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2Patient Bill of Rights and Informed Consent

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Learning Objectives

After reading this chapter, you should be able to

1. Investigate the patient bill of rights movement and the Affordable Health Care Act’s Patient’s Bills of Rights.

2. Describe the history and importance of informed consent in ethical health care.

3. Critically analyze what informed consent requires of practitioners in health care contexts.

Section 2.1The Patient Bill of Rights

Introduction As health care moved away from a more traditional, paternalistic method of putting all deci- sions in the hands of the practitioner, a more holistic approach to decision making became necessary. The consideration of a patient’s autonomy and ability to make decisions was not only a goal, but eventually became a recognized right. This chapter will cover the patient’s role in determining his or her own care and treatment as well as the history and importance of informed consent.

2.1 The Patient Bill of Rights In certain areas, such as the role of patients in their care or the right of patients to review records, health care organizations have attempted to head off and resolve issues by means of a self-governance model. The American Hospital Association (AHA) and the Joint Commission created statements of patient’s rights as a way to uniformly resolve and create a standard for such issues. In turn, regulatory bodies have adopted similar standards for regulations. These regulations result in setting a new floor for acceptable organizational conduct. Health care leaders must determine whether to treat the new regulation as a new standard or as the start- ing place for the next level of service enhancement.

A Brief History of Patient Bills of Rights Starting in the 1970s, a number of issues signaled a health care crisis, including financial strain, an apparent unequal distribution of health care, increased costs, and mounting public distrust of health care insurers and health care corporations that seemed to place profits above patients. The result has been several high profile attempts by administrations to secure rights for patients in the United States, most notably the failed attempt by former president Bill Clinton and former first lady Hillary Rodham Clinton in 1993. The Clinton effort was not merely to establish a patient bill of rights but also a national health care system. The effort died due to the public’s fear of yet another government bureaucracy and the public’s perception that managed care was inher- ently inferior (Skocpol, 1995).

In 2001, Congress considered the Bipar- tisan Patient Protection Act, informally known as the McCain-Edwards-Kennedy Patients’ Bill of Rights. The bipartisan bill was a list of guarantees for Americans already covered by some form of health insurance or group health plan. These rights promised to improve managed care through formal utilization review pro- cesses, required that health coverage be expanded for plan participants to ensure adequate access to care, protected a plan participant’s access to information as

Fuse/Thinkstock A patient bill of rights attempts to lay out a series of rights and standards that all patients are entitled to when receiving medical care, including the right to privacy.

Section 2.1The Patient Bill of Rights

well as the privacy and confidentiality of the information, and minimized possible conflicts of interest as well as inappropriate influences on physicians. The reason for its defeat is not clear; however, the bill was opposed by the U.S. Chamber of Commerce and insurance compa- nies because it had the potential to increase the cost of health plans—and President George W. Bush threatened to veto the bill.

While Congress struggled over a national patient bill of rights, individual agencies and depart- ments within the federal government were successful at promulgating patient bills of rights. One example of this is the 2006 U.S. Department of Veterans Affairs’ (VA) Patient and Nursing Home Resident Rights and Responsibilities, which applies to the VA’s extensive network of research hospitals, clinics, and health care providers. Most notably, the U.S. Department of Health and Human Services established a patient bill of rights, which affected Medicare man- aged care plans in 1998, Medicare hospitals in 1999, and Medicaid patients in 1999.

Some nonprofit organizations have also been more successful at promulgating patient bills of rights than the federal government has been. The AHA adopted its first patient bill of rights in 1973 (1992). Now named The Patient Care Partnership: Understanding Expectations, Rights, and Responsibilities (American Hospital Association [AHA], 2003), the list of guarantees is available in an easy-to-understand document, which is available in a variety of languages and serves to educate patients about their rights and responsibilities as an integral part of the patient care partnership. The document promises clean and safe clinical environments, assures the right to be involved in one’s own health care, guarantees privacy and confidential- ity, clarifies billing and insurance claims, ensures the transparency of health care teams and structures, explains the informed consent process, provides information on advance direc- tives and powers of attorney, and guarantees high-quality care in member hospitals (Ameri- can Hospital Association, 2003).

In the 1990s the Joint Commission’s patient bill of rights (simply titled “patient rights”) went a few steps further than the AHA’s statement when it included ethical protections for human subjects involved in clinical research. The commission’s patient rights emphasized the patient’s duty to cooperate with health care providers to jointly achieve the goals of treat- ment. Currently, the Joint Commission’s patient rights document has expanded to include duties by member organizations to respect, protect, and promote patient rights as well as afford patients the right to access protected services and advocacy services, among other things (Joint Commission, n.d.).

Thirteen of the most common themes found in patient bills of rights are as follows:

The patient has the right to

• considerate and respectful care. • obtain current and understandable information. • medically indicated care, including transfer to another facility. • refuse recommended treatment. • have or obtain an advance directive. • privacy. • confidentiality of communications and records. • review patient records. • be informed of conflicts of interest.

