Legal Ease
Informed Consent
And Its Changing Nature
July 2003
I nformed consent seldom tops lists of doctors’ legal concerns in the twenty-first century, but failures to account for its effects continue to draw physicians into litigation. Nationwide, informed consent is an allegation in 30% to 35% of all malpractice claims. One recent case in California illustrates how present applications of informed consent are harder than ever for doctors to comply with in this day and age.
A Concerning Case in California
In the case of Huerta vs. Defeo, which is presently before a California court, a plaintiff is seeking to expand the type of information that a physician should disclose to a patient prior to performing surgery.1 This case is an example of how informed consent case claims can manifest in unanticipated fashions.
In Huerta, the surgeon presented his spinal surgical patient with a consent document that identified several possible complications involved in spinal surgery, including “death, infection, and paralysis and weakness of the lower extremities.” Following the surgery, the patient experienced symptoms that, while not specifically identified in the consent document, were certainly included under the broad areas identified. The patient claimed that had he been advised of these specific risks, he wouldn’t have undergone the surgery. Notably, the plaintiff also claimed that the physician, during the informed consent process, should have disclosed additional information — including a settlement with the Medical Board of California (MBC) in which the physician agreed to probation.
The fact that a doctor’s disciplinary history can be claimed to be the basis for a failure to provide informed consent reveals how the application of informed consent has mutated, making it even more difficult for doctors to comply with this process.
To understand the evolution of informed consent, I’ll provide some insight into the origins and requirements of informed consent. I’ll also highlight some studies that show that doctors often don’t provide adequate informed consent and that patients usually are unable to recall what information their doctors gave to them before procedures. Finally, I’ll give you some steps to follow to decrease claims for breach of informed consent and suggest a simplified way for presenting informed consent information to your patients that will also decrease the risk of litigation.
The Origins of Informed Consent
The concept of informed consent received its initial articulation in 1914, when Supreme Court Justice Benjamin Cardozo wrote:
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency...”
Cardozo’s strongly worded dicta gave patients potent but still circumscribed power. Although doctors in Cardozo’s day were required to get permission from patients to perform surgery, they weren’t required to explain the potential risks. Presently, the law provides patients with the right not only to consent or not consent to undergo procedures but to be actively engaged in the informed consent process.
What Patients Need To Know
Generally, we must explain the following three things to patients:
• the nature of the procedure
• the “significant” or “material” risks of the procedure
• the reasonable alternatives to the procedure (including, when appropriate, the option of doing nothing).
A “procedure” can be a surgery — or an invasive test or treatment. Significant or material risks are those that involve potentially serious temporary or permanent injury or disability. For major surgery, significant risks may include death, paralysis, hemorrhage or infection.
How Laws Vary
Informed consent law has a variety of permutations in different states. In states such as Florida, failure to provide information does not itself provide a basis for an informed consent claim. The law provides that even if a jury concludes that the doctor didn’t give the patient the information he should have, the jury should still decide the case in favor of the doctor if the jury believes that the patient probably would’ve consented anyway had he received the information.
New York provides a defense to informed consent litigation in cases where the patient assures the provider that he would undergo the treatment regardless of risk, or if the patient indicates that he doesn’t want to be given the information required by law. By statute, certain jurisdictions, including Texas, have concluded that any signed consent form is presumptively valid as informed consent.
State laws generally utilize a “reasonable patient standard,” a “professional standard,” or both, for defining the quantity of information needed.
• Reasonable patient standard. Physicians must disclose what a reasonable person in the patient’s situation must know to provide informed consent.
• Professional standard. A doctor must disclose to patients what a reasonable physician would ordinarily disclose to the patient. Hawaii, Louisiana and Texas have created “disclosure panels,” composed of professional peers, to establish the appropriate information to be disclosed about a given procedure or treatment.
The Difference Between Informed Consent and a Consent Form
It’s important to understand that a consent form and informed consent differ.2 A signed consent form is not a substitute for an oral dialogue between patient and doctor. A medical student or nurse lacks the legal authority to obtain “informed consent” for a patient’s doctor.
Patients’ lawyers know that sometimes patients learn of risks and are initially presented with a consent form immediately prior to a procedure. Some lawsuits claim that even though a patient had questions or didn’t fully understand a proposed procedure, the patient signed the consent form “under duress,” because the staff told the patient that unless he or she executed the consent, the procedure would be canceled.
