A patients right to receive all information relative to his or her condition

Exceptions to the Requirement to Obtain Patient Informed Consent

Several well-established exceptions exist to the requirement otherwise universally to obtain patient informed consent before carrying out health care treatment interventions. The two most important ones are the emergency doctrine and therapeutic privilege.32

Under the emergency doctrine, whenever a patient seeks evaluation and treatment in a life-threatening emergency situation and is unable to communicate his or her wishes regarding treatment (such as when the patient is unconscious), it is generally presumed that the patient would consent to reasonable, lifesaving medical intervention. Consider the following hypothetical case scenario:

A student nurse on a clinical rotation is evaluating a 65-year-old male rehabilitation patient, who is recovering from a left cerebrovascular accident. Suddenly, the patient suffers a myocardial infarction and grasps his chest. The patient is initially unable to speak because of pain and shortness of breath; he then becomes unconscious. What action should the student take? (At the time of the incident, there is no one, including the student's supervisory clinical preceptor, in the clinic area.)

This scenario presents an example of a situation in which the emergency doctrine exception to the law of patient informed consent is applicable. In such a situation, it is generally presumed, as a matter of law, that an ordinary reasonable person would wish to avail himself or herself of lifesaving treatment intervention. Absent clear evidence of contrary patient desires, the student should immediately commence cardiopulmonary resuscitation and activate the emergency medical response system.

Of course, there are exceptions to the exception of a presumption favoring rendition of care in life-threatening emergencies. For example, if a patient's desire not to receive lifesaving care in the event of an emergency has been memorialized in a valid patient advance directive (discussed in Chapter 6), health care professionals and supportive personnel are obligated to respect the patient's autonomy and not initiate lifesaving treatment. A similar exception applies when a valid “do not resuscitate” order (discussed later in this chapter) appears in a patient's medical record.

If a patient's desire not to receive lifesaving care in the event of an emergency has been memorialized in a valid patient advance directive, health care professionals and supportive personnel are obligated to respect the patient's autonomy and not initiate lifesaving treatment.

Therapeutic privilege is rarely invoked and even less often sanctioned by the courts as legally acceptable because the exercise of the privilege derogates from the foundational biomedical ethical principle of respect for patient autonomy and self-determination.

What course of action can a nonphysician health care professional team member treating a patient take when he or she disagrees with a physician's invocation of therapeutic privilege? Consider the following hypothetical case example:

An occupational therapist treating a 32-year-old female patient (who is diagnosed with terminal, end-stage metastatic breast cancer) meets with the other rehabilitation team members for a weekly team conference. At the meeting the patient's attending physician advises the team members that he is discharging the patient to home to allow her to die in peace with her family. The attending physician tells the team treating the patient that he is invoking therapeutic privilege concerning the patient's prognosis. (The patient already knows her diagnosis.) The occupational therapist knows, from her recent conversations with the patient, that the patient wishes to know about her prognosis and apprises the rest of the team of this fact. The physician becomes angry and reminds the occupational therapist that he is the patient's physician and the leader of the rehabilitation team. The physician ends the discussion by imposing a “gag order” on the entire treatment team, ordering all of them to remain silent if asked by the patient about her prognosis.

Is this the end of the matter? Not necessarily. In this case the occupational therapist is unable to abide by the physician's decision as a matter of personal ethics. What can she do? Several acceptable options are open to the occupational therapist. First, the occupational therapist should consider requesting a private meeting with the physician to express her concerns about the gag order. Assume that she does this and poignantly states her position. Assume further that her resistance to his edict enrages the physician, who summarily ejects the occupational therapist from his office stating, “Just do what I ordered!”

At this point, there are three options open to the occupational therapist. She may resign herself to acceptance of the physician's order. However, in this case the patient, who has become accustomed to confiding in the occupational therapist, begins to pressure her for information about her prognosis. Additionally, the occupational therapist's personal code of ethics does not allow her to be untruthful to the patient.

The occupational therapist, at this point, may be justified in removing herself from the patient's treatment team—because she cannot abide by the physician's order—and allowing another occupational therapist who can accept the “gag order” to continue to care for the patient. However, in this case, the occupational therapist believes that this option is unethical and therefore an unacceptable “cop-out.”

