Category Archives: Informed consent (week 6)

A Reflection on Faden and Beauchamp’s Concept of Informed Consent

Faden and Beauchamp differentiate two definitions of Informed consent. In their entry “The Concept of Informed Consent”, they label these two definitions into different senses. The first sense, labeled Sense1, distinguishes informed consent as being “active authorization” by the patient. This is to be differentiated from agreeing or submitting to an authoritative figure, in which Faden gives an interesting example; A child submitting to a punishment such as a spanking from an authoritative figure, like a parent, and the child giving an active directive to do so of their own autonomy are distinct. Sense1 can be defined as a patient of their own autonomy who has substantial understanding of the procedure intentionally authorizing a professional to perform said procedure. Katz views informed consent and shared decision-making between patient and doctor as synonymous, to which Faden Beauchamp do not agree. They view shared decision-making to be manipulative and under the Sense1 definition, a shared decision does not need to be reached for a patient to exercise autonomous authorization.

Conversely, the second sense, labeled Sense2, is defined as effective consent, or obtainment of procedures that satisfy rules and requirements of institutional practice. In other words, the informed consent that was valid in sense1 is only valid in sense2 if they meet the requirements -often of social or legal design- of that said practice. The example Faden gives is a 19-year-old giving authorized consent to a kidney transplant. This meets the definition of informed consent in Sense1, however because the law states the legal age of consent to surgery is 21, the decision is not valid under Sense2. Adequate consent in Sense1 does not always equal adequate consent in Sense2 and vice versa. Faden and Beauchamp rest on the idea that the justification behind obtaining informed consent is in deference to autonomy. While Sense2 is “morally acceptable” even when it differs significantly from Sense1, it can veer away from the absolute necessity for authoritative autonomy and therefore prove problematic in terms of morality.

Informed Consent Reflection

Informed Consent is crucial in the field of medicine and science so that patients or subjects know of the consequences that could arise from a certain procedure or research. Without this framework of consent put in place to allow patients to be autonomous with their decisions, or at least most of their decisions if they are able to make such a decision, the results could be catastrophic.

In the article “The Concept of Informed Consent” by Ruth Faden and Tom Beauchamp, two very clear views of consent were distinguished. These views include autonomous authorization and informed consent as effective consent, or otherwise known as sense1 and sense2 respectively.

Sense1, or autonomous authorization, takes into effect when a patient provides more than an expressed agreement with, or the patient complies, with an arrangement or proposal. The patient would need to actively authorize the professional to move forward with a procedure or research. Sense1 also contains four acts in which the patient is required to follow. These acts include; (1) Substantial understanding (2) Substantial absence of control by others (3) Intentional compliance (4) authorization of a professional. Without the complete actions of one through four, the consent becomes obsolete and is no longer under the branch of informed consent. A patient may abide by the first three steps, but without the fourth, the consent no longer follows such rules set by autonomous authorization and that is what distinguishes informed consent as a kind of autonomous action.

Sense2, or informed consent as effective consent, stated as a “…policy-oriented sense whose conditions are not derivable solely from analysis of autonomy and authorization…” (Faden and Beauchamp). This sense is based on a legally or institutionally effective authorization, and it focuses on regulating the behavior of the professional and it also establishes rules and procedures for the consent of the patient or subject.

Lastly, the article mentions shared decisionmaking between the professional and the patient, and this form of decisionmaking is unethical. This form is unethical due to the manipulative properties and may distort the patient’s views and decisions causing them to possibly make a decision that was unintentional in the first place. Without the framework of informed consent from both senses, the medical and scientific field would be filled with unethical, and morally questionable, practices, completely demolishing the patient or subject and professional relationship.

Unresolved Ambiguities within the Canterbury Court Decision

Defining a foolproof protocol for informed consent within medicine requires courts to quantify something that cannot be quantified. The amount of ambiguity within this court decision may have concerning consequences for patients. The court is overall reasonable in setting precedent for this complex issue. However, potential problems remain, both as a function of the inherently convoluted topic of informed consent and of certain gaps within the court’s ruling.

