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Chapter 8: Ethical Issues in Clinical Medicine

Bernard Lo; Christine Grady

INTRODUCTION
Twenty-first-century physicians face novel ethical dilemmas that can be perplexing and emotionally draining. For example, electronic medical records,
handheld personal devices, and provision of care by interdisciplinary teams all hold the promise of more coordinated and comprehensive care, but
also raise new concerns about confidentiality, appropriate boundaries of the doctor–patient relationship, and responsibility. Chapter 1 puts the
practice of medicine into a professional and historical context. The current chapter presents approaches and principles that physicians can use to
address the ethical issues they encounter in their work. Physicians make ethical judgments about clinical situations every day. Traditional professional
codes and ethical principles provide instructive guidance for physicians but need to be interpreted and applied to each situation. Physicians need to be
prepared for lifelong learning about ethical issues and dilemmas as well as about new scientific and clinical developments. When struggling with
difficult ethical issues, physicians may need to reevaluate their basic convictions, tolerate uncertainty, and maintain their integrity while respecting the
opinions of others. Discussing perplexing ethical issues with other members of the health care team, ethics consultation services, or the hospital ethics
committee can clarify issues and reveal strategies for resolution, including improving communication and dealing with strong or conflicting emotions.

APPROACHES TO ETHICAL PROBLEMS

Several approaches may be useful for resolving ethical issues. Among these approaches are those based on ethical principles, virtue ethics,
professional oaths, and personal values. These various sources of guidance encompass precepts that may conflict in a particular case, leaving the
physician in a quandary. In a diverse society, different individuals may turn to different sources of moral guidance. In addition, general moral precepts
often need to be interpreted and applied in the context of a particular clinical situation. When facing an ethical challenge, physicians should articulate
their concerns and reasoning, discuss and listen to the views of others involved in the case, and call on available resources as needed. Through these
efforts, physicians can gain deeper insight into the ethical issues they face and often can reach mutually acceptable resolutions to complex problems.

ETHICAL PRINCIPLES

Ethical principles can serve as general guidelines to help physicians determine the right thing to do.

Respecting Patients

Physicians should always treat patients with respect, which entails understanding patients’ goals, communicating effectively, obtaining informed and
voluntary consent, respecting informed refusals, and protecting confidentiality. Different clinical goals and approaches are often feasible, and
interventions result in both benefit and harm. Individuals differ in how they value health and medical care and how they weigh the benefits and risks of
medical interventions. Generally, the values and informed choices of patients should be respected.

GOALS AND TREATMENT DECISIONS

Physicians should discuss the goals of care with patients, as well as relevant and accurate information about diagnosis, current clinical circumstances,
likely trajectory and prognosis, and treatment options. Physicians may be tempted to withhold a serious diagnosis, misrepresent it by using
ambiguous terms, or limit discussions of prognosis or risks for fear that patients will become anxious or depressed. Providing honest information
about clinical situations preserves patients’ autonomy and trust and promotes sound communication with patients and colleagues. To help patients
cope with bad news, doctors can adjust the pace of disclosure, offer empathy and hope, provide emotional support, and call on other resources such
as spiritual care or social work. However, patients may choose not to receive such information or ask surrogates to make decisions on their behalf, as
is common with serious diagnoses in some traditional cultures.
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OBTAINING INFORMED CONSENT
Chapter 8: Ethical Issues in Clinical Medicine, Bernard Lo; Christine Grady Page 1 / 7
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Physicians should discuss with patients the nature of proposed care, alternatives, and the risks, benefits, and likely consequences of each option.
Informed consent involves more than obtaining signatures on consent forms. Physicians should promote shared decision-making by educating
likely trajectory and prognosis, and treatment options. Physicians may be tempted to withhold a serious diagnosis, misrepresent it by using
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ambiguous terms, or limit discussions of prognosis or risks for fear that patients will become anxious or depressed. Providing honest information
about clinical situations preserves patients’ autonomy and trust and promotes sound communication with patients and colleagues. To help patients
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cope with bad news, doctors can adjust the pace of disclosure, offer empathy and hope, provide emotional support, and call on other resources such
as spiritual care or social work. However, patients may choose not to receive such information or ask surrogates to make decisions on their behalf, as
is common with serious diagnoses in some traditional cultures.