Therapeutic privilege is rarely invoked and even less often sanctioned by the courts as legally acceptable because the privilege derogates from the foundational biomedical ethical principle of respect for patient autonomy and self-determination.

The last available option to the occupational therapist is perhaps the best one, after exercising all reasonable efforts to discuss the situation civilly with the physician. This option is formally to request an ethics consultation from the institutional ethics committee in the facility. The institutional ethics committee is a multidisciplinary committee of health care professionals and other related professionals that offers consultative services and convenes to hear and make recommendations about cases involving ethical dilemmas. Any health care organization should always have in place a mechanism for licensed and certified health care professionals and others to avail themselves of the advice and intervention of the institutional ethics committee. No stigma should ever be associated with requesting consultation from the institutional ethics committee. Similarly, the fact that the occupational therapist acted reasonably in requesting an ethics consultation should not cause her to suffer retribution from the physician whose judgment is challenged. It may be necessary for facility administrators to educate physicians and other health care professionals about the role(s) of the institutional ethics committee regularly so that misunderstandings and anger over its intervention do not occur.

Two other scenarios (involving the treatment of incompetent or minor patients) may seem to be possible exceptions to the requirement to obtain patient informed consent to treatment; however, such is not the case. When a patient lacks legal capacity to consent to treatment—because the patient cannot understand information conveyed and is legally adjudicated as incapacitated or because the patient is a minor and cannot consent to a particular intervention as a matter of law'a health care professional must obtain informed consent from a surrogate decision maker (or substitute).

The disclosure of information made to a surrogate decision maker is exactly the same as would be made to a competent patient. The surrogate decision maker, appointed by the patient or by law, acts on the patient's behalf and has the same right to have key information disclosed and to have questions answered to the surrogate's satisfaction before treatment commences.

One exception to the general rule that parents or guardians normally consent on behalf of their minor children is that minors, especially when they are nearing the age of majority (age 18), may have the right under applicable state law to exercise autonomy personally to consent (usually without revelation to their parents) to treatment in cases involving elective abortion, treatment of drug (including alcohol) abuse, and the treatment of sexually transmitted diseases. These exceptions to the general rule of substituted consent for minors vary from state to state, and providers must consult proactively with legal counsel to remain current on the state of the law so as to protect the rights of all parties.

Another difficult dilemma involving incapacitated patients centers around informed consent involving patients who, practically but not legally, lack the mental capacity to make knowing, intelligent, voluntary, and unequivocal decisions about their care. Although the determination of patient capacity to make decisions about health care interventions is a question for physicians and jurists, other health care professionals involved in the care of particular patients can offer important input into competency determinations based on their observations and interactions with patients.

Little guidance is available in the health care professional literature for physicians and other health care professionals on mental capacity assessment. An excellent article that presents a framework for patient competency assessment (including dimensions of competence and a series of questions to assess mental capacity) is “Assessing Patient Competence for Medical Decision Making.”33 Another by Spremulli34 offers a screening assessment for capacity developed by the author.

In cases of questionable patient competency to make treatment-related decisions, health care professionals are urged to raise the issue expeditiously with physicians, facility administrators, legal counsel, and institutional ethics committees so that a competency determination can be undertaken, if appropriate. When a question of patient competency exists, a competency assessment is required to comply with legal requirements concerning consent to care and to meet foundational ethical standards, including respect for patient autonomy and dignity, beneficence, and nonmaleficence.

Products and Services Provided

Income generated in an optometric practice is derived from provision and sales of:

Eye examinations and other professional services – the vast majority of patients in an optometric practice attend for eye examinations, which is the key value driver. Only after a complete eye exam is conducted are contact lenses normally prescribed and dispensed. Therapeutic privileges are now available to optometrists in many countries (often requiring appropriate postgraduate training) and this service will also contribute to the income of the practice.

Spectacle dispensing – regardless of how much contact lens activity a practice has, the supply of complete spectacles will always be a necessary part of contact lens practice.

Contact lenses – apart from a stock of ‘off-the-shelf’ designs, the practice may need to have to hand specialist contact designs and products.

Accessories – a range of appropriate contact lens care systems and other accessories need to be available, such as sunglasses, spectacle chains, contact lens and spectacle cases.

Subscription schemes – both contact lens wearers and spectacle-wearing patients benefit from service agreement schemes, which enable them to obtain replacement products and specific professional services at preferential terms. Such schemes are now common and maintain a degree of continuity to the practice.

