The blending of ethics, legalities, and medicine has come to be known as bioethics. The field of bioethics is a relatively new field. Its emergence into history came in the 1960s because there was a need to discuss how research and healthcare decisions and regulations could be made, who could make them, and what their long-term implications would be. In the late 1960s, philosophers, theologians, physicians, lawyers, policymakers, and legislators began to write about these questions, to hold conferences, to establish institutes, and to publish journals for the study of bioethics. In 1969, the Institute of Society, Ethics, and the Life Sciences was established at Hastings-on-the-Hudson, New York [1]. Two years later, the Kennedy Institute of Ethics was established at Georgetown University, Washington, DC [2].

Prior to the 1960s, medical care decisions were part of the paternalistic role of physicians in our society. Patients readily acquiesced care decisions to their physicians because they were regarded almost as family. What drove this resolve of patients to acquiesce their medical care and treatment decisions to their physicians? Rothman believes physicians were given such latitude by their patients because they were well known and trusted by their patients and the community in which they practiced. There were no specialists. One physician took care of a patient and family for a lifetime. The frontier physician often knew the patient from birth to adulthood, made house calls, and was a family friend who knew best what the patient should do with a healthcare concern [3]. Since the 1960s, physicians have generally become strangers to their patients.

The trend away from the family doctor making all the healthcare decisions toward a healthcare system replete with specialists, policy makers, ethical codes, administrative codes, and informed consent was brought about largely by three events in U.S. History. First, World War II research and experimentation (e.g., experimentation on concentration camp prisoners by the Nazis, research on atomic bomb survivors) brought attention to people as test subjects and what rights should be recognized on their behalf. Second, the modern structuring and organization in healthcare delivery moved patients from their familiar surroundings of home and neighborhood clinics to the often intimidating, large hospital. Third, the medical technologic boom brought life-saving interventions; people now live longer due to technology that allowed the discovery of treatment modalities, including the much acclaimed antibiotic therapies.

Extensive publicity about three research projects resulted in the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [4]. The first project involved elderly patients with chronic illness who were injected with live cancer cells in an effort to discover whether the cells would survive in a person who was ill but did not previously have cancer. No consent was obtained from patients or family members before proceeding.

The second significant event began in 1932, when the Public Health Service initiated a syphilis study on 399 black men from Tuskegee, Alabama. The goal of the study was to observe the men over a period of time to examine how the disease progressed in individuals of African descent. When the study began, there was no cure for the disease; however, fifteen years into the study, penicillin was discovered to be a cure for syphilis. The research participants were never informed, and treatment was withheld in spite of the fact that by the end of the experiment in 1972, 128 men had died either from the disease or related complications [5].

Finally, in 1967, children with mental retardation at the Willowbrook State School, New York, were given hepatitis by injection in a study that hoped to find a way to reduce the damage done by disease. Although consent was obtained in this study, the consent sometimes had an element of coercion in that gaining admission to the school was difficult and parents were given a guarantee their child would be admitted if they consented to the participation of their child in the study [6].

It was the New Jersey Supreme Court Decision in the Karen Ann Quinlan case that brought bioethics to the level of the individual through the media and transformed physician paternalistic authority into patient-physician shared decision making [9]. As noted, patient autonomy issues came into public focus in the 1970s when the legal community set a precedent for deciding withdrawal/withholding of life-sustaining treatment. Although there were many related cases with decisions on medical treatment and decision making for competent and incompetent patients, two cases are recognized as landmark cases and were the most important in influencing the medical and legal community. These two cases were most responsible for moving the primary healthcare decision making into the arena of the individual. These court cases are the previously mentioned New Jersey Supreme Court Decision in the Matter of Karen Ann Quinlan (1976) and the U.S. Supreme Court Decision in the Matter of Nancy Cruzan [10]. From these two cases, and more specifically from the Nancy Cruzan case, the Patient Self-Determination Act of 1990 was enacted [11].