OBTAINING INFORMED CONSENT

Physicians should discuss with patients the nature of proposed care, alternatives, and the risks, benefits, and likely consequences of each option.
Informed consent involves more than obtaining signatures on consent forms. Physicians should promote shared decision-making by educating
patients, answering their questions, checking that they understand key issues, making recommendations, and helping them to deliberate. Patients can
be overwhelmed by medical jargon, needlessly complicated explanations, or the provision of too much information at once. Patients can make
informed decisions only if they receive honest and understandable information. Competent, informed patients may refuse recommended
interventions and choose among reasonable alternatives. If patients cannot give consent in an emergency and if delay of treatment while surrogates
are contacted will place their lives or health in peril, treatment can be given without informed consent. People are presumed to want such emergency
care unless they have previously indicated otherwise.

Respect for patients does not entitle patients to insist on any care they want. Physicians are not obligated to provide interventions that have no
physiologic rationale, that have already failed, or that are contrary to evidence-based practice recommendations or good clinical judgment. Public
policies and laws also dictate certain decisions—e.g., allocation of cadaveric organs for transplantation and physician aid-in-dying.

CARING FOR PATIENTS WHO LACK DECISION-MAKING CAPACITY

Many patients are not able to make informed decisions because of unconsciousness, dementia, delirium, or other medical conditions. Although only
courts have the legal authority to determine that a patient is legally incompetent, in practice, physicians determine when patients lack the capacity to
make particular health care decisions and arrange for authorized surrogates to make decisions for them, without involving the courts. Patients with
decision-making capacity can express a choice and appreciate their medical situation, the nature of proposed care, alternatives, and the risks, benefits,
and consequences of each alternative. Patient choices should be consistent with their values and not the result of delusions or hallucinations.
Physicians should use available assessment tools, other resources such as psychiatry consultation, and clinical judgment to ascertain whether
individuals have the capacity to consent and make decisions for themselves. It should not be automatically assumed that a patient who disagrees with
a recommendation or refuses treatment lacks capacity, but such decisions should be probed to be sure the patient has the capacity for an informed
decision and that there are no misunderstandings. When impairments are fluctuating or reversible, decisions should be postponed if possible until the
patient recovers decision-making capacity.

If a patient lacks decision-making capacity, physicians should seek the appropriate surrogate, and ask what the patient would have wanted done.
Patients may designate a health care proxy or a durable power of attorney for health care in advance; such choices should be respected. (See Chap. 9
for further details about advance care planning.) If a patient without decision-making capacity has not previously designated a health care proxy,
physicians usually ask family members to serve as surrogates. Many patients want family members as surrogates, and family members generally have
the patient’s best interests at heart. Statutes in most U.S. states delineate a prioritized list of relatives who may serve as surrogates if the patient has
not designated a proxy. Surrogates’ decisions should be guided by the patient’s values, goals, and previously expressed preferences. However, it may
be appropriate to override previous preferences in favor of the patient’s current best interests if an intervention is likely to provide a significant
benefit, if previous statements do not fit the situation well, or if the patient indicated that the surrogate should have leeway in decisions.

MAINTAINING CONFIDENTIALITY

Maintaining confidentiality is essential in respecting patients’ autonomy and privacy; it encourages them to seek treatment and to discuss problems
candidly, and helps to prevent discrimination. However, confidentiality may be overridden to prevent serious harm to third parties or to the patient.
Exceptions to confidentiality are justified if the risk is serious and probable, there are no less restrictive measures by which to avert risk, and the
adverse effects of overriding confidentiality are minimized and deemed acceptable by society. For example, laws require physicians to report cases of
tuberculosis, sexually transmitted infection, elder or child abuse, and domestic violence.

