HealthStream Regulatory Script
Informed Consent
Release Date: August 2009
HLC Version: 602
Lesson 1: Introduction
Lesson 2: Ethics, Law, & Accreditation
Lesson 3: Special Cases
1
Lesson 1: Introduction
1001
Introduction
Welcome to the introductory lesson on informed consent.
IMAGE: 1001.JPG
This introductory lesson gives the course rationale, goals, and outline.
As your partner, HealthStream strives to provide its customers with excellence in
regulatory learning solutions. As new guidelines are continually issued by regulatory
agencies, we work to update courses, as needed, in a timely manner. Since
responsibility for complying with new guidelines remains with your organization,
HealthStream encourages you to routinely check all relevant regulatory agencies
directly for the latest updates for clinical/organizational guidelines.
If you have concerns about any aspect of the safety or quality of patient care in your
organization, be aware that you may report these concerns directly to the Joint
Commission.
Page 1 of 4
1002
Course Rationale
When you think of informed consent, you may think of the written
consent forms that patients are sometimes asked to sign.
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In fact, informed consent is not the same thing as a consent form.
Instead, informed consent has to do with communication between a
patient and a provider.
This communication allows the patient to make informed decisions
about treatment options.
This course will teach you what you need to know to:
• Protect the patient’s right to make treatment decisions.
• Comply with the doctrine [glossary] of informed consent.
You will learn about:
• Ethics [glossary], law, and accreditation concerns related to
informed consent
• Special cases of informed consent
Page 2 of 4
1003
Course Goals
After completing this course, you should be able to:
• Recognize the basis for informed consent
• Identify Joint Commission requirements for informed consent
• List special cases in which informed consent is not required
• Identify cases in which informed consent is given by someone
other than the patient
NO IMAGE
Page 3 of 4
1004
Course Outline
This introductory lesson gave the course rationale and goals.
FLASH ANIMATION: 1004.SWF/FLA
Lesson 2 covers informed consent ethics, law, and accreditation
concerns.
Finally, lesson 3 describes special cases of informed consent.
Page 4 of 4
Lesson 2: Ethics, Law, & Accreditation
2001
Introduction & Objectives
Welcome to the lesson on ethics, law, and accreditation.
FLASH ANIMATION: 2001.SWF/FLA
After completing this lesson, you should be able to:
• Recognize the basis for informed consent in ethical and legal
doctrine
• Define “full disclosure,” including the various legal standards
for full disclosure
• List the types of procedures that require consent
• Define and distinguish between implied and express consent
• Identify Joint Commission requirements for informed consent
Page 1 of 23
2002
Communication
Remember: Informed consent has to do with communication.
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In this communication, the healthcare provider gives the patient
information. The provider must give this information in a way that the
patient can understand.
This information allows the patient to make healthcare decisions.
Page 2 of 23
2003
Communication Requirements
The healthcare provider has several concerns when it comes to
communicating with patients in the process of informed consent.
IMAGE: 2003.GIF
These concerns are:
• Ethics
• Law
• Accreditation
On the following screens, let’s take a closer look at each type of
concern.
Page 3 of 23
2004
Informed Consent: Ethical Duties
Why do healthcare providers have ethical duties around informed
consent?
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One of the four guiding principles of medical ethics is respect for
patient autonomy.
Respect for patient autonomy means that the healthcare provider
has a duty to protect the patient’s right to make treatment decisions.
This includes the right to accept or refuse treatment.
Page 4 of 23
2005
Informed Consent: Ethical Duties
For patients to make informed choices about accepting or refusing
treatment, they must receive all the necessary information.
IMAGE: 2005.JPG
Therefore, healthcare providers have an ethical duty to provide all the
necessary information.
Page 5 of 23
2006
Ethical Requirements: Full Disclosure
Recap: Healthcare providers have an ethical duty to provide patients
with all the necessary information to make informed choices.
IMAGE: 2006.SWF/FLA
Another term for all the necessary information is full disclosure.
But which information is included in full disclosure?
In general, the following information is considered necessary for
patients to know:
• The diagnosis
• The recommended treatment
• The nature and purpose of the recommended treatment
• The risks and benefits of the recommended treatment
• Other treatments available
• The risks and benefits of other treatments
• The risks and benefits of no treatment
Page 6 of 23
2007
Ethical Requirements: Patient Right to Decide
Remember: The ethical duty to obtain informed consent is based on
the patient’s right to make healthcare choices.
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Always respect this right:
• Present the medical facts accurately.
• Never try to convince the patient to accept a certain type of
treatment by not giving important information.
• Remember that a patient may refuse treatment for any
reason, even if that reason does not make sense to you.
If a patient does refuse treatment, be sure to explain what is likely to
happen because of that decision.
Page 7 of 23
2008
Informed Consent: Legal Requirement
Why do healthcare providers have legal duties around informed
consent?
IMAGE: 2008.GIF
These duties are also based on the patient’s right to accept or refuse
treatment.
