eye

767 2013 Elsevier Inc

48 Chapter

Ophthalmology ethicsAlex V Levin

CHAPTER CONTENTS

Introduction 767Informedconsent 768Confidentiality 769Truthtelling 769Boundaryissues 770Multiculturalism 770Vulnerablepopulations 770Pediatricethics 770Futility 771Medicalerror 771Impairedphysiciansandophthalmicprofessionals 772Resourceallocation 772Researchethics 772Innovation 773Geneticsethics 773Advertising 774Feesplitting 774Medicalindustry 775Cosmeticsurgery 775Financialissues 776Traineesinpatientcare 776Resolutionofethicaldilemmas 776

INTRODUCTION

Issues that challenge our ethical and moral value systems have been part of medicine throughout recorded history.

As early as the 5th century bc, Hippocrates recognized the role of ethics, virtue, and moral compass in the practice of medicine in what has since become known as the Hippo-cratic oath, which physicians in many countries pledge upon receiving their medical degrees. In 1241, Frederick II, the King of Naples, recognized the risks of conflict of interest when physicians engage in business relationships with apothecaries in his Law for the Regulation of the Practice of Medicine. Sir William Oslers 1906 treatise, Equanimities, is filled with commentary on many examples of the ethical issues that physicians face in their daily lives.The 1960s brought an accelerated evolution of medical

technology. Medicine was now able to prolong the end of life, engage in heroic surgical interventions, and save the lives of infants born at increasingly earlier ages of prematurity. With this progress also came increased attention to the ethical issues that attended such advances. The field of bioethics began to take shape and has since undergone remarkable growth to the point where it has become a fundamental part of undergraduate, graduate and continuing medical education as well as everyday practice.In 1993 the American Academy of Ophthalmology pub

lished its manual, The Ethical Ophthalmologist: A Primer. In 1995, the Royal College of Physicians and Surgeons of Canada mandated that ethics education must be part of all residency program curricula regardless of the medical or surgical specialty. Later, the Royal College would develop the Core Competencies of the CanMEDS program for physicians: Medical Expert (the central role), Communicator, Collaborator, Health Advocate, Manager, Scholar, and Professional. Each role has components that involve ethical considerations. Many training programs in ophthalmic assisting and other ophthalmic fields now include ethics in their curricula. Today, most professional societies, including the American Academy of Ophthalmology and the American Academy of Optometry, have published codes and / or guidelines for ethical behavior.

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offer diagrammatic approaches one more simple and workable (481) and the other perhaps more complex and attuned to the deliberations of the person with a deeper interest in bioethics (482) to how these circles of considerations in our lives might intersect to help us address ethical issues in our minds and in our practice.This chapter is not intended to be a prescription of

correct answers to every ethical issue that might confront eye care professionals; each issue below could itself become an entire chapter or book. Rather, it offers identification of issues, and a context in which they might be considered, and raises questions one might ask in trying to bring to consciousness those variables that should be addressed in trying to resolve a moral quandary. The readers of this textbook will likely come from many jurisdictions, professions, and societies, so the following discussion must be interpreted within each specific context.

INFORMED CONSENT

Gone are the days when physicians simply told their patients what must be done to their bodies to treat their disease. Rather, we have developed a healthy recognition of the importance of autonomy: the right of persons to make their own decisions about what they will and will not allow. Informed consent represents a partnership between medical professionals and their patients. Doctors have a fiduciary duty to ensure that each patient understands the treatment recommendations. Admittedly, this is not always entirely possible as patients rarely can achieve the same level of understanding as the doctor. In some cases, the patient may have such strong feelings of trust towards their physician that they make little effort to attain the knowledge level of truly informed consent and instead wish for the doctor to do whats best for me. Yet the obligation of the physician remains to at least attempt to demonstrate that the patient does indeed have some comprehension of the medical plan.Informed consent is more than the signed piece of paper

entitled consent form. Informed consent is a process, documented in the patients health record, wherein the physician or a trained delegate (e.g., the ophthalmic assistant) educates the patient and asks for his or her participation in the decisionmaking process. When the physician delegates this process, there should be an opportunity for the patient to ask questions of the physician and speak directly to the physician if desired. Some situations require little more than the patients action. When a patient sits at the slit lamp and puts their head forward, it is an implied consent to be examined. But when the medical encounter is to involve aspects of risk, in particular risks of bodily harm as in surgery or laser treatment, then more formal informed consent, preferably documented by the patients signature, is required. Performing a procedure

Every individual who plays a role in the ophthalmic care of patients will face ethical dilemmas. In trying to resolve these moral quandaries, each of us brings our own set of moral values and knowledge to the process of resolving the issue at hand. Given the almost infinite variety in our religious, family, cultural, and experiential backgrounds, it seems impossible to have a set of right answers that could dictate our response to ethical dilemmas when they arise. This is further complicated by the intricate details of each situation and the rich context of the lives of our patients, each with their own unique background and circumstances. The writings of philosophers and bioethicists represent many schools of thought (which are well beyond the scope of this chapter), which attempt to give us formulae or orientation of our thought processes to address our ethical challenges. Policy makers have laid out for us guidelines that prescribe acceptable and unacceptable actions and decisions as judged by peers and colleagues in the same institution or field. The law, reacting to events that question our actions within the context of our societys regulations on behavior, places further boundaries on our actions and decisions. Figures 481 and 482

Fig.48-1 A simplified model for ethical consideration recognizing the intersection of ethics, policy and law.

