Origins of Contemporary Medical Ethics

Western medical ethics is believed to have originated with the Hippocratic cult (about 450 to 300 bc ), a group of early physicians who are thought to have been heavily influenced by the Pythagorean thinkers. Rather than ascribing disease to be solely the province of supernatural or deistic causes, this group was responsible for one of the first systemized efforts to impart a naturalistic approach to the study and practice of medicine. In addition to their accomplishments in mathematics, the Pythagoreans developed a moral philosophy that emphasized respect for life. This outlook would account, for example, for the apparent strictures on abortion and euthanasia that are features of a prominent version of the Hippocratic Oath. For different reasons, the oath also prohibits surgery, which was not regarded as a proper part of a physicians’ activities. The attitudes held by the Hippocratic physicians apparently were not widely held among other physician cults of the ancient world.

The Hippocratic tradition urges physicians to “do no harm” and to use their skills for the welfare of the individual patient. For many years these principles were thought to justify medical paternalism because they seemed to generate duties that were mainly intended to minimize physical harm and to improve the patient’s physical well-being. Given that the physician possessed specialized knowledge of the physical structures and causal processes of the patient’s body, the physician and not the patient was considered most qualified to determine a patient’s health care goals and the means to achieving them. On the basis of this reading of the Hippocratic Oath, patients were not thought qualified to shape the course of their individual care because of their general lack of scientific insight into the nature and workings of their own physical condition.

The last 40 years or so have witnessed a trenchant and often passionate critique of the idea that a patient’s best interests are limited to or exhausted by his or her physical wellbeing. Because a patient’s best interests must be determined in light of his or her values and life goals and because the value a patient places on physical well-being depends on how it fits within this larger framework of values and projects, the competent and well-informed patient is generally recognized as the best judge of appropriate health care goals. Few would deny the accuracy of the Hippocratic conception of medicine as a science whose goal is the health and physical welfare of the patient nor challenge the claim that physicians must always look after the best interests of their patients. However, the fact that a competent patient lacks specialized medical knowledge is generally recognized to be less important than the fact that each patient is the most qualified judge of the relative value of his or her physical well-being in relation to his or her larger life goals and projects. For this reason, patient self-determination, as well as its culmination in the doctrine of informed consent, represents the bedrock of contemporary clinical ethics.

As medical science has progressed and physicians have developed the ability to alter the course of a person’s life with the use of an array of medical technology, patients have taken a greater interest in determining the way their lives should be shaped. The early seeds of patient self-determination and the doctrine of informed consent began developing as early as the latter part of the 19th century. This period and the early part of the 20th century saw many legal cases involving surgical patients whose consent to excision of tissues had not been obtained. Under prevailing legal theories, these actions were at first considered torts, such as battery or “unconsented touching.” As medical and judicial systems evolved, they were then gradually brought under a negligence theory. This change strengthened the growing expectation that informing a patient of the reason for the procedure and obtaining consent for it were proper parts of the physician–patient relationship. In theory, at least, obtaining the patient’s informed consent became an essential aspect of the developing standard of care. However, honoring this legal requirement in clinical reality awaited the increased attention to ethical issues that emerged in the late 1960s.

Although we focus here on clinical ethics, no survey of the history of medical ethics can omit society’s reaction to the abuses of human beings perpetrated by physicians and scientists in the concentration camps of Nazi Germany. The revelations at Nuremberg led to the promulgation in Helsinki and Geneva of international standards for the protection of research subjects. Unfortunately, these efforts did not prevent blatantly unethical practices in the context of subsequent research by American investigators. As a result, strict statutory protections were established to ensure the informed consent of research participants, including protocol review by institutional committees. Public recognition of research abuses led to heightened scrutiny of the physician–patient relationship in the clinical setting and greater support for the concept of informed consent.

Technologic advances once again profoundly influenced the direction of medical ethics, beginning in the later 1960s with the arrival of practical artificial respiratory equipment and, in the early 1970s, with the development of materials that facilitated artificial hydration and nutrition. These advances—combined with social and political changes, including the civil rights movement—culminated in the celebrated legal case of Karen Ann Quinlan in 1976. In the Quinlan decision, the New Jersey Supreme Court established that the right to refuse medical treatment was fundamental and could be exercised on behalf of an incompetent patient by informed surrogates who were knowledgeable about the patient’s previous values and lifestyle. The family was found to be in the best position to represent the wishes of their close relative.

In summary, the history of Western medical ethics has featured a transition from the “beneficence” orientation (doing good for the patient) of premodern medicine to the view that the patient must ultimately decide what his or her best interests are after going through a process of informed consent. Both morally and legally, patient self-determination has become the gold standard of modern biomedical ethics. In the next section, we review the prevailing philosophical principles and theories that are often used to further assess ethical problems in modern medicine.

