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3Moral Identity: Codes of Ethics and Institutional Ethics Structures

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Learning Objectives

After reading this chapter, you should be able to

1. Understand the importance of identifying and promoting core principles and values that both reflect an organization’s moral identity and provide a model to aspire to.

2. Explain the role of codes of ethics in health care organizations.

3. Discuss the importance of cultural competence as part of an institution’s code of ethics.

4. Describe the roles of institutional review boards and ethics committees.

Section 3.1Codes of Ethics

Introduction Codes of ethics, institutional ethics committees, and institutional review boards play an important role in shaping and reinforcing a health care organization’s moral identity. In this chapter we will discuss how codes of ethics align with and direct an organization’s moral identity. We will also explore the parameters of codes of ethics, as well as how to create and implement them. Finally, we will examine some of the ethical dilemmas that led to the cre- ation of committees designed to deal proactively, as well as reactively, with ethical issues that health care organizations face.

3.1 Codes of Ethics Codifying the behavior of individuals within a community has ancient roots. The oldest dis- covered physical evidence of a code of ethics was a rock fragment containing the Code of Hammurabi, the edict of King Hammurabi of Babylonia dating back to around 1772 BCE. The American Medical Association’s (AMA) first code of ethics, established in 1847, defined uniform standards for professional education, training, and conduct, as well as established that a physician’s main purpose was to obey the calls of the sick (Baker & Emanuel, 2000). The code was created with physicians and medical personnel in mind and provided strict guidelines on how these employees should conduct themselves with patients, with fellow physicians, with the public, and within their profession in general (American Medical Asso- ciation [AMA], 2017).

While an institutional code of ethics, or code of conduct, should ideally be prescriptive in its language and precise enough to be followed, it may also paint an aspirational portrait of a representative member of the organizational community who lives by the core values of the institution and embodies the moral identity the institution is trying to achieve. For example, Trinity Health (2017) developed a code of guiding behaviors that encourages the following six characteristics:

We support each other in serving our patients and communities.

• Build collaborative relationships within and across boundaries and levels. • Demonstrate a passion for understanding how to be of service to external and internal

customers/constituents, and act accordingly. • Actions are consistent with words publicly and privately. • Make decisions in the interest of the larger community (UEM) [Unified Enterprise

Ministry], not just own function, organization or area. • Once a decision is made, support it publicly and privately. • Focus on the things that unite us (Mission, goals, service), rather than on our

differences.

We communicate openly, honestly, respectfully and directly.

• Listen respectfully to others and value their contribution. • Willingly express point of view directly “in the meeting, not in the hall.”

Section 3.1Codes of Ethics

• Communicate respectfully—whether in agreement or disagreement. • Create an environment which values diverse points of view and experience. • Foster an environment of openness without fear of reprisal.

We are fully present.

• Set aside distractions to be present. • Seek first to understand, then be understood. • Openly appreciate the gifts and contributions of others. • Create a healthy balance between personal and professional life. • Contribute to a positive, optimistic and fun environment.

We are all accountable.

• Focus on finding solutions, not blame. • Lead by positive, motivating example. • Accept responsibility for his or her decisions and actions. • Hold self accountable for the success of the larger organization—across boundaries. • Focus on the high payoff items. • Follow through on commitments.

We trust and assume goodness in intentions.

• Talk directly to an individual when there is a concern or problem, avoid triangle conver- sations or hidden agenda.

• Assume positive intentions in one another. • Act in a way that earns trust and fosters an environment of trust. • Listen to people and really hear what they mean without being dismissive or defensive. • Build trust through open communication throughout the organization.

We are continuous learners.

• Consistently demonstrate openness to new possibilities. • Listen with an open mind. • Challenge “the way it has always been done.” • Provide and accept coaching and feedback. • Encourage new ideas and people to try new ways of getting the job done. • Demonstrate genuine curiosity before judging.

Reprinted by permission of Trinity Health, Livonia, Michigan.