Ethics

Policy

Law

Fig.48-2 A more complex model for ethical consideration that is perhaps more applicable to a person with a deeper interest in bioethics.

Clinical experience/Research

Law

MoralFoundationsPhilosophy

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Ophthalmology ethics | 48 |Chapter

should not be shared with others, especially those outside the patient care team, without the patients documented consent.Ophthalmic professionals must also guard against acci

dental violations of confidentiality that can occur through the discussion of cases in public places such as elevators and registration desks or in easily overheard phone conversations. Patient charts should not be left in accessible view and computer screens with patient information should be protected by password or screen saver. The use of email will be governed by a variety of jurisdictionspecific law and policy as society is still addressing the challenge such communication imposes in our world of increasing electronic interaction. Portable electronic devices and even hardcopy documents taken out of the patient care setting may be easily lost or stolen. Identifiable patient information should not leave the patient care setting in either form unless appropriate safeguards are in place (e.g., remote access to a secure server via a handheld device).The medical professional may also be faced with situa

tions in which there is a conflict between the patients desire for confidentiality and the medical professionals desire to transmit information about the patient to other individuals. A patient may disclose to an ophthalmic assistant that the cause of their periocular ecchymosis was an assault by their spouse, but then ask that the ophthalmologist not be told. The ophthalmologist may become aware through evaluation of ophthalmic findings that a patient is infected with HIV, but the patient does not wish to tell their sexual partner. Sometimes these situations can be anticipated and the patient forewarned that disclosure will obligate the physician to make the necessary transmittal of information either to public authorities (e.g., reportable communicable disease) or private persons who may be at risk. Yet this obligation may hold even if the patient disclosed without being forewarned. In a landmark United States case, Tarasoff v. Regents of the University of California, where a psychiatrist came to know that a patient was likely to murder, the court ruled that the physician did have a duty to warn and protect by either notifying the intended victim or informing the police. The most desirable outcome in such difficult cases would be the resolution of conflict through a trusting partnership between patient and physician, perhaps with the assistance of nursing, counseling, and social work support, but if the ophthalmic professional feels that such partnership is not reasonably achievable in a satisfactory time frame then the duty to breach confidentiality may apply.

TRUTH TELLING

Truth telling is another fundamental tenet that underlies the ethical practice of medicine. It is a foundation to the

without consent may be considered as battery. Clearly there will be situations usually those surrounding emergency medical issues when the informed consent process must be either abbreviated or abandoned, assuming reasonable effort has been made.The eye doctor must inform the patient of all common

risks, no matter how small (including those that might result not only in changes in function but also appearance), and also all serious risks, no matter how uncommon. The disclosure of risk should be considered in the context of what a reasonable patient would want to know. Although the risks are very small, reasonable people would likely want to know about the risk of death from general anesthesia or the risk of blindness from cataract surgery.Comprehension is another foundation of informed

consent. Patients may refuse treatment, even if their decision will result in death or blindness, if they are deemed to have the capacity to do so. If the decisionmaking capacity of the patient is in question (e.g., in Alzheimer disease), then a substitute decision maker must be found. In some jurisdictions this is a legal designation by power of attorney, whereas in other cultures it may be a family designation by virtue of marriage, age, or sibship. Informed consent for children is discussed below.Even when the patient is deemed capable, the ophthal

mologist must ensure that the necessary information for decision making is presented in an understandable way. Risks may be described in relative terms rather than with incidence data. For example, one might say that the risk of an entirely well young adult dying from general anesthesia is less than the risk of dying in a road traffic accident. Although written information is helpful, it must be readable, preferably on a grade 68 level. Consent forms with many pages have become common, yet one can question whether they are likely to be read and understood by an average patient. No document can fully replace the conversation between physician and patient. The patient must be given the opportunity to ask questions and receive answers before making a voluntary decision without influence or coercion.

CONFIDENTIALITY

The ophthalmic health care team, like all medical professionals, has a duty to protect the confidentiality of the patient. The fulfillment of this duty enhances the trust relationship with and respects the autonomy of the patient.Sharing of health records with other medical profession

als is just one aspect of the confidentiality issue. One should remember that, although the chart itself belongs to the physician or the health care institution, the information in the chart belongs to the patient. Information

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with a religious holiday rather than demanding compliance with the original date.There may be times when a cultural belief is not consis

tent with the laws or policies that govern the society in which the patient lives. If a mother has used her urine to treat her childs red eye and in doing so caused the child to contract gonorrhea conjunctivitis, then education to avoid this practice (in addition to bacterial culture and treatment for gonorrhea in the family as well as communicable disease reporting) is certainly indicated. To do so in a culturally sensitive way may be challenging. All medical professionals working in culturally diverse communities are encouraged to read Anne Fadimans book, The Spirit Catches You and You Fall Down (Farrar, Straus and Giroux, New York, 1997).