Mr. Quinlan asserted that his daughter's right of privacy was justification for the request to terminate life support, and the court accepted the relevance of this right both to the treatment termination decision and to Mr. Quinlan's right to assert his daughter's right to privacy. In this way the court eliminated the issue of criminal homicide.

The Karen Ann Quinlan case is significant because it was the first case to deal specifically with the question of withdrawing ventilator support from a permanently unconscious patient. It is often cited as a source for the importance of the privacy right in life and death decisions.

In 1983, Nancy Cruzan presented to the local hospital in a comatose state, a result of an automobile accident that left her in a persistent vegetative state (PVS). What links Ms. Cruzan's case to the principle of the patient's autonomy (and subsequently to issues of right to die) and to the Karen Ann Quinlan Case is the fact that neither individual could speak for herself once the actual situation requiring a decision presented itself. Therefore, the two cases are linked by the fact that family members went forward to speak for the individuals.

Over the years, from the Quinlan and Cruzan cases to the many others (including the more recent Schiavo case) that address patients' rights to refuse treatment and the idea of who can speak for incompetent patients, state courts began to address the issues explicitly. Multiple states reached substantial agreement that:

Although this multi-state consensus was not without exception, these were the precursor principles to the PSDA of 1990, the federal law given over to the states to implement as of December 1, 1991 [11]. This new legislation applied to hospitals, nursing homes, hospice, HMOs/PPOs, and any other facilities that receive funds from Medicare or Medicaid programs. It further mandated that each of the affected facilities must advise their patients of their legal rights and options for accepting or refusing treatment if they (the patients) should become unable to speak for themselves. The primary provisions of the PSDA are:

Although this multi-state consensus was not without exception, these were the precursor principles to the PSDA of 1990, the federal law given over to the states to implement as of December 1, 1991 [11]. This new legislation applied to hospitals, nursing homes, hospice, HMOs/PPOs, and any other facilities that receive funds from Medicare or Medicaid programs. It further mandated that each of the affected facilities must advise their patients of their legal rights and options for accepting or refusing treatment if they (the patients) should become unable to speak for themselves. The primary provisions of the PSDA are:

Finally, legislation was created to keep end-of-life medical decision-making issues out of the courts and in the appropriate arena, with the appropriate players: the patient/family and the healthcare professionals. The central focus of the law is the provision of patient education. The means or the tool for the individual to document his or her wishes for future healthcare decisions is called an advance directive. There are two types of advance directives available. Although both are not required to be completed together, most people are encouraged to do so.

The first type of advance directive is called a physician directive, sometimes called directive to physician [12]. The precedent form is the living will, an earlier, legally non-binding form. The living will allowed an individual to state his/her treatment choices should he or she be found in a terminal state, comatose, and/or in another condition leading to imminent death for which the physician saw no cure. The patient stated that he/she be allowed to die naturally without medical intervention, with only comfort measures employed.

How do we then go from theoretical ethics to the day-to-day practical application of those principles in today's high-tech society? It really boils down to a deductive reasoning process. The process starts with the broad and general, often abstract global ideas of how people should act rightly within society. Then, the process narrows in focus to a smaller group or individual situation in which the ethical principles act as a guide for daily living. Further, when a situation presents itself that contradicts the "norm," it may cause a dilemma. When these dilemmas are of an ethical nature, we often say the situations are controversial or called into question or infringed upon a group or individual's rights based upon accepted ethical theories and moral practices.

How does one move from the general ethical concepts, based on religious or philosophical theoretical frameworks discussed later in this course, and apply them practically to patient/society healthcare decision making? Generally, an ethical conflict presents itself when a person's or group's ethical values or principles are challenged or conflict with one another. It is imperative to identify what principles or values are in conflict so that an appropriate resolution can be made.

A dilemma occurs when one is faced with what is perceived (or is in reality) to be no alternative, only one alternative, or an either/or choice situation. This dilemma scenario leaves the individual with limited, often painful choices. "Have the surgery or die," may be the only two alternatives given to a patient. This can leave the patient immobilized, powerless, feeling subservient and victimized, and with no sense of control.