Many organizations make an effort to gain their customers’, or in health care organizations, their patients’, trust by establishing stringent ethical guidelines regarding how employees are expected to act. In the health care industry, elements like the nature of care and employees’ access to extremely personal information make it especially important that patients feel con- fident in their chosen health care facility. Therefore, it is not only important for health care organizations to establish and practice proper codes of ethics, but also to increase transpar- ency by posting them for anyone to see.

Section 3.1Codes of Ethics

The principles of medical ethics represent an attempt to balance the tension between pro- fessional standards and legal requirements. Therefore, the code of ethics was created with three sections: the principles of medical ethics, ethical opinions of the council on ethical and judicial affairs, and reports of the council on ethical and judicial affairs (Riddick, 2003). The AMA established the Council on Ethical and Judicial Affairs (CEJA) to “maintain and update the Code of Medical Ethics and promote adherence to the Code’s professional and ethical standards” (AMA, 2018). The principles of medical ethics established by the AMA and the opinions of CEJA make up the AMA Code of Medical Ethics. CEJA’s opinions focus on scenarios in which ethical issues may arise, such as abortion, capital punishment, and genetic testing. Many of these scenarios cover patient-physician relationships, hospital relations, and profes- sional rights and responsibilities, and are used to periodically update the Code of Medical Ethics (the most recent update having been published in 2017). These updates occur depend- ing on the numerous changes in health care over the years, such as the evolution of medical technology.

The AMA’s code of ethics covers many areas and provides important require- ments for physicians and health care workers; however, the main focus is patient welfare. Physicians must keep patients’ best interests in mind and be honest when treating patients. They should also be involved with their com- munities by serving as many patients as possible, regardless of their ability to pay. Physicians must also show they are com- petent enough to treat and communicate treatment plans with their patients. Com- petence is key in developing trust with patients, and it is important for physicians to be able to communicate clearly so patients are well-informed about poten- tial or ongoing treatment. Even physicians at the top of their fields will have a tough time gaining patient trust if they lack skills in com- petence and communication.

Professional Considerations Ultimately, the AMA Code of Medical Ethics acts as a guiding document to help health care facilities develop their own codes of ethics. Though the AMA’s code originally focused on physicians’ treatment of patients, adherence to ethical codes should be mandatory for reg- istered nurses, nurse practitioners, administrative personnel, management personnel, and even allied health care workers. Indeed, any group that is involved with patient care should be held to the same ethical standards as physicians, even health care workers who are not clinical, such as those in health information management, billing, and compliance depart- ments. The following sections cover in more detail ethical expectations for different roles in the health care profession.

iStockphoto/Thinkstock In shaping an entity’s moral identity, it is crucial to clearly define and communicate ethical expectations for all members of the organization’s staff.

Section 3.1Codes of Ethics

Physicians Health care disparities and inequalities are a reality of a growing population and a daily issue for health care providers. Regardless, physicians are obligated to provide care without regard to race, socioeconomic status, religion, or political affiliation (Bringedal, Bœrøe, & Feiring, 2011). These expectations should be reflected in all health care organizations’ codes of ethics. According to Reiter and Runyan (2013), other ethical dilemmas such as issues of privacy and professionalism can occur in primary care settings where multiple family members receive care through the same practice. In order to prevent such issues arising, an organization’s code of ethics should require all health care providers to follow the privacy rules under the Health Information Portability and Accountability Act (HIPAA) (covered in Chapter 5) by providing confidentiality to all patients.

Nurses Nurses typically spend more time with their patients than physicians do; therefore, it is just as, if not more, important that nurses follow their organization’s code of ethics. Nursing care can include both physical and mental interventions, and nurses must protect any information a patient provides during all types of care. According to Mylott (2005), nurses are account- able to their patients to make ethically sound health care decisions, and guidelines for doing so should be included in all health care organizations’ codes of ethics. The field of nursing covers such a broad spectrum that nurses may often work outside of direct patient care. How- ever, no matter the capacity in which they work, nurses are responsible for advocating for their patients and following a strong code of ethics.

