Human Subjects Research

Among the most sweeping reform in the second half of the 20th century was in the arena of medical research with human subjects. For much of medicine’s history, the improvement of care for patients has been through the trial-and-error method of experimentation. Few therapies, when initially applied, had any guarantee of success, and some were fraught with the risk of further injury or debilitation to the patient. Early medical researchers were practicing physicians whose small-scale experiments were conducted solely for therapeutic benefit. The goal of experimentation was undertaken not as much to benefit future patients as to heal the very individual under the immediate care of the practicing physician.5 Most research was, at least in its intent, benevolent and humanistic, with the Hippocratic ideal of “doing no harm” providing the guiding norm of the experimenter’s conduct. Nonetheless, two key events revealed how flagrantly this norm can be ignored when the focus shifts to utilitarian goals rather than the safety and welfare of humans.

Nazi Germany, forever remembered for war crimes committed against humanity, was instrumental in perpetrating mass exterminations of innocent members of “undesirable” ethnic groups and other minorities. The techniques for these exterminations were perfected by Nazi physicians whose gruesome acts were later publicly revealed in the Nuremberg trials and documented by American observer Dr. Leo Alexander.⁶ The trials revealed how physicians and administrators conspired to engage in medical experiments such as forced sterilizations, poisonings, the infliction of simulated combat injuries, exposure to infections and extreme weather conditions, and ultimately the refinement of euthanasia techniques on those deemed mentally or physically “defective.” There were approximately 275,000 victims over a 10-year span of time. After these staggering revelations, an international tribunal of judges developed what is known as the Nuremberg Code, a statement of 10 principles that govern the ethical conduct of medical experimentation with human subjects. At the heart of the code is that the “voluntary consent of the human subject is absolutely essential” and that freedom from coercion, force, duress, or deception is a condition of participation in any form of experimentation. Expanding the moral framework for the conduct of medical research in the Nuremberg Code, the World Medical Association adopted the Helsinki Declaration in 1964.

Unfortunately, the efforts of Nuremberg and Helsinki did not end the problems with human research. Within the United States, these important principles did not filter into the conduct of physician experimenters, which became all too apparent in the infamous research project known as the Tuskegee Syphilis Study. From 1932 to 1972, the U.S. Public Health Service (USPHS), later known as the Centers for Disease Control and Prevention (CDC), engaged in a research study that involved 400 African American men in Macon County, Alabama. What began as a small time-limited project to improve the treatment of syphilis among poor minorities expanded into a full-blown plan marked by deception and discrimination that yielded no new information about the disease and offered no bona fide treatment for subjects.⁷ Initiated with hopes of understanding the disease and finding the definitive cure, the study evolved into an observation of how the disease progressed through its various stages, often culminating in death.

Participants in the study were led to believe that they were being provided treatment for what the physician researchers called bad blood, a euphemistic term for any kind of blood-related condition. Treatment amounted essentially to various placebos combined with painful nontherapeutic spinal taps. Subjects were induced to participate in the study through the offer of free treatment, meals, and transportation. Free burial insurance was promised on the condition the research subjects permit an autopsy upon their deaths for documentation of the effects of the end stages of the disease. Even when the curative antibiotic of penicillin became widely available, subjects of the study were prohibited from receiving it so researchers might continue to track the disease’s effects on the unsuspecting subjects’ bodies. The deception and coercion continued until USPHS investigator Peter Buxtun learned of the project from a colleague. Frustrated in his attempts to end the study by working within the USPHS, Buxtun turned to the press, and reporter Jean Heller broke the story in July 1972.⁸

The public and political outcry that followed the revelation of the study culminated in its immediate suspension and congressional passage of the Federal Research Act of 1974, which created two significant entities.⁹ First, the act established what is now known as the Office for Human Research Protections, which mandates that all institutions receiving federal funding for research with human subjects maintain institutional review boards with oversight for the safety and ethical treatment of research subjects. Second, the act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The multi-profession commission was assigned to craft guidelines that would serve as a moral foundation for future human research regulation.⁵ By 1979, the commission had arrived at a policy statement known as the Belmont Report.¹⁰ The report highlighted three basic ethical principles that guide all medical research involving humans in the United States. The principle of respect for persons requires that participation in research be based on the voluntary informed consent of the subject of the study. The principle of beneficence calls for a comprehensive risk and benefit assessment that weighs the potential harm against the potential benefit to the current subjects or future patients. The principle of justice requires that research subjects be chosen equitably and that a fundamental fairness in both benefits gained and risks incurred be shared by research participants. Justice also requires that the more vulnerable members of society, such as children, prisoners, pregnant women, and the mentally challenged, be given added protection in research.