Section 2.1The Patient Bill of Rights

• refuse participation in research with no diminishment of care. • reasonable continuity of care. • be informed of care costs and policies for patient responsibilities and resolution

of conflicts. • be informed of patient rights.

The first 12 of these themes were found in the first patient bill of rights in the United States, the 1973 American Hospital Association’s Patients’ Bill of Rights. The last theme became pop- ular in the 1990s after the Joint Commission on Accreditation of Health Care Organizations (now known simply as “the Joint Commission”) added it to its own patient bill of rights.

In the cases of the AHA and the Joint Commission, their patient bills of rights only apply to member organizations and do not have the force of law outside of the organizations that have adopted it. There have been some efforts to establish a patient bill of rights as law on either a state-by-state basis or nationally through the federal government. The American Civil Lib- erties Union (ACLU), a nongovernment association with wide-reaching influence, drafted a model patient bill of rights for states to enact (Annas, 2004).

The ACLU bill showcases even more stringent standards than either the AHA or the Joint Commission bill. The ACLU’s bill emphasizes respect for an individual’s autonomy by guar- anteeing the patient’s full involvement in his or her health care. For example, according to the ACLU’s bill of rights, patients retain a right to access, examine, and photocopy all of the information in their medical records. The bill also details the information that should be dis- closed by health care providers as part of the informed consent process, and it demands that patients have around-the-clock access to patient rights advocates familiar with the provisions in the ACLU’s patient bill of rights (Annas, 2004).

At least 23 states have enacted statewide patient bills of rights. While none have the rigor of the ACLU’s patient bill of rights, all of them have given the majority of the minimal protec- tions and rights conferred by the AHA’s bill. All health care organizations within each of these states, as described in the law, must comply. In at least one state, Illinois, the patient bill of rights statute established fines and penalties for violations of its terms (Paasche-Orlow, Jacob, Hochhauser, & Parker, 2009).

The Patient Protection & Affordable Care Act (2010), more commonly known as the Afford- able Care Act (ACA), was the first federal law to promulgate a national statement of patient’s rights. Although the term is not used in the act, certain provisions of the ACA have been labeled by the administration as a patient’s bill of rights. The assembled provisions of the Affordable Care Act’s Patient’s Bill of Rights differ from the other patient bills of rights discussed so far in that they pertain primarily to insurance coverage; however, they do touch on many ethical and legal aspects of health care today (Patient Protection & Affordable Care Act, 2010). The rights outlined in ACA are as follows:

• Health care coverage must be provided to Americans with preexisting conditions. • Renewal of health care coverage must be guaranteed every year. • Insurance companies are barred from charging patients more based on gender.

Section 2.1The Patient Bill of Rights

• The additional amount that insurance companies can charge individuals due to advanced age, where they live, family size, and tobacco use is limited.

• Coverage for a detailed list of health benefits must be provided. • The use of wellness program incentives to set prices that discriminate against ben-

eficiaries who do not participate is disallowed. • Individuals have the ability to choose a preferred physician. • Individuals have the right to keep children on a parent’s health plans for an extended

period of time. • Annual and lifetime spending limits on coverage are barred. • Protections must be provided against arbitrary patient dumping by insurance

companies. • Insurance companies must publicly justify raising premiums. • Premiums must be spent primarily on health care, not administrative costs. • Emergency service coverage exclusions by insurance companies are barred.

Though the bulk of these rights have already been rolled out, some will not be available until 2019 (Patient Protection & Affordable Care Act, 2010).

Web Field Trip: Hospitals with Patient Bills of Rights

In this web field trip, you will search online and locate three different patient bills of rights found on hospital websites. Critically assess the three bills of rights using the rubric given below. This rubric looks at some of the most common problems found by a recent study of patient bills of rights (Paasche-Orlow et al., 2009).

Web Field Trip Instructions

1. Perform an online search for three different patient bills of rights from hospitals or other health care organizations (such as health systems, health plans, long-term care facilities, etc.).

2. Grade each patient bill of rights using the rubric below and assess whether each has any potential problems, gaps, or missing elements that should be covered.

3. Compare the three patient bills of rights. Did you identify any ethical problems that the patient bills of rights might not be well suited to handle? Are there elements in one doc- ument that you think would be appropriate in the others? Is each patient bill of rights that you found appropriate for the type of health care organization it belongs to?

4. Write down your web field trip’s comparative assessment of patient bills of rights. Include revisions or recommendations to improve each of the patient bills of rights that you have found, covering the issues you have spotted.

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Section 2.1The Patient Bill of Rights

Web Field Trip: Hospitals with Patient Bills of Rights (continued)

Language of patient bills of rights

Readability A recent study found that while the average American adult reads at an 8th-grade reading level, hospital patient bills of rights require a 14th-grade reading level (sophomore in college) to be understood, with state patient bills of rights having an average readability of 15th grade (junior in college). A 5th- or 6th-grade reading level is recommended for hospital patient bills of rights (Paasche-Orlow et al., 2009).