Additional complications to informed consent exist. Although in some states, the law deems a signed consent form as evidence that the patient did give an informed consent, malpractice defense attorneys can’t easily refute a plaintiff’s claim that the consent form was signed without comprehending its contents. Nevertheless, a consent form signed by a patient after patient-doctor discussion and after obtaining information on which to base an informed decision shields a doctor against claims that a patient’s consent wasn’t an informed one.
Are You Overlooking this Protective Element?
Having a one-on-one discussion with your patient can go a long way to protect you against potential lawsuits. However, these conversations are often not utilized by physicians. In a study published in the Journal of the American Medical Association in 1999, researchers at the University of Washington in Seattle found that most patients have too little decision-making dialogue with their doctors. In fact, there was minimal discussion about the patients’ understanding of the treatments or procedures they were to receive.
Researchers studied audiotapes from 1,057 routine office visits to primary-care physicians and surgeons. Dialogue was coded to ensure the doctors covered seven subjects deemed vital for informed decision-making, including pros and cons of the treatment being discussed and the alternatives, as well as the patients’ treatment preference.
A “basic” decision was classified as one with minimal effect on the patient, involving something that the medical community agrees is important and useful, such as testing for cholesterol levels. A “complex” decision would affect a patient extensively, and involve something considered controversial and possibly have an uncertain outcome — for example, whether to take a test for a cancer-causing gene. While 17% of “basic” decisions were rated as “informed,” that label applied to only 0.5% of the “complex” decisions.
Even if doctors fully explain information to patients, most patients don’t appear to integrate or recall this information. One study investigated 100 patients who were interviewed by an independent medical observer in a teaching hospital surgical unit between 2 and 5 days after their operations. Although all of the patients interviewed were fully aware that they’d had an operation, 27 did not know which organ was operated on, and 44 were unaware of the exact nature of the surgical procedure.3
In general, studies show that only about 35% of patients recall the risks that were explained to them.4 Another study concluded that the fulfillment by neurosurgeons of the doctrine of informed consent may very well be mythical.5
Written information and audiovisual aids have been found to increase patient recall and understanding. In one study, two patient groups were observed during the routine consent process. Patients in both groups were either to undergo a thyroidectomy or parotidectomy. Each group received a verbal checklist of risks specific for the surgery to be performed. The intervention group also received a pamphlet with written information accompanied by illustrations.
The overall risk recall rate for both procedures was 39.1%. The recall rate of the intervention group was 50.3% compared with 29.5% for the control group (P<.001).6
The law still deems that written and audiovisual materials supplement but don’t replace a discussion of informed consent.
Creating a Well-Tuned Consent Form
Here are some pointers for developing a useful and protective informed consent form.
• Make sure the form is written in plain language that is easy for patients to understand.
• Talk to colleagues and other specialists about what information they present to patients. This will enhance and possibly expand the information you add to your informed consent form.
• Include information in the consent form that is procedure-specific. So for example, a consent form for Mohs might include alternatives of therapy such as radiation, or no treatment.
• Include language in the form to indicate that the patient had an opportunity to ask questions and that all questions were answered.
• Make sure to give the consent form to patients at a visit before the procedure.
• At the conclusion of an informed consent discussion, ask the patient to sign the form, and then you sign it as well. Make sure the patient has a copy. By giving the patient a copy of the consent, the consent becomes better evidence that a dialogue has taken place.
• Finally, reference the discussion and consent in the medical record.
Discussing the Risks with Patients
Because the list of potential risks is lengthy, a two-step litmus test should be used for deciding what risks to discuss with patients. First, inform patients of serious potential risks, even if the risk of occurrence is minimal such as death, permanent disability, infection, bleeding, organ damages, serious anesthetic or drug reactions, and other potentially serious complications specific to that particular patient. Second, for other risks, follow the 1% rule: If a less serious complication has even a 1% chance of occurrence, it should be disclosed.
The Changing Face of Informed Consent
I believe that the requirement for oral dialogue should be abandoned by all states in favor of deeming written consent forms as valid expression of informed consent. Then all states could follow the practices of Hawaii, Louisiana and Texas whose “disclosure panels” (composed of professional peers) have established the appropriate information to be disclosed about a given procedure or treatment.
Changes in medicine make written consent forms the most appropriate embodiment of consent. In this age of for-profit-hospitals, HMOs and physician ratings, providing patients with the highest level of comfort and understanding of the procedures they’ll undergo is the logical step to take.
Informed consent continues to be a fertile field for plaintiff’s lawyers and a thicket for physicians. But by taking practical steps to optimize written consent forms, we’ll increase our patients’ understanding and minimize our legal liability.