With this information gathered, it should be apparent whether or not a value conflict exists. Many times, just the process of gathering information allows for clarification and for differences to be resolved. If an ethical conflict ensues, the next step is to articulate the ethical principles that are opposing one another. The most common ethical principles involved in healthcare settings today are patient autonomy, beneficence, non-maleficence, fidelity, right-to-know, justice, and veracity (Table 1).

Under the deontologic umbrella, an action is deemed right or wrong according to whether it follows pre-established criteria known as imperatives. An imperative in our language is viewed as a "must do," a rule, an absolute, a black and white issue. This is an ethic based upon duty linked to absolute truths set down by specific philosophical schools of thought. As long as the principles dictated by these imperatives are met with dutiful compliance, one is said to be acting ethically [18].

One of the most significant features of deontologic ethics is found in John Rawls' Theory of Justice, which states that every person of equal ability has a right to equal use and application of liberty [19]. However, certain liberties may be at competition with one another. There are also some principles within the same ethical theoretical system that can conflict with one another. An example of this conflict might involve a decision over allocation of scarce resources. Under the principle of justice, all people should receive equal resources (benefits), but allocation can easily become an ethical dilemma when those resources are scarce.

Natural law ethics, also known as the virtue system of ethics, is a system in which actions are seen as morally or ethically correct if in accord with the end purpose of human nature and human goals. The fundamental maxim of natural law ethics is to do good and avoid evil. Although similar to the deontologic theoretical thought process, it differs in that natural law focuses on the end purpose concept. Further, natural law is an element in many religions while at its core it can be either theistic or non-theistic.

The final ethical theory to be discussed here is the modern ethical system of thought that centers on the diversity of cultures and beliefs. Therefore, at its core, this ethic assumes that all discourse and interaction is transcultural because of the strengths and differences in values and beliefs of groups within society. This concept has been developed into what has become known as the transcultural ethical theory.

In the last decade, the ethics of caring has become a specific moral focus of nursing. Attention is being paid to the need for cross-cultural ethical issues in both medicine and nursing. The concept of transcultural nursing was penned by Dr. Madeleine Leininger and focuses on a comparative analysis of differing cultures, health-illness values, patterns, caring behavior, and nursing care[29]. Decisions are made on the basis of the value or worth of someone by the quality of inter-relationships.

These differences of values, beliefs, or ethical principles are present in healthcare environments. They are much more pronounced when the individuals' values differ greatly from those of the healthcare professionals who care for them. This system of ethics is a holistic framework, built around a model of interrelated precepts: transcultural caring dynamics, principles, transcultural context, and universal source. These precepts form the foundation for facilitating the transcultural ethical decision making (Figure 2).

These differences of values, beliefs, or ethical principles are present in healthcare environments. They are much more pronounced when the individuals' values differ greatly from those of the healthcare professionals who care for them. This system of ethics is a holistic framework, built around a model of interrelated precepts: transcultural caring dynamics, principles, transcultural context, and universal source. These precepts form the foundation for facilitating the transcultural ethical decision making (Figure 2).

The chief goal of an ethical decision-making framework is to determine right from wrong in situations where clear demarcations do not exist or are not readily apparent to the nurse who is faced with the decision. Nurses must clarify their own values and subscribe to a particular ethical system or theory before an ethical decision-making framework can be used successfully. A framework provides a method for nurses to answer key questions about the dilemma and to organize their thinking in a more logical and clear manner. There are several forms that ethical decision-making frameworks can take. They are all based on the scientific or problem-solving method that forms the basis for the nursing process. The problem-solving model is the basis for the ethical decision-making framework that follows.