Administrative Personnel The health care system has evolved over decades into a multifaceted industry. Advancements in information technology in particular have not only changed how patients purchase and manage their health care, they are also responsible for an increase in the amount of informa- tion available to patients prior to visiting their physicians. Patients can go online and gain insight into myriad health care issues before ever setting foot in a doctor’s office. Similarly, health care facilities are now able to retrieve a patient’s medical records from anywhere in the world with the click of a button. However, the growth of information technology also gives rise to new risks regarding the privacy and protection of these records. Therefore, it is critical that health care workers (regardless of whether they are clinical or administrative) under- stand their responsibilities under a code of ethics.

Ongoing education covering the rules and expectations for adherence to an organization’s ethical practices can help ensure staff compliance, as can clear communication of any disci- plinary actions resulting from instances of noncompliance. As advances in technology and other innovations continue to change the health care landscape, it is important that all health care workers follow the ethical rules and regulations set by their organizations. Byrd and Winkelstein (2014) note that several medical associations, such as the AMA, American Nurs- ing Association, and the Medical Library Association, provide guidelines specific to the roles of a variety of health care professionals. These guidelines can be used to assist organizations with developing codes for ethical decision making at all levels of service. Figure 3.1 outlines steps that an organization can take to help develop a successful code of ethics.

Section 3.1Codes of Ethics

Figure 3.1: Steps to developing a code of ethics

Employee behaviors often cause headaches for leaders of health care organizations. However, with a little planning, addressing inappropriate behaviors can be handled with a solid code of ethics.

Web Field Trip: Maimonides Medical Center Code of Mutual Respect

In this web field trip, you will listen to a 2008 episode of The Brian Lehrer Show, a radio program on WNYC, in which Brian Lehrer interviews Dr. David L. Feldman, vice president of perioperative services at Maimonides Medical Center in Brooklyn, New York. Feldman talks about how the Joint Commission, which accredits and certifies health care organizations in the United States, has begun to crack down on rude behavior by health care professionals and how health care organizations are combating this problem. Feldman talks about how Maimonides has instituted its Code of Mutual Respect that all staff and employees must abide by. It is firmly grounded in the core principles of the institution and, together with its detailed Corporate Compliance Code of Conduct, helps foster an ethical work environ- ment that is conducive to quality health care without settling for the minimal standards that “compliance” alone may connote.

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Section 3.1Codes of Ethics

Cultural Considerations Since all institutions serve their own unique communities, a code of ethics should also take the culture of the community it serves into consideration. Therefore, many institutions pro- mote cultural competence, an awareness of and ability to function “effectively . . . within the context of the various cultural beliefs, behaviors, and needs presented by consumers and communities” (U.S. Department of Health and Human Services, Office of Minority Health, 2001). Although cultural competence training programs have become customary in many health care organizations, the definition of these programs and terms remains imprecise. The Department of Health and Human Services’ Office of Minority Health has defined some of the terms necessary for a robust implementation of cultural competence training. While many of these concepts remain open to debate, for the purposes of our discussion we will adopt the Office of Minority Health’s definitions.

Defining Culture and Cultural Competence The Office of Minority Health makes the following statement about what culture is and how it influences health care:

The thoughts, communications, actions, customs, beliefs, values, and institu- tions of racial, ethnic, religious, or social groups. Culture defines how health care information is received, how rights and protections are exercised, what is considered to be a health problem, how symptoms and concerns about the problem are expressed, who should provide treatment for the problem, and what type of treatment should be given. In sum, because health care is a cultural construct, arising from beliefs about the nature of disease and the human body, cultural issues are actually central to the delivery of health ser- vices treatment and preventive interventions. (U.S. Department of Health and Human Services, Office of Minority Health, 2001, p. 4)

Web Field Trip: Maimonides Medical Center Code of Mutual Respect (continued)

Instructions 1. Listen to “Paging Dr. Jekyll,” a 2008 episode of The Brian Lehrer Show: https://www

.wnyc.org/story/28252-paging-drjekyll/ 2. Read Maimonides Medical Center’s (2018) complete Code of Mutual Respect: https://

www.maimonidesmed.org/about-us/core-principles/code-of-mutual-respect 3. Write a short critical paper (less than one page) in which you critique the Code of

Mutual Respect. Assess whether there are any potential gaps or missing elements that might be helpful to include in future versions, and try to identify any ethical problems that the code might not be well suited to handle. If appropriate, come up with some policy recommendations for revisions to the code that will cover the issues you have spotted.