Prevailing Theories and Principles

The term medical ethics, as it is used in contemporary society, is somewhat ambiguous. It may refer to those rules of conduct established by the formal bodies of the medical profession in the course of regulating itself, such as the prohibition of the sexual exploitation of one’s patients, or it may refer to novel ethical dilemmas that actually confront health care workers and have no obvious solution in terms of traditional values and ethical codes, such as the removal of life-support systems from irreversibly comatose patients.

Two philosophical approaches dominate the literature. Tracing its roots to the German philosopher Immanuel Kant (1724–1804), the Kantian tradition holds that people have a fundamental right to be treated as ends in themselves and not merely as a means to some other end. The basis of the Kantian view is that each person has the capacity to take on projects and to give a distinctive shape to his or her own life. This capacity must be respected in each individual because the value of all other things is derived from the exercise of this capacity. Patient self-determination and informed consent are, therefore, the preeminent Kantian values for clinical ethics, because without them we cannot freely set the ends for ourselves that give all other things their moral worth. As such, they represent the necessary conditions for treating a patient as an end in himself or herself.

Utilitarianism traces its roots back to the English philosophers Jeremy Bentham (1748–1832) and John Stuart Mill (1806–1873). Utilitarianism is a form of consequentialism, which holds that actions or policies are right in proportion to the extent to which they promote the aggregate happiness or well-being. Whereas the Kantian can claim that physicians have special duties to their patients, which derive from the need to respect their patients as ends in themselves, the utilitarian must argue that any duties physicians owe to their patients are rooted in the fact that fulfilling those duties maximizes overall happiness.

Although the principle of autonomy is commonly regarded as the first principle of contemporary medical ethics, those with a more utilitarian slant believe that it is conceptually balanced by the principle of beneficence; the obligation to do good for the patient. Beneficence is closely associated with the traditional Hippocratic obligation to at least not harm the patient, or the principle of nonmaleficence. Arguments that establish the moral basis of beneficence and nonmaleficence are available both to Kantian and utilitarian theories. The main difference between these theories, therefore, lies not in the principles they recognize but in the way they justify those principles and the way they order them in relation to one another.

Origins of Contemporary Medical Ethics

Western medical ethics is believed to have originated with the Hippocratic cult (about 450 to 300 bc ), a group of early physicians who are thought to have been heavily influenced by the Pythagorean thinkers. Rather than ascribing disease to be solely the province of supernatural or deistic causes, this group was responsible for one of the first systemized efforts to impart a naturalistic approach to the study and practice of medicine. In addition to their accomplishments in mathematics, the Pythagoreans developed a moral philosophy that emphasized respect for life. This outlook would account, for example, for the apparent strictures on abortion and euthanasia that are features of a prominent version of the Hippocratic Oath. For different reasons, the oath also prohibits surgery, which was not regarded as a proper part of a physicians’ activities. The attitudes held by the Hippocratic physicians apparently were not widely held among other physician cults of the ancient world.

The Hippocratic tradition urges physicians to “do no harm” and to use their skills for the welfare of the individual patient. For many years these principles were thought to justify medical paternalism because they seemed to generate duties that were mainly intended to minimize physical harm and to improve the patient’s physical well-being. Given that the physician possessed specialized knowledge of the physical structures and causal processes of the patient’s body, the physician and not the patient was considered most qualified to determine a patient’s health care goals and the means to achieving them. On the basis of this reading of the Hippocratic Oath, patients were not thought qualified to shape the course of their individual care because of their general lack of scientific insight into the nature and workings of their own physical condition.

The last 40 years or so have witnessed a trenchant and often passionate critique of the idea that a patient’s best interests are limited to or exhausted by his or her physical wellbeing. Because a patient’s best interests must be determined in light of his or her values and life goals and because the value a patient places on physical well-being depends on how it fits within this larger framework of values and projects, the competent and well-informed patient is generally recognized as the best judge of appropriate health care goals. Few would deny the accuracy of the Hippocratic conception of medicine as a science whose goal is the health and physical welfare of the patient nor challenge the claim that physicians must always look after the best interests of their patients. However, the fact that a competent patient lacks specialized medical knowledge is generally recognized to be less important than the fact that each patient is the most qualified judge of the relative value of his or her physical well-being in relation to his or her larger life goals and projects. For this reason, patient self-determination, as well as its culmination in the doctrine of informed consent, represents the bedrock of contemporary clinical ethics.

