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Applying Ethics in Research and Evidence-Informed Practices

CATHERINE ROBICHAUX

LEARNING OBJECTIVES AND OUTCOMES

Nurses are advocates for patients involved in research studies and their role in ensuring adequate informed consent for participation is well documented (Judkins-Cohn, Kielwasser-Withrow, Owen, & Ward, 2014). This role has expanded dramatically, however, with recommendations from the Institute of Medicine (IOM; 2011) and the American Nurses Credentialing Center (ANCC, 2014) Magnet^® program requirements, among other regulatory and accrediting bodies. As seen in Box 7.1, Provision 7 of the Code of Ethics also states, “The nurse, in all roles and settings advances the profession through research and scholarly inquiry . . .” (2015).

As nurses’ participation in research has increased, so has the number of alternatives sites in which research is conducted such as special clinics and private offices. Nurses may be involved in offering research information, recruiting and monitoring participants, obtaining/maintaining data, and writing and/or presenting results. They may be primary or coinvestigators or be involved in critiquing research, quality improvement studies, and clinical practice guidelines. Nurses are also required to provide safe, effective nursing interventions using current research findings and evidence-based outcomes. In all these roles and settings, nurses are responsible for understanding the principles and issues underlying the ethical conduct of research and evaluate the ethical components of research studies and evidence-based practice recommendations/guidelines (Barrett, 2010; Grady & Edgerly, 2009). The purpose of this chapter is to provide you as a practicing nurse with a clear understanding of your role responsibilities in research and related issues.

Box 7.1

Ethics in Research and Evidence-Informed Practice—Provision 7 and Relevant Statements From the Code of Ethics (2015)

Source: American Nurses Association (2015).

You will see the terms “evidence-based” and “evidence-informed” practice used in this chapter and in others. The former is the more frequently used term, originally defined as the “conscientious, explicit use of current best evidence in making decisions about the care of individual patients” (Sackett et al., 1996, p. 71). Although this definition has been expanded, evidence-informed practice, as described in the Code of Ethics (2015, p. 43) and by Fowler (2015), reflects a more comprehensive understanding:

Fowler (2015) also notes that this interpretation and application influences not only direct patient care but ultimately affects health systems worldwide. In so doing, evidence-informed practice works to reduce inequalities in care and is a matter of justice. The difference in understanding between these two terms is discussed further in the section Ethics and Evidence-Informed Practice. Additional interpretive statements relevant to ethics in research and evidence-informed practice are included in Box 7.1.

Question to Consider Before Reading On

1.   Have you participated in a research study? What was your role? Discuss your experience with a class peer or colleague.

CASE SCENARIO

Question to Consider Before Reading On

1.   How would you respond to Sarah’s initial misunderstanding of the clinical trial intervention?

BRIEF HISTORY OF ETHICAL GUIDELINES

The Code of Ethics for Nurses (American Nurses Association [ANA], 2015) and other guidelines are vital to our understanding of ethical research and evidence-informed practice. This understanding encompasses more than one document or a set of regulations and depends on the attention, knowledge, integrity, and courage of the professionals involved.

Nursing regulatory boards such as ANA and those in other countries such as Australia and Great Britain (Australian Nursing Federation [ANF], 2009; Haigh & Williamson, 2009; Royal College of Nursing [RCN], 2009) have provided direction for nurses in various roles on the ethical conduct of research and measures required to protect those participating in the process. These directions and mandates have resulted from ethical breaches committed during human experimentation in the past.

After World War II, the Nuremberg trials were conducted to prosecute Nazi leaders and physicians for crimes against humanity including subjecting prisoners to appalling procedures done in the name of clinical research. At this time, there were no regulations, codes, or formal documents that contained standards for ethical research on human subjects so the trials resulted in development of the Nuremberg Code (1949). The three essential elements of the Nuremberg Code are voluntary and informed consent, a favorable risk–benefit ratio, and the right to withdraw from a study without repercussion. These elements form the basis of subsequent ethics codes and international research regulations including the Declaration of Helsinki (World Medical Association, 1964), which states that the interests of the subject should supersede those of society and every subject should receive the best-known treatment available (Layman, 2009; Rice, 2008).