Page 8 of 23
2009
Informed Consent: Legal Requirement
All 50 states in the U.S. accept that patients have a right to choose
their own treatment. Therefore, all 50 states have a legal doctrine of
informed consent.
IMAGE: 2009.SWF/FLA
This means that healthcare providers in any state may be fined or
sued if they do not obtain informed consent for treatment.
A provider who treats a patient without any consent at all may be
sued for medical battery.
A provider who treats a patient without informed consent may be
sued for medical malpractice.
Page 9 of 23
2010
Legal Requirement: Consent vs. Informed Consent
Be sure to understand the difference between consent and informed
consent.
IMAGE: 2010.SWF/FLA
When a patient agrees to treatment, this is consent.
When a patient agrees to treatment after receiving all the necessary
medical information, this is informed consent.
What happens if a patient gives consent, but not informed consent?
If the patient suffers injury related to the information he or she did not
receive from the provider, the patient may sue the provider for medical
malpractice.
Page 10 of 23
2011
Legal Requirements
Remember: Each state has its own laws about informed consent.
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Therefore, exact requirements differ from state to state.
Keep this in mind as we continue on the following screens to review
the legal requirements for:
• Which procedures require consent
• Who must obtain consent
• Full disclosure
• Consent forms
Page 11 of 23
2012
Legal Requirements: Which Procedures Require Consent
Informed consent must be obtained for any medical or surgical
procedure that involves touching the patient’s body.
Consent for these procedures may be:
• Implied
• Express
Click on each of type of consent for more information.
CLICK TO REVEAL
Implied consent
Implied consent is not direct written or spoken consent.
Instead, it is consent given through the patient’s
behavior. For example, a patient gives implied consent
when he or she:
• Stands in line for a vaccination
• Comes to the doctor’s office after making an
appointment for a checkup
In these cases, the healthcare professional does not
need to obtain direct written or spoken consent from the
patient to proceed.
Express consent
Express consent refers to consent by direct written or
spoken words. This type of consent is required for
procedures such as invasive surgery. For certain
procedures, spoken consent may not be enough. State
law may require written consent. In any case, it is
always best to have a signed written consent form,
even if it is not required legally. Express consent
remains valid only for a limited period of time.
Page 12 of 23
2013
Legal Requirements: Who Must Obtain Consent
The attending physician has the legal duty to obtain informed consent.
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The physician may give this responsibility to a representative.
If the representative does not obtain valid informed consent, the
physician remains legally responsible.
Page 13 of 23
2014
Legal Requirements: Full Disclosure
Remember: Full disclosure means all the information that a patient
should be given to make informed healthcare decisions.
Requirements for full disclosure vary from state to state.
Most states use one of the following standards to determine how
much information the patient must be given:
• Reasonable physician standard
• Reasonable patient standard
• Subjective standard
Click on each of the standards for more information.
CLICK TO REVEAL
Reasonable physician standard
This standard says that a healthcare provider must give
the patient all the information that a typical physician
would give the same patient in the same situation. If the
provider gives all of this information, he or she has
given full disclosure.
Reasonable patient standard
This standard says that a healthcare provider must give
all the information that an average patient in the same
situation would need to make an informed decision. If
the provider gives all of this information, he or she has
given full disclosure.
Subjective standard
This standard says that a healthcare provider must give
all the information that this particular patient needs, in
this particular situation, to make an informed decision. If
the provider gives all of this information, he or she has
given full disclosure.
Page 14 of 23
2015
Legal Requirements: Full Disclosure
The legal standards for disclosure can seem vague.
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In general: If you meet the ethical requirement for full disclosure, you
will meet the legal requirement.
In addition, some states require disclosure of:
• Any research and/or economic interests that may affect the
healthcare provider’s medical judgment
• Academic qualifications and licensure status
• Experience in performing the recommended treatment
Page 15 of 23
2016
Legal Requirements: Consent Forms
Specific requirements for written consent forms vary from state to
state.
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For more information, check with a lawyer in your state.
Also, be certain that you are familiar with your facility’s policies.
Page 16 of 23
2017
Informed Consent: Accreditation
Why do healthcare providers have accreditation concerns around
informed consent?
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The Joint Commission requires healthcare providers to obtain
informed consent before treating patients.
Page 17 of 23
2018
Accreditation: Full Disclosure
The Joint Commission requirements for full disclosure are similar to
legal and ethical requirements.
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Page 18 of 23
2019
Accreditation: Disclosure in Special Cases
The Joint Commission requires disclosure of extra information in
certain cases.
CLICK TO REVEAL
These cases are:
• Participation in a research study
• Use of blood or blood components
• Use of anesthesia
Participation in a research study
When the recommended treatment is part of a research
study, the following extra information must be given:
• The patient’s right to withdraw from the
study at any time
Click on each to reveal more information.