As medical science has progressed and physicians have developed the ability to alter the course of a person’s life with the use of an array of medical technology, patients have taken a greater interest in determining the way their lives should be shaped. The early seeds of patient self-determination and the doctrine of informed consent began developing as early as the latter part of the 19th century. This period and the early part of the 20th century saw many legal cases involving surgical patients whose consent to excision of tissues had not been obtained. Under prevailing legal theories, these actions were at first considered torts, such as battery or “unconsented touching.” As medical and judicial systems evolved, they were then gradually brought under a negligence theory. This change strengthened the growing expectation that informing a patient of the reason for the procedure and obtaining consent for it were proper parts of the physician–patient relationship. In theory, at least, obtaining the patient’s informed consent became an essential aspect of the developing standard of care. However, honoring this legal requirement in clinical reality awaited the increased attention to ethical issues that emerged in the late 1960s.

Although we focus here on clinical ethics, no survey of the history of medical ethics can omit society’s reaction to the abuses of human beings perpetrated by physicians and scientists in the concentration camps of Nazi Germany. The revelations at Nuremberg led to the promulgation in Helsinki and Geneva of international standards for the protection of research subjects. Unfortunately, these efforts did not prevent blatantly unethical practices in the context of subsequent research by American investigators. As a result, strict statutory protections were established to ensure the informed consent of research participants, including protocol review by institutional committees. Public recognition of research abuses led to heightened scrutiny of the physician–patient relationship in the clinical setting and greater support for the concept of informed consent.

Technologic advances once again profoundly influenced the direction of medical ethics, beginning in the later 1960s with the arrival of practical artificial respiratory equipment and, in the early 1970s, with the development of materials that facilitated artificial hydration and nutrition. These advances—combined with social and political changes, including the civil rights movement—culminated in the celebrated legal case of Karen Ann Quinlan in 1976. In the Quinlan decision, the New Jersey Supreme Court established that the right to refuse medical treatment was fundamental and could be exercised on behalf of an incompetent patient by informed surrogates who were knowledgeable about the patient’s previous values and lifestyle. The family was found to be in the best position to represent the wishes of their close relative.

In summary, the history of Western medical ethics has featured a transition from the “beneficence” orientation (doing good for the patient) of premodern medicine to the view that the patient must ultimately decide what his or her best interests are after going through a process of informed consent. Both morally and legally, patient self-determination has become the gold standard of modern biomedical ethics. In the next section, we review the prevailing philosophical principles and theories that are often used to further assess ethical problems in modern medicine.

Prevailing Theories and Principles

The term medical ethics, as it is used in contemporary society, is somewhat ambiguous. It may refer to those rules of conduct established by the formal bodies of the medical profession in the course of regulating itself, such as the prohibition of the sexual exploitation of one’s patients, or it may refer to novel ethical dilemmas that actually confront health care workers and have no obvious solution in terms of traditional values and ethical codes, such as the removal of life-support systems from irreversibly comatose patients.

Two philosophical approaches dominate the literature. Tracing its roots to the German philosopher Immanuel Kant (1724–1804), the Kantian tradition holds that people have a fundamental right to be treated as ends in themselves and not merely as a means to some other end. The basis of the Kantian view is that each person has the capacity to take on projects and to give a distinctive shape to his or her own life. This capacity must be respected in each individual because the value of all other things is derived from the exercise of this capacity. Patient self-determination and informed consent are, therefore, the preeminent Kantian values for clinical ethics, because without them we cannot freely set the ends for ourselves that give all other things their moral worth. As such, they represent the necessary conditions for treating a patient as an end in himself or herself.

Utilitarianism traces its roots back to the English philosophers Jeremy Bentham (1748–1832) and John Stuart Mill (1806–1873). Utilitarianism is a form of consequentialism, which holds that actions or policies are right in proportion to the extent to which they promote the aggregate happiness or well-being. Whereas the Kantian can claim that physicians have special duties to their patients, which derive from the need to respect their patients as ends in themselves, the utilitarian must argue that any duties physicians owe to their patients are rooted in the fact that fulfilling those duties maximizes overall happiness.

Although the principle of autonomy is commonly regarded as the first principle of contemporary medical ethics, those with a more utilitarian slant believe that it is conceptually balanced by the principle of beneficence; the obligation to do good for the patient. Beneficence is closely associated with the traditional Hippocratic obligation to at least not harm the patient, or the principle of nonmaleficence. Arguments that establish the moral basis of beneficence and nonmaleficence are available both to Kantian and utilitarian theories. The main difference between these theories, therefore, lies not in the principles they recognize but in the way they justify those principles and the way they order them in relation to one another.

The Provider–Patient Relationship

Decision Making for Incapacitated Patients

Treatment Decisions Requiring Special Attention

Critical Care and End-of-Life Decision Making: Special Concerns

The circumstances that surround critical care and end-of-life decision making are often made more controversial and problematic for both patients and providers because of uncertainty about the moral and legal permissibility of certain actions or decisions. This is particularly true when death is a likely or even intended consequence of a choice. In addition, many philosophically based terms are sometimes interjected into discussions without universal clarity or certainty about their intended meanings. For example, comparisons such as ordinary versus extraordinary or withholding versus withdrawing sometimes conjure up misguided notions about what is or is not acceptable in the course of delivering patient care. The unnecessary inclusion of confusing terms often clouds the underlying reasons and justifications for choices made either by or on behalf of a patient.