I nformed consent seldom tops lists of doctors’ legal concerns in the twenty-first century, but failures to account for its effects continue to draw physicians into litigation. Nationwide, informed consent is an allegation in 30% to 35% of all malpractice claims. One recent case in California illustrates how present applications of informed consent are harder than ever for doctors to comply with in this day and age.
A Concerning Case in California
In the case of Huerta vs. Defeo, which is presently before a California court, a plaintiff is seeking to expand the type of information that a physician should disclose to a patient prior to performing surgery.1 This case is an example of how informed consent case claims can manifest in unanticipated fashions.
In Huerta, the surgeon presented his spinal surgical patient with a consent document that identified several possible complications involved in spinal surgery, including “death, infection, and paralysis and weakness of the lower extremities.” Following the surgery, the patient experienced symptoms that, while not specifically identified in the consent document, were certainly included under the broad areas identified. The patient claimed that had he been advised of these specific risks, he wouldn’t have undergone the surgery. Notably, the plaintiff also claimed that the physician, during the informed consent process, should have disclosed additional information — including a settlement with the Medical Board of California (MBC) in which the physician agreed to probation.
The fact that a doctor’s disciplinary history can be claimed to be the basis for a failure to provide informed consent reveals how the application of informed consent has mutated, making it even more difficult for doctors to comply with this process.
To understand the evolution of informed consent, I’ll provide some insight into the origins and requirements of informed consent. I’ll also highlight some studies that show that doctors often don’t provide adequate informed consent and that patients usually are unable to recall what information their doctors gave to them before procedures. Finally, I’ll give you some steps to follow to decrease claims for breach of informed consent and suggest a simplified way for presenting informed consent information to your patients that will also decrease the risk of litigation.
The Origins of Informed Consent
The concept of informed consent received its initial articulation in 1914, when Supreme Court Justice Benjamin Cardozo wrote:
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency...”
Cardozo’s strongly worded dicta gave patients potent but still circumscribed power. Although doctors in Cardozo’s day were required to get permission from patients to perform surgery, they weren’t required to explain the potential risks. Presently, the law provides patients with the right not only to consent or not consent to undergo procedures but to be actively engaged in the informed consent process.
What Patients Need To Know
Generally, we must explain the following three things to patients:
• the nature of the procedure
• the “significant” or “material” risks of the procedure
• the reasonable alternatives to the procedure (including, when appropriate, the option of doing nothing).
A “procedure” can be a surgery — or an invasive test or treatment. Significant or material risks are those that involve potentially serious temporary or permanent injury or disability. For major surgery, significant risks may include death, paralysis, hemorrhage or infection.
How Laws Vary
Informed consent law has a variety of permutations in different states. In states such as Florida, failure to provide information does not itself provide a basis for an informed consent claim. The law provides that even if a jury concludes that the doctor didn’t give the patient the information he should have, the jury should still decide the case in favor of the doctor if the jury believes that the patient probably would’ve consented anyway had he received the information.
New York provides a defense to informed consent litigation in cases where the patient assures the provider that he would undergo the treatment regardless of risk, or if the patient indicates that he doesn’t want to be given the information required by law. By statute, certain jurisdictions, including Texas, have concluded that any signed consent form is presumptively valid as informed consent.
State laws generally utilize a “reasonable patient standard,” a “professional standard,” or both, for defining the quantity of information needed.
• Reasonable patient standard. Physicians must disclose what a reasonable person in the patient’s situation must know to provide informed consent.
• Professional standard. A doctor must disclose to patients what a reasonable physician would ordinarily disclose to the patient. Hawaii, Louisiana and Texas have created “disclosure panels,” composed of professional peers, to establish the appropriate information to be disclosed about a given procedure or treatment.
The Difference Between Informed Consent and a Consent Form
It’s important to understand that a consent form and informed consent differ.2 A signed consent form is not a substitute for an oral dialogue between patient and doctor. A medical student or nurse lacks the legal authority to obtain “informed consent” for a patient’s doctor.
Patients’ lawyers know that sometimes patients learn of risks and are initially presented with a consent form immediately prior to a procedure. Some lawsuits claim that even though a patient had questions or didn’t fully understand a proposed procedure, the patient signed the consent form “under duress,” because the staff told the patient that unless he or she executed the consent, the procedure would be canceled.