Information

The patient with decisional authority (or the properly identified surrogate decision maker) is entitled to all the information available about his or her condition that would be relevant to making a decision about treatment. This information includes not only known or estimated risks and benefits of proposed therapies and their alternatives but also the implications of having no treatment at all.28 The free flow of information to the patient, however sensitively it may need to be conveyed, is obviously vital for a valid consent process. Likewise, for the provider to suggest an individually appropriate treatment course for that patient, the patient must be encouraged to communicate openly with the provider.13

Full information is one of the legal pillars of informed consent, the other being the free and uncoerced consent itself.13 Exceptions to such disclosure do exist, namely, the “therapeutic privilege,” which permits the physician to withhold information from the patient or to seek consent from an appropriate surrogate when provision of such information would be so detrimental that the result would be counter-therapeutic and would bring about harm.21 Concern is often expressed about doing harm to the patient, particularly by physicians in fields in which terminal illness is common, about the “inhumanity” of telling the patient the unvarnished truth.29 However, distinguishing between the inherently unwelcome nature of bad medical news and information that might actually induce negative physical consequences in the patient is important. The majority of patients who have been surveyed desire to have information given, even if it foretells their coming demise.30 In fact, the real need for the therapeutic privilege is rare if it is employed for its actual intent, rather than for the purpose of affording the physician the opportunity to avoid a difficult discussion. Although it is appropriate that information be imparted in a sensitive manner, imparted it should be, nonetheless.

At such times it might be tempting to speak first with, for example, the patient’s adult child to enlist his or her support before an encounter with an older patient. For several reasons, this temptation should be avoided. First, certain classes of patients, such as those who are elderly, are too easily stereotyped as unable to manage emotionally powerful information, even though they may be quite functional in other areas of their lives and lacking any psychiatric history relevant to this issue. Second, the information is, after all, confidential information. Because it is of more concern to the patient than to anyone else, he or she has the right to hear it first. Third, the misguided attempt to enlist the adult child’s help could backfire in several ways. The grown child may not be prepared for the loss of a parent, may not enjoy the patient’s confidence, or may even have a personal agenda that is in conflict with or opposed to the best interests of the patient. There is no barrier to asking the patient whether it would be desirable for the physician to have a conversation with a particular relative, whether privately or with the patient, so that all three can cooperate in planning for the patient’s future. In the final analysis, however, the confidentiality of the patient must be respected.

Truth-telling

Another duty the physician has toward patients and family is that of veracity, or truth-telling. This duty relates to the patient’s right of autonomy, since it is not possible to exercise that right if the patient does not have an accurate sense of the present situation, future prognosis, and options available. One can imagine situations, however, when this duty seems to conflict with other duties or responsibilities. For instance, in situations where certain information is deemed potentially detrimental to a patient, some physicians have invoked “therapeutic privilege” in withholding that information. The courts have looked with disfavor upon this practice (Thornburgh v. American College of Obstetricians, 1986), however, and recent revisions of the American Medical Association Code of Ethics have deemed the practice “ethically unacceptable” (American Medical Association, 2010–2011). Other challenging situations include potential pressures to withhold or alter information provided to a third party, such as an insurance company, in order to procure needed services for a patient (Morreim, 1991). While the pressures are real and the motivations for considering such a course of action may be noble, there is no ethical justification for lying.

However, there may be situations in which complete disclosure is not required, and may even be contraindicated. For instance, patients may waive their right to informed consent if they freely choose not to know the risks, benefits, and alternatives of a given procedure (Faden et al., 1986). In certain cultures, the locus of decision-making is not so much the patient (as it is under the autonomy-dominated American model), but rather the family. In such cases, it is appropriate to ask the patient how much information he or she would like to receive, and whom he or she would want to make medical decisions. In so doing, patients’ autonomy as well as their cultural background are respected (Searight and Gafford, 2005).