Reforms and regulations that emerged from Tuskegee and the Belmont Report now ensure that essential elements are present in medical or behavioral research studies that involve persons. These elements are voluntary participation, informed consent, comprehension by the subject of the nature and purpose of the study, full disclosure of risks and benefits, disclosure of alternatives to participation in research, and the option to withdraw from the study without penalty.

End-of-Life Cases

Controversial patient care cases involving end-of-life decisions hold a prominent place in the development of the bioethics movement. Three cases are particularly noteworthy; all involved young women, each of whom was severely incapacitated and unable to participate in decisions regarding life-sustaining treatment. The first landmark case is that of Karen Ann Quinlan. Karen Ann was a 21-year-old woman who suffered an anoxic brain injury as a result of an overdose. She never regained consciousness and was sustained by a ventilator and feeding tube. Eventually she was given a diagnosis of a persistent vegetative state (PVS), a neurological condition in which she was believed to have no awareness of herself, others, or her surroundings. After some months Karen Ann’s parents, following what they believed would be her own wishes, asked the physicians caring for her to remove the ventilator and allow a natural death. The physicians refused, thus setting the stage for a legal battle that eventually landed before the New Jersey Supreme Court. The court ruled in the favor of Karen Ann’s parents on the basis that Karen Ann had a fundamental right to privacy including the right not to receive treatment against her will.11

Remarkably, Karen Ann lived another 10 years after the removal of the ventilator while being sustained on the feeding tube. She died in 1986.

The second case involved Nancy Cruzan, a 24-year-old woman who also suffered a severe anoxic brain injury as a result of an auto accident in 1983. Like Karen Ann, she was eventually determined to be in a PVS. Nancy was not ventilator dependent but did have a gastrostomy tube for feeding and hydration. Four years after her injury, Nancy’s parents asked her physicians to remove the feeding tube as Nancy had previously stated that she would not want to be artificially kept alive if she could not be “at least halfway normal.”¹² Her physicians and the state of Missouri opposed, leading to what has been referred to as the first “right to die” case to go before the U.S. Supreme Court. The court issued its ruling in June 1990 in which it acknowledged an individual’s right to refuse treatment, even life-sustaining feeding tubes. Yet the court also said that states could require “clear and convincing” evidence that such refusal was made when that person was still competent. Further clarifying evidence of Nancy’s wishes emerged later, leading to the withdrawal of the feeding tube. Nancy died in December 1990.

The Cruzan case and the memory of the Quinlan case before it propelled the creation of federal legislation designed for individuals to state their desire to refuse life-sustaining treatment under the conditions set forth by the Supreme Court even without capacity and the ability to communicate. The Patient Self-Determination Act of 1990 established on a national level the legitimacy of previously written advance directives as valid legal expressions of an individual’s desire to limit or refuse treatment in end-of-life circumstances.¹³ These advance directives, often referred to as living wills (and. in many states, include durable power of attorney for health care decisions), in theory meet the “clear and convincing” evidence standard required by the U.S. Supreme Court. While all 50 states recognize and honor some form of written advance directives, problems persist in these difficult cases in both the interpretation of generalized written statements and the infrequency of their use among the public.^14,15 Another attempt to assist patients, families, and clinicians in understanding a patient’s wishes for end-of-life care is found in the growing influence of the Physician Orders for Life-Sustaining Treatments (POLST) paradigm.¹⁶ POLST documents, intended for those with life-limiting or terminal disease processes, provide more specific guidance than generalized advance directives. POLST creates a specific set of medical orders by a physician based upon the expressed wishes and values of a patient. POLST is not a complete substitute for an advance directive. Rather, it builds upon and complements the wishes of the patient as expressed in an advance directive.

