Informed Consent

Introduction

Health care providers treating patients need to obtain patient consent before proceeding. The same holds for medical researchers carrying out research on human subjects.

This consent can be truly “informed” only after the patient or subject understands the nature of the test, treatment, or research and the possible risks and benefits. The process of obtaining informed consent typically results in a document or form signed by the patient or subject stating that he or she agrees to allow the test, procedure, or study to be carried out.

Controversy about the topic of informed consent includes the issues of whether legal and moral understandings of informed consent are different, whether the moral requirements for informed consent are ever truly met, and under what circumstances providers may provide treatment in the absence of informed consent.

Legal vs. Moral Requirements for Informed Consent

Legal requirements: In many parts of the world, and certainly in the United States, providers and healthcare institutions are legally required to obtain informed consent from patients before administering tests, procedures, and other therapeutic interventions, and before allowing participation in research studies. This legal requirement is commonly considered satisfied if:

the patient has decision-making capacity (decisional capacity) and
the patient signs a consent form or document.

Various interpretations exist of the necessary conditions for a patient to possess decision-making capacity:

Sufficient age, commonly eighteen
Ability to understand the nature, possible risks, and anticipated benefits of the proposed intervention
Ability to use the information provided to come to a freely chosen decision
Not mentally impaired so as to prevent understanding
Judgment not compromised by illness, medication, or alcohol

The determination of whether a patient possesses decisional capacity is sometimes difficult to make and open to question. When a patient’s awareness is compromised by sedation or the nature of the illness or injury, the determination of whether the “consenting” patient really possesses decision-making capacity may affect the decision to proceed with treatment.

The patient must not only be able to provide consent, the patient must actually give consent. Usually this is indicated by the patient signing his or her name to a statement saying consent is being given. In some contexts oral consent or something less than a signature may be considered sufficient, though an impartial third party may be required as a witness that consent was given.

The claim of informed consent might be challenged if it is shown that the consent was obtained by coercion of the patient (or subject) or the consent was given under duress.

Moral requirements: Some ethicists believe that the true moral requirements for informed consent are more extensive than merely having a patient with decisional capacity and a signed consent document. The principle of respect for patient autonomy, for instance, may be held to require that it be verified that the patient or subject truly understands the nature and other details of the intervention. On this view, the provider should engage the patient in dialogue until the provider is sure the patient really understands what has been explained.

For example, in a particular jurisdiction the legal requirements of informed consent may be satisfied and yet any of the following still have occurred:

the clinician going over the procedure and other details rushed through the process so quickly that the patient did not really understand much at all
the consent was obtained at the last minute, right before the procedure was about to take place, and the patient did not feel free to back out at that time even if he or she had wanted to
the patient was daydreaming when crucial information was explained
the information presented was too technical for the patient to grasp
the patient wanted more time to think about the information before deciding
the information, whether written or oral, was presented in a language that was not the native language of the patient
the patient feels coerced in a subtle way by the expectations of family members, the physician, or other healthcare workers
the research subject is financially poor and consents to participate in the study just so he or she can receive money that is being offered

Any of the above in the right circumstances could prevent the patient or research subject from understanding important details of the nature of the intervention or research study or voluntarily giving his or her consent.

To ensure truly informed consent, the following practices have been suggested. In certain contexts some of these may not be practical or needed.

Information presented should include, as appropriate, the nature of the recommended procedure, test, or other intervention, risks and expected benefits, the diagnosis behind the treatment recommendation, and the certainty of the diagnosis. Also presented should be alternative treatment options (including the option of non-treatment) along with their details (nature, risks, benefits), who would do them and where they would be done. The patient should be told about cost and insurance coverage, whether the treatment is the standard of care or experimental, and the right to a second opinion on the diagnosis or treatment.
Information should be explained to the patient in a language he or she can understand. This may require translators and/or consent forms in multiple languages.
Technical details should if possible be in a form the patient can understand.
The provider or other clinicians should not attempt to slant information presented so as to coerce or manipulate the patient’s choice.
The patient should understand he or she can refuse tests, treatment, or participation and what consequences that may have for his or her health.
The provider should make reasonable efforts to ensure the patient understands what has been said: asking the patient to repeat back, not overwhelming them with long explanations or forms at one time, making sure they feel comfortable asking questions and expressing emotions.
The patient or research subject may need time to think about it before deciding.
The provider should be able provide recommendations and advice when requested by the patient.
The patients values, religious beliefs, and cultural or ethnical traditions should be explored to the extent these might have an influence on making a decision.
The attempt should be made to allow the patient to make a free and uncoerced decision apart from the influence, expectations, or threats of family and friends.
Subjects in research study should not be misled or otherwise deceived about the true nature of the research.
Subjects in a research study should be given the opportunity to reconsent or refuse further participation should the study change significantly

In the context of actual healthcare delivery in hospitals and medical offices, the above guidelines probably represent more of an ideal than common practice. Certainly many times patients have been asked to give consent without receiving a full explanation of the nature and possible risks of the procedure. For example, often the patient undergoing a routine blood test will not be advised about possible complications of the blood draw.