Limited English proficiency

For patients who have limited English proficiency, or only speak another language, and are likely to be encountered by the hospital, it is recommended (and in some cases required) that patient bills of rights be made available in the patients’ own language. However, not all health care organizations and states have provided trans- lated patient bills of rights, and when they do, the resulting docu- ment tends to be at a higher grade level than the original (Paasche- Orlow et al., 2009).

Use this chart as a reference when assessing the three patient bills of rights you found online.

Readability level Wording for the right to know the names of providers

5th grade (probably the most appropriate reading level for patient bills of rights)

“The doctors and nurses must tell you their names.”

8th grade (probably the highest accept- able reading level for a patient bill of rights)

“Tell you the names and roles of the people caring for you.”

12th grade (a reading level that is too high for a patient bill of rights)

“Be informed of the name and position of the doctor who will be in charge of your care in the hospital.”

16th grade (a reading level that is unread- able by the majority of Americans)

“Upon request, to obtain from the facility in charge of his care the name and specialty, if any, of the physician or other person respon- sible for his care or the coordination of his care.”

Source: From Paasche-Orlow, M. D., Jacob, D. B., Hochhauser, M., & Parker, R. M. (2009). National survey of patients’ bill of rights statutes. Journal of General Internal Medicine, 24(4), 492.

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Section 2.1The Patient Bill of Rights

Web Field Trip: Hospitals with Patient Bills of Rights (continued)

Patient Bill of Rights Grading Rubric

Use this rubric for each of the three patient bills of rights you found online.

Criteria 0 Points 1 Point 2 Points 3 Points Totals

Themes None of the 13 themes found in the bulleted list above can be found in the patient bill of rights you chose.

1 to 3 of the 13 themes above can be found in the patient bill of rights.

4 to 8 of the 13 themes above can be found in the patient bill of rights.

9 to 13 of the 13 themes above can be found in the patient bill of rights.

Ethical norms

None of the 4 ethi- cal norms (respect for autonomy, beneficence, nonma- leficence, justice) are embodied in the patient bill of rights you chose.

1 of the 4 ethical norms (respect for autonomy, beneficence, nonma- leficence, justice) is embodied in the patient bill of rights.

2 to 3 of the 4 ethi- cal norms (respect for autonomy, beneficence, nonma- leficence, justice) are embodied in the patient bill of rights.

All 4 of the 4 ethical norms (respect for autonomy, beneficence, nonma- leficence, justice) are embodied in the patient bill of rights.

Readability The patient bill of rights you chose is excessively difficult to read (approxi- mately 14th-grade level or above).

The patient bill of rights you chose is much too difficult to read (approxi- mately 12th-grade level or above).

The patient bill of rights you chose is too difficult to read (approxi- mately 9th-grade level or above).

The patient bill of rights you chose is appropriate (approxi- mately 8th-grade level or below).

Availability in other languages

The patient bill of rights you chose is not made available in languages other than English.

The patient bill of rights is avail- able in 1 language other than English.

The patient bill of rights is avail- able in 2 languages other than English.

The patient bill of rights is available in 3 or more languages other than English.

Section 2.2Informed Consent

2.2 Informed Consent The legal and ethical requirement of informed consent has two key components: the ethical principle of respect for persons and their autonomy, and the value of integrity as a virtue to be fostered in health care. It is important to understand what does and does not constitute informed consent (see Table 2.1).

Table 2.1: What is informed consent?

Informed consent IS: Informed consent IS NOT:

A dialogue that fosters knowledge and comprehension

A form

An ongoing process Something a health care practitioner does “to” a patient

Berg, Appelbaum, Lidz, and Parker (2001) offer four different, but related, definitions of this doctrine. At its core, informed consent is the idea that health care decisions should be made in a collaborative manner between the primary stakeholder (i.e., the patient) and the stake- holder’s physician or health care team. In Western biomedicine, informed consent is seen not only as a requirement for practitioners to observe, but perhaps a duty that patients have as well.

Informed consent can also be described as a set of legal rules that prescribes certain behaviors and procedures for health care professionals as they interact with patients. Some of these legal rules result in penalties to providers who deviate substantially and detrimentally from these expectations.

Apart from legal rules, informed consent is also an ethical doctrine deeply rooted in the mod- ern Western medical tradition as well as the West’s cultural valuation of autonomy. It can be argued that informed consent promotes and cultivates an individual’s agency and right to self- determination by fostering and pro- moting autonomous decision making in health care.

Finally, informed consent can be described as an interpersonal process whereby patients and their health care team inter- act with one another to (a) set goals for treatment and (b) jointly select a course of medical care aimed at achieving those goals.

Modern Informed Consent Nineteenth-century philosophers like John Stuart Mill emphasized the ethical duty to respect the rights of individuals to

Jochen Sands/Digital Vision/Thinkstock Informed consent can be seen as a running dialogue between doctor and patient in which they jointly set treatment goals and plans.