Section 3.1Codes of Ethics

Culture is of the utmost importance in a clinical encounter. It is often essential to appropriate diagnosis and treatment, and it is always central to caring for the patient because it is a major determinant of an individual’s health beliefs, values, percep- tions, and behaviors. Culture helps deter- mine how people form interpersonal rela- tionships (Mattingly & Garro, 2000) and informs the cultivation of collective as well as individual identities (Holland, 1998).

The Principles of Cultural Competence The essential principles of cultural com- petence are:

1. acknowledgment of the impor- tance and prevalence of culture in people’s lives,

2. respect for cultural differences, and

3. minimization of the negative consequences arising from cul- tural differences (Paasche- Orlow, 2004, pp. 347–348).

Generally, cultural competence promotes two of the four principles of health care ethics: respect for patient autonomy and justice. However, in most cultural competence materials, the reasons given for its importance are practical; among the most popular reasons are that it helps to (a) eliminate health disparities in the population, (b) meet legislative or regulatory guidelines, and (c) decrease the likelihood of medical malpractice claims (Paasche-Orlow, 2004). However, the most important reason to be a culturally competent professional is the intrinsic good that arises from having a moral commitment to a culturally responsive, patient- centered practice. In this context, cultural competence is not only characteristic of good health care professionals and the organizations to which they belong, but is perfectly aligned with the goals of practicing medicine.

There are cultural competence guides and programs available that support students’ aware- ness of cross-cultural health care and foster an interpretive method of understanding patients. These guides state explicitly that any descriptions of cultures found in cultural competence materials are never the final word but rather a constructive starting point for the dialogue with particular patients and their families. Such materials can be found, for example, at the Office of Minority Health website: http://www.thinkculturalhealth.hhs.gov.

Cusp/SuperStock Achieving cultural competence can help diminish health disparities that are disproportionately faced by minority groups.

Section 3.1Codes of Ethics

Cultural Competence and the Culture of Health Care Cultural competence education programs typically emphasize the importance of patient cul- tures, but they are silent on a very important dimension of health care delivery: the cultures of health care organizations and providers. Historically, references to culture in health care applied almost exclusively to the patient. In fact, in some popular cultural competence books, culture is defined simply as the patient’s perspective. However, doctors, nurses, allied health professionals, and health care administrators are also deeply imbedded in their diverse personal cultural backgrounds, the culture of Western biomedicine, and the culture of their respective professions or fields (Taylor, 2003). It is therefore important to understand that the patient (and often the patient’s family, loved ones, community, and religious heritage) and the health care professional (and the practitioner’s community and culture) meet at the intersection of both of their cultures, as well as the prevailing laws, mores, norms, and guide- lines of the clinical context. (Figure 3.2 shows the levels of competencies that people possess in working with other cultures.)

A Peek at Practice: Cultural Competence in Action

Despite its importance, it may not always be clear to institutions and health care profes- sionals what they can do on a regular basis to practice cultural competence. In her arti- cle “Why More Hospitals Should Prioritize Cultural Competency,” law professor Olympia Duhart (2017) suggests that professionals keep the following practices in mind as they are providing care:

• Be creative and expansive about addressing language barriers. • Be alert for, and responsive to, mental health challenges. • Be mindful of stereotypes.

Visit https://hbr.org/2017/05/why-more-hospitals-should-prioritize-cultural -competency to read the full article, then answer the following questions.