VULNERABLE POPULATIONS

One must be particularly careful when addressing ethical dilemmas where the patient is part of a vulnerable population such as children (see below), prisoners, minorities, and other groups who may, by virtue of their position in society, prejudice, and prior unjust treatment, have impaired decisionmaking capacity or a lack of proper empowerment. Illness and infirmity may in themselves make the patient more vulnerable and less able to engage in capable decision making. The ophthalmic team must guard against bias and parentalism in these cases and maintain a healthy respect for the autonomy of these individuals. It is easy to become blinded by our beneficent parentalistic desires to benefit the patient and in so doing ignore the importance of autonomy for all patients. One might argue that extra care is required in order to ensure the rights, boundaries, privileges, and autonomy of such patients.

PEDIATRIC ETHICS

The ethical issues surrounding the care of children have enormous scope that extends well beyond the reaches of this chapter. Children are indeed a vulnerable population yet they do have a right to respect for their autonomy, which, even if they are not currently able to express it, will eventually blossom.It is recommended that children be involved in their

health care as much as possible, including discussions about their disease and proposed treatment. Infants and young children may not have the ability to participate meaningfully in the informed consent process so their parents / guardians become substitute decision makers, although the physician must ascertain that the decisions of these individuals are indeed in the best interest of

resolution of many issues discussed in this chapter (e.g., informed consent, duty to warn). Truth telling enhances trust and partnership and also aids the patient in understanding their disease. Sometimes, however, the ophthalmic team will receive requests to withhold the truth. The daughter of a 75yearold man with ocular melanoma might say, Please dont tell my father he has cancer. Although the physician may empathize with the daughters sentiment and truly feel that such information might do more harm than good if disclosed to the patient, it should be recognized that the courts in the Western world have found this principle of therapeutic privilege to be tenuous at best. Research studies have shown repeatedly that in general, patients do want to be told the truth about their condition and the health care team should endeavor to do so. Much has been written about patient communication and the breaking of bad news. It would benefit the physician to become skilled in these techniques. Exploring the reasons for the request of nondisclosure will likely lead to a strengthening of the doctorfamilypatient relationship and easier resolution of the ethical dilemma.

BOUNDARY ISSUES

Respect for persons also entails that their bodies not be violated in nonconsensual ways such as sexual advances or touching. This principle applies not only between coworkers in an ophthalmology office or clinic but also between health care professionals and their patients. Violation of boundaries may also come in the form of personal affronts without actual physical touching. Examples might include comments with inappropriate sexual content, or aggressive and condescending behavior. The field of organizational ethics addresses many of these scenarios and the relationships between coworkers in various roles. In general, it is advisable for health care professionals to similarly avoid such behaviors, gestures, and advances towards their patients, including activities such as dating or sexual liaison.

MULTICULTURALISM

Many societies represent a rich blend of ethnicity, religion, and culture. With this variety in the patient population, ophthalmic professionals will likely encounter behaviors that seem foreign, if not objectionable. One must respect that there are a wide variety of behaviors to which the terms right and wrong do not apply. Rather, tolerance and understanding, often reached simply through dialogue, become the basis of therapeutic success and patient compliance. For example, there are ways for a patients appointment to be altered to a time that does not conflict

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result in any benefit. If an eye is hopelessly blinded by glaucoma and the entirely asymptomatic patient (i.e., with no pain) desires another surgery to bring the pressure down from 30, the doctor may refuse. Of course, there should be ample evidence to support the physicians position. If this difference in viewpoint leads to an irresolvable conflict between the doctor and patient, then the doctor can attempt to find an alternative care provider for the patient. Indeed, physicians may do this under any circumstance in which they feel they can no longer provide a therapeutic alliance with the patient, provided that the decision is not made on the basis of class or cultural distinction, prejudice, or malicious intent.

MEDICAL ERROR

Error is part of medicine. Much attention has been paid to error in medicine, with large studies confirming its high incidence and prevalence. Every ophthalmic team member will at some time make an error that may or may not lead to patient harm. Of course, we must always strive to reduce error and many strategies have evolved to encourage this, including the systems approach, which attempts to prevent error by adapting the environment in which we work. For example, if two eye drop bottles are so similar that they could easily be mistaken for each other, it may be desirable to place colored tape around one bottle or move the two different medications to different locations in the office. Marking the eye to be operated before surgery and preoperative time outs are system interventions to avoid performing surgery on the wrong eye or patient.Another approach to error, which has been unfortu

nately all too prevalent in medicine, is that of individual blame, punishment, and secrecy. The aviation industry has been a leader in the recognition that a nonpunitive approach and the encouragement of error reporting with team problem solving is the most productive path towards error reduction. Likewise, disclosure to patients is a fundamental part of an ethical response. Research studies continue to show that patients do want to know when errors are made.Disclosure of error leads to a reduction in malpractice

claims and judgments as well as an increase in the trusting partnership between doctor and patient. Disclosure may present difficult challenges. Is a rupture of the posterior capsule during cataract surgery by a skilled surgeon a complication (i.e., a known adverse event with a known frequency that accompanies any procedure) or an error? If the outcome of surgery is not influenced (i.e., intraocular lens in the bag, no vitreous loss, quiet eye), does the patient need to know? Some would argue that disclosure of such an event would be too complicated for the patient to understand even though this same patient was presumed to understand enough to give consent for surgery.