Although the United States was involved in the creation of the Nuremberg Code, federal regulations regarding research and IRB approval were not developed until 1974 with the National Research Act followed by guidelines based on principles outlined in the Belmont Report (The National Commission for the Protection of Subjects of Biomedical and Behavioral Research, 1978). The Belmont Report serves as the basis for regulations affecting research sponsored by the U.S. government including studies supported by the National Institute for Nursing Research (NINR). This report identifies three major principles in evaluating research: respect for persons, beneficence, and justice. These principles maintain that an individual must understand what he or she is being asked to do, make a reasoned judgment about the effect(s) of his or her participation, and make a choice free of coercive influence. In addition, individuals incapable of making their own informed choices should be protected. The investigator is obligated to ensure that the research is based on a sound design and has undergone review, and that the obligation to maximize benefits and minimize risks is heeded (Horner & Minifie, 2011a; Layman, 2009; Polit & Beck, 2014).

The Belmont Report also delineates the difference between research and treatment, emphasizes the assessment of risks and benefits, and reiterates the importance of informed consent. In addition, several populations are identified as “vulnerable” or requiring additional protection including children, pregnant women and fetuses, neonates, prisoners, and the institutionalized mentally disabled. Following development of the Belmont Report, the Department of Health and Human Services (DHHS) issued the Federal Policy for the Protection of Human Subjects or the “Common Rule” in 1991 to provide a uniform approach to human research in the United States. This document has been revised and amended several times with the latest revision occurring in 2009 (DHHS). While these regulations and guidelines may seem excessive, several egregious, unethical research studies that occurred in the United States before, during, and even after their development indicate the ongoing need for awareness and monitoring of research practices. Table 7.1 describes the purpose of these studies and the ethical breaches that occurred (Hardicre, 2014; Horner & Minifie, 2011a; Polit & Beck, 2014; Wilson & Stanley, 2006).

Table 7.1

Examples of Unethical Research in the United States

Sources: Hardicre (2014); Horner and Minifie (2011a); Polit and Beck (2014); Wilson and Stanley (2006).

Question to Consider Before Reading On

1.   What elements of the Nuremberg Code are included in the informed consent used in your workplace?

COMPONENTS OF ETHICAL RESEARCH

Ethical conduct of research includes, but is not limited to, the three basic ethical principles outlined in the Belmont Report. These principles were integrated and expanded upon by Emanuel et al. (2000, 2011) in their framework for evaluating the ethics of research studies and adapted for critical care nursing research by Richmond and Ulrich (2013). This framework extends from study development through dissemination of findings and addresses aspects of care and virtue ethics. Framework components include assessment of social value, scientific validity, fair subject selection, favorable risk–benefit ratio, independent review, informed consent, respect for potential and enrolled subjects, and research integrity. While nurses may not be called upon to evaluate all components of the framework, an understanding is necessary as identified in the ANA Code of Ethics (2015) interpretive statements and Quality and Safety Education for Nurses (QSEN; Cronenwett et al., 2007) competencies (Boxes 7.1 and 7.2).

Question to Consider Before Reading On

1.   Choose two of the QSEN competencies from Box 7.2. How are they demonstrated in your current practice?

Social Value

A study that has social value must help the researcher determine how to improve people’s health and/or well-being. This can be accomplished directly through findings that may lead to better tests or treatments for disease, such as in the Case Scenario, or by obtaining data that increases understanding or leads to future research. As noted, “If the research doesn’t help in . . . these ways, it wastes money and resources” (Emanuel, Abdoler, & Grady, 2011, p. 4). Clinical trials are certainly not the only type of research and nurses may be engaged in additional studies that evolve from clinical experience, the literature, or priority areas such as those identified by specialty groups. The assessment of social value or significance remains the same for all research studies. Conducting a needlessly redundant investigation or one based on a trivial research question does not meet the criterion of social value. It is also unethical to put potential participants at risk of harm or discomfort when no benefit may be realized (Gennaro, 2014). In the Case Scenario, Jeanie realizes that the biological agent has potential social value for future breast cancer patients. However, she questions Sarah’s understanding of the value of the intervention in her own treatment, potential risks, and side effects.