Discussion Questions

1. Based on what you have read in this chapter and the discussion of competence training in the article, what types of cultural competence training do you think would be effective in the hypothetical case Duhart presents?

2. Now consider patients who come from third-world or non-English-speaking countries. What kind(s) of cultural competence training would you recommend to those providing care for this group?

3. What cultural competence issues might arise when treating the following patients? a. Victims of Hurricane Katrina suffering from PTSD b. Low-income victims of Hurricane Katrina who lack insurance and suffer from

mental illness 4. Should health care facilities provide paperwork in languages other than English? If

they do not, and a patient does not follow their discharge instructions correctly, is this an ethical issue?

Section 3.1Codes of Ethics

Figure 3.2: Cultural competence

Cultural competence is an important factor in health care service and delivery. Indiana University’s Equity Project identified six specific levels of cultural competence, as depicted in this graph.

Source: Whittman, P., & Velde, B. P. (2002). Attaining cultural competence, critical thinking, and intellectual development: A challenge for occupational therapists. American Journal of Occupational Therapy, 56(4), 454–456.

Section 3.2Institutional Structures That Foster and Support Moral Identity

Blindness to the culture(s) of modern American health care can make health care practi- tioners unaware of embedded prejudices and discriminatory policies within well-meaning health care organizations. Cultural competence should thus foster not only the capacity to understand patients better and be responsive and respectful of their desires and needs, but also awareness of the cultural biases of health care professionals and their potential discrim- inatory effects on patients. Blindness to biomedical cultural perceptions and prejudices in health care can keep us from seeing how the culture of medicine is complicit in the cultivation and transmission of stigma and racial bias as well as other causes of health disparities in gen- eral (Betancourt, Green, Carrillo, & Park, 2005; Taylor & Lurie, 2004).

3.2 Institutional Structures That Foster and Support Moral Identity

In shaping its moral identity, a health care organization must also organize internal structures to address medical and administrative ethical issues and concerns. In addition to establishing a code of ethics and conduct, officials such as compliance officers, risk management officers, and officers of general counsel provide a broad range of oversight. Working alongside these officials are institutional committees such as ethics committees and review boards.

Institutional Ethics Committees In 1976, the New Jersey Supreme Court decision regarding Karen Ann Quinlan paved the way for the establishment of institutional ethics committees in hospitals around the country. Soon after returning home from a party, the 21-year-old Quinlan experienced two 15-minute periods of respiratory arrest. She was rushed to a hospital, where she lapsed into a persis- tent vegetative state. Her father, Joseph Quinlan, approached the court with a request to be appointed Karen’s guardian so that he might consent to remove her from life support. Karen’s physicians, the local prosecutor, and the state attorney general opposed the request. Until the Quinlan case, the nation’s appellate courts had not decided a termination-of-life-support issue. Therefore, this was a case of first impression for the New Jersey Supreme Court. Quot- ing Karen Teel’s article from the Baylor Law Review, “The Physician’s Dilemma: A Doctor’s View: What the Law Should Be,” the court in its opinion stated:

I suggest that it would be more appropriate to provide a regular forum for more input and dialogue in individual situations and to allow the responsibil- ity of these judgments to be shared. Many hospitals have established an Eth- ics Committee composed of physicians, social workers, attorneys, and theolo- gians, which serves to review the individual circumstances of ethical dilemma and which has provided much in the way of assistance and safeguards for patients and their medical caretakers. Generally, the authority of these com- mittees is primarily restricted to the hospital setting and their official status is more that of an advisory body than of an enforcing body. (Teel, 1975, as quoted in In re Quinlan, 1976)

Today ethics committees, also called bioethics committees, act in an advisory capacity to help determine whether to continue life support for patients with dire prognoses. Ethics

Section 3.2Institutional Structures That Foster and Support Moral Identity

committees were rarely found in hospitals in 1976, when Karen Ann Quinlan collapsed. Largely due to the recommendation in In re Quinlan, and subsequent endorsement by other state appellate courts that hospitals establish institutional ethics committees, today most health services organizations—from nursing homes to the largest academic medical cen- ters—have some version of an institutional ethics committee.