Exceptions to the Informed Consent Requirements

Q68.9 Four recognized exceptions to the usual informed consent requirements are listed in Box 68.2. (1) An important exception pertains to emergency treatment, where the patient’s condition presents a risk of death or serious disability, if the treatment is not administered immediately, the patient is currently unable to make and express an autonomous decision, and no suitable surrogate is available. (2) The principle of ‘therapeutic privilege’ is applicable in those extremely rare cases, in which withholding information is essential to the particular patient’s best interests, because disclosing the pertinent information would be likely to result in imminent, serious harm to the patient. (3) Risks commonly known to the public need not be explicitly disclosed. (4) A waiver of the patient’s right to be informed occurs when the patient voluntarily and knowingly agrees to decline receipt of the explanation to which he or she would otherwise be entitled. Importantly, none of these exceptional circumstances are commonly applicable to the use of systemic drugs, or to surgical procedures, performed in dermatology.

A more complicated concern is the appropriate process for obtaining informed consent to treat minors.27 The most prudent general practice is to include parents in decisions, involving minors, regarding any therapy carrying a significant potential risk.

However, some exceptions to this admonition exist. An ‘emancipated minor’ is defined as a fully self-supporting person living separate and apart from parents and/or one who is married, a parent himself or herself, or serving in the military. By comparison, a ‘mature minor’ is recognized by some state statutes as a person, usually 14 or 15 years of age or older, with a degree of maturity rendering that individual capable of understanding relevant information and rationally deciding whether to undergo nonrisky medical interventions. In both the emancipated and the mature minor situations, treatment decisions may be made by the patient, based on adequate information provided by the physician, without parental involvement, unless the minor desires such involvement. In the absence of facts supporting either of these exceptions, however, involving the patient’s parents in diagnostic or therapeutic decisions is generally the most conservative, legally safe, and wise approach to take.

Informed consent

In many ways the issues surrounding informed consent illustrate the issue of autonomy and thus are worth investigating. However, autonomy is not just about informed consent, it is a matter of respect of which respecting the right to informed consent is a component (see Case 13). The discussion of informed consent here is not that of human research, emergencies, or when the patient is not competent as these are not relevant to the current case. A public health emergency, medical emergency, patient waiver (essentially a consent to not give consent for the treatment), “therapeutic privilege” when obtaining the consent could harm the patient, and patient incompetence are recognized exceptions to the necessity of informed consent (Cocanour, 2017).

Beauchamp and Childress (2013, pp. 110–125) identified a number of different forms of consent, including implicit or implied, presumed, and explicit, with the latter written or verbal. An example of implicit or implied consent is that when a patient sees a physician or healthcare professional, the patient can reasonably expect that he or she will be asked a number of questions and be examined. The mere presence of the patient in the clinician’s examining room implies consent for the history and physical examination. However, in certain circumstance, such as examining genitalia, breast, or rectum, explicit consent may be required or best practice, particularly in circumstance where a reasonable patient may not expect such an examination. In surgery, the patient consents to an operation but does not provide explicit consent to the standard procedures involved. For example, the patient would not have to give explicit consent as to the nature of the suture material. Further, often there are a large and complex constellation of physicians and healthcare professionals involved in the care of a particular patient. There is the reasonable presumption that personal health information would be exchanged freely among those involved in delivering the care (with certain notable exceptions). Indeed, these presumptions are codified in the US Health Insurance Portability and Accountability Act of 1996 (Pub.L. 104-191, 110 Stat. 1936, enacted August 21, 1996 section 45 CFR 164.506).

There are four fundamental criteria for informed consent; the patient must be (1) competent; (2) of legal age for consent, although minors may have a right to assent or even consent if deemed sufficiently mature, see Case 13; (3) adequately informed; and (4) able to make uncoerced decision (Cocanour, 2017). It is important to appreciate that such medical informed consent is no different from the elements of any valid contract between people (and corporations) in most pluralistic modern democracies. These elements include: (1) offer and acceptance; (2) consideration, typically an exchange of goods; (3) capacity to enter into a contract; (4) good faith (e.g., disallowing innocent typographical errors to invalidate a contract); and (5) lawful purpose. The elements of a valid contract have existed for hundreds of years and so it is striking that medical informed consent should have gained appreciation essentially since the 1970s. The interesting question is why did the prior relationship between patient and physician or healthcare professional appear to be unlike a valid contract? A valid contract implies a balancing of power between those making and those accepting the contract. Historically (and to this day), the power between the patient and the healthcare delivery system has not been balanced (see Chapter 4).