Section 2.2Informed Consent

choose for themselves, as well as the concomitant duty of governments and third parties to refrain from obstructing the autonomous decisions of others. These ideals were particularly consonant with American values of self-reliance and the view that individuals are best able to look after their own interests and welfare. Even in cases where it appears that an individual is choosing poorly, Americans generally believe in the value of respecting the person’s self- determination—especially when making health-related decisions. Note that autonomy has been a key consideration in the development of informed consent. In an early case (Schloen- dorff, discussed below), the physician is portrayed as an expert adviser with fiduciary duties to the patient. The question explored by the courts has been “What are the limits to a patient’s right to autonomy?” Therefore, in Roe v. Wade (1973), the issue was the point at which the state’s interest in preserving life overcomes women’s right to personal liberty. Other courts have been asked to strike a balance between competing state interests. In one example from 1983, 26-year-old Elizabeth Bouvia, in pain as the result of cerebral palsy and arthritis, peti- tioned the California courts to permit her to starve to death; the court refused, saying that the state’s interest in preserving life outweighed her right to self-determination. Three years later, after further deterioration, she again petitioned the court. The Court of Appeal granted her request, and in doing so stated:

Here Elizabeth Bouvia’s decision to forego medical treatment or life-support through a mechanical means belongs to her. It is not a medical decision for her physicians to make. Neither is it a legal question whose soundness is to be resolved by lawyers or judges. It is not a conditional right subject to approval by ethics committees or courts of law. It is a moral and philosophical decision that, being a competent adult, is her’s [sic] alone. (Bouvia v. Superior Court of Los Angeles County, 1986)

Schloendorff v. Society of New York Hospital Although the seminal cases of informed consent appeared in 1972, the concept of consent can be found as dictum in the 1914 Schloendorff case. In the case of Schloendorff v. Society of New York Hospital (1914), Justice Benjamin Cardozo articulated what would eventually become the accepted rule in law and bioethics concerning informed consent and established the doc- trine as the core pillar of patient autonomy.

In this case we discover that Mary Schloendorff sought medical help for a tumor, which physi- cians asked to examine more thoroughly “under ether.” Schloendorff consented to the anes- thetized examination but later claimed that she had explicitly withheld consent for surgery. Despite this, the doctors operated while she was unconscious. In addition to claiming that she was wronged by the unauthorized surgery, she also claimed that complications arising from the surgery resulted in leg injuries as well as lost fingers due to gangrene.

As part of the opinion for New York’s highest court, Cardozo commented, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body” (Schloendorff, 1914). However, Schloendorff lost her case against the hospital and her doctors due mainly to the fact that the hospital had immunity as a charitable institution and the court ignored her harms and wrongs. Despite this, subsequent legal cases have often quoted Car- dozo’s dictum and have used Schloendorff in support of rights to bodily integrity, self-deter- mination, and privacy (Lombardo, 2005). In fact, Schloendorff is commonly thought to be the case that cemented the legal doctrine of informed consent in the United States.

Section 2.2Informed Consent

Five Requirements of Informed Consent in Health Care Organizations In health care it is generally accepted that there are five requirements necessary for there to be informed consent. These requirements are:

1. Adequate disclosure of information 2. Decisional capacity of the patient 3. The patient’s comprehension of information 4. Voluntariness (freedom from coercion) 5. Consent of the patient

Let’s look at all of these in turn.

Adequate Disclosure of Information First, there must be adequate disclosure of information. As shown in the Canterbury v. Spence case study at the end of the chapter, there are three main disclosure standards: a subjective standard, where each patient is told what he or she would want to know in order to make a decision; a professional community standard, or what a reasonable physician in the same field and general geographic region would reveal in the same or similar cases; and a reason- able patient standard, or what a reasonable patient would consider important to his or her decision to consent to the proposed treatment. Disclosure standards may vary from state to state, with the majority having adopted the reasonable patient standard.

Courts, the medical profession, and ethicists have long discussed what should and should not be disclosed to patients. The consensus has generally been that doctors must disclose information about the patient’s health, including the diagnosis and prognosis, as well as infor- mation about appropriate medical treatment options. When disclosing information about medical options that are appropriate, doctors should clearly state the purpose or aim of the treatment, what the treatment will consist of, the benefits that are likely to accrue from the intervention, the likely and important risks and burdens of the proposed treatment, and the range of appropriate alternatives available to the patient—always including the option of no treatment.

Decisional Capacity of the Patient Another requirement of informed consent is for the patient to have the capacity to make a decision for the particular choice in question. Note that competence and capacity, which are shorthand for “decision-making capacity,” have different meanings but are often used inter- changeably. Competence is a legal concept and is integral to laws regarding minors, guardian- ships, and powers of attorney. Capacity, although a legal concept in some states, concerns decision-making ability as applied to a specific decision and is generally determined by the attending physician. Therefore, to consent to medical treatment, a patient must not be legally incompetent (e.g., a minor or someone deemed incompetent by a court of law) nor have his or her decision-making capacity hindered in any way (e.g., someone who is unconscious).

