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Module 3 Introduction

When deciding what to do in a clinical healthcare situation, it helps to take things one step at a time by following an Ethical Order of Operations:

In most cases, following these steps will get you to the point where you are ready to have a productive conversation with the patient/surrogate/guardian about why you are recommending certain options, with the hope of obtaining informed consent so that you can move forward with the patient’s care. Getting consent is an important part of respecting patient autonomy, yet getting consent doesn’t always guarantee that the patient is making a truly autonomous choice. For example, take a moment to puzzle about the following questions:

• What information does a patient need to know in order to make an autonomous choice? Does a patient need to know absolutely every detail about a medical test or procedure, or is some information unnecessary? Could providing too much information be overwhelming for the patient and undermine their autonomy? Does providing too little information leave the patient uninformed and undermine their autonomy?
• Can the way that information gets presented influence or change a patient’s choice? How do knowledge imbalances between providers and patients affect the way that patients understand information? How much medical terminology can a typical patient be expected to understand? How much explaining of technical terminology should providers be expected to do? Why do many patients feel embarrassed to ask questions, and what can providers do to help empower patients to ask questions?
• Can external pressures stop a patient’s consent from being truly voluntary? How do power imbalances between providers and patients affect the way that patients react to information? When a provider mentions an option, do most patients think that the provider is “recommending” that option? How might the provider’s tone of voice or word choice affect the way a patient responds to the information? How might the pressure coming from the patient’s family/community affect the decision that the patient makes?

Answering these questions is important for ensuring that the principle of respect for autonomy is satisfied when obtaining patient consent, and respecting patient autonomy can also include thinking about the conditions under which patient information can be shared with others. This module will challenge you to consider what information is actually necessary or useful to provide to patients, as well as how to frame & communicate that information in a way that patients will actually understand.

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3.1) Criteria for Obtaining Informed Consent

Obtaining informed consent is always necessary before any diagnostic tests, treatments, therapies, or other interventions can move forward. The only exception to this are emergency situations if immediate intervention is required in order to stabilize the patient’s condition. Informed consent is most commonly obtained directly from the patient directly, so long as the patient has decision-making capacity. However, informed consent can also be obtained from a family member if the patient has autonomously chosen to defer their decision-making to another individual, from a surrogate decision-maker (or healthcare power of attorney) if the patient lacks capacity, or from a guardian if the patient has been deemed legally incompetent. For simplicity, we will refer to these other individuals as “proxies” for the patient. Informed consent is necessary for almost any action a healthcare provider wants to perform to ensure that the patient’s autonomy is respected, and failing to get consent fails to satisfy the principle of respect for autonomy.

When obtaining informed consent, a healthcare provider must first present the recommendation(s) and then inform the patient or proxy about the recommendation(s). But what information should be included in this discussion and how can the provider ensure that the patient can make a truly autonomous decision? The five common components of informed consent^[1], which we will refer to as the “informed consent criteria,” help to provide guidance for ensuring that the patient’s consent is sufficiently informed:

1. The patient must have the capacity to meaningfully engage with the recommendation and make a decision. If the patient lacks decision-making capacity or is legally incompetent, a surrogate decision-maker or guardian must be consulted instead. This is the first step in obtaining informed consent because it is about determining who has the authority to provide informed consent for the patient, and thus who the provider should be “informing” in order to try and obtain consent to move forward with the recommendation.
2. The healthcare provider must then give adequate disclosure to the patient or proxy. This is one of the most important steps because it constitutes the informed part of informed consent. In order to adequately inform the patient or proxy, the provider has an obligation to disclose clear and accurate information about what the recommendation involves, including detailing the risks and benefits associated with the recommendation. This requires the healthcare provider to make a judgement about what information is necessary to disclose, and what information might be unnecessary or inappropriate to provide.
3. Once the relevant information has been adequately disclosed, next it becomes important to ensure that the patient or proxy has a sufficient understanding of the information that has been communicated. This often goes beyond the more basic level of understanding that a patient must display when assessing decision-making capacity. Rather than simply assessing the degree to which the patient can engage in a productive conversation about their diagnosis and the possible recommendations, this criteria is about assessing the extent to which the patient understands the specific medical information that has been disclosed about the specific recommendation in question, helping to ensure that the patient has adequately been informed.
4. After the necessary information has been disclosed to the patient or proxy and they have a reasonable understanding of that information, the patient or proxy is finally in a position to make a decision about whether to provide consent. But to satisfy the principle of respect for autonomy, the provider must also ensure that the decision is voluntary on the part of the patient or proxy. This means that the decision is made freely and is not the product of any undue pressure or coercion by an external force.
5. Finally, once all the previous criteria have been met, provider is in a position to obtain consent from the patient or proxy. But importantly, satisfying the previous criteria DOES NOT obligate the patient or proxy to actually provide consent; the very point of this process is to ensure that the patient or proxy is informed enough to decide whether they want to provide consent. If consent is given (often by the signing of a document), this final step has been met and the provider is permitted to move forward with the recommendation that has been discussed. If consent is not given, the provider is prohibited from moving forward due to patient or proxy’s refusal. The provider can then try to obtain consent for a different recommendation or allow the patient’s condition to remain untreated, depending on the specific circumstance surrounding the refusal.