Beneficence or Acting in Patients’ Best Interests

The principle of beneficence requires physicians to act for the patient’s benefit. Patients typically lack medical expertise, and illness may make them
vulnerable. They rely on and trust physicians to treat them with compassion, provide sound recommendations and promote their well-being.
Physicians encourage such trust and have a fiduciary duty to act in the best interests of the patient, which should prevail over physicians’ self-interest
or the interests of third parties such as hospitals or insurers. Physicians’ fiduciary obligations contrast sharply with business relationships, which are
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Chapter 8: Ethical Issues in Clinical Medicine, Bernard Lo; Christine Grady Page 2harm
characterized by “buyer beware,” and not by reliance and trust. A related principle, “first do no harm,” obliges physicians to prevent unnecessary /7
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by recommending interventions that maximize benefit and minimize harm, and forbids physicians from providing known ineffective interventions or
acting without due care. Although often cited, this precept alone provides limited guidance because many beneficial interventions pose serious risks.
Beneficence or Acting in Patients’ Best Interests
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The principle of beneficence requires physicians to act for the patient’s benefit. Patients typically lack medical expertise, and illness may make them
vulnerable. They rely on and trust physicians to treat them with compassion, provide sound recommendations and promote their well-being.
Physicians encourage such trust and have a fiduciary duty to act in the best interests of the patient, which should prevail over physicians’ self-interest
or the interests of third parties such as hospitals or insurers. Physicians’ fiduciary obligations contrast sharply with business relationships, which are
characterized by “buyer beware,” and not by reliance and trust. A related principle, “first do no harm,” obliges physicians to prevent unnecessary harm
by recommending interventions that maximize benefit and minimize harm, and forbids physicians from providing known ineffective interventions or
acting without due care. Although often cited, this precept alone provides limited guidance because many beneficial interventions pose serious risks.

Physicians increasingly provide care with a multidisciplinary team. Team members contribute different types of expertise to the provision of
comprehensive, high-quality care for patients. Physicians should collaborate with and respect the contributions of the various members of the
multidisciplinary team. Physicians should also initiate and participate in regular communication and planning to avoid diffusion of responsibility and
ensure accountability for quality patient care.

INFLUENCES ON PATIENTS’ BEST INTERESTS

Conflicts can arise when patients’ refusal or request of interventions thwarts their own goals for care, causes serious harm, or conflicts with their best
medical interests. For example, simply accepting refusal of mechanical ventilation for reversible respiratory failure by a young adult with asthma, in the
name of respecting autonomy, is morally constricted. Physicians should elicit patients’ expectations and concerns, correct their misunderstandings,
and try to persuade them to accept beneficial therapies. If disagreements persist after such efforts, patients’ informed choices and views of their own
best interests should prevail.

Physicians should appreciate that patients, who face increasing co-payments and out-of-pocket expenses, may not be able to afford tests and
interventions that are ordered. Physicians should follow up with patients who don’t fill prescriptions or skip doses, discuss alternative drugs, and
when possible, prescribe medications that are affordable to the patient.

Organizational policies may sometimes conflict with patients’ best interests. For example, limitations on work-hours could lead to a shift-worker
mentality that undermines physician’s dedication to patient’s well-being and sense of responsibility for decisions. Forced handoffs might actually tend
to increase the risk of errors unless other measures are taken. Patients’ best interests may be served by flexibility in work-hour limits in some cases,
especially if there is rapport with the patient or family that is not easily transferred to another provider. For example, a resident may want to discuss
decisions about life-sustaining interventions or comfort a family member over a patient’s death (Chap. 9). Physicians, residents, and medical students
should take responsibility for helping to design and improve work-hour schedules based on empirical evidence.

Patients’ interests are also served by improvements in overall quality of care resulting from the increasing use of evidence-based practice guidelines
and performance benchmarking. However, practice guideline recommendations may not serve the interests of each individual patient, especially when
another plan of care may provide substantially greater benefits. In such situations, physicians should prioritize their duty to act in the patient’s best
interests. Physicians should be familiar with relevant practice guidelines, be able to recognize situations in which exceptions might be reasonable, and
be prepared to justify an exception.

Acting Justly

The principle of justice provides guidance to physicians about how to ethically treat patients and make decisions about allocating important resources,
including their own time. Justice in a general sense means fairness: people should receive what they deserve. In addition, it is important to act
consistently in cases that are similar in ethically relevant ways, in order to avoid arbitrary, biased, and unfair decisions. Justice forbids discrimination
in health care based on race, religion, gender, sexual orientation, or other personal characteristics (Chap. 7).