Additional complications to informed consent exist. Although in some states, the law deems a signed consent form as evidence that the patient did give an informed consent, malpractice defense attorneys can’t easily refute a plaintiff’s claim that the consent form was signed without comprehending its contents. Nevertheless, a consent form signed by a patient after patient-doctor discussion and after obtaining information on which to base an informed decision shields a doctor against claims that a patient’s consent wasn’t an informed one.
Are You Overlooking this Protective Element?
Having a one-on-one discussion with your patient can go a long way to protect you against potential lawsuits. However, these conversations are often not utilized by physicians. In a study published in the Journal of the American Medical Association in 1999, researchers at the University of Washington in Seattle found that most patients have too little decision-making dialogue with their doctors. In fact, there was minimal discussion about the patients’ understanding of the treatments or procedures they were to receive.
Researchers studied audiotapes from 1,057 routine office visits to primary-care physicians and surgeons. Dialogue was coded to ensure the doctors covered seven subjects deemed vital for informed decision-making, including pros and cons of the treatment being discussed and the alternatives, as well as the patients’ treatment preference.
A “basic” decision was classified as one with minimal effect on the patient, involving something that the medical community agrees is important and useful, such as testing for cholesterol levels. A “complex” decision would affect a patient extensively, and involve something considered controversial and possibly have an uncertain outcome — for example, whether to take a test for a cancer-causing gene. While 17% of “basic” decisions were rated as “informed,” that label applied to only 0.5% of the “complex” decisions.
Even if doctors fully explain information to patients, most patients don’t appear to integrate or recall this information. One study investigated 100 patients who were interviewed by an independent medical observer in a teaching hospital surgical unit between 2 and 5 days after their operations. Although all of the patients interviewed were fully aware that they’d had an operation, 27 did not know which organ was operated on, and 44 were unaware of the exact nature of the surgical procedure.3
In general, studies show that only about 35% of patients recall the risks that were explained to them.4 Another study concluded that the fulfillment by neurosurgeons of the doctrine of informed consent may very well be mythical.5
Written information and audiovisual aids have been found to increase patient recall and understanding. In one study, two patient groups were observed during the routine consent process. Patients in both groups were either to undergo a thyroidectomy or parotidectomy. Each group received a verbal checklist of risks specific for the surgery to be performed. The intervention group also received a pamphlet with written information accompanied by illustrations.
The overall risk recall rate for both procedures was 39.1%. The recall rate of the intervention group was 50.3% compared with 29.5% for the control group (P<.001).6
The law still deems that written and audiovisual materials supplement but don’t replace a discussion of informed consent.
Creating a Well-Tuned Consent Form
Here are some pointers for developing a useful and protective informed consent form.
• Make sure the form is written in plain language that is easy for patients to understand.
• Talk to colleagues and other specialists about what information they present to patients. This will enhance and possibly expand the information you add to your informed consent form.
• Include information in the consent form that is procedure-specific. So for example, a consent form for Mohs might include alternatives of therapy such as radiation, or no treatment.
• Include language in the form to indicate that the patient had an opportunity to ask questions and that all questions were answered.
• Make sure to give the consent form to patients at a visit before the procedure.
• At the conclusion of an informed consent discussion, ask the patient to sign the form, and then you sign it as well. Make sure the patient has a copy. By giving the patient a copy of the consent, the consent becomes better evidence that a dialogue has taken place.
• Finally, reference the discussion and consent in the medical record.
Discussing the Risks with Patients
Because the list of potential risks is lengthy, a two-step litmus test should be used for deciding what risks to discuss with patients. First, inform patients of serious potential risks, even if the risk of occurrence is minimal such as death, permanent disability, infection, bleeding, organ damages, serious anesthetic or drug reactions, and other potentially serious complications specific to that particular patient. Second, for other risks, follow the 1% rule: If a less serious complication has even a 1% chance of occurrence, it should be disclosed.
The Changing Face of Informed Consent
I believe that the requirement for oral dialogue should be abandoned by all states in favor of deeming written consent forms as valid expression of informed consent. Then all states could follow the practices of Hawaii, Louisiana and Texas whose “disclosure panels” (composed of professional peers) have established the appropriate information to be disclosed about a given procedure or treatment.
Changes in medicine make written consent forms the most appropriate embodiment of consent. In this age of for-profit-hospitals, HMOs and physician ratings, providing patients with the highest level of comfort and understanding of the procedures they’ll undergo is the logical step to take.
Informed consent continues to be a fertile field for plaintiff’s lawyers and a thicket for physicians. But by taking practical steps to optimize written consent forms, we’ll increase our patients’ understanding and minimize our legal liability.