How much information physicians should disclose, when, and to whom, leaves room for debate. The court states the information needs to be “relevant” to the case and a reasonable person who would work on it must approve of this. The “relevance” of information is undeniably ambiguous, but perhaps this is impossible to cover with a single law, as the risks for craniectomies require more thorough explanation than those of wisdom teeth surgery, for example. The court provides an adequate incentive for physicians to notify patients of all potential, relevant risks: the patient can hold the physician liable in court for something that the physician did not warn them of and that had causal relationship from their procedure.

There remain many problems with the wide latitude of behavior legally protected by therapeutic privilege. It is hard to argue that this does not become a direct threat to patient autonomy. The lack of stipulations makes patients vulnerable to abuse, as the physician can take advantage of the patient with legal justification. Invoking this privilege during treatment for a patient with anxiety and depression who may experience distress is wrong, as they are still competent, autonomous beings. In extremely rare cases, such as delusional parasitosis, the use of therapeutic privilege may be appropriate. The court doesn’t specify the legal conditions when it is permissible to withhold information from the patient. The court seems to try to distinguish between non-disclosure and paternalism, but really what is the difference in practice? 

Another potential issue arises in the court’s assertion that physicians should not have to warn of inherent risks of surgery, such as infection, as people of “average sophistication” should already know such things. While in many cases this may be true, there is no algorithm for measuring someone with “average sophistication.” Infection is a serious complication and it is the patient’s right to be told.

There are bound to be points of contention in this court decision, as putting this principle into action ultimately becomes very legally intricate in the world of medicine.

Concept of Informed Consent — A reflection on Faden and Beauchamp

In the article “The Concept of Informed Consent,” Faden and Beauchamp discuss two ways of understanding informed consent: informed consent as autonomous authorization and informed consent as effective consent. The first sense of informed consent would require that a specific patient actively agree to a given procedure; to simply acquiesce — the way someone might acquiesce to punishment that she does not desire — is not sufficient. Instead, the patient must autonomously authorize the procedure 1) knowing the nature of the procedure, 2) not being controlled in her decision making, 3) intending to undertake the specific procedure, and 4) saying “yes” explicitly. This idea of informed consent would seem to require some discernible mental event in the patient; its identification might be very fact specific. Faden and Beauchamp distinguish this type of informed consent from that of “shared decision making” because informed consent does not require that the patient participate in the identification of possible treatments. It simply requires a clear and autonomous decision to go forward with one of the treatments presented by the doctor. 

The second sense of informed consent is as effective consent; this means that the physician has accorded with procedures that satisfy the rules in a particular medical context. Here the doctor must satisfy disclosure and competency rules. He must, for instance, tell the patient what the procedure is and the possible outcomes that might result. He must also make sure that the patient is of age and mentally competent. However, there doesn’t necessarily need to be some autonomous mental event within the patient in order for the doctor to proceed. Faden and Beauchamp find the second option less satisfying philosophically because, instead of getting at whether informed consent truly took place, it simply provides a framework by which to make inferences about possible consent. It gives circumstances that often go along with consent rather than necessarily identifying it in a given case. I agree that Faden and Beauchamp’s first sense is more philosophically compelling because it requires the showing of autonomous consent under particular circumstances. On the other hand, the second theory might be a more efficient legal test, because it doesn’t require as much scrutiny about the patient’s state of mind (which is difficult to identify) and instead gives certain observable criteria — such as age, mental capacity, or sobriety — that can stand in for autonomy, understanding, and intentionality. 

Faden and Beauchamp’s Informed Consent – reflection

Faden and Beauchamp make the claim in “The Concept of Informed Consent” that it is possible to have sense1 of informed consent (autonomous authorization) and fail to have sense2 of informed consent (policies that are enforced in the context of institutions). It is also possible they claim to have the roles reversed, where informed consent in sense2 has been achieved but not sense1. Their argument is valid, however in order to resolve many of the issues they bring up near the end of the selected passage, it is imperative to implement (or atleast strive to do so to the best of one’s ability) both sense1 and sense2 of informed consent at all times in medical practice, so as to protect the doctor/researcher and patients/subjects.

