Research with human subjects

Among the most sweeping reform in the second half of the twentieth 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 other than the safety and welfare of humans.

Nazi Germany will forever be remembered for war crimes committed against the human race. Millions of victims lost their lives not only to the actual military conflict of World War II but also to the 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 war criminal 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 be 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. Even within the United States, these important principles did not filter into the consciousness or conduct of physician experimenters, which became all too apparent in the infamous research project now 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. During the course of 40 years, 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 When the study first began in the early 1930s, the treatment for syphilis consisted of a difficult regimen of arsenic and mercury vaccinations. Although the treatment offered some control, this method proved to be no definitive cure for the illness. The study was initiated with hopes of understanding the disease and finding the definitive cure, but evolved merely into an observation of how the disease progressed through its various stages, culminating in death in many cases.

Participants in the study were led to believe that they were being provided real 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 that the research subjects permit an autopsy on their deaths for documentation of the effects of the end stages of the disease. Even after World War II, when the curative antibiotic of penicillin became widely available, subjects of the study were prohibited from receiving it so that 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 that receive 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 commission, composed of physicians, researchers, attorneys, theologians, and philosophers, 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 (unlike Tuskegee) 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 be present in every medical or behavioral research study that involves 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 (as in the case of treatment associated with clinical trials), and the option to withdraw from the study without penalty.

More recently, President Barack Obama authorized the Presidential Commission for the Study of Bioethical Issues to conduct a thorough review of domestic and international regulations on human subjects research to determine whether current rules still provide adequate protection. This directive occurs following the new revelations of unethical research in Guatemala from 1946 to 1948 in the U.S. Public Health Services Sexually Transmitted Diseases Inoculation Study.¹¹

End-of-life cases

Controversial patient care cases involving end-of-life decision making 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 therapy. The first landmark case is that of Karen Ann Quinlan.¹² Karen was a 21-year-old woman in New Jersey who, in 1975, suffered a severe anoxic brain injury after an accidental overdose of alcohol and drugs. Karen never regained consciousness and remained dependent on a ventilator for breathing and a feeding tube for nutrition and hydration. Eventually, she was given the diagnosis of a persistent vegetative state (PVS), a neurologic condition characterized by a “complete unawareness of the self and the environment, accompanied by sleep-wake cycles with either complete or partial preservation of the hypothalamic and brainstem autonomic functions.”¹³ Patients with PVS display “eyes open” unconsciousness and may have gross involuntary movements, but do not respond to external stimuli or engage in any purposeful activity. After some months, Karen’s parents came to the realization that their daughter would likely never regain consciousness or the ability to have any meaningful interaction with others. Following what they believed would be her own wishes, they asked physicians to remove the ventilator and allow Karen to die a natural death. Karen’s physicians adamantly opposed this idea, believing this to be an act of euthanasia, or worse, murder. Karen’s parents then petitioned the courts, and her case eventually came before the New Jersey Supreme Court. The Supreme Court ruled in the parents’ favor on the basis that Karen had a fundamental right to privacy and the right not to have treatment continued against her will. The Court wrote that “the State’s interest (to preserve life) weakens and the individual’s right to privacy grows as the degree of bodily invasion increases and the prognosis grows dim. Ultimately there comes a point at which the individual’s rights overcome the State’s interest.”¹² Physicians slowly weaned Karen from the ventilator while continuing her tube feedings and hydration (Karen’s parents never asked for the removal of the tube). Remarkably, Karen lived an additional 10 years before she died in a nursing home in 1986.

A second landmark case is that of Nancy Cruzan, a case sometimes referred to as the first “right to die” case to go before the United States Supreme Court.¹⁴ In 1983, Nancy was a 24-year-old woman who lost control of her vehicle on an icy road late one night in Missouri. She was found lying face down in a ditch after being ejected from her overturned car. Nancy had stopped breathing and had no detectable heartbeat for a brief period of time. Rescue personnel intervened to restore her respiratory and cardiac function. Like Karen Ann Quinlan, Nancy had had an anoxic brain injury that led to the eventual diagnosis of a PVS. Nancy was eventually transferred from an acute care setting to a rehabilitation facility where, despite years of effort, no improvements were seen in her condition. Unlike Karen Ann, Nancy was not dependent on a ventilator but was similarly sustained with a gastrostomy tube for feeding and hydration. Four years after her injury, Nancy’s parents asked physicians to remove the feeding tube with the understanding that Nancy would die. They contended that Nancy had remarked about never wanting to be artificially sustained if she could not be “at least halfway normal.”¹⁴ Physicians resisted, and Nancy’s parents turned to the courts for help. The Supreme Court of Missouri ruled against them with the argument that sufficient evidence of Nancy’s true wishes did not exist to justify the withdrawal of life support, particularly in light of the consequence of death. Denial of the Cruzans’ wishes on Nancy’s behalf led to an appeal to the U.S. Supreme Court and set the stage for one of the most famous medical legal cases in U.S. history.