For patients who possess decisional capacity, the choice of whether to initiate, withhold, or withdraw care is one solely within the orbit of the patient’s value system, even if the likely or intended consequence of the patient’s choice is significant harm or even death. Despite the discomfort that many providers have with this concept, it is one in accord with the moral and legal frameworks supporting patient autonomy. Thus, a patient can decline the option of life-prolonging surgery, can ask that mechanical ventilation be withheld if respiratory distress occurs, and can even ask for the withdrawal or cessation of such life-prolonging measures as dialysis, artificial nutrition, and hydration (in most jurisdictions), as long as the patient possesses the capacity and information to assess the benefits and burdens of such choices. However, in some jurisdictions, such choices may nonetheless require a legal process to carry out the request. This step may stem more from concern about injecting safeguards into such decision processes rather than any move away from fundamental moral or common law support for such patient decisions. Moreover, in most jurisdictions, such patient requests would be accorded respect even if they were transmitted through an appropriately executed living will or appointed surrogate once the patient loses decisional capacity.

Questions of whether there is any moral or legal difference between withholding and withdrawing care, whether the care involved is of an “ordinary” versus “extraordinary” nature, or whether it is acceptable to omit an action that may lead to the patient’s death but not to purposefully act in such a way that may bring about death raise concerns about word origins and their current meaning and significance in the context of care. Many of these terms, although perhaps drawing some useful distinctions in their earlier, theologic origins or perhaps pointing to areas that warrant additional attention, in and of themselves do not determine the morality or legality of the choice carried out. For example, a provider who makes the distinction that “extraordinary” care may be withheld or withdrawn, yet “ordinary” care must be initiated or continued tells us little about the precise nature of the care or its effect on the patient at issue.

Although in simpler times distinguishing what was ordinary from what was not perhaps seemed easier, the sophistication of the machinery or commonness of its application in today’s sophisticated acute care environment creates situations in which an appropriate intervention for one patient may not be acceptable or even beneficial to another similarly situated patient. In such determinations, the importance is not in what the care is labeled but rather how it affects that patient and fits into the patient’s perspective in terms of benefits versus burdens. One patient may believe the receipt of artificial nutrition via a gastrostomy tube is desirable and acceptable, whereas another may view it as extraordinarily burdensome and inconsistent with his or her view of what best suits his or her interests. Such differences between the patients in the meanings that are assigned only underscore how physicians and patients may view choices differently. A provider should not presume that a patient regards a certain course of care in a way similar to the provider.

Similarly, attempts to explain omissions or withholdings as being morally or legally permissible and actions or withdrawals as impermissible only confuse and distort the reasons and justifications that will make such choices either permissible or not. Merely because a provider decides not to initiate a process does not necessarily relieve that provider of responsibility if the outcome was one intended or foreseen. This is particularly so in the context of patient–provider relationships, in which the provider owes duties to the patient and in which a decision not to act may be as influential and responsible for patient’s outcome as any concrete activity that the provider undertakes. For example, a decision to withdraw artificial ventilation from a patient, which may or may not bring about the patient’s death, is not necessarily any less permissible or unacceptable than the choice to omit or withhold its use in the first place. Some people may believe a distinction exists between an act that is believed to cause the death of the patient and one that merely holds back a possibility from an already dying patient, but from a moral and legal point of view, arguments used to withhold treatment should be equally justifiable and binding as decisions to withdraw or cease. Judicial decisions that have addressed this matter concur that no logical distinction exists.

A decision not to initiate care can be viewed just as “causative” in terms of patient outcome as any act of withdrawing, if the outcome was one that was foreseen and could have been avoided if a different choice was made. In such circumstances the important point is not so much whether one is acting or omitting or withholding or withdrawing, but rather why one is undertaking that course and whether it can be justified in terms of the patient’s preference or the best interests of the patient as determined by an appropriate surrogate. Moreover, many commentators have clarified that decisions not to initiate care, because of fear that, once started, a treatment cannot later be stopped, may actually harm certain patient populations. Some patients might benefit from a trial of therapy, even if later on the therapy may no longer serve the patient’s interests and should be withdrawn in the name of beneficence, nonmaleficence, or patient autonomy. Not to have tried an intervention for fear of not being able to stop it lacks logic and defies the nature of providing medical care, which often means that certain risks are undertaken for certain potential benefits. One must always remember the provider’s duty to relieve pain and suffering and not to cause harm to the patient.