The chief goal of an ethical decision-making framework is to determine right from wrong in situations where clear demarcations do not exist or are not readily apparent to the nurse who is faced with the decision. Nurses must clarify their own values and subscribe to a particular ethical system or theory before an ethical decision-making framework can be used successfully. A framework provides a method for nurses to answer key questions about the dilemma and to organize their thinking in a more logical and clear manner. There are several forms that ethical decision-making frameworks can take. They are all based on the scientific or problem-solving method that forms the basis for the nursing process. The problem-solving model is the basis for the ethical decision-making framework that follows.

The chief goal of an ethical decision-making framework is to determine right from wrong in situations where clear demarcations do not exist or are not readily apparent to the nurse who is faced with the decision. Nurses must clarify their own values and subscribe to a particular ethical system or theory before an ethical decision-making framework can be used successfully. A framework provides a method for nurses to answer key questions about the dilemma and to organize their thinking in a more logical and clear manner. There are several forms that ethical decision-making frameworks can take. They are all based on the scientific or problem-solving method that forms the basis for the nursing process. The problem-solving model is the basis for the ethical decision-making framework that follows.

Although ethical dilemmas and the decision-making skills involved in resolving these dilemmas are complex and multifaceted, mastery of these skills is well within the capability of the healthcare professional. The specialty area of ethical decision making, like most other specialties, has its own language and terminology that must be understood and mastered. However, the science of ethical decision making does not depend on a set of static rules that are unchanging. Ethical decisions are based on a framework of ethics that is dynamic and useful in day-to-day situations.

In their professions, nurses and physicians are frequently taught to apply very strict standards in the determination of patient capacity or ability to make decisions. A framework for ethical decision making presupposes that nurses and physicians making decisions know that a system of ethics exists, the content of that ethical system, and that the system applies to similar decision-making problems despite the multiple variables. As an example, many institutions have adopted policies that do not allow a medicated patient to sign consent forms within a specified time. But the chronic pain management patient on continuous narcotic pain control may not have the capacity of reason.

From an ethical point of view, the patient is a capable decision maker if he or she can understand information relevant to the decision at hand, interact and communicate with caregivers about the decision, and weigh the possible alternatives. A general checklist on which to set up an ethical framework comes from Judith Ross. One might abide by the following steps [39]:

Whenever possible, the patient/family makes the final healthcare decision. The first and most important step is to gather and assess the facts. The nurse can be instrumental in facilitating the stages of ethical action. The following is a general outline of each step and process that develops as one moves through the steps. In each step, questions are offered to help the healthcare professional gather all the information necessary to assist the patient and healthcare team in the decision-making process.

There are five fundamental components to the cognitive decision-making process as identified by ethicists Kenyon and Congress. They encompass naming the dilemma, sorting the issues, solving the problem, acting, and evaluating and reflecting [40,41]:

Kohlberg presumes that there are six stages of moral development that individuals advance through in much the same way that infants learn first to roll over, to sit up, to crawl, to stand, and finally to walk. There are two important correlates of Kohlberg's system [39]:

Stage 5: Here, the decision maker justifies decisions by explaining that acts will contribute to social well-being and that each member of society has an obligation to every other member.

Stage 6: At this final stage decisions are justified by appeals to personal conscience and universal ethical principles.

It is important to understand that Kohlberg's stages do not help to find the right answers, as do ethical theories. Instead, recognizing these stages help us to know how people arrive at decisions. As a result, if the same question was asked of someone at each of the six levels, the answer might be the same in all cases, but the rationale for the decision may be different. For example, let us suppose we are caring for a terminally ill man in great pain who is asking the doctor or the nurse for enough barbiturates to commit suicide. Here are examples of the rationale for the healthcare professional's decision and reply in each stage.

Stage 1: "No, because I could lose my license if anybody found out I had done that."

Stage 2: "No, because if I became known as a doctor or nurse who did that kind of thing, other doctors and nurses might not refer patients to me."

Stage 3: "No, because that is against the law and professionals should obey the law," or "No, because my colleagues would no longer respect me if they knew I had done that."