In 1992, the Joint Commission, an independent, non-profit organization, provided accredi- tation and certification to more than 20,000 health care organizations in the United States. The Joint Commission required that hospitals institute a mechanism to resolve ethical issues such as that of Karen Ann Quinlan and others that had proved so vexing and contentious in the 1970s and 1980s. Today this requirement is usually met by having some variation of an institutional ethics committee. These committees are designed to deal proactively, as well as reactively, to ethical issues that the organization faces. Joint Commission standards and the reaccreditation process constitute a form of oversight of such committees. In many facilities, the oversight of bioethics committees is the responsibility of the medical staff.

There are a variety of institutional ethics committees used today. Some focus on clinical eth- ics issues (including offering clinical ethics consultation), while others look at research ethics (see discussion of institutional review boards later in this chapter), and still others confront administrative ethical or legal issues. There are also specialized committees (or subcommit- tees) that look at a subset of the issues mentioned above. Some institutions have multiple ethics committees, while others have a single general-purpose one, and still other health care organizations may have none. When a particular health care ethics committee is required by accreditation standards or law, its membership composition is usually prescribed by mini- mum standards in order to foster diversity of views and avoid conflicts of interest.

Activities and Functions As a best practice, the form of any organiza- tional structure should follow its function. Functions of ethics committees can take a number of forms (e.g., consultation, policy development, education), and the subject matter can vary (e.g., clinical, administra- tive, research-oriented). This section will discuss these variables. Large and com- plex health services organizations, such as acute-care hospitals and academic health centers, would probably benefit from hav- ing ethics committees with expertise in clinical ethics and a separate committee or committees that deal with administra- tive ethical issues. This kind of specializa- tion and division of labor is desirable. The ethical issues involved in clinical care— for example, whether life support should be removed from a patient or whether a patient who is unable to consent should have a particular surgery—often depend

Andrew Shurtleff/AP Photo At the University of Virginia Medical Center, neurologist Madaline Harrison chairs a committee of physicians and other hospital employees that formally reviews ethics policies and develops regulations that will address a range of issues. Institutional ethics committees can be invaluable in resolving ethical issues that arise in health care organizations.

Section 3.2Institutional Structures That Foster and Support Moral Identity

on an understanding of disease processes and physiology. The issues also generally involve the patient, the patient’s family, and the nursing and physician staff. These issues are quite different than those in health care administration, which take the form of deciding whether to purchase certain equipment or end a certain program. The participants are usually admin- istrative and management personnel and can include the governance of, and representatives from, the public. Unfortunately, it is still relatively rare to see an administrative ethics com- mittee that is specifically devoted to meeting regularly and discussing administrative ethical issues (Darr, 2011).

Clinical ethics committees may be involved in policy development, ethics case review and consultation, and advisory opinions upon request. Their policy development role can range from reviewing or developing the informed consent forms and policies of the institution, to making large-scale resource allocation policies for emergencies or natural disasters. As we will see in Chapter 6, institutional ethics committees have also been called on to provide over- sight (along with the institution’s risk-reduction mechanisms) for cases of medical mistakes and to establish and maintain a culture of patient safety in an organization (Meaney, 2004).

A growing concern is that both clinical ethics consultation and institutional ethics commit- tees reflect the diversity of modern health care contexts and develop the competence and sensitivity to effectively and respectfully deal with cross-cultural clinical affairs. In 2014, the American Society for Bioethics and Humanities (ASBH) published its “Code of Ethics and Pro- fessional Responsibilities for Healthcare Ethics Consultants” and is considering a certification process for clinical ethical consultants, so the role of institutional ethics committees in clini- cal ethics consultation may yet again be changing in the near future (Fox, 2016).

Institutional ethics committees are now largely seen as necessary and essential components of ethical health services organizations. Both clinical and administrative ethical issues are often better dealt with through committees, rather than through unilateral decisions made by executives or directors. However, committees should be evaluated from time to time to assure that groupthink or institutional allegiances are not biasing the committee’s ethics decisions, and to assure that the institution is continually helping foster an ethical environment that helps the organization better achieve its stated goals.