Nonetheless, certain actions on the part of providers and requests on the part of patients trigger additional scrutiny and other societal interests that may take priority over a pure vision of patient autonomy or provider beneficence. For example, societal interests in the sanctity of life and concern for the prevention of suicide are generally used to deny support for patient requests for suicide assistance or for provider services to purposefully administer a medication or another intervention for the purpose of causing the patient’s death (what is sometimes known as “active euthanasia”). Although much sympathy is generated for the plight of desperately ill patients seeking relief from their terminal conditions and often grand jury investigations of such matters fail to indict involved parties, most states maintain strict theoretical sanctions and legal prohibitions on provider involvement in such cases.

In two decisions the U.S. Supreme Court reiterated the traditional American condemnation of suicide and upheld the value of the individual human life by unanimously striking down two lower court decisions that had found a constitutional right to die with the aid of a doctor. Although the Court ruled that the constitution does not guarantee Americans such a right, it left the individual states with the power to determine the legality of physician-assisted death. In October of 1997, the state of Oregon enacted the Death with Dignity Act into law, becoming the first state to legalize and regulate physician-assisted death. The state’s first legal physician-assisted death took place on March 24, 1998. In 2006, the Supreme Court specifically addressed a challenge to this Oregon law in the case of Gonzales v Oregon, ruling that the United States Attorney General could not enforce the Controlled Substances Act against Oregon physicians who prescribed drugs for assisted suicide in the terminally ill, in accord with the Oregon law. The Court affirmed the ability of a state to pass legislation permitting physician-assisted death under defined circumstances.

As these events in Oregon attest, we may be witnessing a shift in societal consensus about how to prioritize values when fundamental questions about the meaning of life and death are the issue. The debate concerns the precise role of the physician and the nature of physician–patient relationship in an era of such sophisticated and often partially successful care that it is sometimes difficult to discern whether, on the whole, an intervention would benefit or burden a patient. Some argue that supporting physician involvement in the intended death of a patient destroys the essential role of the provider as healer and would create an air of uncertainty that would ultimately damage the trust that exists between patient and provider. Others believe that one essential role of the modern physician is relief of suffering, and the possibility of such physician involvement might encourage otherwise desperate patients to try one more round of therapy or intervention, comforted by the knowledge that failure would not lead to unremitting pain or unendurable misery. As the effects of Oregon’s Death with Dignity Act become clear and as more states move to enact legislation, the debate over these issues will intensify.

Although the Supreme Court found no constitutional right to physician-assisted death, the Court seemed to recognize the existence of a legitimate conflict between the needs of some terminally ill individuals and the larger interests of society. In fact, some have argued that, although patients cannot legally ask physicians to end their suffering by invoking a constitutional right to assistance in dying, patients may very well have a constitutional right to palliative care.

However, all judicial decisions that have examined cases of the withholding or withdrawal of patient care have distinguished such circumstances from cases of active euthanasia or other forms of killing or suicide. No physician who has participated in treatment decisions to withhold or withdraw care has ever been found criminally liable and responsible for the patient’s death. Cases of assisted suicide and euthanasia have been distinguished on the basis of the nature of the patient’s prognosis and clinical circumstances. Patients who refuse care or ask for its withdrawal and who will then die from their underlying conditions are not considered to be committing suicide, nor are the providers who respect such decisions considered to be assisting suicide or killing the patients.

One final distinction deserves examination: the administration of pain relief with the knowledge, though perhaps not the intent, that such medication may ultimately shorten the patient’s life or even cause the patient’s death. Under the theologic doctrine of “double effect,” such action is usually explained and justified by referring to the primary effect and intent of the action, that of relieving pain, while recognizing the possibility or even likelihood that another effect, that of the patient’s shortened life or even death, is a possible result of the action. The action is considered permissible because the intent was to relieve suffering, not to cause death.

Theoretically, in current legal climates, the knowledge that an outcome is possible—though not necessarily intended—might still lead to liability on the part of the provider. However, we know of no successful litigation against a provider for administering pain relief to a patient with significant need, even if the outcome of the relief also meant an earlier death for the patient. Justification for such actions are usually, in current climates, based on either the patient’s choice to risk death to achieve pain relief (or a similar decision by an authorized surrogate) or on the widely recognized additional role of the provider to relieve pain when possible. Such provider actions are generally distinguished in legal forums from more common examples of “active euthanasia.” In fact, many commentators have suggested that it would be unusually cruel and harmful to a patient to respect the patient’s wish that care be withdrawn or withheld, yet not provide him or her with pain medication to ease the transition to death.

Artificial Nutrition and Hydration

The use of artificial means to nourish and hydrate patients who are unable to take in food on their own has generated significant debate concerning definitions of “medical care” versus “comfort care.” For many caregivers, the question raised is whether there are any limits to patient self-determination or provider obligations in the context of the physician–patient relationship. Many believe that withholding or withdrawing “medical care” in accord with a patient’s self-determination is permissible, whereas the provision of artificial nutrition and hydration represents the intrinsic “caring” nature of human interaction and, therefore, must always be provided as a fundamental demonstration of humanity and compassion.