The case of Terri Schiavo is yet another tragic end-of-life case complicated by the absence of an advance medical directive and the lack of clear communication and understanding among family members over end-of-life wishes.^17,18 Like Quinlan and Cruzan before her, Terri suffered an anoxic injury from a cardiac arrest that rendered her a total care patient in a PVS for 15 years. Terri was kept alive by a gastrostomy tube. Initially Terri’s husband, Michael, and her parents, Bob and Mary Schindler, were united in their efforts to keep Terri alive in the hopes of her recovery. Over time, however, Michael came to the conclusion that Terri would not recover and sought to remove the feeding tube. Terri’s parents, deeply religious, opposed. The disagreement between them led to a bitter and international public dispute waged in the courts for more than a decade. A lower court found in favor of Michael with the U.S. Supreme Court refusing to hear the case on three separate occasions, each time affirming the appropriateness of the lower court findings. In the end, the gastrostomy tube was removed and Terri died in March 2005. The official cause of death by the medical examiner was listed as “complications from anoxic encephalopathy.”¹⁹

The cases of Quinlan, Cruzan, and Schiavo reveal the ongoing struggle clinicians and families face in making decisions on behalf of patients with incapacitated conditions. The legacy of these cases highlights the continuing difficulties in withdrawing or withholding treatment in the care of patients with life-threatening conditions and little or no hope of recovery. Even the closest of kin can sometimes be unclear about what their loved ones would desire in critical cases.²⁰

Proponents of the principle of autonomy drive yet another option for end-of-life decision making, physician-assisted death (PAD) or physician-assisted suicide (PAS). Oregon was the first state to legalize this option through its Death with Dignity Act passed in 1997. The Death with Dignity Act “allows terminally ill Oregonians to end their lives through the voluntary self-administration of lethal medications, expressly prescribed by a physician for that purpose.”²¹ Since then, seven other states have legalized PAD (Washington, Vermont, California, Hawaii, Maine, New Jersey, and Colorado by legislation; Montana by court ruling). The passage of the California statute was significantly influenced by the case of Brittany Manyard, a young California woman diagnosed with terminal brain cancer who moved to Oregon to have the option for PAD that was not available in her home state.²² She died in 2014 at the age of 29 years with her husband and mother by her side after ingesting a lethal medication provided to her by an Oregon physician. Her personal public appeal spurred California legislators and Governor Jerry Brown to enact the law.²³

Informed Consent

Informed consent is the process of communication between a patient and physician that results in the authorization or understanding for a specific medical intervention.25 Informed consent is rooted in respect for persons, patient autonomy, and self-determination and formalizes a component of the covenant between the patient and the physician. It is built on the principles of trust and truth-telling regarding the use of a particular intervention or treatment to achieve a desired medical outcome. Informed consent stands on the practice of shared decision making, a building block to active participation by the patient.²⁶

Despite the clarity of definition for the informed consent process, multiple questions or potential ethical conflicts can arise for nursing staff within the perioperative period. A simple question such as “What were they going to do again?” asked by an anxious patient in the preoperative holding area can set off a series of internal alarms in the mind of a nurse. Does the patient need reassurance or more information? Is it a momentary failure of memory or a lack of adequate understanding of the procedure that prompted the question? Who secured the consent of the patient? How was the request approach conducted? How does the nurse understand the professional and ethical obligations in the face of a seemingly unsure patient and the pressure of a tight operating room (OR) schedule?