the child. Although adults have the right to refuse treatment for themselves, even though such refusal could lead to death or blindness, they do not have the right to make such decisions for their children in most jurisdictions in North America. In such cases, if the health care team is unable to form a partnership with the family that would lead to a satisfactory resolution of the conflict, then the physician may be obligated to approach the child protection or legal system for intervention on behalf of the child. Before resorting to these means, attempts to resolve conflicts with the use of social workers, clergy, mental health professionals, and other mediators can be helpful.Likewise, parents may not harm their children and there

is a firm legal obligation to report a suspicion of child abuse or neglect to child protection authorities. This is a legal as well as a moral obligation. Some physicians fail to report because of a lack of confidence in the system, a fear that parent and child will be separated unjustly, uncertainty over the diagnosis, a feeling that a wellknown good family could never abuse or neglect their child, a fear of lost patient referrals, or a disinclination to have to take time to go to court to testify. In reality, the facts suggest that these fears and concerns are largely unjustified and inaccurate. In all cases, the health professionals legal obligation to report is the primary responsibility.Older children may have some ability to participate in

their own care decisions even if they are not mature enough to give full consent. In these situations, one should try to obtain the childs assent, or agreement, to proceed with the medical plan. This can be done by involving the child in the decisionmaking process with the parents / guardians, asking the child directly about their questions or concerns and even documenting in the chart that this process occurred, with or without the childs signature. Ascertaining when a child is able to give consent, separate from that of the parents, may be defined by law (and varies by jurisdiction) or simply by the assessment of the ophthalmic team. In Ontario, there is no legal age of consent. Older children and adolescents may have wishes that differ from those of their parents. Taking a familycentered approach to care, which attempts to find therapeutic alliance, will require time, patience, and perhaps the support of other professionals in the field. The health care team is advised to maintain a manifest respect for the childs autonomy, confidentiality, and right to know the truth about their care.

FUTILITY

Just as the adult patient may decide against treatments proposed by the physician, the physician may refuse to give a treatment requested by the patient if, in the best judgment of the physician, the treatment is unlikely to

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with the individual about whom there is concern are advisable. If there is sufficient evidence that incompetency to practice exists, then delay in intervention will inevitably lead to patient harm. It is highly recommended that these issues be addressed before such events occur.

RESOURCE ALLOCATION

The allocation of scarce resources has become an increasingly frequent ethical challenge as the cost of ophthalmic care continues to rise as a result of remarkable technologic advances. Should only those with the means to afford it have access to multifocal intraocular lenses? Should limited operating theater time be allocated to the surgeons who do the most expensive operations with remarkable powers to restore vision on patients with uncommon diseases or to the surgeons who do much less expensive operations on larger numbers of patients with less profound impacts on vision? Should we use the most expensive suture in keeping with the surgeons preference even if there is no demonstrable benefit to the patient? Should the donor cornea go to the 1monthold infant with unilateral Peters anomaly or to the 70yearold person with bilateral pseudophakic bullous keratopathy?Resolution of these issues is often difficult, complex

and far removed from the patient, yet still impacting their care. A full discussion of these issues is beyond the scope of this chapter, but perhaps the starting point is recognition of the best interest of the patient (benefi-cence), if not all patients, in the resource allocation decisionmaking process. There is also an ethical duty to best represent the interests of society which can at times compete with the interests of an individual patient. Clearly we cannot provide every possible aspect of medical care to every patient but we can use a utilitarian approach to achieve the greatest good. For an excellent discussion of this and other ethical issues in a practical format, the reader is referred to Bioethics at the Bedside provided by the Canadian Medical Association Journal (http://www.collectionscanada.gc.ca/eppparchive/100/201/300/cdn_medical_association/cmaj/series/bioethic.htm).

RESEARCH ETHICS

In academic health science centers, and sometimes in community ophthalmic practice as well, there is a desire to achieve advancement in ophthalmic care through research. The researcher has certain ethical responsibilities towards the research subject, which include informed consent, confidentiality, disclosure, and respect for persons. There is also a duty to ensure that the patient is not

Others would wish not to worry the patient unnecessarily, although the principle of such therapeutic privilege, as discussed above, is tenuous and runs contrary to what patientbased research would recommend. Indeed, the outcome for posterior capsule rupture may include a higher risk of retinal detachment and glaucoma. The surgeon may take special actions (e.g., dilated postoperative examination, more frequent postoperative visits) to guard against such complications. The patient may wonder why their care is different from other patients who were befriended in the pre or postoperative waiting areas before surgery and are seen again at followup visits.Disclosure of error is difficult for physicians and all

members of the health care team. It is recommended that the health care team address error in a positive alliance designed to identify error and the risk factors that led to its occurrence as well as the measures that can be taken to prevent its reoccurrence. Patients will want to know what the expected outcome of an error might be and what measures are being taken to prevent or address those complications should they arise.