All courts of law that have addressed this question, including the U.S. Supreme Court, have equated the use of artificial nutrition and hydration with the use of other medical technologies and “high-tech” progenies, such as mechanical ventilation and dialysis. They have thus permitted its withholding or withdrawal in accord with the interests of patient self-determination. In the political arena, some legislatures have even made exceptions to their living will or health care proxy legislation to make allowance for such a distinction and, in some circumstances, to refuse to grant permission for patients or surrogates to have such care withheld or withdrawn. Given the sometimes passionate nature of the debate and the pluralistic nature of our society, a compromise has been reached in many instances that recognizes the right of individuals to determine the course of their care, particularly when providers feel unable to abide by such patients’ requests. This accommodation usually calls on either individual or institutional providers to disclose to patients and families, before the onset of a relationship, the perspective of the provider about this type of care.

Dilemmas in Team Decision Making: The Role of the Anesthesiologist

Dilemmas in the clinical setting may emerge not only from interaction with patients and families but also in the relationships that are forged under a system of team coverage of patient care needs. Particularly for the neurosurgical patient–whose problems may span the disciplines of neurology, surgery, and anesthesiology, among others–the collection of providers who join to meet the specific needs of an individual patient may generate interdisciplinary disputes, rivalry, or even antagonisms, which may subtly, or perhaps not so subtly, affect patient care. In this regard, the role of the consultant anesthesiologist is briefly examined as just one example.

A cardinal rule of the Hippocratic tradition, which emphasized the appropriateness of calling in consultants, was that physicians were never to disagree with their colleagues in front of the patient. In our own time, the notion of a “united front” before the laity has perhaps a greater command over medicine than in other professions, so that even when physicians are in substantial disagreement over the appropriate course, they rarely present their disagreement to the patient. Considering that the patient whose condition is serious enough to warrant consultation is often in an emotionally vulnerable position, this policy might not seem to be an unwise one.

However, modern legal analysis and case law support the independent authority and responsibility of the anesthesiologist as separate and distinct from other members of the healthcare team. Although the anesthesiologist may have little or no participation in the initial decision to intervene surgically, he or she has separate responsibility to review the patient’s condition and to obtain an independent informed consent directly from the patient or the patient’s surrogate for the use of anesthetics. In effect, the anesthesiologist must review the feasibility of anesthetic intervention for the particular patient and separately determine whether the surgery should proceed on the basis of this review. The actions or determinations of the anesthesiologist are no longer viewed as subordinate to those of the surgeon. The anesthesiologist has an independent duty to the patient, separate and apart from that of the surgeon or any other member of the health care team. Such duty carries through the entire perioperative period, until such time as the anesthesiologist discharges the patient from his or her care.

Ethical Issues in Innovative Neurosurgery: Role of the Anesthesiologist

The anesthesiologist’s specific duties toward the surgical patient, as discussed in the previous paragraph on team decision making, also extend toward patients undergoing experimental or innovative procedures. Such innovations may occur within or outside of formal clinical studies, as we explain here. Perhaps even more pressing than during standard operations, the anesthesiologist may function as an important consultant to the neurosurgeon (and perhaps, sometimes, as an advocate for the patient) by helping the neurosurgeon appropriately identify those procedures that are, in fact, experimental enough to warrant additional scrutiny and review. The additional review and patient protections required for experimental surgery may not always be apparent to the neurosurgeon, because they traditionally have not always been recognized by the surgical profession in general. Prior research has shown that surgeons generally do not readily identify those innovations that are in fact experimental or that amount to research with human subjects; they do not often submit their innovative procedures to rigorous testing in the form of (controlled) clinical trials nor their innovative surgical techniques to their institutional review boards (IREs) for prior review and monitoring.

Every day, US surgeons modify existing operations, attempting to improve their techniques and outcomes. Sometimes this modification occurs on an individual patient basis; sometimes a group of patients undergoes an innovative procedure. Sometimes a group of patients serves as a prospective or historical control. Innovative operations find their way into the professional journals and conferences as case reports, case series, or case-control studies, and a very small percentage as prospective clinical trials. But many, perhaps most of them, have one thing in common: they were performed under the heading of therapy, not of research. Whether they started out as spontaneous technique modifications necessary for a particular patient situation or as informal studies with or without protocols, most of these studies were done without prior IRB review and without specific research consent from patients. In some instances, such review and consent would have been appropriate and necessary, but uncertainties and disagreements exist among surgeons as to what constitutes routine variations on surgical techniques that require no prior approval and what are new or innovative techniques warranting IRB review and patients’ specific informed consent for an experimental procedure or a research study. This area is where the neurosurgical anesthesiologist can become an important ally of both patients and science, by helping surgeons to correctly identify those innovations that would better be performed under the heading of research. It is, therefore, of paramount importance that anesthesiologists be familiar with the definitions and regulations for human subject research and with the workings of the local IRB.