The elements of a valid contract, and thus medical and research informed consent, are derivative of the fundamental right to bodily integrity and freedom of thought (conscience). These may not be deontological rights but they are de facto rights if there is a universal commitment to enforcement. Universality can be established if a sufficient number of reasonable persons blinded to their self-interest make it so.

In the case presented, the critical issue is the patient being adequately informed. Information provided by the patient usually includes: (1) diagnosis, if known; (2) nature and purpose of the recommended treatment; (3) burdens, risks, and expected benefits; and (4) all reasonable options, including forgoing any treatment. The last element, information regarding all reasonable options, is central to the case presented. Recently added is any potential conflict of interest on the part of those involved in executing the care, for example, whether the physician has a financial interest in the use of levodopa.

The Method of Specification

These four principles or clusters of principles constitute the basic conceptual framework for the analysis of cases and topics in biomedical ethics. At first, this framework is too abstract and content-thin to adequately deal with concrete problems, so it requires enrichment with context-specific secondary principles and rules. For example, the principle of respect for autonomy is specified to the rule of informed consent, stating that any medical treatment is permissible only if the patient has been informed about it and consented to it beforehand. However, it is not sufficient to just state such a rule; it needs detailed explication. For instance, the elements of informed consent, standards of disclosure, required level of understanding, conditions of voluntariness in decision, and criteria of competence to decide have to be determined in order to bring the rule of informed consent to bear on medical practice.

Examples for the specification of the principle of nonmaleficence are the rules not to kill, not to cause pain or suffering, not to incapacitate, which may be further specified with regard to the context of biomedicine. Another example is the so-called therapeutic privilege, stating that a physician may legitimately withhold relevant information from the patient if disclosing the information would bear the risk of harming the patient (e.g., causing depression, resignation, or anxiety). The uses of placebos for therapeutic purposes, hoping for the psychological effect of such remedies, and for scientific purposes, to compare the effect of a drug with a placebo, are examples for the specification of the principle of beneficence. These rules need detailed context-specific explication as well to become operative in medical practice.

Some rules can be interpreted as specifications of two or more principles. For instance, medical confidentiality can be regarded as specification of the principle of nonmaleficence, because patients may be discriminated against in their private and professional life if certain diagnoses become known, such as HIV/AIDS. At the same time, medical confidentiality specifies the principle of respect for the autonomy of persons: it is the patients’ business to decide what kind of information on their state of health may or may not be disclosed to a third person.

Generally speaking, specification is a form of interpreting moral norms. It involves a particular form of reasoning from abstract and content-thin principles to concrete, action-guiding directives by filling in more and more content into the norms in order to reduce their abstractness, to shape their scope, and to make them more and more suitable for dealing with concrete issues and cases. Although the basic idea is straightforward and was implicit in Beauchamp and Childress’ account from the beginning, it was not before 1990 that Henry Richardson developed an explicit account of specification. Technically, specification establishes a relation between two norms, one of them less specific and one of them more specific. This relation is characterized by two conditions: (1) the syntactic condition of glossing the determinables or adding clauses (i.e., spelling out where, when, by what means) to whom, or by whom the less specific norm is to be followed in a given context; (2) the semantic condition of extensional narrowing (i.e., everything that satisfies the specified norm must also satisfy the less specific norm but not vice versa). These two conditions ensure that although the specified norm is different in content, it preserves the normative commitment of the less specific norm from which it is derived. For example, the principle of respect for autonomy is to be followed in the context of healthcare by following the rule of informed consent. Every act that satisfies informed consent also satisfies the principle of autonomy but not vice versa. The rule of informed consent preserves the normative commitment of the principle of respect for autonomy in the particular context of medical treatment.

Specifying moral norms is not a matter of logical deduction or subsumption, but a matter of structured, conceptual reasoning based on deliberative rationality. Often, there is some room for discretion and disagreement over the exact specification of norms. All specified norms are potentially subject to further specification which may result in a sequence of more and more specified norms. In this way, the four general principles can be brought to bear on concrete cases and issues. Since different topics require different pathways of specification, a systematic and comprehensive application of the method of specification leads to a large net of specified norms of different levels of specificity. To develop a net that is woven densely enough to deal with all problems in bioethics (or other areas of applied ethics) is one of the main tasks in principlism.

What is any part of an individual's health information?

What are the 4 elements of the patient's right?

What is the patient's right to privacy?

Why is patient autonomy important?