Sense1 of informed consent in medicine emphasizes that a patient must not simply yield to a professional when enrolling in research or commencing a medical program, but rather have the competence to understand disclosed information and freely agree to such a thing. While this does aim to ensure that autonomy is upheld and doctors are not able to implement paternalistic measures, problems are able to arise in practical situations. For example, when a doctor performs surgery on someone who may actually have autonomously authorized verbally said procedure, but when something accidentally goes wrong then sues the doctor for malpractice. In this instance, sense2 of informed consent is necessary to protect the doctor in the court of law. 

Conversely, sense2 of informed consent in medicine is defined as authorization deemed to be effective for medical and research settings; it satisfies the rules of an institution and is heavily relied upon in legal situations. Sense2 aims to settle the problem presented when only sense1 is relied upon. However with simply sense2, patients may be unprotected from what they personally view as harm. The legal authorization of research or medical intervention by a patient effectively transfers responsibility and authority to the professional and if the criteria that constitutes the legal authorization (i.e. sense2) does not employ the need of a subject’s competence to understand disclosed information and freely agree to such a thing then other problems arise. Thus reinforcing the fact that sense1 is needed to protect patients.

The authors end the passage by affirming that sense2 should and often is developed with sense1 in mind, but bring up some problems about how to exercise both in practice. I argue that both should be applied at all times, even for minor procedures so that patients and doctors are protected both in terms of general wellness and legal situations. 

Reflection on The Concept of Informed Consent by Faden and Beauchamp

In “The Concept of Informed Consent”, by Ruth Faden and Tom Beauchamp, they discuss the two primary philosophies of informed consent, which they label Sense1 and Sense2. Sense1’s primary focus is on patient autonomy and the requirements for true authorization. Under this definition, informed consent is given if “A patient with (1) substantial understanding and (2) substantial absence of control by others (3) intentionally (4) authorizes a profession to do intervention”. Overall, Sense1 concentrates on autonomous authorization and patients’ rights. 

Conversely, Sense2 focuses on the legal aspects of informed consent. Sense2 is a policy-oriented lens that doesn’t take into consideration the patient’s right to autonomy. While Sense1 had specific steps to determine if autonomous authorization has given informed consent, under Sense2, any consent is informed consent. Autonomous authorization does not exist, merely authorization that has been well documented through procedures that satisfy the rules in institutional practice. 

While Sense1 and Sense2 may seem mutually exclusive, they can be implemented simultaneously. For example, a patient may give autonomous authorization while also documenting said authorization in the form of a consent agreement, thereby reflecting both definitions of informed consent. However, just because both definitions of informed consent can be reached, it doesn’t mean they always are in practice. Faden and Beauchamp present and example wherein a minor gives the autonomous authorization to donate one of her kidneys to her dying twin sister. While the sister’s life is saved, because she is a minor, her parents decide to sue the healthcare team because they violated her Sense2 informed consent. This highlights that Sense1 and Sense2 are not only individually important but ought to be obtained when the situation grants it. 

Ultimately, Faden and Beauchamp conclude that only Sense1 truly captures the traditional meaning of “Informed consent”, which I agree with. I would argue that, for most people, informed consent is given when a doctor explains the procedure to you and you decided to proceed. This is encapsulated in the Sense1 definition of informed consent and isn’t covered in the Sense2 definition. To me, Sense2 is more of a legal definition, and while important, doesn’t necessarily apply when strictly discussing bioethics and patients’ right to autonomy. Consequently, if I had to rank the value or importance of these definitions, I would say Sense1 should be prioritized over Sense2. ( Though, as illustrated by the kidney example, both ought to be obtained).

Reflection on the idea of “informed consent” proposed by Katz.