Necessary knowledge to make judgments about research and innovative practice can be found in documents from both federal agencies and professional societies. The oversight of research, innovation, and standard health care involves multiple jurisdictions: the separate states; federal agencies involved with regulation, funding, or reimbursement; professional societies; and health maintenance organizations (themselves operating under state and/or federal rules) may all be involved. Increasingly, the courts may play a significant role.

At the federal level, there are the regulations of the U.S. Department of Health and Human Services (DHHS) and its Office of Human Research Protections (OHRP; formerly Office for Protection of Research Risks [OPRR]). DHHS has issued a Code of Federal Regulations Title 45 Part 46, on “Protection of Human Subjects.” “45 CFR 46,” or the Common Rule, so called because it has been adopted by all but 17 state agencies, provides formal definitions of research and the human subject of such research. Subpart A of 45 CFR 46, or the Federal Policy for the Protection of Human Subjects, sets out definitions and general regulations for performing research with human subjects. Research is defined as any systematic investigation designed to develop and contribute to generalizable knowledge. Human subject is defined as a living individual about whom an investigator obtains either (1) data through interaction or intervention (eg, surgery) or (2) identifiable private information. The other subparts of the document specify what additional guidelines are to be followed in case of vulnerable populations.

The Common Rule applies to all research involving humans that is conducted, supported, or otherwise subject to regulation by any federal department or agency. In other words, any institution that receives federal funding falls under and must abide by the Common Rule. This makes the DHHS ultimately responsible over all human subject research that is directly or indirectly funded by federal money. DHHS thus technically has jurisdiction over all surgical clinical research as well, as long as it is conducted in health care institutions that receive federal money. DHHS’s definitions of research and human subject are applicable in surgery as much as they are in noninterventional specialties. However, the problem lies in the fact that not all surgical research activities are defined as such and thereby escape the overview of local IRBs and, ultimately, of the Office of Human Research Protections and DHHS. Part of the reason is that surgeons do not always recognize their efforts to improve surgical technique as research (which sometimes is appropriate, sometimes not) and another part is that surgeons are not always adequately aware of the fact that DHHS definitions sometimes do apply to their innovative activities. The lack of awareness is most probably due to inadequate familiarity with the Common Rule and its definitions and regulations.

The U.S. Food and Drug Administration (FDA) gained regulatory powers to ensure the safety and effectiveness of new medical devices and medications. The law stipulates that all medical devices manufactured after 1976 are subject to an approval process and then subjected to regulatory controls according to their level of patient risk. However, unless an innovative surgical technique involves such an investigational device or an experimental drug, the FDA has no responsibility or jurisdiction over surgical research.

Local agents under the DHHS Common Rule that do have formal jurisdiction are institutional review boards (IRBs).The IRB, also known as the research ethics committee, has been the local protection mechanism for human research subjects since the latter part of the 20th century. IRBs have the authority and responsibility for approving or disapproving proposals to conduct research involving human subjects.

Voluntary guidelines have been issued by surgical societies such as the American College of Surgeons (ACS). The Committee on Emerging Surgical Technologies (CESTE) of the ACS has issued statements specifically addressing the ethical and responsible implementation of new surgical techniques and innovations.

These self-imposed guidelines for emerging surgical technologies and their application to the care of patients were formulated in 1994 and 1995. In part, they read as follows:

• 1.
  

  The development of a new technology must be accompanied by a scientific assessment of safety, efficacy, and need …

  
  
• 2.
  

  Diffusion into clinical practice requires appropriate education of surgeons and evaluation of their use of the new technology …

  
  
• 3.
  

  Widespread application of new technologies must be continuously assessed and compared with alternative therapies to ensure appropriateness and cost-effectiveness through outcome studies.

The introduction of new technology to surgeons and the public must be done ethically in accordance with the Statement on Principles of the American College of Surgeons.

These principles require prior and continued IRB (or equivalent) review of the protocol, full description of the procedure, and informed consent of the patient. However, current guidelines remain open to individual interpretation and are not restrictive in character. Other than issuing a reprimand or expelling an unruly surgeon from the Fellowship, the ACS does not have responsibility or legal jurisdiction over the practices of its Fellows, let alone over U.S. surgeons who are not members of the ACS. As such, the Statement on Emerging Surgical Technologies is not legally binding. Other surgical organizations, such as the Society of University Surgeons (SUS), have also attempted to address the challenge of surgical innovations by offering guidance.

Until definitive guidelines or laws regulating innovative and experimental surgery have become established, it is up to individual neurosurgeons, aided by their team, including neuroanesthesiologists, to determine which procedures should be introduced as innovative practice and which should be submitted to more formal scrutiny, such as IRB review and other oversight mechanisms.