ALLOCATION OF RESOURCES

Justice also requires that limited health care resources be allocated fairly. Universal access to medically needed health care remains an unrealized
moral aspiration in the United States and much of the rest of the world. Patients without health insurance often cannot afford health care and lack
access to safety-net services. Even among insured patients, insurers may deny coverage for interventions recommended by the physician. In this
situation, physicians should advocate for patients and try to help them obtain needed care. Doctors might consider—or patients might request—the
use of lies or deception to obtain such benefits. For example, a physician might sign a disability form for a patient who does not meet disability criteria.
Although motivated by a desire to help the patient, such deception breaches a basic ethical guideline and undermines physicians’ credibility and
trustworthiness.

Allocation of health care resources is unavoidable because resources are limited. Many allocation decisions are made at the level of public policy, with
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physician input. For example, the United Network for Organ Sharing (https://unos.org/) provides criteria for allocating scarce organs. Ad hocPage
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allocation by the physician at the bedside is problematic because it may be inconsistent, unfair, and ineffective. Physicians do have an important role,
however, in avoiding unnecessary interventions. Evidence-based lists of tests and procedures that physicians and patients should question and
discuss are available through Choosing Wisely (http://www.choosingwisely.org/). At the bedside, physicians should act as patient advocates within
situation, physicians should advocate for patients and try to help them obtain needed care. Doctors might consider—or patients might request—the
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use of lies or deception to obtain such benefits. For example, a physician might sign a disability form for a patient who does not meet disability criteria.
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Although motivated by a desire to help the patient, such deception breaches a basic ethical guideline and undermines physicians’ credibility and
trustworthiness.

Allocation of health care resources is unavoidable because resources are limited. Many allocation decisions are made at the level of public policy, with
physician input. For example, the United Network for Organ Sharing (https://unos.org/) provides criteria for allocating scarce organs. Ad hoc resource
allocation by the physician at the bedside is problematic because it may be inconsistent, unfair, and ineffective. Physicians do have an important role,
however, in avoiding unnecessary interventions. Evidence-based lists of tests and procedures that physicians and patients should question and
discuss are available through Choosing Wisely (http://www.choosingwisely.org/). At the bedside, physicians should act as patient advocates within
constraints set by society, reasonable insurance coverage, and evidence-based practice. For example, if a patient’s insurer has a higher copayment for
nonformulary drugs, it still may be reasonable for physicians to advocate for nonformulary products for good reasons (e.g., when the formulary drugs
are less effective or not tolerated).

VIRTUE ETHICS

Virtue ethics focuses on physicians’ character and qualities, with the expectation that doctors will cultivate such virtues as compassion,
trustworthiness, intellectual honesty, humility, and integrity. Proponents argue that, if such characteristics become ingrained, they help guide
physicians in unforeseen situations. Moreover, following ethical precepts or principles without any of these virtues could lead to uncaring doctor–
patient relationships.

PROFESSIONAL OATHS AND CODES

Professional oaths and codes are useful guides for physicians. Most physicians take oaths at medical school white-coat ceremonies and graduations,
and many are members of professional societies that have professional codes. Physicians pledge to the public and to their patients that they will be
guided by the principles and values in these oaths or codes. Oaths and codes—including the Hippocratic tradition—focus on ethical ideals rather than
on daily pragmatic concerns, and have been criticized for lack of patient or public input and the limited role given to patients in making decisions.

PERSONAL VALUES

Personal values, cultural traditions, and religious beliefs are important sources of personal morality that help physicians address ethical issues and
cope with the moral distress they may experience in practice. While essential, personal morality alone is a limited ethical guide in clinical practice.
Physicians have role-specific ethical obligations that go beyond their obligations as good people, including the duties to obtain informed consent and
maintain confidentiality discussed earlier. Furthermore, in a culturally and religiously diverse world, it is not uncommon for patients and colleagues to
have personal moral beliefs that differ from those of their physicians.