The nurse might begin by seeking verification of a signed written consent form. Whereas the presence of the form might satisfy the technical act of granting consent, it may or may not fulfill the ethical obligation. Informed consent is more than a means of securing a signature. Rather, it is a process of open, two-way communication that implies full disclosure and provides detailed information on the nature of a specific procedure. A comprehensive informed consent process not only reviews the diagnosis and purpose of the intervention but also outlines its potential risks and benefits. It includes alternative treatment options, if any, and the risks and benefits of forgoing the treatment procedure. Informed consent assumes that the threshold elements of patient capacity and voluntary nature are met.^27,28 Research conducted during the perianesthesia phase of care should likewise follow ethical, professional, and legal guidelines, a potentially ethical challenge for the nurse with the dual role of provider and research collaborator.²⁹

Questions may also arise regarding the duration and scope of a signed informed consent. Could the signature in the previous scenario been from a posture of haste and convenience, making it more implied than informed? Could it have been secured appropriately but over 90 days prior to surgery? Should the consent still be valid for the patient who is now unsure about the nature of the procedure? Is the timing of the consent still valid? What is the nurse’s understanding of the consent process and obligation to confirm that the patient now understands the potential benefits, risks, and surgical outcomes?³⁰

Informed consent requires that the process be completed by a clinician able to provide the intervention and in a manner that allows time and space for patients to ask questions, seek clarification, and discuss potential options for care. This includes consents for anesthesia, which should include the type of anesthesia (e.g., general, monitored anesthesia care, regional, IV sedation, or other modality). All benefits, risks, and alternatives should be discussed, and a mutually agreeable plan of care should be documented and communicated to the care team. An adequate informed consent process is further challenged by potential language barriers such as complex medical terminology, cultural diversity, and functional limitations among populations with cognitive impairments.^31,32 All these issues underscore the significance of effective communication in the patient–physician relationship and among members of the interdisciplinary team.

What, then, is the ethical responsibility of the nurse in the holding area faced with the patient’s question of uncertainty and the surgical team’s schedule? To what extent is the nurse’s ethical obligation to serve as a patient advocate in support of an informed decision? How might the nurse’s obligation be affected for the patient who adds the statement, “At least my surgeon promised to be there for the entire operation,” when the nurse knows of that particular surgeon’s tendency toward intermittent presence while residents perform most operations? What if the nurse understood from a colleague that the patient’s original consent was provided under pressure to comply? Specific questions such as these identify just a few of the immediate moral dilemmas that have implications for clinical practice and patient outcomes.

Autonomy and the COVID-19 Pandemic

While patient autonomy and informed consent remain the hallmark of shared decision making in the physician–patient relationship, the onset of the COVID-19 pandemic provided some potentially unique challenges to clinical ethics. Perhaps nowhere is this challenge more daunting than when it comes to limiting access to scarce resources such as ventilators that are critical to CPR. Inpatient resuscitation resulting in hospital discharge was already low, approximately 25%.56 Driven to develop guidelines on the use of scarce resources such as ventilators, hospitals were challenged to further balance medical indications with patient preferences when it comes to interventions such as ventilator access and resuscitation. The question then becomes at what point a public health crisis warrants limiting access to resources or a public health crisis risks a resurgence of physician paternalism.⁵⁷ The necessary development of “crisis standards of care” by informed and reliable professional societies assists in clinical decision making and the uniform application of appropriate ethical guidelines.⁵⁸ Similar concerns of equity and fairness in the distribution of resources are raised with regard to the variety of COVID-19 vaccine allocation frameworks that have been proposed. Planners at the federal, state, and local levels are challenged by the task to ensure that those with the greatest need and those who historically have suffered inequities in access to health care services are not disadvantaged in the vaccine implementation process.⁵⁹

Civility

A fundamental ethical responsibility for all health care providers is working to create an environment that promotes respect and collegiality. One classic example is ensuring the establishment of a culture of civility and safety in the OR.60 Take an instance of the surgeon who, throughout the induction, intubation, and line placement, criticized and mocked the anesthesia team with repeated phrases such as “How long is this going to take? I have several cases to get done today . . . could you amateurs call for a real anesthesia team?” Or the instance of the surgeon who, over the objections of OR staff, ordered them to prematurely “flip” rather than carefully reposition the patient, resulting in the displacement of the arterial and one intravenous lines, leading to pooling of blood on the floor. These type of examples may not be uncommon, but potentially under-reported as well.⁶¹ While the immediate ethical responsibility to report may lie with frontline staff in these instances, the responsibility to act and protect them clearly sits with management, even at the highest levels of an organization.