In “The Concept of Informed Consent”, Ruth and Tom discuss the idea of an informed consent. They claim that an informed consent may be thought of in terms of sense one, in which the person making the consent authorizes the action being done to him in an autonomous matter. For example, patient being fully aware of a kidney transplant procedure, willing to receive a kidney, and knowing the risks associated with the procedure is giving an informed consent in sense one. Sense two, on the other hand, an informed consent in sense to may refer to the legislative procedures that is required in order to carry out a medical procedure, and one of that does not necessarily contain an autonomously made consent of the individual herself.

Then, Katz argues that informed consent made in sense two should be closer to informed consent made in sense one, entailing that any legislation or procedural consent before an operation should mean that the patient should give an autonomous consent, notably by himself.

In one of his arguments, Kats argue that “shared decision” making between a patient and a doctor is not a decision made independently by the patient, and thus is not autonomous. However, when this example is given, it is not clearly stated whether what level of communication is intervening with the autonomous decision of the patient. Surely, doctors should not give physical threats to go through medical procedures. However, merely informing the patients about the procedure could not be considered as ‘forcing’ the patient to make the decision, and some clear distinction of how decision is forcefully imposed on the patient is needed.

In all circumstances, I believe that any steps taken to ensure that a fully authorized decision, for instance leaving one day in between making the decision, is rightfully justified in the grounds of making sure that the patient is fully aware of the situation. However, in examples such as minors needing to make informed decisions with the consent of a parent, matters become more complex. In this specific example, the criteria that I believe should be applied is whether we believe that the minor is able to make fully autonomous decisions with rational capabilities that resemble a full-grown adult.

This criteria should apply to every other cases of decision being made in favor of other people, and instead of setting rules such as restricting age or diagnosing patients as mentally ill and therefore granting others to make decisions for them, I believe that it is morally rightful that hospitals and governments make case by case evaluations of the rationality and autonomous capabilities of people.

Evaluating the underlying assumptions in arguments for paternalism

In “Paternalism”, Gerald Dworkin provides various arguments for and against the use of paternalism and gives exceptions to when paternalism should be specifically allowed. One specific distinction that Dworkin makes is the difference between pure paternalism, which is the case in which the people whose freedom is restricted is identical to the people whose intended to benefit from such intervention, and impure paternalism, which is the case in which by trying to protect the welfare of one group, we also restrict the freedom of those other then who are granted the benefit.

Dworkin then observes that it is impure paternalism which is inherently evil as it restricts the will and autonomy of a person. With this fundamental assumption in mind, Dworkin gives fundamental several scenarios in which paternalism could be applied without rightfully preserving the will of a person.

However, before analyzing his claims, I firstly reject the assumption that personal autonomy should be preserved. Similar to how Plato suggests in his work “the republic”, I believe that attempting to preserve everyone’s right to choose their own value will hinder the society as a whole in pursuing what is know as the “common good” such as health, wellbeing and prosperity. If the society allows individuals to pursue values that go against these common goods without restriction, more people will be influenced and more likely to be influenced in a way that their “free will” chose values that harm the society’s values as stated in Hobbes “natural condition of mankind”.

On the other hand, if we accept this assumption, there are still faults in Dworkins theories. Although I agree with the notion that the burden of persuading the paternalistic measures should be imposed upon the government, a perfectly fair persuasion of the government on the many individuals would be practically impossible as it is absurd to physically consult with every individual’s interests. However, not doing so would oppose Mill’s idea that it is wrong to violate one’s autonomy.

Another claim Dworkin makes is that we are justified in pursuing paternalism if we know that an individual would agree with it after experiencing the situation himself, for instance, dying of lung cancer after smoking too many cigarettes. However, this claim is, again, absurd, as one cannot accurately predict the future, and even if they were to know surely, if the individual does not believe in that promised future, it still means that we are violating the autonomy of that person in the present. In this case, as Kant might say, the burden of death due to choosing to smoke cigarettes should not be in the concern of others, if it means that it violates ultimate values of autonomy, but we should instead fault the wisdom of the individual who chose such fate, even if the person valued a long and healthy life.