I nformed consent seldom tops lists of doctors’ legal concerns in the twenty-first century, but failures to account for its effects continue to draw physicians into litigation. Nationwide, informed consent is an allegation in 30% to 35% of all malpractice claims. One recent case in California illustrates how present applications of informed consent are harder than ever for doctors to comply with in this day and age.
A Concerning Case in California
In the case of Huerta vs. Defeo, which is presently before a California court, a plaintiff is seeking to expand the type of information that a physician should disclose to a patient prior to performing surgery.1 This case is an example of how informed consent case claims can manifest in unanticipated fashions.
In Huerta, the surgeon presented his spinal surgical patient with a consent document that identified several possible complications involved in spinal surgery, including “death, infection, and paralysis and weakness of the lower extremities.” Following the surgery, the patient experienced symptoms that, while not specifically identified in the consent document, were certainly included under the broad areas identified. The patient claimed that had he been advised of these specific risks, he wouldn’t have undergone the surgery. Notably, the plaintiff also claimed that the physician, during the informed consent process, should have disclosed additional information — including a settlement with the Medical Board of California (MBC) in which the physician agreed to probation.
The fact that a doctor’s disciplinary history can be claimed to be the basis for a failure to provide informed consent reveals how the application of informed consent has mutated, making it even more difficult for doctors to comply with this process.
To understand the evolution of informed consent, I’ll provide some insight into the origins and requirements of informed consent. I’ll also highlight some studies that show that doctors often don’t provide adequate informed consent and that patients usually are unable to recall what information their doctors gave to them before procedures. Finally, I’ll give you some steps to follow to decrease claims for breach of informed consent and suggest a simplified way for presenting informed consent information to your patients that will also decrease the risk of litigation.
The Origins of Informed Consent
The concept of informed consent received its initial articulation in 1914, when Supreme Court Justice Benjamin Cardozo wrote:
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency...”
Cardozo’s strongly worded dicta gave patients potent but still circumscribed power. Although doctors in Cardozo’s day were required to get permission from patients to perform surgery, they weren’t required to explain the potential risks. Presently, the law provides patients with the right not only to consent or not consent to undergo procedures but to be actively engaged in the informed consent process.
What Patients Need To Know
Generally, we must explain the following three things to patients:
• the nature of the procedure
• the “significant” or “material” risks of the procedure
• the reasonable alternatives to the procedure (including, when appropriate, the option of doing nothing).
A “procedure” can be a surgery — or an invasive test or treatment. Significant or material risks are those that involve potentially serious temporary or permanent injury or disability. For major surgery, significant risks may include death, paralysis, hemorrhage or infection.
How Laws Vary
Informed consent law has a variety of permutations in different states. In states such as Florida, failure to provide information does not itself provide a basis for an informed consent claim. The law provides that even if a jury concludes that the doctor didn’t give the patient the information he should have, the jury should still decide the case in favor of the doctor if the jury believes that the patient probably would’ve consented anyway had he received the information.
New York provides a defense to informed consent litigation in cases where the patient assures the provider that he would undergo the treatment regardless of risk, or if the patient indicates that he doesn’t want to be given the information required by law. By statute, certain jurisdictions, including Texas, have concluded that any signed consent form is presumptively valid as informed consent.
State laws generally utilize a “reasonable patient standard,” a “professional standard,” or both, for defining the quantity of information needed.
• Reasonable patient standard. Physicians must disclose what a reasonable person in the patient’s situation must know to provide informed consent.
• Professional standard. A doctor must disclose to patients what a reasonable physician would ordinarily disclose to the patient. Hawaii, Louisiana and Texas have created “disclosure panels,” composed of professional peers, to establish the appropriate information to be disclosed about a given procedure or treatment.
The Difference Between Informed Consent and a Consent Form
It’s important to understand that a consent form and informed consent differ.2 A signed consent form is not a substitute for an oral dialogue between patient and doctor. A medical student or nurse lacks the legal authority to obtain “informed consent” for a patient’s doctor.
Patients’ lawyers know that sometimes patients learn of risks and are initially presented with a consent form immediately prior to a procedure. Some lawsuits claim that even though a patient had questions or didn’t fully understand a proposed procedure, the patient signed the consent form “under duress,” because the staff told the patient that unless he or she executed the consent, the procedure would be canceled.