IMPAIRED PHYSICIANS AND OPHTHALMIC PROFESSIONALS

Patients have the expectation that their ophthalmic caretakers are competent. To violate this entrustment by allowing the practice of professionals who are under the influence of drugs or alcohol, or otherwise impaired by medical illness or knowledge deficiency, would be an unethical breach of our duty to do no harm (nonmalefi-cence). Most professional regulatory bodies have mechanisms by which such professionals can find supportive help designed to achieve reentry into the medical care system once the individual is deemed competent to practice again.Difficulties arise when a member of the team is unsure

about the status of a colleagues competence, in particular with regards to deficiencies of knowledge, suboptimal skillsets (e.g., the surgeon with bad hands), or unsatisfactory decision making. Older professionals may be felt to be not with the times. One must be careful that such determinations are made without prejudice and not by individual observations. Some practitioners, such as the retinal surgeons who are asked to retrieve dropped pieces of lens matter from the vitreous, may occasionally or even regularly see what at first appears to be the error or incompetence of another ophthalmologist. They must be careful to remind themselves that the true story of the events that led to the occurrence is not known and may have a satisfactory explanation. Assuming the incompetence of another surgeon, and in particular reporting this to the patient, is fraught with danger on many levels. Consultation with coworkers and even frank discussions

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and led to disaster; anterior chamber closed loop intraocular lenses are but one example. Some would argue that a better understanding of innovation would arise if we instead referred to it as nonvalidated intervention. One might doubt that patients would have much interest in being subjected to nonvalidated care. Yet patients are attracted to the sexy innovations that they read about in the media (e.g., small sutureless incisions); they want to be cared for by ophthalmologists who are on the cutting edge. Others would argue that innovation is part of clinical care and an intrinsic part of medicine, especially the surgical subspecialties, and therefore not a form of research.Some innovations occur in emergency settings where

REB review is not possible. When faced with an expulsive hemorrhage, the surgeon will use any reasonable means they can think of at that moment to close the eye. Other situations require somewhat urgent innovation, but perhaps with enough time to get an expedited review and compassionate approval from an REB with not much more effort than a letter to the REB chair. The majority of major practice changes are done with sufficient forethought that REB approval could indeed be sought, with the aim of ensuring the optimal outcome while protecting the best interests of patient and researcher. Some authors have recommended a system parallel to the REB specifically for innovation a system designed to be more expeditious and attuned to the unique nature of surgical practice. Institutions may adopt procedures where peer review is a minimum, perhaps in the form of approval by the departmental chief, before proceeding.All of these considerations have in common a desire to

enforce some regulation of the current freedom of ophthalmologists to do whatever they want and thus respect the rights of the patient to informed consent, truth telling and protection from harm while facilitating the progress of ophthalmic care.

GENETICS ETHICS

Genetics has become an increasingly prominent part of virtually every aspect of medicine. Ophthalmic professionals must have a working knowledge of genetics in almost every aspect of the field, from agerelated macular degeneration and cataract to steroidinduced glaucoma and congenital malformations. Advances in genetics are already bringing to ophthalmology the possibility of genebased therapy for a variety of diseases.Recognition of the role of genetics in eye disease brings

with it some special ethical challenges. There may be confidentiality issues with the sharing of information within families and the need to obtain such information to give appropriate genetic counseling. Insurance companies may have a desire to obtain information about patient risk for

enrolled in a frivolous project unlikely to yield meaningful results, a project where the potential benefits are outweighed by potential harm, or a project that enhances discrimination toward the patient or the group they represent. Refusal to participate must not influence the care or the access to care that a patient receives.Recognizing the difficulties in honoring these obliga

tions, all research should be evaluated in advance and approved by a research ethics board (REB, also known as institutional review board, IRB) the membership of which should be multidisciplinary, with representation of the lay public as well. REBs are available both inside and outside academic institutions. Research done in the community is not an excuse for avoidance of REB review. Most jurisdictions are now requiring even retrospective chart reviews to obtain such approval. REBs may try to streamline these processes. Although the process of REB approval may seem arduous, its objective is to facilitate good research rather than impede progress, while protecting both the researcher and the patient.

