Definition: Informed consent is the requirement that physicians share decision-making with patients. Informed consent is an extension of the principle of autonomy, introduced in FPC in the organs block. Informed consent is how physicians operationalize respect for patient autonomy.
Clinical Applications: The phrase “informed consent” has a variety of meanings, depending on the context and speaker. Two broad categories of meaning are:
1) Mutual decision-making between the doctor and the patient. This is the broadest definition of informed consent. It involves an open exchange of information, education on options and alternatives for care, and assisting the patient in making a decision that is consistent with his/her values.
2) Obtaining the patient’s consent for medical procedures or participation in research trials. This sense of informed consent focuses purely on legal requirements for disclosure rather that shared decision-making. Often, it only involves a warning of the risks of proposed interventions and may simply refer to a legal procedure that protects physicians and medical centers from litigation (e.g., having a patient sign a waiver/consent form before surgical procedures). However, simply having a patient sign a form is not informed consent. The signature should only be seen as confirmation that a conversation between the physician and patient occurred.
Between these two extremes lie various interpretations of informed consent and the degree to which the doctor assists the patient and assists him/her in making an informed choice.
In order to meet the broadest definition of informed consent, the following are required:
Competence – the ability for the patient to understand and make decisions. Assessing patient competence in making autonomous decisions will be introduced during Brain, Mind, and Behavior.
Disclosure – the doctor shares information and advice that are necessary for the patient to make an informed decision about medical treatment. Physicians should share:
the nature of the proposed intervention(s)
expected benefits, risks, and likely consequences of proposed action (including emotional and social consequences)
alternatives to the proposed intervention along with the benefits, risks, and likely consequences (alternatives that other reasonable physicians would recommend)
recommendations, opinions, and advice. Physician recommendation and advice are often essential for patients to make sound decisions.
This is the key part of informed consent. The amount of information shared should be sufficient for the patient to understand the decision. Patients do not need to become medically savvy or gain medical knowledge like a physician. The physician must explain the information in simple terms yet convey the benefits and risks of the intervention enough so that the patient can decide if the benefits outweigh the risks. Physicians should elicit and answer all patient questions.
Understanding – the patient not only receives the information, but must also understand the implications of what the doctor has shared. It is important to remember that patients are often in emotional states that limit or impair understanding and rational decision-making so it is the doctor’s duty to facilitate this understanding.
Voluntariness – the patient makes the decision while free of coercion, persuasion, or manipulation
Consent – the patient agrees to participate in the discussed treatment plans and gives consent for necessary procedures
Examples of situations involving informed consent:
Broad definition: Translating statistics about risks and benefits into terms and concepts that are meaningful to a patient with breast cancer deciding between lumpectomy and mastectomy; discussing treatment options with a patient with prostate cancer; explaining the potential emotional consequences of a positive test for the BRCA1 gene mutation; discussing the risks and benefits of a renal biopsy including how the information from the biopsy will be used to benefit the patient and the potential risks and their likelihood and how they would be treated.
Narrow/legal definition: Asking a patient to sign a consent form for a surgical procedure in the emergency room; and translating an emergency room informed consent form into a foreign language for non-native English speakers.
Clinical Applications: The phrase “informed consent” has a variety of meanings, depending on the context and speaker. Two broad categories of meaning are:
1) Mutual decision-making between the doctor and the patient. This is the broadest definition of informed consent. It involves an open exchange of information, education on options and alternatives for care, and assisting the patient in making a decision that is consistent with his/her values.
2) Obtaining the patient’s consent for medical procedures or participation in research trials. This sense of informed consent focuses purely on legal requirements for disclosure rather that shared decision-making. Often, it only involves a warning of the risks of proposed interventions and may simply refer to a legal procedure that protects physicians and medical centers from litigation (e.g., having a patient sign a waiver/consent form before surgical procedures). However, simply having a patient sign a form is not informed consent. The signature should only be seen as confirmation that a conversation between the physician and patient occurred.
Between these two extremes lie various interpretations of informed consent and the degree to which the doctor assists the patient and assists him/her in making an informed choice.
In order to meet the broadest definition of informed consent, the following are required:
Competence – the ability for the patient to understand and make decisions. Assessing patient competence in making autonomous decisions will be introduced during Brain, Mind, and Behavior.
Disclosure – the doctor shares information and advice that are necessary for the patient to make an informed decision about medical treatment. Physicians should share:
the nature of the proposed intervention(s)
expected benefits, risks, and likely consequences of proposed action (including emotional and social consequences)
alternatives to the proposed intervention along with the benefits, risks, and likely consequences (alternatives that other reasonable physicians would recommend)
recommendations, opinions, and advice. Physician recommendation and advice are often essential for patients to make sound decisions.
This is the key part of informed consent. The amount of information shared should be sufficient for the patient to understand the decision. Patients do not need to become medically savvy or gain medical knowledge like a physician. The physician must explain the information in simple terms yet convey the benefits and risks of the intervention enough so that the patient can decide if the benefits outweigh the risks. Physicians should elicit and answer all patient questions.
Understanding – the patient not only receives the information, but must also understand the implications of what the doctor has shared. It is important to remember that patients are often in emotional states that limit or impair understanding and rational decision-making so it is the doctor’s duty to facilitate this understanding.
Voluntariness – the patient makes the decision while free of coercion, persuasion, or manipulation
Consent – the patient agrees to participate in the discussed treatment plans and gives consent for necessary procedures
Examples of situations involving informed consent:
Broad definition: Translating statistics about risks and benefits into terms and concepts that are meaningful to a patient with breast cancer deciding between lumpectomy and mastectomy; discussing treatment options with a patient with prostate cancer; explaining the potential emotional consequences of a positive test for the BRCA1 gene mutation; discussing the risks and benefits of a renal biopsy including how the information from the biopsy will be used to benefit the patient and the potential risks and their likelihood and how they would be treated.
Narrow/legal definition: Asking a patient to sign a consent form for a surgical procedure in the emergency room; and translating an emergency room informed consent form into a foreign language for non-native English speakers.
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