Additional complications to informed consent exist. Although in some states, the law deems a signed consent form as evidence that the patient did give an informed consent, malpractice defense attorneys can’t easily refute a plaintiff’s claim that the consent form was signed without comprehending its contents. Nevertheless, a consent form signed by a patient after patient-doctor discussion and after obtaining information on which to base an informed decision shields a doctor against claims that a patient’s consent wasn’t an informed one.
Are You Overlooking this Protective Element?
Having a one-on-one discussion with your patient can go a long way to protect you against potential lawsuits. However, these conversations are often not utilized by physicians. In a study published in the Journal of the American Medical Association in 1999, researchers at the University of Washington in Seattle found that most patients have too little decision-making dialogue with their doctors. In fact, there was minimal discussion about the patients’ understanding of the treatments or procedures they were to receive.
Researchers studied audiotapes from 1,057 routine office visits to primary-care physicians and surgeons. Dialogue was coded to ensure the doctors covered seven subjects deemed vital for informed decision-making, including pros and cons of the treatment being discussed and the alternatives, as well as the patients’ treatment preference.
A “basic” decision was classified as one with minimal effect on the patient, involving something that the medical community agrees is important and useful, such as testing for cholesterol levels. A “complex” decision would affect a patient extensively, and involve something considered controversial and possibly have an uncertain outcome — for example, whether to take a test for a cancer-causing gene. While 17% of “basic” decisions were rated as “informed,” that label applied to only 0.5% of the “complex” decisions.
Even if doctors fully explain information to patients, most patients don’t appear to integrate or recall this information. One study investigated 100 patients who were interviewed by an independent medical observer in a teaching hospital surgical unit between 2 and 5 days after their operations. Although all of the patients interviewed were fully aware that they’d had an operation, 27 did not know which organ was operated on, and 44 were unaware of the exact nature of the surgical procedure.3
In general, studies show that only about 35% of patients recall the risks that were explained to them.4 Another study concluded that the fulfillment by neurosurgeons of the doctrine of informed consent may very well be mythical.5
Written information and audiovisual aids have been found to increase patient recall and understanding. In one study, two patient groups were observed during the routine consent process. Patients in both groups were either to undergo a thyroidectomy or parotidectomy. Each group received a verbal checklist of risks specific for the surgery to be performed. The intervention group also received a pamphlet with written information accompanied by illustrations.
The overall risk recall rate for both procedures was 39.1%. The recall rate of the intervention group was 50.3% compared with 29.5% for the control group (P<.001).6
The law still deems that written and audiovisual materials supplement but don’t replace a discussion of informed consent.
Creating a Well-Tuned Consent Form
Here are some pointers for developing a useful and protective informed consent form.
• Make sure the form is written in plain language that is easy for patients to understand.
• Talk to colleagues and other specialists about what information they present to patients. This will enhance and possibly expand the information you add to your informed consent form.
• Include information in the consent form that is procedure-specific. So for example, a consent form for Mohs might include alternatives of therapy such as radiation, or no treatment.
• Include language in the form to indicate that the patient had an opportunity to ask questions and that all questions were answered.
• Make sure to give the consent form to patients at a visit before the procedure.
• At the conclusion of an informed consent discussion, ask the patient to sign the form, and then you sign it as well. Make sure the patient has a copy. By giving the patient a copy of the consent, the consent becomes better evidence that a dialogue has taken place.
• Finally, reference the discussion and consent in the medical record.
Discussing the Risks with Patients
Because the list of potential risks is lengthy, a two-step litmus test should be used for deciding what risks to discuss with patients. First, inform patients of serious potential risks, even if the risk of occurrence is minimal such as death, permanent disability, infection, bleeding, organ damages, serious anesthetic or drug reactions, and other potentially serious complications specific to that particular patient. Second, for other risks, follow the 1% rule: If a less serious complication has even a 1% chance of occurrence, it should be disclosed.
The Changing Face of Informed Consent
I believe that the requirement for oral dialogue should be abandoned by all states in favor of deeming written consent forms as valid expression of informed consent. Then all states could follow the practices of Hawaii, Louisiana and Texas whose “disclosure panels” (composed of professional peers) have established the appropriate information to be disclosed about a given procedure or treatment.
Changes in medicine make written consent forms the most appropriate embodiment of consent. In this age of for-profit-hospitals, HMOs and physician ratings, providing patients with the highest level of comfort and understanding of the procedures they’ll undergo is the logical step to take.
Informed consent continues to be a fertile field for plaintiff’s lawyers and a thicket for physicians. But by taking practical steps to optimize written consent forms, we’ll increase our patients’ understanding and minimize our legal liability.
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October 2024
Volume 32
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