The effect of incompetency or lacking decision-making capacity is that the patient cannot make health care decisions for him- or herself, and a suitable proxy decision maker must be found.

Section 2.2Informed Consent

The Patient’s Comprehension of Information The requirement of comprehension goes one step further than decisional capacity. Not only must the patient be fully capable and legally able to make a decision, but the health care professionals eliciting consent must take steps to ensure that the patient comprehends the information being dis- closed. For example, a patient who does not speak the same language as the health care provider may have decision-making capacity and the legal competence to make health care decisions and yet be unable to comprehend the information being disclosed.

Patients should comprehend the disclosed information and integrate it with their preferences and values in order to arrive at a decision. The law does not require a health care professional to test compre- hension. However, if a professional is aware of facts that contradict sufficient comprehension, it is not enough simply to assume that a patient comprehends the information and understands how it will impact quality of life both now and in the future. Informed consent requires that health care professionals determine whether a patient truly comprehends the information.

B BOISSONNET/BSIP/SuperStock Under the doctrine of informed consent, health care providers must not only provide patients with adequate information about their patients condition and treatment, but ensure that patients comprehend the information.

A Peek at Practice: Assessing Decision-Making Capacity and Comprehension

The following strategies are ways in which health care professionals routinely assess the decision-making capacity of patients and whether those patients comprehend the disclosed information and are able to integrate their goals, preferences, and values to arrive at well- reasoned decisions:

• Ask patients to summarize the pertinent medical information in their own words (sometimes referred to as requiring patients to “talk back”). This assesses patients’ understanding of their condition or the procedure.

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Section 2.2Informed Consent

Voluntariness The requirement for voluntariness in the informed consent doctrine is to ensure that the patient is not being coerced or unduly influenced into making a decision. The health care professional should therefore attempt to foster an environment in which the patient is free from undue constraint to make a decision. Examples of undue constraint might be elevated pain or discomfort that could cloud the patient’s decision-making ability or the influence of those who have the potential to assert power or control over a patient (social influences such as authoritarian doctors, family members, or friends).

As John Donne (1623) insightfully remarked, “no man is an island,” and there is no such thing as a completely autonomous decision maker who is never swayed by the needs and percep- tions of others or never feels constrained in his or her decision making by commitments and responsibilities. As social beings, our decisions are tugged at from all sides, and therefore at least partly constrained. However, the requirement of voluntariness for informed consent addresses only that which arguably rises to the level of coercion or excessive influence.

A Peek at Practice: Assessing Decision-Making Capacity and Comprehension (continued)

• Ask patients to explain their choice and how it fits in with their values or life plan. This assesses patients’ ability to integrate their health care status with their goals, preferences, and values.

• If a patient’s choice seems uncharacteristic for him or her, or dangerous, unreason- able, or incompatible with the patient’s stated preferences, goals, or values, then fur- ther assessment of the patient’s decision-making capacity may be needed—perhaps by requesting a psychiatric consultation.

Practitioners must guard against their bias to deem a patient capable of making decisions as long as the patient agrees with the practitioner’s recommendation. Using the above strategies helps ensure that health care providers make their assessment based not only on the choice but also on the patient’s understanding and rationale.

Discussion Questions

1. If a particular patient is suspected of not giving informed consent due to a possibly compromised decision-making capacity, should the clinician attempt a more rigor- ous assessment, which may lead to a clinical finding of incapacity and perhaps even a legal determination of incompetence, or should the patient be left alone unless he or she starts withholding consent for treatments that the doctor thinks are necessary?

2. What ethical principles may be compromised if only patients who are deciding against medical advice have their decision-making capacity scrutinized and possibly even revoked, while other patients who lack decision-making capacity (and thus are inca- pable of giving their informed consent) are not treated this way provided they always agree with the doctor? Are there any biases at play?

Section 2.2Informed Consent

Consent of the Patient The last requirement for informed consent in health care decision making is an actual act of consent. This can be documented as a signature on an informed consent form but may also consist of virtually any voluntary act of agreement, including signing an “X,” a verbal response, and even a nod—as long as the act is unambiguous (Kovacs v. Freeman, 1997). There may be policies at certain health care organizations that require specific acts of consent, but these are usually internal policies set up by risk management as a hedge against legal liability, and not strictly a legal or ethical necessity.

Under this requirement, it is imperative that the complex process of informed consent not be simply reduced to a physical act like signing an informed consent form. Commentators Can- dalis and Lidz (2010) observed in a study that health care professionals often misunderstand informed consent as being “simply a part of routine clinical explanations . . . [which] are often paternalistic monologues rather than collaborative decision-making processes” (p. 336). Informed consent is often seen as merely the piece of paper that patients are required to sign before practitioners can do their job. In the same study, it was shown that patients are also likely to view informed consent as nothing more than a self-protective piece of evidence that the doctor or hospital can use to escape legal liability. Furthermore, the researchers found that 68% of patients in one study thought that the consent form actually permitted physicians to take over a patient’s decision making.