INNOVATION

Ophthalmology is a highly technologic field. It is not uncommon for ophthalmologists to find themselves trying something new. Such presumed advances may come as the result of publications in the peerreviewed literature, a throwaway publication, a presentation at a meeting, conversations with colleagues, or de novo from the creative mind of a thoughtful practitioner. The innovation may be as simple as a new way of tying a knot during surgery or as complex as a piggyback intraocular lens implanted into a neonate to deal with aphakic high hyperopia with a predicted removal of the second lens at a later date. Other examples include new intraocular lenses, new techniques for refractive surgery, and smaller instrumentation for retinal surgery. Some innovations are applications of technology and experience from one patient population to another (e.g., intraocular lenses in children) and others are new only to that physician (e.g., switching to smaller gauge phacoemulsification). Should innovation be allowed to proceed outside that purview of the research paradigm with involvement of an REB?Research is designed to answer questions and improve

the care of patients. Research studies are constructed to follow the scientific method, which allows these questions to be answered in a fashion that minimizes bias and the influence of chance. Research is also distinguished by the informed consent, which allows a patient to understand the level of evidence base for the intervention in the context of their care, and the REBmandated monitoring, which protects participants from unintended harm as early as possible. Unfortunately, there are many examples of innovation that proceeded without a research protocol

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patients. Advertising presents a conflict of interest wherein the physicians motive of financial gain, practice advancement, and perhaps ego enhancement could potentially result in techniques that are either coercive or even untruthful. This would likely violate our duty to do no harm. Of course, physicians can choose not to advertise, at which point the ethical issue is moot. But if they do choose to advertise they should do so in a way that may remedy some of these concerns.Advertisement should be truthful and not misleading.

Advertising does not replace informed consent. Some jurisdictions prohibit patient testimonials or acrimonious comparisons with other colleagues. Some professional societies review and regulate advertising to ensure that the potential patient is not influenced by style rather than content. Catchy radio jingles or print slogans may unduly influence and coerce patients into uninformed choices. Consultation with professional regulatory bodies is advised to ensure that the undesired effects of the conflict are minimized and the benefits to the patient maximized.

FEE SPLITTING

There are several forms of fee splitting. In the most typical arrangement, one caretaker (e.g., an ophthalmologist) pays back the referring professional (e.g., an optometrist) as a demonstration of gratitude for a referral and presumably to provide an incentive for further referral. This reward is referred to as a kick back or profit sharing and may take the form of cash or other benefits such as tickets to a sporting event, free meals, gift certificates, or even cash. Another arrangement might involve a shared practice wherein members of the group all benefit from the aggregate activity of the group and therefore encourage referrals to each other. An example might be the multispecialty ophthalmology group where all cataract patients are sent to the retina specialist within the group for preoperative examination. Lastly, fee splitting may take the form of comanagement. The ophthalmologist delegates the postoperative care of patients to another provider, often an optometrist, and provides a payment in cash or in kind for that service. Alternatively, the optometrist may bill the patient directly for services that would otherwise fall under the care of the surgeons postoperative care and as such may not have been billable.Although some may perceive these arrangements as

beneficial to the patient, providing continuity of care and improved access to care, others have identified the conflict of interest that may be inherent, particularly if the patient is unaware of the arrangement. Research has shown that patients are, in general, unhappy with these relationships. Some jurisdictions have policy or law which proscribes against these arrangements. Health care providers should

diseases not yet developed and then classify the asymptomatic disorder as preexisting, and therefore uninsurable in the United States; the Genetic Information Nondiscrimination Act of 2008 prohibits insurance companies from using genetic information in this fashion.Parents may ask about prenatal testing for ocular disease

and consider terminating pregnancies of otherwise healthy infants. They may ask for presymptomatic predictive testing of their children for genetic disease that is unlikely to develop until the child is an adult. There is some evidence that there may be harmful psychosocial effects to both positive and negative predictive test results. Perhaps a child identified as having the gene mutation for retinitis pigmentosa in the family will be steered away from certain career options only to find that, when they become of age to pursue a career, there is a cure for their disease and they have missed the opportunity to prepare for the field they desire. Depression and even suicide may follow a positive predictive test. A negative test in a highly affected family with a diseasebased identity may result in the child being ostracized as not one of the group.Ultimately, ophthalmologists might even have to

contend with the issue of eugenics as we become capable of weeding out gene defects from society through sperm and egg selection or gene repair. Should parents be allowed to choose the iris color of their children? There is a primate model for correction of Xlinked recessive redgreen color deficiency. Is this a disease? With the recent successful treatment of Leber congenital amaurosis using intraocular gene therapy we are beginning to see the power and potential of this technique. With that must come a careful appraisal of the potential ethical implications.It would be unreasonable to expect all ophthalmologists

to be up to date with every genetics advancement; however, the ophthalmic team must be cognizant of these ethical issues in genetics. When faced with such dilemmas, it is useful to call on the support and intervention of genetics professionals such as ocular geneticists, genetic counselors, or medical geneticists. They can act as consultants and partners to help address the concerns brought forward by the patient or anticipated by the team.