Because the overall goal of obtaining informed consent is to ensure that the patient’s autonomy is being respected, each of the above informed consent criteria is important for satisfying the principle of respect for autonomy. If any of these criteria fail to be met, the consent that was obtained may be considered illegitimate and any resulting actions could be considered a violation of the patient’s autonomy. Any actions that involve touching the patient could even be considered assault if legitimate consent has not been provided. This makes it essential that providers do their due diligence when informing patients and obtaining consent for any recommended testing or medical procedures. However it can still be challenging to determine exactly what information to provide to patients, or how to best communicate to patients. As such, the following sections will examine some of the complexities that can arise when providing information with the goal of obtaining informed consent.

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3.2) Determining What Information to Disclose

The obligation to obtain “informed consent” in healthcare is a surprisingly modern idea. In the United States, there was virtually no discussion of informed consent in medicine before the 1950’s, and the current requirements for obtaining informed consent didn’t begin to emerge and become standardized until the late 1970’s.^[2] For most of history, medicine was decidedly paternalistic. This includes many of the notable figures in medicine and ethics such as Hippocrates (who gave us the “Hippocratic Oath” in the 4th century BC), Thomas Percival (whose writings helped establish the foundation for modern medical ethics in 1803), and William Osler (who became the first Physician-in-Chief at Johns Hopkin’s Hospital in 1889). These and others often expressed a “doctor knows best” attitude about medicine, meaning they thought doctors should be able to provide the “necessary treatments” without any patient input. They sometimes even discussed how to avoid disclosing information that they thought might upset patients or get in the way of the treatments they wanted to provide. Patients were seen as bodies to be fixed, rather than as individuals who should have a say in what was done to them. This is very much the opposite of healthcare today, so what changed?

In the United States, the moral and legal requirements for informed consent arose through the courts as patients began to fight for their legal rights to be heard, to be informed, and to be respected. In the 1950’s, Salgo v. Leland Stanford, Jr. University Board of Trustees (1957), introduced the idea of consent needing to be “informed” for the first time.^[3] The court ruling suggested that when obtaining consent, providers must inform the patient by disclosing specific elements such as the nature of the procedure, any risks & benefits associated with the procedure, and any known alternatives to the procedure. However, reforms didn’t happen overnight, and providers continued to question what information, if any, was really necessary for them to disclose when treating patients.

It wasn’t until the late 1970’s that another court case, Canterbury v. Spence (1972), helped to establish the idea that informed consent criteria should be patient-centered, based on what a “reasonable person” would consider important information to know. According to the court ruling, patients have the right to decide whether to consent or refuse treatment, and “that right can be effectively exercised only if the patient possesses enough information to enable an intelligent choice.”^[4] These court rulings helped to shape and standardize our modern understanding of informed consent, grounded in the idea of respecting a patient’s right to autonomy. And as we will see below, these rulings also help to offer guidance when providers are determining what information is necessary to disclose to a patient.

The Four Elements of Adequate Disclosure:

Adequate disclosure is one of the most important criteria when obtaining informed consent because without it, the patient would be uninformed and their consent would not be valid. However, it is also one of the most challenging criteria to meet, because it requires the healthcare provider to make a judgement about what types of information to disclose, and how much information to provide, in order to “adequately inform” the patient about the recommendation/procedure. And because the information about a particular test or procedure can vary based on how it might affect a patient’s unique medical circumstance, healthcare providers cannot be handed a complete checklist of all and only the information they need to provide. Certainly some types of information can be written out in advance (as you might see on an “informed consent form”), but providers often still need to make professional judgements about what to share with patients when discussing their recommendation. Fortunately, the court ruling in Salgo has helped to outline the four “elements of adequate disclosure” that help to guide healthcare providers in meeting the standards of adequate disclosure:

• The Nature of the Procedure: The provider should give the patient an overview of what the procedure will entail. This includes informing the patient of what they will need to do to prepare for the procedure, what the procedure will involve from a medical standpoint / how the procedure will be performed, how long the procedure is expected to take, and what the patient should expect in terms of recovery after the procedure.
• Risks associated with the Procedure: The provider should inform the patient about all of the possible risks associated with the procedure. This includes both generally known risks and also specific risks related to the patient’s medical condition. The provider should also discuss how likely it is that each risk of harm will occur, and should not leave out any risks on the basis that they are considered unlikely to occur.
• Benefits of the Procedure: The provider should inform the patient about the reasons the procedure is being recommended. This can include both the general benefits and also how it will likely benefit the patient’s unique medical circumstance. This allows the patient to weigh the benefits and harms for themselves, in order to determine whether they think the procedure is likely to produce a net-benefit in relation to their specific goals of care.
• Alternatives to the Procedure: The provider should inform the patient about any reasonable alternatives to the procedure (meaning alternatives that are calculated to produce a net-benefit), as well as informing the patient that they have the option of refusing the procedure. This is because choosing not to do a procedure is often considered as an alternative to the procedure itself, and it should be made clear to patients that they have a choice about whether to move forward with the procedure.

The four “elements of adequate disclosure,” listed above, are helpful for determining the types of information that are important to disclose to patients. However, more guidance is still needed, because providers also need to determine how much detail is necessary to include for each element. For example, when discussing the “nature of the procedure,” is it necessary to tell the patient about the historical developments that brought about the procedure? About the medical science and theory behind the procedure? About the techniques involved in the procedure? About the instruments that will be used during the procedure? About new developments in carrying out the procedure? This list can go on almost infinitely, because there is a wealth of information that can be provided about nearly any medical procedure. But is all this information really necessary or helpful to the patient, or is some information simply overwhelming or unnecessary? To determine how much information counts as an “adequate” amount, we can next turn to the court ruling in Canterbury for guidance.

The “Reasonable Person” Standard:

When thinking about how much information providers ought to disclose to patients, the obvious answer might seem to be that “providers should share the whole truth about the procedure.” After all, aren’t providers doing something wrong when they knowingly withhold important details from patients? While it is correct to say that providers shouldn’t intentionally leave out important details, it is less obvious that every detail that makes up “the whole truth” is actually important. Sometimes, providing too much information can be confusing or overwhelming, making it challenging for the other person to figure out which details actually matter most.

In the above example, your goal in speaking to the florist was to learn whether you should get a bouquet of peonies, tulips, or both. So did the florist’s response help you to make this decision? Probably not, despite having providing you with more than enough information. The issue, in fact, is that the florist provided you with too much information. The florist provided you with the “whole truth” about each option, meaning they gave you absolutely all the information they knew about the subject. But not all of this information was actually helpful or necessary for deciding which type of flower would make for a better bouquet! Some of the information WAS relevant, such as knowing about the shapes of blooms, the colors options for the blooms, and the growing season/availability for each type of flower. But this information becomes difficult to focus on when it is surrounded by unnecessary additional facts, such as the history and social significance of each type of flower.

It should be easy to see how providing too much information can also raise similar issues in a healthcare context. If a patient is presented with two treatment options and asks their provider for a recommendation about which option would be best, if their healthcare provider attempted to provide the “whole truth” just like the florist did, it would result in a confusing overload of unnecessary information. This is because most patients don’t need to know all of the scientific facts or historical details about a procedure in order to make a decision about whether an option would be helpful to treat their current health condition. And providing too much unnecessary or unhelpful information can quickly overwhelm the patient, making it challenging for them to figure out which information IS actually relevant for making an autonomous decision. So when disclosing information related to the elements of adequate disclosure, the provider doesn’t need to give the patient the “whole truth,” but should instead focus on only providing information that would be “reasonably meaningful” to the patient’s decision.

This brings us back to Canterbury, the court case that helped to establish the idea that information provided should be “reasonably meaningful” to the patient based on what a reasonable person would consider important information to know. In that court case, the physician provided too little information by failing to mention the risk of paralysis, which turned out to be a serious issue when the patient became paralyzed due to the procedure. But it would have also created an issue in the opposite direction if the physician had provided too much information, for example if the risks were hidden among two dozen other irrelevant facts, such that patient wasn’t able to easily sort through or understand the relevant risks. The patient’s ability to understand the information and use it in making a judgement about the relevant options is important for being able to make an autonomous decision. So when disclosing information related to the “elements of adequate disclosure,” providers must use their professional judgement to make thoughtful decisions about how much information is actually necessary to provide in order to ensure that the patient is reasonably informed without being overwhelmed.