Institutional Review Boards On the heels of the Nazi medical “research” atrocities of World War II, the Nuremberg Code (1947), along with the later Declaration of Helsinki (World Medical Association, 1964/1975/1983), became the basis for the federal regulations that govern most medical research in the United States (Public Welfare Protection of Human Subjects, 2004). These regulations also require independent committees to review and approve research protocols. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) issued The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, which identified the three basic principles for research involving human subjects:

1. respect for persons 2. beneficence/nonmaleficence 3. justice

Section 3.2Institutional Structures That Foster and Support Moral Identity

The Belmont Report, as well as the regulations we now follow in clinical research in the United States, differentiates between clinical practice that benefits the patient and nontherapeutic research (where the subject is not expected to benefit directly from the trial). In the latter, the commission found the need for further regulatory requirements, such as informed con- sent, assessment of risks and benefits, and selection of subjects. These further requirements, which include the voluntariness of the subjects and the requirement of informed consent, also suggest the principles of respect for persons, nonmaleficence, and the virtues of justice and honesty. All are integral parts of our regulatory frameworks (Public Welfare Protection of Human Subjects, 2004; FDA, 2013).

The Belmont Report and subsequent regulations set the legal standard for the protection of subjects involved in clinical research in the United States. To implement the regulations and oversee research, an organizational structure called the institutional review board (IRB) was established. As a result, to conform to the regulations and to protect human subjects in clinical research, health care organizations conducting research with any level of federal funding must establish IRBs. IRBs are independent committees with diverse memberships that authorize and review most research that falls within the government’s definition of research involving human subjects (Public Welfare Protection of Human Subjects, 2004; FDA, 2013). IRBs must follow processes and guidelines set forth by the U.S. Department of Health and Human Services as well as the U.S. Food and Drug Administration (for trials that are likely to produce products or drugs meant for public sale). The processes and guidelines embody the principles set forth in The Belmont Report, such as informed consent documentation and periodic compliance review. IRBs must contain both scientific and nonscientific members and at least one representative from the community (Public Welfare Protection of Human Sub- jects, 2004). Although the direct effect of the regulations is limited to government-funded research, the indirect effect is that such research is so pervasive that the regulations establish the standard of practice for civil torts.

As a result, if a drug company, a medical device manufacturer, or even a college professor seeks to perform federally funded or FDA-approved research that involves human subjects, the research, and particularly the protection of the human subjects, must be approved and overseen by an IRB. Although found in other organizations, IRBs are part of many educational organizations and health care facilities. An IRB’s mandate is to ensure ethical clinical research and minimize risks to subjects. This is done by determining whether the risks to potential subjects are reasonable relative to any anticipated benefits to subjects or society. IRBs must also make sure that informed consent is obtained from subjects, or their legally authorized proxies, as well as monitor the trial’s safety, equity, and confidentiality. Additional safeguards are necessary when the proposed subjects are likely to be especially vulnerable to coercion or undue influence; in fact, the bulk of the regulations concerning IRBs are focused on the requirements for informed consent.

Other Structures To support its Code of Mutual Respect, Maimonides Medical Center has established a “respect hotline” telephone line, along with an e-mail account where behavior that is inconsistent with its Code of Mutual Respect can be reported. Maimonides has other institutional structures to help organize responses to ethical lapses as well as help foster and protect the organization’s moral identity. For example, there is the Medical Staff Subcommittee on Respect, which moni- tors physician compliance with the code (Maimonides, 2009). Committees such as this are a common way of handling day-to-day ethical issues that may arise within an institution.

Chapter Highlights

Chapter Highlights • A health care organization’s code of ethics should both reflect and uphold the organi-

zation’s core principles and values. • Codes of ethics should be applied to all personnel in the field of health care, including

physicians, nurses, administrative personnel, and anyone else who comes into contact with patients and/or patients’ information.