Informed consent remains an important process and requirement for both the legal and ethical practice of medicine. Ideally, it is an open dialogue between the health care provider and the patient, which evidences medicine’s and society’s deep commitments to respecting and cultivating people’s right to decide for themselves what should be done to their bodies. Informed consent is not (or should not be) a bureaucratic requirement or mindless task to be checked off before medical care is undertaken. It should reflect an ongoing process and a commitment to joint collaboration between the health care team and the patient for as long as treatment is being rendered.

Just as there is confusion between informed consent and documentation of informed consent (i.e., the consent form), confusion over who is responsible for obtaining informed consent can also occur. It is most often the physician who is responsible for obtaining consent. The physi- cian can authorize employees and agents—such as office staff, physician’s assistants, or nurse practitioners—to assist him or her in this regard, but liability remains with the physician. Prudent physicians will take care that those assisting them are well schooled in the require- ments of informed consent. Most likely, such assistants will be other health care profession- als. Other entities such as hospitals will generally have policies that prohibit their employees from participating in the informed consent process, for fear of increasing the institution’s liability. Such entities will relegate their employees to obtaining documentation of the previ- ously obtained consent. The documentation is generally a signature on a consent form. There- fore, the physician and his or her employees or agents must focus on the patient’s need to understand information relevant to the treatment decision. Meanwhile, other entities, while not responsible for obtaining consent, must be alert and responsive to indications that the patient does not consent.

Chapter Highlights

Chapter Highlights • Patient bills of rights are the regulatory embodiment of patient autonomy

found at both the state and national level. • In March 2010, President Obama signed the Affordable Care Act into law. The

law is designed to make preventative health care accessible and affordable to Americans without health care. The implications of this law will have a tremen- dous impact on how health organizations operate in the United States.

• The patient autonomy aspect of health care often takes the form of informed consent. The elements of informed consent are:

1. Adequate disclosure of information

2. Decisional capacity of patient

3. The patient’s comprehension of information

4. Voluntariness (freedom from coercion)

5. Consent of the patient

Case Study: Canterbury v. Spence

As one might imagine, case law has developed locally rather than through a single national pronouncement. So it was in the District of Columbia in 1972 when the court’s opinion organized and reasoned through the various issues surrounding consent. As a basic state- ment of the issues, the case has become foundational to the concept of informed consent. “The record we review tells a depressing tale,” began Judge Spottswood William Robinson III’s opinion in Canterbury v. Spence (1972). Though the case culminated in a 1972 opinion, the saga of Canterbury v. Spence spanned decades.

Background

In 1958, a 19-year-old man named Jerry Canterbury, originally from West Virginia, was working in Washington, D.C. as a desk clerk for the FBI when he first experienced what would eventually become severe and chronic neck pain. By 1959 Canterbury began seeing Dr. William T. Spence, a D.C. neurosurgeon, who scheduled a myelogram in order to pinpoint the source of the pain. The test showed a filling defect in Canterbury’s spine, which required an in-patient laminectomy to remove a part of vertebra that Spence suspected had caused a ruptured disk. Canterbury and his mother were concerned about the surgery, but when they conveyed their concerns to Spence, all they were told was that the procedure was a routine surgery. The operation was performed the next week and seemingly went well.

While in recovery, Canterbury felt a strong pain in his bladder and called for a nurse to assist him in going to the bathroom. Instead, the nurse gave him a urinal and left. During his attempt to urinate while half sitting, half lying on his right side, Canterbury fell out of his bed. It was later revealed at trial that conflicting orders were written regarding how Canterbury was supposed to urinate. While this confusion was problematic, it was a small portion of Canterbury’s overall difficulties.

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Case Study: Canterbury v. Spence (continued)

A few hours after Canterbury’s fall, he began to experience numbness in his legs and pain in his chest. A second surgery was performed that evening to alleviate the numbness, which was turning into paralysis, but the paralysis remained after the surgery. Eventually, Can- terbury’s condition did begin to improve, and by May 1959, though partly disabled and incontinent, he left the hospital on crutches.

During the next few years, the FBI relocated Canterbury to several different locations in order to minimize the lasting harmful effects of the surgery and subsequent fall, which included bouts of paralysis, continued pain, and incontinence. Eventually, Canterbury resigned from the FBI and proceeded to bounce from job to job. By 1962 he decided to sue Spence for failing in his duty to disclose the risks involved with a laminectomy; he also sued the hospital for leaving him unattended after his surgery.