ADVERTISING

Physician advertising is now legal in many jurisdictions. Some ophthalmologists have rejected this as an affront to the profession that degrades our field to a business no different from auto sales. Others have embraced advertising as a means of public education at a time when informed consent has received so much attention.The main ethical principle that applies to this and the

financially related issues that follow below is that of conflict of interest. Rarely do physicians advertise solely for the altruistic benefit of disseminating information to

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rather in recognition of the positive effect such expenditures have on company profit.Most ophthalmic and other medical professional societ

ies, as well as the institutions in which physicians work, now have policies regarding interaction with medical industry. These policies grew out of the recognition of the potential for influence on the decision making of medical personnel if they stand to benefit from the largesse of industry in a personal way. Some physicians have rejected restrictions out of a feeling of entitlement, especially in times when physician fees are dropping and other restrictions on practice are increasing. Physicians may assert that their own autonomy to conduct their lives as they see fit is no less important than that of the patient. This conflict rages on and is most apparent at large meetings, where companies present enormous and elaborate displays and every conference participant may be given a tote bag and a neck strap for their identification badge emblazoned with drug company logos.The pharmaceutical industry has also recognized the

ethical dilemmas these relationships and activities engender. As a result they have implemented voluntary restrictions. Companies may contribute much in the way of information and financial support for medical meetings and claim that they have not influenced the scientific content (although there are many drug companysponsored talks on exhibit floors in addition to the official scientific program). The risk of the public perception of impropriety and the potential for adverse manifestations of conflict of interest in direct patient care remain to be resolved.

COSMETIC SURGERY

As discussed above, patients have the autonomous right to choose what they will and will not allow to be done to their bodies (with the exception of futile interventions; see above). Cosmetic surgery acts on a patients wish to have something normal about their body changed to another normal variant, often at large cost. Proponents of cosmetic surgery would argue that the patient does not perceive the condition as normal and therefore making the change, so that the patient feels more normal, is well within the helping nature of the medical profession. Analyzing the philosophical differences on this topic is beyond the scope of chapter, but the ethical issue of conflict of interest is again worthy of consideration.Laser refractive surgery has proliferated worldwide. In

many communities, as a procedure not covered by insurance plans, surgeons may charge sizeable fees and perform the surgery exclusively in private clinics. People have flocked to have this surgery, allowing enormous numbers of patients to abandon their contact lenses and glasses. But interviews of the lay public suggest that many go for the procedure because they believe that the surgery will fix

initiate and sustain referral practices based on the best interest of the patient rather than their own financial gain. The American Academy of Ophthalmologys stance has been to encourage ophthalmologists to provide postoperative care for their own patients unless there are compelling reasons why this cannot be accomplished (e.g., surgeon leaving town for holiday) and only if the patient is informed in advance. In situations where the conflict of interest persists, physicians are encouraged to disclose these relationships to the patient in a further attempt to avoid any illusion of impropriety.One must recognize that disclosure of a conflict of

interest does not remove the conflict. Patients may not be empowered, especially when made vulnerable by status, illness, or age to act in response to such disclosures as they may feel that to do so would deny them access to the provider they want and to whom they were referred. This may leave the patient uncomfortable, suspicious, and more likely to be a dissatisfied participant in their care.

MEDICAL INDUSTRY

Medical industry provides us with our therapeutic agents, diagnostic agents, medical technology, and surgical equipment. It is a necessary and integral part of medicine. In addition to the use of these products, physicians will have direct interaction with representatives of medical industry in the form of sales representatives wanting to give information about new products, opportunities to try new products, invitations to participate or lead industrysponsored educational events with or without social components, invitations to become a spokesperson for industry products, invitations to write papers / conduct research / write monographs sponsored by industry, offers of grants to support research activities or program development, gifts of free samples of medications or gifts ranging from items of nominal value for medical use (e.g., note pads with the drug company name on each page), to more significant gifts such as sporting event tickets, free meals, and even allexpensespaid trips to lovely locations with or without a sometimes nominal educational component.As the reasonable patient would likely expect that the

medical decisions of their ophthalmologist are free from influence and conflict of interest, it is not difficult to see why multiple studies have shown that patients generally object to such relationships between physicians and medical industry. Research also indicates that, despite the oftenheard claims of physicians to the contrary, these practices do affect our prescribing patterns. It is then not surprising to learn that medical industry spends billions of dollars on advertising and such contacts with physicians, presumably not out of purely altruistic motives but

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doctor or refusing referrals from optometrists. The former act is a type of deception, whereas the latter causes the patient inconvenience and potential care delays in having to seek an alternative referral route. This is but one example of bending the billing rules, other forms of which range from illegal to legal but questionably ethical. In the United States there is an entire industry devoted to advising physicians on how to best code for patient visits and surgery to achieve the greatest reimbursement. Although all illegal acts are not within the ethical and moral acceptability of the practice of medicine, some legal acts may also challenge our ethics boundaries. Creative billing also tends to raise the cost of health care to society, creating yet another conflict of interest and potential nonmaleficence.