• When creating a code of ethics, institutions should take into account the culture(s) rep- resented in the communities they serve. Institutions should strive to provide cultural competence training to all health care personnel.

• There are various institutional structures that foster and support the moral identity of health care organizations, including the now nearly universal institutional ethics committees and review boards that resolve ethical disputes, ensure compliance, consult with clinicians, and form ethical policies in health services organizations.

Case Study: Preventative Ethics

Instructions: Identify the potential ethical dilemma in each of the scenarios below. Think about ways in which a change in policy or in the behavior of staff or employees of the health care organization could either help avoid the potential ethics issue or prevent similar dilem- mas from occurring in the future.

Scenario A: After taking stock of your hospital’s inventory, you calculate that the number of working mechanical ventilators, while sufficient for the regular daily requirements of a hospital such as yours, are dangerously below the number suggested to keep on hand in case of emergencies such as an influenza epidemic. While some of the costs involved in stockpiling this kind of equipment are covered by the federal and state governments, pur- chasing the additional ventilators would still mean a sizable investment by your organiza- tion. You did not plan for this in this year’s budget, which has already been approved by the board of directors. If you choose to purchase the ventilators in the unlikely event that they will be needed this year, you will have to seek special permission from the board to amend the budget. The board, to be sure, will not be pleased by this seeming oversight, and you dread thought of having to do this.

1. What is/are the potential ethical dilemma(s)? 2. What is/are your proposed solution(s), and why?

Scenario B: You notice that more of your nursing facility’s senior citizens are now arriv- ing at your facility with advanced directives that state their treatment preferences at the end-of-life. While you welcome this new development, you also notice that many of the advance directives contain boilerplate language that states “no heroic measures should be used when there is no longer hope for a meaningful recovery.” Much of the care that your patients receive at the end-of-life involves all sorts of medical procedures and interventions that would have been seen as “heroic” not so long ago. In addition, none of the advance directives you’ve seen recently have specified what sorts of medical treatments and what circumstances the patient thinks are “heroic” and which are not.

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Chapter Highlights

Critical Thinking and Discussion Questions

1. Why is it necessary for a health care organization to establish a code of ethics? 2. What role does the Council on Ethical and Judicial Affairs (CEJA) play in regard to the

American Medical Association’s (AMA) Code of Medical Ethics? 3. What three elements of the AMA’s Code of Medical Ethics do you believe are most

important? 4. What institutional structure oversees human subject research that is at least par-

tially federally funded?

Key Terms code of ethics A compilation of rules for ethical conduct for a community or society. Although the values that codes are aim- ing to protect, endorse, or foster are often implied in the language used, codes gener- ally focus on specific behaviors and actions that are forbidden or state the minimal behavior necessary to avoid incurring a punishment.

cultural competence The ability of a health care provider to effectively tend to consumers and communities with particu- lar cultural beliefs, behaviors, and needs.

institutional ethics committee A group whose task is to deal proactively and reac- tively with ethical issues that its organiza- tion faces. Also called a bioethics committee.

institutional review board (IRB) An independent committee made up of diverse organizations and community members that review the ethics of research involving human subjects. IRBs are highly regulated and subject to significant governmental oversight.

Case Study: Preventative Ethics (continued)

1. What is/are the potential ethical dilemma(s)? 2. What is/are your proposed solution(s), and why?

Scenario C: You have always been proud of the fact that your clinic’s staff and employees rarely complain to you or your management team of ethics or compliance violations or concerns. However, after reading a journal article on the general reluctance of staff and employees to report ethical concerns or even grave problems to supervisors, you begin to wonder if your clinic’s “clean record” is true. The research article suggested that absent clear policies for non-retaliation toward whistleblowers, many ethical problems remain unreported. You wonder how difficult it will be to justify initiating any new policies if there is no evidence that the policies are needed to address any specific problems at your clinic.

1. What is/are the potential ethical dilemma(s)? 2. What is/are your proposed solution(s), and why?