The Trial

After the trial court entered a directed verdict in favor of the defendants, the lawsuit, upon the plaintiff/patient’s motion, went to the D.C. Court of Appeals. A fundamental problem for the case was causation—what caused Canterbury’s paralysis? Was it his initial condi- tion? The surgery? The fall? The second surgery? Related to the problem of causation was the issue of negligence. If Spence was liable for negligence, it would have to be demon- strated not only that the paralysis was caused by something that he did, but that he failed to comport with a standard of care. Instead, Canterbury’s lawyer focused on Spence’s failure to obtain legal consent. However, this line of argument was tricky, since Canterbury had indeed consented to the surgery (though with no details about the surgery or information about the risks and hazards associated with it).

Canterbury v. Spence held that physicians have an obligation to disclose all reasonable infor- mation about treatments to patients. Specifically, the holding stated that the fiduciary rela- tionship between physician and patient—one in which most patients are wholly dependent on the medical knowledge of their doctor to help them decide—creates the obligation to inform patients of the medical treatment options. This obligation requires that the physi- cian disclose any limitations of the proposed treatment, any viable alternatives, and any associated risks. The scope of this obligation is shaped by the patient’s right to self-deci- sion, a right that is dependent on being apprised of all relevant medical information.

The Scope of Disclosure in Informed Consent

The court in Canterbury v. Spence was faced with the task of determining what was meant by “all relevant information.” The court could have adopted the professional standard of disclosure, or “reasonable doctor rule,” which is what a reasonable practitioner in the medical community would have customarily disclosed to his or her patients under the same or similar circumstances. One could argue that adopting a professional standard for disclo- sure was what physicians like Spence had already been following—that is, providing next to no information. The court rejected the reasonable doctor rule because the rule failed to recognize the role of the patient in the therapy decision.

In discussing the scope of information to be provided, the court evaluated a full disclosure standard, meaning that a physician would have to disclose all of the information related to medical options. This is also referred to as the subjective standard of disclosure. The

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Chapter Highlights

Chapter Highlights • Patient bills of rights are the regulatory embodiment of patient autonomy

found at both the state and national level. • In March 2010, President Obama signed the Affordable Care Act into law. The

• The patient autonomy aspect of health care often takes the form of informed consent. The elements of informed consent are:

1. Adequate disclosure of information

2. Decisional capacity of patient

3. The patient’s comprehension of information

4. Voluntariness (freedom from coercion)

5. Consent of the patient

Case Study: Canterbury v. Spence

Background

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Case Study: Canterbury v. Spence (continued)

The Trial

The Scope of Disclosure in Informed Consent

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Chapter Highlights

Case Study: Canterbury v. Spence (continued)

court decided that a full disclosure standard placed an unrealistic burden on physicians and was unnecessary from a patient’s viewpoint.

Instead, the court chose to look to the patient’s right of self-decision to shape the limits of disclosure. However, it is also unreasonable to expect physicians to know what the patient would find useful. Furthermore, in a lawsuit for failure to disclose, how would courts know if a patient was telling the truth about whether he or she would have wanted to know some- thing that the physician did not disclose?

For these reasons, the Canterbury opinion ruled for what was termed an “objective” scope of disclosure—what information a reasonable person would likely find significant when making a decision about a proposed treatment. This is sometimes referred to as the rea- sonable patient standard of disclosure. Citing other cases, the court held: “In broad out- line, we agree that ‘[a] risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy’” (Can- terbury v. Spence, 1972). It must be noted that states such as California have extended the reasonable patient standard by placing emphasis on the patient’s need to know (Cobbs v. Grant, 1972). This objective scope contains two exceptions. First, the duty to disclose does not apply in emergency situations when a patient is incapable of consenting and the harm of failing to treat is greater than any risk of the treatment (this is known as the “emergency privilege”). Second, a physician can withhold information if a patient is so ill or emotion- ally distraught that disclosure might damage the patient by compromising rational decision making or otherwise harm the patient more than it would help. This exception, known as “therapeutic privilege,” is regarded suspiciously when invoked by physicians today; it is highly circumscribed and seen as a last resort in the law and ethics of health care.

It must be noted that informed consent is a state concept, and therefore a practitioner must look to his or her state law for the current application of the reasonable physician or rea- sonable patient standard and the therapeutic privilege.

The Retrial

The court found in favor of Canterbury and ordered a retrial in front of a jury. However, Can- terbury lost the retrial after it was revealed that he willingly consented to undergo a second laminectomy years after the first had left him paralyzed. This is due to the requirements of negligence claims under tort law (which we will discuss more fully in Chapter 6). Under negligence requirements in tort law, in order to be successful in this type of lawsuit, it is not enough for a physician to have wronged the patient by failing in his or her duty to disclose; the failure to disclose must also have directly caused a harm to the patient. Furthermore, the patient must also demonstrate that had he or she been informed of the risk, he or she would have forgone the treatment. Since Canterbury willingly consented to undergo a sec- ond laminectomy years after the first surgery (to alleviate some of the injuries sustained in the first laminectomy), the retrial court reasoned that he could not believably claim that had he been apprised of the risks of the first surgery and the convalescent period afterward, he would not have agreed to the surgery.