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3.3) Presenting Medical Information to Patients

Once we have a clear idea of what information is important to communicate, the next step is determining how to communicate that information effectively. The previous discussion acknowledges that there is a knowledge imbalance between patients and providers, which is to be expected because providers have undergone extensive medical training whereas most patients have not. But there is also a significant power imbalance between between patients and providers, because patients are the ones seeking help when they feel at their worst while providers are the gatekeepers of potential medical assistance. On top of that, navigating healthcare often feels scary and unfamiliar to patients who don’t have a lot of experience with it, while navigating healthcare can feel very routine and easy for providers who do it regularly as their job. This means that information that might seem standard to a provider can easily come across as alarming or confusing to their patients. So in order to effectively communicate information to patients such that they can make informed, autonomous decisions based on that information, healthcare providers need to be aware of these imbalances in order to take a step back and understand things from their patient’s perspective.

Thinking about how a patient might hear or interpret medical information is a good start to thinking about how to appropriately frame & communicate that information in a way that patients will actually understand. One of the simplest things that can make a big difference for patients is avoiding the use of (or thoroughly explaining) medical jargon. But what is “medical jargon,” exactly? If you’re asking that question, it’s because the word “jargon” is an example of “jargon!” The phrase “medical jargon” refers to specialized language and vocabulary used by insiders of the medical profession who have the expert knowledge to understand it, but which is so specialized that it would be confusing or even unintelligible to outsiders of the profession (such as patients).

Because the importance of informed consent is to allow patients to make informed decisions about their medical care, it matters that patients are able to comprehend the information that is provided. As seen in the example above, if the information is communicated using abbreviations and terms that patients are likely unfamiliar with, the patient will be unable to make sense of the information and remains effectively uninformed about the decision. This is why it is best practice to avoid the use of medical jargon when communicating technical information to patients.

But even when the information is being communicated in plain language, it also matters how that information is framed and presented. When communicating, we are always making choices about how to frame and present our ideas, even if we’re doing it sub-consciously. For example, in witting this Module, I’ve had to make choices about the ordering of the sections (the order in which the information gets presented) and the phrasing of each sentence (how each idea gets explained). Every sentence I write presents me with a choice, and sometimes a struggle, about how to explain things most clearly for my audience (you). Some sentences I’ve written and re-written three or four times to try and get right, and some sentences could probably still be written more clearly than they are. Even when using the same vocabulary, the meaning of an idea can become more or less clear based on how it is framed.

The “framing of information” is the idea that the way facts and information get be presented can often lead to different decisions or judgements about the information. The examples above illustrate different ways in which the patient’s prognosis could be framed, some with a positive tone, some with a negative tone, and some with a more neutral tone. And the differences in tone may influence some patients to think about the information differently; if presented with a positive tone, the patient might be more willing to consent to the surgery, but if presented with a negative tone the patient might doubt whether the surgery is really worth it for them. It isn’t always obvious which of these framings is best, as one patient may prefer information to be framed positively while another prefers it be framed more neutrally or realistically. Because of this, there is no single correct answer as the best way to frame challenging medical conversations or to present complex information, and the best way to frame the information will likely depend on being sensitive to the needs and attitudes of the particular patient you’re talking to.

One final situation to consider is a when a healthcare provider lacks certain information altogether. In some cases, especially when the patient first presents with an issue and the provider wants to run diagnostic tests in order to determine the source and extent of the issue, the provider needs to get informed consent from the patient without actually knowing all the medical facts (hence the point of the testing). But how should a provider present information in order to obtain informed consent when they don’t have all the facts themselves? This situation is referred to as the “condition of doubt” because the provider is in doubt about what the facts are. For example, a patient might ask “could my frequent migraines be caused by a brain tumor?” If no diagnostic tests have been run yet, the answer could turn out to be either yes or no, so the provider can’t say “yes” and they can’t say “no.” Should the provider say “I don’t know” or “I’m not sure yet?” Some patients might appreciate that level of honesty, while others might become even more anxious.

