all communications with research subjects.
Provision 7: The nurse, in all roles and settings, advances the profession through research and scholarly inquiry, professional standards development, and the generation of both nursing and health policy.	· Areas addressed include research and scholarly inquiry, developing/maintaining/implementing professional practice standards, and nursing and health policy development. · The researcher meets professional standards. · Example: The nurse researcher develops a study to learn about the lived experiences of refugees. The information is then used to influence nursing practice in the care of refugees.
Provision 8: The nurse collaborates with other health professionals and the public to protect human rights, promote health diplomacy, and reduce health disparities.	· Areas addressed include health as a universal right, collaboration for human rights and diplomacy, and reduction of health disparities. · The researcher collaborates to protect subjects. · Example: The nurse researcher collaborates with a physician in designing a qualitative study to determine the impact of yoga therapy on the lived experience of patients with multiple sclerosis.
Provision 9: The profession of nursing, collectively through its professional organizations, must articulate nursing values, maintain the integrity of the profession, and integrate principles of social justice into nursing and health policy.	· Areas addressed include articulation and assertion of values, integrity of the profession, integrating social justice, and social justice in nursing and health policy. · The researcher represents the profession through all interactions.