Privacy and Confidentiality

Maintaining the privacy and confidentiality of patients remains a challenge for health care organizations and clinicians. Privacy and confidentiality are complementary rather than synonymous concepts.62Privacy suggests that a patient has the right to control general access and distribution of personal information about his or her health and implies that boundaries that protect a patient’s personal space are respected within a clinical setting. Confidentiality relates to the personal trust that intimate information shared by a patient with a clinician is used only for the patient’s medical benefit. As such, information is shared with those members of the interdisciplinary team on a need-to-know basis. Information should be shared with third parties only with permission of the patient except in the cases of an identified surrogate for the patient who lacks decision-making capacity. Discussion and consent regarding release of information in this situation should be managed in the preoperative phase. The ethical responsibility to maintain privacy and confidentiality proceeds from the principle of respect for persons that promotes human dignity and maximizes patient control.⁶² This responsibility applies to the preoperative setting when marking surgical sites to ensure minimal exposure. It also applies to treatment of patients under the effects of anesthesia by eliminating and addressing derogatory or disrespectful behaviors or communications.^63–65

One of the most significant challenges to patient privacy during the perioperative period is the physical setting of the postanesthesia care unit (PACU). More often than not, the PACU is configured as a multipatient care area with only curtains for privacy. Private communications between patients and clinicians are subject to being overheard by other patients or even visitors. The literature continues to support increased visitation for patients in the PACU as a means of decreasing family anxiety.^66–68 Family-centered care responds to visitation preferences of families and significant others yet increases the potential to compromise privacy obligated to other patients. This potential ethical compromise can be mitigated through consistent policy and practice.^69,70

Respect for confidentiality has been given renewed attention as a result of health care reform for nurses who care for young adults who are not minors yet remain on parental health insurance plans. Another conflict that may emerge stems from the rights of parents who wish to be present when a minor child awakens from surgery. Staff members not directly involved in the care of specific patients may encounter neighbors and friends recovering from surgery who would have preferred to remain unnoticed. In addition, the changing world of social media creates new challenges that can blur the line between personal and professional boundaries. What constitutes responsible use of social networks?^71,72 Can nurses, for example, “friend” patients on Facebook or talk about a patient scenario even without identifying factors?

How does the PACU nurse observe multiple patients while ensuring privacy? The typical PACU nurse monitors more than one patient, thus exposing patients to potential violations of personal space in the interest of patient safety. An additional challenge to the nurse can be finding the appropriate way to respond to the physician who performs examinations without properly drawing the curtain or who engages in intimate conversations with patients without proper discretion as to volume and content.

Teaching hospitals carry additional potential dilemmas in maintenance of patient privacy. The parameters of what is ethically permissible or appropriate relative to observation or examination by students or others in training of patients who are anesthetized remains ethically ambiguous. Should examination itself, the type of examination, the number of students observing, the nature and extent of the consent process, or some combination of these factors drive the parameters of ethical appropriateness? Should informed consent include details regarding these parameters? What is the extent of ethical obligation on the perianesthesia nurse to speak up as a patient advocate?

The professional responsibility to maintain confidentiality and privacy is clearly required from the perianesthesia nurse. The exchange of privileged patient information should follow the organization’s policies on confidentiality and the code of ethical conduct of the appropriate professional organization, which would include at a minimum the sharing of information on a need-to-know basis and the proper collection of patient data for research purposes.

Patient Safety

The ethical responsibility for all clinicians and health care providers to act in the best interest of patients is no more evident than in the obligation to ensure patient safety. The significance of this obligation on perianesthesia nurses is both organizational and personal. Minimally, this obligation stems from the ethical principle of nonmaleficence. Organizational obligation includes responsibility to ensure that the environment is safe for patients. Critical to patient safety is the requirement that a clinician at any given point in the treatment process demonstrate appropriate competencies for the level of provided care. Competency implies possession of the knowledge, skills, attitudes, and behavior to deliver the appropriate level of care on a consistent basis.73 Clinicians are obligated to know and to function within the standard of care of their professional role and the professional standards of practice within their discipline.⁷⁴ This responsibility can be particularly challenging for nurses in the PACU, an environment frequently characterized by overcrowding because of limited intensive care unit beds and staffing shortages and where nurses might be asked to provide care outside the unit’s scope.⁷⁵

The principle of beneficence speaks to the perianesthesia nurse’s responsibility to a wide range of ethical obligations. Ethical dilemmas faced by clinicians can include how to respond to a colleague who appears impaired in some way, what to do regarding the reporting of a medical error, or how to respond to a situation in which a colleague is engaged in deceptive practice or illegal behavior—all situations that affect maintenance of a safe environment and adherence to ethical practice and organizational guidelines.