The patient undergoing a surgical intervention in a major hospital will almost certainly be presented with a detailed consent form to sign, though it might be presented very close in time to the actual procedure. They, as well as smaller medical practices, may have a more general blanket consent form to sign. In the case of minor routine tests sometimes no consent form is presented to the patient. In some instances consent is considered implied by the continued physical presence of the patient.

Is Truly Informed Consent Even Possible?

Critics sometimes charge that truly informed consent is impossible or never occurs. A variety of reasons are given for this view:

Patients don’t know enough and aren’t smart enough: Patients do not have the needed technical background, or intelligence, to understand the nature of the procedure and accurately assess the risks involved.
Patients are not experts at risk assessment: Even patients who think they understand enough to assess the risks probably don’t. The patient may be asked to decide between options involving vague probabilities of this or that outcome happening. The patient is asked to decide based on assessing risks of possible outcomes he or she has no real feel for, since the patient hasn’t lived them (for example, life with limited mobility, life in a wheelchair, life with a failed intervention requiring repeated hospitalizations, etc.).
Providers cannot give unbiased presentations: No physician can present all the details of the situation as he or she knows it; it would take too long and the patient would not understand the technical details. So the presentation will necessarily be selective. The physician will inevitably present the information in a way that makes the option the physician thinks best to be the one the patient most likely will choose.
Patients are looking for provider guidance: The patient may even just ask the physician, “What do you recommend?” or “What would you do?” Patients don’t want a presentation of all the options, they want to be told what the provider would do and then be able to say yes or no. But this is not truly informed consent.

Far from respecting patient autonomy, critics charge, the illusion of informed consent serves only to masquerade paternalism on the part of the physician or healthcare team.

Defenders of the concept of informed consent try to blunt or refute these criticisms along the following lines:

Informed consent requires not all possible information but just enough adequate information:Strictly speaking, if absolutely complete knowledge is required to make an informed decision, not even the physician has this much. Medical decisions are often made under uncertainty. What matters is not that the patient or physician have absolutely all possible information but that he or she have adequate information. Many technical details can be left out if they have no relevance to the decision of which option to choose. For most patients, sufficient time spent explaining and discussing options can result in enough information to be able to make an informed decision.
The careful provider can present options fairly: The charge of paternalism is too hasty. The physician can try to be objective and present the material fairly enough for the patient to decide. Educators and journalists are often able to present various sides to a controversy even though they may have their own individual opinions. The fact that a selection of the details must be made does not preclude the selection from being a balanced presentation.

Reimbursement for medical research participation presents a special case where critics charge informed consent is unlikely due to the coercive power of the prospect of payment. Significant amounts of cash or providing a subject with an appliance or other goods or services may be too strong to resist and influence the subject’s decision to participate. Prisoners may be swayed by privileges given for research participation, privileges they otherwise might not be able to obtain. Researchers often claim that reimbursement is meant to compensate subjects for the time and effort of participation, but such reimbursement may act as an intentional or unintentional incentive to gain participation. This subject remains an area of controversy.

Exceptions to the Requirement of Informed Consent

Emergency situations arise in which a person requiring immediate life-saving treatment is unconscious or otherwise temporarily incapacitated and therefore cannot give informed consent. Family members should be consulted and asked to give “surrogate” consent, but sometimes they are not readily available. “Therapeutic privilege” is commonly invoked to justify treating a patient in the absence of explicit consent.

In such cases the recommendation is commonly made to document the circumstances and explain the situation to the patient as soon as possible.

Similar situations may arise when the patient cannot give informed consent because of a longer-term incapacitating disease or impairment or because the patient is a minor. In such cases surrogate consent may be requested from parent or legal guardian. They are presumed to be acting in the patient’s best interests and so the relevant information should be explained to them.

A more controversial situation occurs when the physician believes obtaining informed consent could cause harm to the patient. An emotionally unstable patient may experience debilitating anxiety, fear, nervousness, etc. upon hearing detailed explanations of procedures and risks and become depressed and even suicidal. Some ethicists argue that in situations in which this would preclude the patient from making a rational decision, the physician is morally permitted to withhold information.

Tom Regan, Empty Cages