ETHICALLY COMPLEX PROFESSIONAL ISSUES FOR PHYSICIANS

CLAIMS OF CONSCIENCE

Some physicians have conscientious objections to providing, or referring patients for, certain treatments such as contraception. Although physicians
should not be asked to violate deeply held moral beliefs or religious convictions, patients need medically appropriate, timely care. Institutions such as
clinics and hospitals have a collective duty to provide care that patients need while making reasonable attempts to accommodate health care workers’
conscientious objections—for example, when possible by arranging for another professional to provide the service in question. Patients seeking a
relationship with a doctor or health care institution should be notified in advance of any conscientious objections to the provision of specific
interventions. Since patients commonly must select providers for insurance purposes, switching providers for a specific service can be burdensome.
There are also important limits on claims of conscience. Health care workers may not insist that patients receive unwanted medical interventions and
may not refuse to treat patients because of their race, ethnicity, national origin, gender, or religion. Such discrimination is illegal and violates the
physician’s duty to respect patients. While legally more controversial, refusal to treat patients because of their sexual orientation or gender identity is
ethically inappropriate because it falls short of helping patients in need and respecting them as persons.

OCCUPATIONAL RISKS

Some health care workers, fearing fatal occupational infections, have refused to care for certain patients, such as those with HIV infection, Ebola virus
disease, or severe acute respiratory syndrome (SARS). Such fears about personal safety need to be acknowledged. Health care institutions should
reduce occupational risk by providing proper training, protective equipment, and supervision. To fulfill their mission of helping patients, physicians
should provide appropriate care within their clinical expertise, despite sometimes considerable personal risk.
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MORAL DISTRESS Page 4 / 7
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Health care providers, including residents and medical students, may experience moral distress when they feel that the ethically appropriate action to
take in a particular situation is hindered by institutional policies, limited resources, decision-making hierarchies, or other reasons. Moral distress can
OCCUPATIONAL RISKS
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Some health care workers, fearing fatal occupational infections, have refused to care for certain patients, such as those with HIV infection, Ebola virus
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disease, or severe acute respiratory syndrome (SARS). Such fears about personal safety need to be acknowledged. Health care institutions should
reduce occupational risk by providing proper training, protective equipment, and supervision. To fulfill their mission of helping patients, physicians
should provide appropriate care within their clinical expertise, despite sometimes considerable personal risk.

MORAL DISTRESS

Health care providers, including residents and medical students, may experience moral distress when they feel that the ethically appropriate action to
take in a particular situation is hindered by institutional policies, limited resources, decision-making hierarchies, or other reasons. Moral distress can
lead to anger, anxiety, frustration, fatigue, and work dissatisfaction. Discussing complex or unfamiliar clinical situations with colleagues and seeking
assistance with difficult decisions helps to alleviate moral distress, as does a healthy work environment characterized by open communication and
mutual respect. In addition, physicians should take good care of their own well-being, and be aware of the personal and system factors associated with
stress, burnout, and depression. A physician’s health can affect how he or she cares for patients.

CONFLICTS OF INTEREST
Acting in patients’ best interests may sometimes conflict with the physician’s self-interest or the interests of third parties such as insurers or hospitals.
From an ethical viewpoint, patients’ interests are paramount. Even the appearance of a conflict of interest may undermine trust in the profession.

FINANCIAL INCENTIVES

Health care providers may be offered financial incentives to improve the quality or efficiency of care. Such pay-for-performance incentives, however,
could lead physicians to avoid sicker patients with more complicated cases or to focus on benchmarked outcomes even when such a focus is not in the
best interests of an individual patient. In contrast, fee-for-service payments might encourage physicians to order more interventions than may be
necessary or to refer patients to laboratory or imaging facilities in which they have a financial stake. Regardless of financial incentives, physicians
should recommend available care that is in the patient’s best interests—no more and no less.

RELATIONSHIPS WITH PHARMACEUTICAL COMPANIES

Financial relationships between physicians and industry are increasingly scrutinized. Gifts from drug and device companies may create an
inappropriate risk of undue influence, induce subconscious feelings of reciprocity, impair public trust, and increase the cost of health care. Many
academic medical centers have banned drug-company gifts of branded pens and notepads and meals to physicians. The federal Open Payments
website provides public information on the payments and amounts that drug and device companies give to individual physicians by name. The
challenge is to distinguish payments for scientific consulting and research contracts—which are consistent with professional and academic missions
and should be encouraged—from those for promotional speaking and consulting whose goal is to increase sales of company products.