Stage 4: "No, because if everyone did that, the doctors and nurses would no longer be trusted to save lives."

Stage 5: "No, even though the patient might suffer less, we need to be faithful to our respect for life because otherwise we might lose our standards and abuse our authority."

Stage 6: "No, because I personally believe that no one has a right to take his or her own life, and so I cannot be a party to such an action."

Every profession that deals with human rights and liberties eventually develops professional ethics (either formally or informally) to guide the responsible behavior of its members. In healthcare, the deductive process by which ethical principles are applied to situations common to the profession is called bioethics. It is a branch of applied ethical theory at least as old as the Hippocratic Oath and as current as the dilemmas posed by the unique clinical practice of today.

Paternalism sees the nurse urging patients to choose treatment plans based on the physician's idea of best interest. Paternalism is the view that professionals understand the patient's best interest better than the patient and are entitled to act so that a patient's well-being is promoted, even if the patient does not agree. In certain cases, individual liberties might be compromised in favor of the superior judgment of healthcare workers.

This sharing of beliefs between patient and nurse is the ethics of caring as proposed in the holistic nature of nursing. Caring allows the nurse more of an involved role than consumerism, as nurses and patients share, rather than enforce, their different convictions about life and death. At the same time, caring stops short of paternalism in that the nurse merely illustrates how to make an ethical decision by applying her own ethical principles. The primary goal is to empower the patient to make his or her own decision. It is essential that the nurse be able to understand her own ethical systems and to place those of her patient within proper perspective, even if they are different from her own, all without being judgmental. In this way, the ethics of caring makes clear how ethical decision making has become so central for nursing.

When developing policy of any kind, it is important to research the state statutes that apply to the agency policy information, ensuring that it is in sync with the law. Also, use the community's similar agencies as resources. Find out if they have similar policies or guidelines that they would be willing to share. Most facilities are willing to share this kind of information. Use your own agency resources; a risk manager, ethics consultant, or ethics committee can be very helpful. The following is an example of a policy for ethical decision making in patient care that can be used and/or adapted for your agency's use.

As any ethical situations arise, the team member should:

Using the acronym R.O.L.E. as their framework, note that the authors identify the same decision-making issues as the framework and algorithm examples discussed in this course.

R: Risks of medical treatment. In this case the proposed treatment bears little risk to the patient. Few people have life-threatening complications from laceration repair; therefore, the chance of the patient experiencing untoward harm from the procedure is remote.

O: Opinion of the patient. Why does the patient want to leave the emergency department? Does he understand the risks and benefits of the procedure? Is he competent to make this decision in his intoxicated state?

L: Life quality. Will not having the laceration repaired significantly affect the patient's quality of life? Would an unsutured wound healing for an extended period affect the patient in his profession and render him unable to earn a living? For example, would he be unable to wear required safety equipment, such as a helmet or goggles, because of the laceration? Is the patient involved in a profession, such as acting, where a potentially disfiguring scar could affect his career?

E: External factors. Is there any obligation on the part of the healthcare team to third parties (i.e., those who may be traveling at the same time as the patient and who may be endangered from a safety standpoint)?

Upon returning to the unit, you talk with your supervisor, who listens carefully and questions you at length. Finally, she says, "It seems as if you have nothing concrete to act upon and are only experiencing feelings. I think you would be risking a lot of trouble for yourself and the hospital if you acted rashly at this time. Accusing people with no evidence and making them go through a traumatic experience is something I would hesitate to do."

From the Journal of Nursing Administration, we find a case to study regarding the public and professional responsibility of hospitals [46]. Hospitals throughout the country are held in high esteem within their communities for public service. They earn the public's trust by providing safe, good quality patient care. Many community hospitals serve as teaching sites for students' practicum programs, as did the hospital in this case study. Health facilities also have an obligation to share the responsibility for the quality of the nursing program by providing practice sites and nursing role models. In the case presented, the hospital should have been more proactive in addressing the quality of this practice issue.