When providers are in the condition of doubt, they need to inform their patients of the reasons for the diagnostic testing and other information related to the elements of adequate disclosure, but without being able to say anything for certain about the nature of the patient’s issue. This requires providers to be even more thoughtful about deciding exactly what information is important to communicate, and how to frame that information in a way that is helpful for the patient’s understanding without providing any false hope or raising any unnecessary concerns. This is a delicate line to walk, and even if the provider is very thoughtful in communicating that information, there is still no guarantee that the patient will hear or interpret the information in the way the provider expected. Communicating effectively with others raises a series of interpersonal challenges to overcome, but if we take seriously the need to inform patients in order to support and respect their autonomous decision-making, it is a challenge that providers must rise to meet.

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3.4) Ensuring Voluntary Choices

The previous sections have been focused on the second and third criteria for obtaining informed consent: Providing adequate disclosure and ensuring patient understanding. Assuming these are done well, it is then important that the provider ensure that the patient’s decision is voluntary, meaning that the patient is making an autonomous decision free from undue pressure or coercion. One way that a patient’s decision might fail to be voluntary would be if the provider withheld specific information in order to sway the patient’s decision one way or another. However, because that would not only be inappropriate but would fail to meet the criteria for adequate disclosure, we can assume that any healthcare provider taking informed consent seriously would refrain from doing this.

What is more likely is that the patient’s decision would fail to be voluntary because of outside pressures from their own family, friends, or community. For example, if a patient’s spouse says “you need to agree to the surgery or I’ll divorce you,” the patient isn’t fully able to consider the merits and drawbacks of the surgery when making a decision, given that their choice is being constrained by the ultimatum their spouse gave. This is an example of an “external constraint” on autonomy. An “external constraint” is a circumstances where factors that are external to the patient (meaning they are social pressures being placed on the patient) constrain the patient’s ability to freely make their own decision. This is in contrast to an “internal constraint” which was about the patient’s cognitive ability to process the information. An external constraint occurs when a patient has decision-making capacity, but is unable to fully exercise it because they don’t feel like they have a real choice in the matter due to external factors such as the desires of their family and friends.

But not all social pressures rise to the level of an “external constraint.” Many patients prefer that the people they’re close to accompany them to the hospital, or visit them while they’re there, and it’s natural for these loved ones to have opinions about the care the patient receives. When your mother suggests that you get a flu vaccine or a regular check-up “just to be safe,” she isn’t taking away your autonomous ability to decide whether to do these things. And if your significant other tells you that they think surgery sounds like a good idea, or that they think you should agree to the surgery, that isn’t necessarily putting undue pressure on you either. An external constraint only occurs when the desires of someone else are expressed so strongly, or in a way that stops the patient from being able to make a genuine choice about whether to consent. There can be a fine line between love, concern, and undue pressure, so it has become common practice that providers will often ask family members to leave the room in order to speak with the patient one-on-one. This can give the patient the space to speak freely about any concerns they may have, or to ask any questions they might have been afraid to ask with others present.

Other healthcare practices, such as keeping patient medical information confidential, can also help to limit potential external constraints and help to ensure patients feel comfortable making autonomous choices. The Health Insurance Portability & Accountability Act (HIPAA) is a federal law that set the standards for protecting patient health information by keeping it confidential. Confidentiality in healthcare means that patient information must be protected from unauthorized disclosures, and that patient information can only be accessed by authorized individuals on a need-to-know basis, such as other healthcare providers or health insurers. So if a patient receives a certain diagnosis or is presented with certain treatment options, no other individuals including the patient’s family, friends, or employers have a right to access that information.

Confidentiality is also important for helping the patient to feel comfortable sharing information with their providers, knowing that whatever they disclose will be kept private as well. Sometimes a patient’s health concerns involve sensitive subjects such as substance addiction, sexual disfunction, or involve sensitive parts of the body that are uncomfortable to discuss. Confidentiality helps to ensure that the patient is in control of their own health information, whether it’s information they are disclosing or information being disclosed to them. The patient can then make their own decisions about what to do with their private information, including who they want to allow or deny access to that information. This helps to ensure that patient’s decisions are free from external constraints, such as coercion or undue pressure from family and friends, because confidentially allows the patient to feel comfortable knowing that whatever they decide will not be discussed with others without their express permission. 

The one exception to patient confidentiality, allowed by HIPAA, are situations in which the patient lacks decision-making capacity and is appointed a surrogate decision-maker. The surrogate becomes a “personal representative” for the patient, meaning they become an authorized individual who is provided information on a need-to-know basis in order to make decisions about the patient’s care. Because a healthcare provider still needs to obtain informed consent for any test or procedure, even when the patient lacks capacity, the surrogate decision-maker needs to be informed just as the patient would have been so that they can provide informed consent or an informed refusal on the patient’s behalf.

Works Cited