LEARNING CLINICAL SKILLS

Not all conflicts of interest are financial. Medical students, residents, and physicians’ interests in learning, which fosters the long-term goal of
benefiting future patients, may conflict with the short-term goal of providing optimal care to current patients. When trainees are learning procedures
on patients, they lack the proficiency of experienced physicians, and patients may experience inconvenience, discomfort, longer procedures, or
increased risk. Seeking patients’ consent for trainee participation in their care is always important, and particularly important for intimate
examinations, such as pelvic, rectal, breast, and testicular examinations, and for invasive procedures. Patients should be told who is providing care
and how trainees are supervised. Failing to introduce students or not telling patients that trainees will be performing procedures undermines trust,
may lead to more elaborate deception, and makes it difficult for patients to make informed choices about their care. Most patients, when informed,
allow trainees to play an active role in their care.

RESPONSE TO MEDICAL ERRORS

Errors are inevitable in clinical medicine, and some errors cause serious adverse events that harm patients. Most errors are caused by lapses of
attention or flaws in the system of delivering health care; only a small number result from blameworthy individual behavior (Chaps. 3 and 6).
Physicians and students may fear that disclosing errors will damage their careers. However, patients are owed an explanation, and appreciate being
told when an error occurs, receiving an apology, and being informed about efforts to prevent similar errors in the future. Physicians and health care
institutions show respect for patients by disclosing errors, offering appropriate compensation for harm done, and using errors as opportunities to
improve the quality of care. Overall, patient safety is more likely to be improved through a quality improvement rather than a punitive approach to
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errors, except in cases of gross incompetence, physician impairment, boundary violations, or repeated violations of standard procedures.
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PHYSICIAN IMPAIRMENT

Physicians may hesitate to intervene when colleagues impaired by alcohol abuse, drug abuse, or psychiatric or medical illness place patients at risk.
Errors are inevitable in clinical medicine, and some errors cause serious adverse events that harm patients. Most errors are caused by lapses of
attention or flaws in the system of delivering health care; only a small number result from blameworthy individual behavior (Chaps.University of Pikeville
3 and 6).
Physicians and students may fear that disclosing errors will damage their careers. However, patients are owed an explanation, andAccess Provided by:
appreciate being
told when an error occurs, receiving an apology, and being informed about efforts to prevent similar errors in the future. Physicians and health care
institutions show respect for patients by disclosing errors, offering appropriate compensation for harm done, and using errors as opportunities to
improve the quality of care. Overall, patient safety is more likely to be improved through a quality improvement rather than a punitive approach to
errors, except in cases of gross incompetence, physician impairment, boundary violations, or repeated violations of standard procedures.

PHYSICIAN IMPAIRMENT

Physicians may hesitate to intervene when colleagues impaired by alcohol abuse, drug abuse, or psychiatric or medical illness place patients at risk.
However, society relies on physicians to regulate themselves. If colleagues of an impaired physician do not take steps to protect patients, no one else
may be in a position to do so.

USE OF SOCIAL MEDIA

Increasingly, physicians use social and electronic media to share information with patients and other providers. Social networking may be especially
useful in reaching young or otherwise hard-to-access patients. However, the use of social media, including blogs, social networks, and websites, raises
ethical challenges and should be approached prudently to avoid harmful consequences for patients. Injudicious use of social media can pose risks to
patient confidentiality, cross professional boundaries, and jeopardize therapeutic relationships. Internet and social networking postings are usually
permanent and may be accessible to the public, physicians’ employers, and their patients. Unprofessional posts can lead to adverse consequences for
a provider’s reputation, safety, or even employment, especially if they express frustration or anger over work incidents, disparage patients or
colleagues, use offensive or discriminatory language, reveal highly personal information, or picture a physician intoxicated, using illegal drugs, or in
sexually suggestive poses. Physicians should separate professional from personal websites, social networking accounts and blogs, and should follow
guidelines developed by institutions and professional societies on using social media to communicate with patients.