In the current climate of the country and the opioid crisis in the world, it becomes particularly important to address any concerns about possible impairment or suspected diversion of drugs that would threaten the safety of patients at a vulnerable context in the hospital. It becomes ethically incumbent on nursing leaders, charge nurses, or nursing peers to report any impairment, question of impairment, or any signs of diversion to the appropriate chain of command.⁷⁶ Addressing the issue can also be done with understanding and help with the professionals involved since addiction is a significant medical condition. Such obligation extends to the benefit of the practitioner as well as there are programs specifically developed for health care professionals, many with state licensing boards.

The nurse is obligated to follow best practice processes and be proactive about eliminating errors. One example of proactive practice is calling a “time-out” prior to any procedure. If guidelines for anything from a nerve block to correct site surgery are not followed properly during the procedure, the nurse calls a time-out and stops the procedure until it is corrected.^77,78 Time-out is the opportunity to adhere to safety. As the advocate for patients at a vulnerable time, the nurse should be empowered to speak up, and organizations should support those efforts.

The transfer of the patient from the OR to the PACU has the potential to introduce a number of ethical dilemmas related to patient safety. One common dilemma faced by the perianesthesia nurse in the PACU setting is the obligation to determine unintended intraoperative awareness. The responsibilities of the nurse in this instance can be multiple. The nurse must make an initial assessment with an interview of the patient who emerges from the influence of anesthesia to determine whether any recollection of events exists or whether the patient experienced pain during the surgical procedure. If the finding is affirmative, the nurse must then determine how to communicate the information. Clear documentation of the patient’s response and notification of the surgeon and the anesthesia provider are critical. Equally important is communication of the patient’s experience to the intensive care unit or floor nurse who will assume care for the patient and who can identify resource personnel who could be available to support the patient who has experienced such trauma. The ethical dilemma becomes more complicated should the perianesthesia nurse discover that a pattern of unintended intraoperative awareness emerges as the result of care by a specific anesthesia provider or surgeon.

The hand-off from the OR to the PACU can be complicated by the pressure of time. What essential information needs to be passed from the OR nurse or the nurse anesthetist to the PACU nurse? How should the transfer of a patient whose condition is marginally stable or one whose condition is hemodynamically stable but in pain be handled between the nurse anesthetist and the PACU nurse? How could this situation be compromised by a demanding OR schedule that anticipates a speedy return to the OR by the anesthetist? Current literature supports the use of a structured process for hand-offs to ensure that all essential information is communicated. Many PACUs use the same structured process from anesthesia to PACU nurse and then PACU nurse to receiving nurse, allowing for consistency and safer continuity of care.^79,80

Minimal responsibility in this instance includes documentation of the patient’s status upon arrival, information on the surgical and anesthesia course, and collaboration in the care of the patient until the PACU nurse accepts responsibilities. The proper medication management, particularly as it applies to pain in the postoperative period, remains a critical ethical obligation and can be a source of tension between the transferring anesthesia provider and the receiving PACU nurse. This process can be particularly complicated for the pediatric patient or the geriatric patient with cognitive impairment because clinicians may need knowledge and specialized training for such populations. Again, standardization of procedures and proper communication skills are key factors in successful patient transfers and outcomes.⁸¹ See Chapter 26 for more information about transition from the OR to the PACU.