The U.S. Supreme Court received the case in December 1989 and issued a ruling in June 1990. In somewhat of a split decision, the Court, on Constitutional grounds, affirmed both certain rights and requirements for all parties in determining a course of action in cases like Cruzan’s. The Court acknowledged an individual’s right to refuse treatment, even such treatment as life-sustaining tube feeding and hydration. Yet the Court went on to say that the state of Missouri could require “clear and convincing evidence” that such refusal was made while that person was still competent. On these grounds, the Cruzan case was remanded to Missouri for further adjudication. The emergence of new evidence that indicated that Nancy would not have wanted life-sustaining treatment in her current condition led to a Missouri lower court permitting 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 if rendered incompetent and unable 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 for no treatment in end-of-life circumstances.¹⁵ These advance directives, often referred to as living wills (and in many states including durable power of attorney for health care decisions), in theory meet the “clear and convincing” evidence standard required by the U.S. Supreme Court. Currently, all 50 states recognize and honor some form of written advance directives. However, problems persist in these difficult cases in both the interpretation of generalized written statements and the infrequency of use among the public.^16,17 As the next case shows, the absence of clear communication and understanding among family members over end-of-life wishes in medical care sometimes yields disastrous consequences.

The case of Terri Schiavo is the most recent of the series of tragic end-of-life cases to be pushed onto the national stage.^18,19 Terri was a 26-year-old woman in 1990 when she had a cardiac arrest most likely as a result of an electrolyte imbalance from an ongoing eating disorder. Like Quinlan and Cruzan before her, she had a severe anoxic injury that rendered her a total care patient in a PVS for 15 years, dependent on a percutaneous endoscopic gastrostomy tube for nutrition and hydration. Early on in her care, Terri’s husband, Michael, and her parents, Bob and Mary Schindler, were united in efforts to keep Terri alive and restore her to some level of conscious functioning. Within a few years, Michael came to the conclusion that Terri would not make any recovery and sought to remove the feeding tube to allow Terri to die. The Schindlers, deeply religious, vehemently opposed this request. They believed that removal of the tube was an act of murder and that continued aggressive effort could restore Terri to wakefulness. The Schindlers also questioned the diagnosis of PVS; they believed that Terri both recognized and communicated with them in her own limited way.

Fundamental disagreement between Michael and the Schindlers over Terri’s fate led to a bitter and international public dispute waged in the courts for more than a decade. The Schindlers petitioned to have Michael removed as Terri’s guardian and garnered the support of the Florida state legislature and Governor Jeb Bush, who signed a one-time stay forbidding the removal of the feeding tube pending further legal appeal. On three separate instances, the U.S. Supreme Court refused to hear the case, each time affirming the appropriateness of lower court findings in favor of Michael Schiavo. In the end, Michael’s position as Terri’s guardian was upheld and the courts allowed the removal of the percutaneous endoscopic gastrostomy tube. Terri died on March 31, 2005, with her husband at her side. After her death, Michael permitted, at the request of the Schindlers, a neuropathologic autopsy that revealed severe atrophy of the brain. The official cause of death by the medical examiner was listed as “complications from anoxic encephalopathy.”²⁰

The cases of Quinlan, Cruzan, and Schiavo reveal the ongoing struggle that 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. A lack of public consensus has limited the development of social and institutional policy to guide clinicians. Even the closest of kin can sometimes be unclear about what their loved ones would desire in critical cases.²¹

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.²³ 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.

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.²⁴

Questions may also arise regarding the duration and scope of a signed informed consent. The nurse in the previous scenario may have noticed that the signed consent was properly secured but completed in the surgeon’s office nearly 90 days ago. Should the consent still be valid for the patient who is now unsure about the nature of the procedure? What if, inside the OR, the surgeon determines that a change or expansion to the original procedure is indicated? Is the consent still valid? How much latitude is afforded the surgeon? What is the nurse’s obligation to confirm that the patient understood the potential surgical outcomes?