Box 7.2

Ethics in Research and Evidence-Informed Practice: Relevant QSEN Competencies

Source: QSEN Institute (2014).

Scientific Validity

To be scientifically valid and ethical, a research study should be conducted in a methodologically rigorous manner and be expected to have useful results and add to the body of scientific knowledge. Whether a clinical trial or other quantitative or qualitative study, it must be designed using accepted principles and methods, be feasible, and have an appropriate data analysis plan. Nurses may be involved in ensuring the scientific validity of a study as primary investigators or coinvestigators or as members of an IRB. As care providers, nurses contribute to the scientific validity of a study through evaluation of adherence with the protocol or requirements and monitoring participants for adverse events. They also assess the impact of participation on the patient’s/subject’s disease process and overall well-being (Grady & Edgerly, 2009; Richmond & Ulrich, 2013). For example, in the Case Scenario, Jeanie is concerned about the potential effects of the biological agent on Sarah’s quality of life.

Fair Subject Selection

Nurses may be involved in recruiting and enrolling patients in a research study. Fair subject selection means that the scientific goals of the study, not convenience, vulnerability, or other factors form the basis for recruiting individuals or groups to participate. As seen in Table 7.1, in the past certain individuals became research subjects because they were easily accessible or compromised in their ability to understand and/or protect themselves. This is also a consideration in the chapter Case Scenario as Jeanie is assessing Sarah’s understanding of participating in the clinical trial and whether she may be vulnerable given her present condition.

Question to Consider Before Reading On

1.   Patients like Sarah, who are asked to be research participants, are often considered “vulnerable” because of their advanced illness. What additional safeguards can the nurse implement when recruiting such patients for research studies?

Since it is important that research results be useful to the population for whom the intervention is intended, certain groups or individuals should not be excluded without good reason. This requirement comes from past instances when women and children were excluded from research studies. If a potential intervention is likely to be used for women and/or children, then these groups should be included. The IRB review process requires investigators to identify inclusion/exclusion criteria and justify why certain individuals or groups may be excluded.

Favorable Risk–Benefit Ratio

To be ethical, the risks in participating in a research study must be balanced by benefits to the subjects and/or the importance of new knowledge to be gained. This comparison is called the risk–benefit ratio. “The riskier the research study, the more benefit it must offer to be considered ethical” (Emanuel et al., 2011, p. 5). For example, in the Case Scenario, the potential risks of participating may be quite high for Sarah and could include accelerating disease progression and mortality. Therefore, the overall benefit of determining the safety and efficacy of the new investigational agent for treatment of breast cancer must be considered highly important to meet this ethical requirement.

All research involves some degree of risk but in many studies, the risk is considered minimal or expected to be no more than is encountered in daily life or during routine physical care, procedures, or tests. When risks are more than minimal, they are considered burdensome and the researcher must ensure that steps are taken to reduce their occurrence. Potential risks for participants may be fatigue, emotional distress, loss of privacy, and loss of time, among others. Such risks must be weighed against possible benefits including satisfaction from participation, direct benefit from the intervention, or gains from incentives or stipends provided. Aspects of the risk–benefit ratio are addressed in IRB review process and throughout the course of the study. As a caregiver, the nurse is often in the best position to assess daily risks and possible burdens for the patient/participant and communicate these to the investigator and/or research team (Grady & Edgerly, 2009). In the chapter Case Scenario, although Jeanie is new to the oncology unit, she has extensive experience in assessing the effects of various interventions and treatments on patients’ physical condition and well-being. Her professional relationship with Sarah contributes to Jeanie’s ability to determine Sarah’s complete understanding of the proposed clinical trial.

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