TRAINEES IN PATIENT CARE

When trainees (e.g., medical students, ophthalmology residents, ophthalmic assistant students) are participating in the care of patients, there may be a reluctance to inform the patient for fear that the patient may reject this arrangement. In fact, research shows that patients do want to be told about the nature of such arrangements and, if properly informed and assured that appropriate supervision is in place, usually welcome this interaction and may even feel that they are making a positive contribution to the health care system. Some authors have argued that patients have a moral obligation to participate in the training of future professionals, particularly in a publicly funded health care system such as Canada, but this does not necessarily abrogate our truthtelling duties. The ethical principles of truth telling and disclosure play a strong role in this setting. A utilitarian approach, seeking the greatest good for both the patient and society, would argue that the success of these relationships, largely through the graded allocation of responsibility to trainees and the provision of appropriate supervision, is supported by the high functioning of the training system and its lack of demonstrable negative outcome impact on patient care. In fact, the highest level of care is often delivered at the academic centers where trainees are routinely part of health care delivery.

RESOLUTION OF ETHICAL DILEMMAS

The ophthalmic team is confronted by a wide variety of ethical issues. This chapter has attempted to identify many of those issues and offer some pertinent points for reflection and consideration when attempting to resolve the dilemmas. Although there may not be a perfect right answer in each case, ophthalmic professionals should

their bad eyes. Most of these people have normal healthy eyes, seeing 6/6 with their preoperative refractive correction. Their eyes are just a different shape from the average. If the surgery were presented as a procedure which cuts their healthy eyes to allow them to go without glasses, would there be as much interest?The laser refractive surgery field has gone to enormous

lengths to achieve informed consent, with some practices offering documents in excess of 10 pages for the patient to sign a practice that may raise some questions about truly informed consent (see Informed consent above). Yet, if a surgeon stands to reap exceptional financial benefit for a procedure that is not medically necessary (although some cosmetic surgeons would argue that the patients desire for surgery is a compelling indication), is there not a potential for bias, conflict of interest and incentive, for the surgeon to recommend or even advertise (see above) the procedure. This conflict may not be readily apparent to the patient despite assumptions by the physician to the contrary.

FINANCIAL ISSUES

In addition to the ethical issues discussed above, many of which have financial implications for the physician (e.g., fee splitting, advertising, medical industry, cosmetic surgery), all medical practitioners are also faced with moral challenges related to charging and collecting fees for services rendered. Although altruism is an ethical principle that should pervade much of medicine, there will in almost every setting be a business component: expenses must be covered, employees must be paid, and the physician deserves an income commensurate with their skill, training and success. Opportunities abound for making minor, or even major, manipulations in billing practices that will further increase income while staying within the law and out of detection by the patient.This potential conflict of interest and the ethical issues

that such practices raise, have long been troubling to the ophthalmic profession and served as the basis over the last century for the emergence of the American Academy of Ophthalmologys increasing interest in ethics with the establishment of a Code and an Ethics Committee. The potential conflict of interest was also recognized in the United States in the form of safe harbor legislation that put restrictions on potentially unethical arrangements. More subtle billing practices may also raise similar concerns that profit motives conflict with the best interest of the patient. In the past, in some Canadian provinces, ophthalmologists got paid more if the patient was referred from a physician as opposed to an optometrist even though the same service is performed. Some ophthalmologists were very creative in getting around this rule by writing consultation letters back to the patients family

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consider the relevant key ethical principles, institutional policies and societal law. Multidisciplinary conversations with peers and colleagues can be particularly helpful. Difficult situations arise when an employee (e.g., ophthalmic assistant) has a different viewpoint on an ethical issue from the supervisor or employer. Open conversation can often resolve these conflicts. Consultation may be sought from bioethicists or other professionals who have had formal training in the field. Many written resources are now available; ethical issues have found their way into hundreds of journal articles on virtually every topic as well as the resources mentioned above, books, and internetbased courses and case discussions. The University of Toronto Joint Centre for Bioethics website (www.jointcentreforbiothics.ca/) is another useful resource that can link readers to a wide variety of information on bioethics and case management.Each reader of this chapter and every professional in the

field of ophthalmic care will be faced with the task of resolving ethical dilemmas. The word ethics is indeed a

plural word. There is more than one ethic depending on the specifics of the situation at hand and the background of the professional. Understanding the rich context of the patients situation their culture, family, disease, prognosis, education level, religion, support systems, alternative health care practices, and wishes is perhaps the first step in laying the foundation for understanding and conflict resolution. Practitioners must also understand their own orientation and bias when dealing with these issues. Each of us may make different decisions, but we must do so in a comfort zone that lies within the policy guidelines and law that govern our practice as well as the ethics boundaries beyond which most reasonable people would recognize transgression. Within those boundaries is a wide zone of possible pathways to resolution of an ethical quandary. Choosing the resolution that best suits the needs and desires of the patient is paramount, and finding a solution that is agreeable to the ophthalmic team and the individual practitioner responsible for the patients care is most desirable.

48 Ophthalmology ethicsChapter contentsIntroductionInformed consentConfidentialityTruth tellingBoundary issuesMulticulturalismVulnerable populationsPediatric ethicsFutilityMedical errorImpaired physicians and ophthalmic professionalsResource allocationResearch ethicsInnovationGenetics ethicsAdvertisingFee splittingMedical industryCosmetic surgeryFinancial issuesTrainees in patient careResolution of ethical dilemmas

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