ETHICAL ISSUES IN CLINICAL RESEARCH

Clinical research is essential to translate scientific discoveries into beneficial tests and therapies for patients. However, clinical research raises ethical
concerns because participants face inconvenience and risks in research, which is not designed specifically to benefit them but rather to advance
scientific knowledge. Ethical guidelines for researchers require them to rigorously design research, minimize risk to participants, and obtain informed
and voluntary consent from participants and approval from an institutional review board (IRB). IRBs determine that risks to participants are acceptable
and have been minimized, and recommend appropriate additional protections when research includes vulnerable participants. Physicians may be
involved as clinical research investigators or may be in a position to refer or recommend clinical trial participation to their patients. Physician-
investigators may feel an inherent tension between conducting research and providing health care. Awareness of this tension, familiarity with the
ethics of research, collaboration with others on the research and clinical teams, and utilizing research ethics consultation can help to mitigate the
tension. Before starting clinical research, investigators should receive training in the ethics of clinical research. Courses and guidance on the ethics of
clinical research are widely available.

Physicians should be critical consumers of clinical research results and keep up with the expanding scope of research and advances that change
standards of practice. Precision medicine initiatives aim to individualize clinical care by sometimes combining clinical information from electronic
health records, genomic sequencing of leftover biomaterials originally obtained for clinical care, and data from personal mobile devices. Furthermore,
physicians and health care institutions are analyzing data routinely collected and available in electronic health records in order to improve the quality
of care in real-world clinical settings; these efforts may be through quality improvement, comparative effectiveness research, or learning health care
systems. These new types of research raise important issues about informed consent, privacy, and risk.

GLOBAL CONSIDERATIONS

International Research

Clinical research is increasingly conducted at multiple sites and across national borders. Societal, legal, and cultural norms and perspectives about
research may vary and there are many ethical challenges. Physician-investigators involved in international research should be familiar with
international guidelines, such as the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and
the International Council on Harmonisation Good Clinical Practice guidelines, as well as national and local laws where the research is taking place.
Partnering with local researchers and communities is essential not only to demonstrate respect but also to facilitate successful clinical research.

Global Health Field Experiences

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Chapter 8: Ethical Issues in Clinical Medicine, Bernard Lo; Christine Grady Page 6 / 7
Many physicians and trainees choose to gain valuable experience by providing patient care in international settings. Such arrangements, however,
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raise ethical challenges—for example, as a result of differences in beliefs about health and illness, expectations regarding health care and the
physician’s role, standards of clinical practice, resource limitations, and norms for disclosure of serious diagnoses. Additional dilemmas arise if
research may vary and there are many ethical challenges. Physician-investigators involved in international research should be familiar with
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international guidelines, such as the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and
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the International Council on Harmonisation Good Clinical Practice guidelines, as well as national and local laws where the research is taking place.
Partnering with local researchers and communities is essential not only to demonstrate respect but also to facilitate successful clinical research.

Global Health Field Experiences

Many physicians and trainees choose to gain valuable experience by providing patient care in international settings. Such arrangements, however,
raise ethical challenges—for example, as a result of differences in beliefs about health and illness, expectations regarding health care and the
physician’s role, standards of clinical practice, resource limitations, and norms for disclosure of serious diagnoses. Additional dilemmas arise if
visiting physicians and trainees take on responsibilities beyond their expertise or if donated drugs and equipment are not appropriate to local needs.
Visiting physicians and trainees should receive training and mentoring and seek information regarding cultural and clinical practices in the host
community, respect local customs and values, work closely with local professionals and team members, and be explicit about their skills, knowledge,
and limits. Leaders of global health field experiences should ensure that participating physicians receive training on ethical and cultural issues,
mentoring, backup, and debriefing and that plans for evacuation are in place in case they are needed.

FURTHER READING

Beauchamp T, Childress J: Principles of Biomedical Ethics , 7th ed. New York, Oxford University Press, 2013.

Bilimoria KY et al: National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 374:713, 2016. [PubMed: 26836220]

Emanuel EJ et al: What makes clinical research ethical? JAMA 283:2701, 2000. [PubMed: 10819955]

JAMA Conflict of Interest Theme Issue. JAMA 317:1707, 2017.

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Chapter 8: Ethical Issues in Clinical Medicine, Bernard Lo; Christine Grady Page 7 / 7
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