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. The content of these discussions should be documented and communicated to members of the interdisciplinary 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.^25,26 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 who is 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.

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.⁴⁹ Privacy suggests that a patient has the right to control general access and distribution of personal information about one’s 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 the decision-making capacity. The ethical responsibility to maintain privacy and confidentiality proceeds from the principle of respect for persons that promotes human dignity and maximized patient control.⁵⁰ Such responsibility is particularly critical for the most vulnerable of patients. 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.⁵⁰

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. Staff members not directly involved in the care of particular patients may encounter neighbors and friends who are recovering from surgery and would have preferred to remain unnoticed. One particular conflict that may emerge stems from the rights of parents who wish to be present when a minor child awakens from surgery. Although sensitivity to the needs of children is shown, the presence of parents in the PACU can compromise the privacy obligated to other patients.

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 has shown appropriate competencies for the level of care being provided. Competency implies possession of the knowledge, skills, attitudes, and behavior to deliver the appropriate level of care on a consistent basis.⁵¹ 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.⁵² 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 of care.⁵³

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. Responsibility extends to the nurse’s obligation to follow best practice processes and to take initiative to eliminate errors, such as calling “time out” if guidelines such as those designed to ensure correct site surgery are not followed properly.^54,55

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 regarding unintended intraoperative awareness. The responsibilities of the nurse in this instance can be multiple. With an interview of the patient who is emerging from the influence of anesthesia to determine whether any recollection of events exists or whether the patient experienced pain during the surgical procedure, the nurse must make an initial assessment. 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 the 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? Minimal responsibility in this instance includes documentation of the patient’s status on arrival, information on the surgical and anesthesia course, and collaboration in the care of the patient until the PACU nurse accepts responsibilities.⁵⁶ The assessment and management of 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.⁵⁶ Special care should be taken not to underestimate the level of pain severity and undertreat the patient. The safe transfer of care should be extended again when the patient moves from the PACU to another care setting. Although guidelines for the safe transfer of care have been identified by both the American Society of PeriAnesthesia Nurses and the American Society of Anesthesiologists, successful patient outcomes in these situations are facilitated with clear and proper communication skills.

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 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.⁵⁷

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 in advance such potential conflicts and reference any organizational personnel policies that address this conflict. Generally speaking, refusal of anticipated conflicts of moral conscious is ethical provided no compromise to patient safety exists.

Ethics committees and consultation services

The Standards of The Joint Commission require that hospitals have an identifiable process for the resolution of ethical dilemmas. Subsequently, most hospital-established ethics committees are charged with three functions: the development of policies to address recurrent difficult situations, such as DNR or withdrawal of care orders; education to the organization that addresses issues faced by the organization or its specialty disciplines; and consultation to patients, families, and staff for the mediation of conflicts or exploration of treatment options. Although guidelines to determine the functioning of ethics committees can vary by organization, generally speaking, access to the ethics committee is available to any individual with standing in a case. This access includes patients or surrogates and staff involved in the care of the patient. Consultation services are generally provided by a subcommittee of the membership that possesses some training in clinical ethics. Consultations, whether by the committee as a whole or by subcommittee, serve as nonbinding recommendations that identify the ethically appropriate options of care available to the physician and patient.

Consultation provided by members of the ethics committee can be a critical resource for the perianesthesia nurse who is uncertain about the appropriate ethical course in a given clinical situation. The goal of ethics consultation is the improvement of patient outcomes through a process of reasoned decision making. Consultation typically takes the form of facilitation and dialogue to ensure that the key ethical issues and the essential perspectives of persons with standing in a case are provided adequate voice. The value of ethics consultation is the availability and timely response of a neutral resource to assist staff in the exploration of ethically appropriate alternatives to a situation that lacks consensus. The reality that an ethics consultation, like a medical consultation, is a resource, not a final decision, may disappoint clinicians who seek a quick resolution for a complex situation or an ally to advance a particular position.

Ethics case review methodology

The struggle around ethical dilemmas for most clinicians occurs when a clinical situation creates a conflict of personal values or when the rights of individual patients appear to not be respected. The use of a pragmatic tool to examine a moral problem is a valuable resource for the novice and the experienced clinician. Thoughtful case analysis requires a reasoned methodology ensuring that a reasoned 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. Detailed case-based approaches are available.⁵⁸ In general, the literature points to five common elements for the case review process: assessment and gathering, establishment of ethical questions, identification and analysis of alternatives, selection and implementation, and evaluation.