Many organizations are implementing Enhanced Recovery after Surgery (ERAS) as an evidence-based standard protocol of care. ERAS is a multimodal perioperative care pathway designed to achieve early recovery for patients undergoing major surgery.⁸² ERAS starts at the inception of planning a surgical procedure and continues through discharge. The concepts of ERAS include patient optimization prior to surgery, reduction of infection, intraoperative fluid optimization and normothermia, reduced opioid use with implementation of multimodal pain plans, and early postoperative fluid intact and mobilization.⁸³ Embedded in all aspects of a patient’s care, a team concept is inherent in its successful implementation and eventual improved patient outcomes.

Perioperative departments in many health care organizations have moved to team education and work on team dynamics to become successful in the full implementation of ERAS with surgical patients.⁸⁴ Organizations have done so by establishing intense team education and engagement with skilled team dynamics educators, anesthesia, surgeons, ambulatory clinics, pre- and postoperative units, intraoperative nursing teams, and inpatient units; all of which have an impact on the success of the ERAS protocol and positive patient outcomes. Team training allows the team members to become comfortable with one another and learn how to determine how communication will occur, and should occur, with all team members. Communication is one of the guiding principles of team dynamics and, with the flow of the patient through the ERAS protocol, it is imperative that this occurs verbally and electronically for patient success.

A corollary of the ethical principle of respect for persons and the obligation to ensure patient safety is truth-telling. The ethical responsibility to tell the truth in medicine exists at both the organizational and individual patient levels. Organizationally, the perianesthesia nurse needs to determine the ethical course of action in disclosing potential safety problems under the pressure to move patients efficiently through the system. At an individual patient level, the perianesthesia nurse is challenged to determine the ethical course of action in facilitating disclosure of a medical error, even one seemingly inconsequential.^85–87

At one point or another, all health care professionals encounter a case that conflicts with their own personal value system or that creates significant emotional discomfort. Perianesthesia nurses are no different. Nursing professionals should make every effort to anticipate such potential conflicts in advance and refer to any organizational personnel policies that address this conflict. Generally speaking, refusal of anticipated conflicts of moral conscience is ethical provided no compromise to patient safety exists.

Ethics Committees and Consultation Services

Ethics Case Review Methodology

The use of a pragmatic tool to examine an ethical dilemma is a valuable resource for both the novice and the experienced clinician. Thoughtful case analysis requires a reasoned methodology, ensuring that a systematic approach is followed and that influential factors are given appropriate consideration. The use of a case-based methodology can facilitate responsible reflection with an objective theoretic framework while attending to the specifics of a particular situation. The following adaptation offers a pragmatic approach to moral problem solving.^88,89

• Assessment: What are the facts? What are the patient’s medical condition and prognosis? What are the needs of the patient (e.g., relief from suffering)? What are the current goals of treatment or care? What are the patient’s preferences? What is the patient’s capacity for decision making? For the patient who lacks capacity, have any care preferences been previously expressed or documented? If not, does the family/surrogate have an understanding of the patient’s values or what the patient would have wanted given the current medical condition? If not known, what are the family/surrogate preferences?
  
• Moral Diagnosis: How are the ethical questions in the situation being framed by the participants who hold moral standing? Have all relevant persons been heard? Is the ethical dilemma clearly articulated? Separate facts from feelings. Clarify the points of disagreement or uncertainty. Identify and rank all relevant moral considerations. What ethical guidelines apply? Consider laws that may apply while carefully separating ethical from legal options during discussion. Are there similar cases in the literature that might be instructive? Identify and list the full range of morally acceptable options for resolving the case.
  
• Goal Setting, Decision Making, and Plan Implementation: What options for resolution of the dilemma seem most appropriate and why? Do the goals of treatment or plan of care need to be revised? What resources can be brought to the situation for assistance? How would you negotiate a plan among the affected parties and achieve consensus on a plan? What would help resolve the conflict? Is consultation with the institutional ethics committee indicated? Is judicial review indicated? If so, consider consultation with risk management.
  
• Evaluation: The implementation of any medical decision includes an element of ongoing evaluation. Consideration of the benefit of any intervention and the goals of treatment should be subject to periodic and regular review. Evaluation should include consideration of what could have been done to prevent the problem from occurring. Retrospective review might consider a range of issues from communication between providers and patient/family to assessment of institutional policy and practice.