Ethics Related to Brain Death

The ancients often regarded the heart as the center of vitality, and for millennia the determination of death was the absence (or cessation) of a heartbeat. In the event of severe brain damage, either traumatic or cerebrovascular, cessation of the respiratory drive resulted in breathing cessation and rapid death by cessation of heartbeat.

In the mid-twentieth century the invention of the positive pressure ventilator led to the technical ability to maintain respiration, and, therefore, cardiac function, in the absence of much of or even all brain function. Further development and wider availability of ventilators and the evolution of intensive care units (ICUs) events led to increasing numbers of cases in which pulmonary and cardiac function were maintained in the face of devastating brain function and no chance of recovery. This led to confusion about what defined death in such cases. The determination of death had multiple ethical, legal, and medical implications, and medicine was unsettled.

In view of these uncertainties the ensuing decades saw new criteria developed to define death as brain death, not cardiac function cessation. Discussions of brain death as the redefinition of death occurred initially in France (“coma dépassé”) in the 1950s and 1960s, and the initial formal definition of “irreversible coma” in the US was made by an ad hoc committee at Harvard, which resulted in publication of the Harvard Criteria (1968). Research to determine what constituted brain death continued for years, to assure that a “brain death” definition of death ensured irreversibility of the medical state. Finland was the first nation to pass a law that death would be defined by brain death.

Neuropathological studies of subjects who had been in prolonged coma revealed that the brainstem, locus of the respiratory drive and other brainstem reflexes, was always involved significantly and extensively in cases in which brain injury had resulted in (irreversible) brain death. Thus the formal criteria to determine death evolved with specific procedures and examination requirements to assure that there were no other reasons for unresponsiveness than destruction of brain tissue. The presence of potentially reversible states such as hypothermia, residual anesthesia, or drug overdose had to be ruled out. A careful neurological examination at two time points 24 hours apart, determined by two clinicians with expertise in the examination for determination of brain death, became standards for such determination of death. Procedures that were specified for assessing absence of brainstem reflexes, such as respiratory drive, corneal reflexes, and caloric responsiveness, became standardized. Most hospitals and hospital systems reviewed and approved brain death criteria to be applied whenever the clinical situation presented itself.

Of course, not all cases of protracted coma or unconsciousness will meet criteria for brain death. The term persistent vegetative state has been used to describe cases in which there is destruction of sufficient regions of brain to preclude recovery to full consciousness, but preservation of brainstem function sufficient to enable maintenance of respiration. The public’s understanding of the difference between brain death, especially brainstem death, and a chronic vegetative state in which people do not recover consciousness is frequently confused, aided by press or lay spokespeople who are unfamiliar with the differentiation of the two terms and for whom the term “vegetable” carries a striking negative as well as disrespectful connotation. Confusion, religious dicta or opinions, and multiple legal issues have also clouded full understanding. Even the term “brain death” as somehow differentiated from “death” (when we would argue they are inseparable) is a difficult term to explain. Widespread legal cases such as that of Terri Schiavo have also led to misunderstanding and beliefs that people who are neurologically devastated will somehow awaken, given enough time, hope, and prayer. Federal, state, and hospital rules and regulation regarding brain death and criteria for determining the same have aided the clarification in individual cases as families and friends confront these issues suddenly and in a state of emotional upset. Many religious groups have established rules for dealing with the new medicine of brain death, and consultation with the chaplain or the family’s religious leader may be helpful in acceptance of facts of a case.

Neurosurgeons and neurologists (who may, along with some anesthesiologists, be part of a hospital brain death consultation team) are familiar with persistent vegetative states (PVS) and the evaluation of the unconscious patient and determining a prognosis in the case of PVS. If the cause of the unconsciousness is trauma, up to 6 months of unconsciousness is necessary to term someone as in a persistent vegetative state. If the cause is vascular (widespread ischemia with or without hemorrhage), a period of 3 months leads to a PVS diagnosis. In the case where a diagnosis of brain death is confirmed, it is legally permissible to remove a person from life support; careful documentation of the strict observance of the brain death protocols is required.

Anesthesiologists play varying but important roles in the diagnosis and care of nonconscious patients with an impending diagnosis of brain death, including ascertainment of the clearance of anesthesia if the patient was under anesthesia, participation in the determination of patient status if the patient was not under their care (brain death protocol execution requires experienced physicians who are not caring for the patient), and aiding in explaining the status of the patient to family and friends. The latter is important especially in the case where naïve, unrealistic, or religious views or suppositions oppose cessation of life support. In such cases, ethical and humane care for the family and efforts to educate them are the responsibility of the physician as well as the chaplain or clergy, members of the ethics committee, and members of the health care team.