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Case Study: Canterbury v. Spence (continued)

Discussion Questions

1. The court in Canterbury v. Spence noted that there was no particularly good reason to defer to the specialized knowledge that doctors possess in order to determine what information should be disclosed to a patient. The court reasoned that although it makes sense to allow the medical profession to determine the technical medical standards of care, it is not necessary to be a doctor to evaluate the sufficiency of the disclosure. Do you agree with the court? Write down which of the three standards of disclosure presented in this case study you prefer and why.

2. On retrial, the defense argued that Canterbury’s agreement to undergo a second lam- inectomy belies his testimony that he would not have undergone the first laminec- tomy had he known about the risks. Demonstrating your understanding of both sides of the issue, how should the court have ruled? While the duty to inform patients of the risks and benefits of medical treatment options is now a well-settled legal and ethical doctrine, what if a patient refuses the information? Does a patient have a duty to give informed consent (and not just a right to give it)? Why or why not?

Activity

After reading about Canterbury v. Spence, consider the following scenario:

You are in your office, attending to your normal duties as a hospital administrator, when Dr. P., a neurosurgeon in your hospital, stomps into the room. You are aware that one of Dr. P’s patients was recently paralyzed from a fall she took in her hospital room while recover- ing from a laminectomy performed by him. You are also aware that Dr. P. did not warn the patient to not attempt to get out of bed in her current state, since doing so could greatly increase her chances of injury, paralysis, and even death. He also did not alert her nurses of this danger, nor did he order any special care or observation for this patient.

“I’m just so sick of it,” he fumes. “I know that for a laminectomy I’m supposed to tell patients all the risks associated with the surgery, but c’mon! I was operating on the woman’s spine for cryin’ out loud! It goes without saying that surgery on your spine involves a risk of paralysis!

“What really gets me is that I wasn’t even in the room when she got paralyzed! So the patient doesn’t understand that if you just came out of spine surgery, still groggy from the anesthe- sia, you probably shouldn’t be traipsing around your hospital room. Why should I have to tell her this obvious fact? It seems to me that it was just her poor judgment that caused her fall and paralysis, not anything that I had a duty to do.”

1. Write down how you would respond to Dr. P. and what recommendations you would make for what he should or should not have disclosed to the patient.

2. Which of the three standards for disclosure (subjective, professional, or reasonable patient) did you recommend to Dr. P. in question 1, and why?

3. How would you decide whether a potential risk related to a particular medical treat- ment should be disclosed under the reasonable patient standard? How would you go about determining what a reasonable patient would want to know?

Chapter Highlights

Case Study: Canterbury v. Spence (continued)

court decided that a full disclosure standard placed an unrealistic burden on physicians and was unnecessary from a patient’s viewpoint.

The Retrial

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Case Study: Canterbury v. Spence (continued)

Discussion Questions

Activity

After reading about Canterbury v. Spence, consider the following scenario:

1. Write down how you would respond to Dr. P. and what recommendations you would make for what he should or should not have disclosed to the patient.

2. Which of the three standards for disclosure (subjective, professional, or reasonable patient) did you recommend to Dr. P. in question 1, and why?

Chapter Highlights

Critical Thinking and Discussion Questions

1. What are the issues that caused several presidential administrations to explore establishing a patient bill of rights?

2. Name five requirements of informed consent in health care. Describe what each of these five requirements entails.

3. Identify and describe the pros and cons of each of the three main disclosure stan- dards in the law and ethics of informed consent in health care.

Key Terms Affordable Care Act’s Patient’s Bill of Rights The articulation of a set of rights for patients and health consumers covered by the Affordable Care Act. The bill of rights focuses on protecting patients from unscru- pulous health insurers but also touches on many ethical and legal aspects of health care today.

emergency privilege An exception to the duty to elicit informed consent from a patient; it is invoked when a patient is incapable of consenting and the harm of failing to treat is greater than any risk of the treatment.

informed consent The idea that health care decisions should be made in a collab- orative manner between the patient and the physician or health care team; it is also an ethical doctrine and a set of legal rules that prescribes certain behaviors and proce- dures for health care professionals.

professional standard of disclosure The standard expectation of what any reason- able practitioner in the medical community would disclose to his or her patients given the same or similar circumstances.

reasonable patient standard of dis- closure What information a reasonable person would likely find significant when making a decision about a proposed treat- ment. Sometimes referred to as an objective scope of disclosure.

subjective standard of disclosure A stan- dard requiring physicians to disclose all of the information related to medical options that a particular patient would want to know.

therapeutic privilege An exception to a health care provider’s duty to disclose information required for informed con- sent; it can be invoked if the patient is so ill or emotionally distraught that disclosure might damage him or her by compromising rational decision making or otherwise harm the patient more than it would help.