Use of blood or blood components
When blood or blood components are part of the
recommended treatment, the following extra information
must be given:
• Risks of blood transfusion
• Alternatives to blood transfusion
Use of anesthesia
When anesthesia will be used during the recommended
treatment, the following extra information must be
discussed with the patient:
• Type of anesthesia that will be used
• Risks of anesthesia
• Name and qualifications of anesthesia provider
• Previous patient problems with anesthesia,
drugs, or allergies
• Patient concerns
Page 19 of 23
2020
Review
Informed consent is the same thing as a written consent form
TRUE / FALSE INTERACTION
a. True
b. False
[CORRECT ANSWER: B]
[FEEDBACK FOR A: Incorrect. This statement is false.
Informed consent is an entire process of
communication, not just the form that the patient signs.]
[FEEDBACK FOR B: Correct. This statement is false.
Informed consent is an entire process of
communication, not just the form that the patient signs.]
Page 20 of 23
2021
Review
FLASH INTERACTION: 2021.SWF/FLA
Page 21 of 23
2022
Review
Legal full disclosure may be based on the reasonable physician standard, the reasonable patient
standard, or the subjective standard.
FLASH INTERACTION: 2022.SWF/FLA
Page 22 of 23
2023
Summary
You have completed the lesson on ethics, law, and accreditation.
NO IMAGE
Remember:
• Informed consent has to do with communication between a
patient and a healthcare provider. This communication gives
the patient the information necessary to make informed
treatment decisions.
• Healthcare providers have a legal and ethical duty to give
patients “full disclosure.” In general, full disclosure includes
diagnosis, treatment options, risks and benefits of each
option, and risks and benefits of no treatment.
• Never hold back information to convince a patient to accept
treatment. This is unethical. It could also lead to a medical
malpractice suit.
• A patient may refuse treatment for any reason. This includes
reasons that do not make sense to the healthcare provider.
• A patient must give informed consent for any medical or
surgical procedure that involves touching his or her body.
• Implied consent is given by patient behavior. Express consent
is given by direct written or spoken words.
• The attending physician has the legal responsibility to obtain
informed consent.
Page 23 of 23
Lesson 3: Special Cases
3001
Introduction & Objectives
Welcome to the lesson on special cases of informed consent.
FLASH ANIMATION: 3001.SWF/FLA
After completing this lesson, you should be able to:
• Recognize the role of informed consent in an emergency
• Define the extension doctrine
• Recognize how informed consent applies to minor children in
different situations
• Recognize how informed consent applies to incapacitated
patients
Page 1 of 19
3002
Special Cases: Overview
Remember: Informed consent is an important part of healthcare.
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In special cases, however, direct consent is not necessary.
In other cases, consent is needed, but from someone other than the
patient.
Page 2 of 19
3003
Exceptions: Emergencies
In an emergency:
• It may be necessary to give immediate treatment to prevent
death or serious harm.
• It may be impossible to obtain consent.
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In such a case
• Patient consent is presumed. [glossary]
• Treatment may be given without the usual process of
informed consent.
Note: Emergency treatment should not be given if the healthcare
provider knows that the patient would not want treatment. For
example, CPR should not be given to a patient with a do-notresuscitate (DNR) order.
Page 3 of 19
3004
Exceptions: Extension Doctrine
Many states use the extension doctrine when it comes to informed
consent.
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On the next screen, let’s take a closer look at the extension doctrine,
using an example.
Page 4 of 19
3005
Extension Doctrine: Example
A patient gives informed consent for surgery on the spleen. During the
procedure, the surgeon sees a mass on the liver.
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The patient is under anesthesia. Therefore, she cannot give informed
consent for dealing with the liver mass.
According to the extension doctrine, the consent for the original
procedure (spleen surgery) covers the additional procedure (liver
surgery) if:
• The additional procedure is medically appropriate.
• The additional procedure will not interfere with the patient’s
ability to have children.
• The patient has not previously refused the additional
procedure.
Page 5 of 19
3006
Extension Doctrine: Summary
In summary, the extension doctrine is used when:
• A patient gives informed consent for a procedure.
• During that procedure, additional issues come up.
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Page 6 of 19
3007
Minors
Many special cases of informed consent have to do with minor
children.
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These special cases are:
• Treating the parents of minor children
• Ability of minors to consent to care
• Refusing treatment for minors
• Minors and custody
Let’s take a closer look at each of these issues, on the following
screens.
Page 7 of 19
3008
Parent of a Minor Child
In some states, a patient cannot refuse treatment if:
• The patient is the parent of a minor child.
• Refusing treatment could interfere with the parent’s ability to
care for the child.
• The child has no other potential legal guardian.
IMAGE: 3008.JPG
In such a case, it is legal to treat the parent even if he or she refuses
to give consent.
Page 8 of 19
3009
Ability of Minors to Consent to Care
Minors do not have the legal right to give informed consent for
treatment.
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A legal guardian must give informed consent for a minor.
Page 9 of 19
3010
Refusing Treatment for Minors
A parent has the right to give informed consent for treatment of his or
her children.
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A parent also has the right to refuse treatment for his or her children.
Healthcare providers must respect these rights.
If a healthcare provider believes that a parent is not acting in the best
interests of a child, the provider may ask for a court order to go
against the parent’s decision.
Page 10 of 19
3011
Refusing Treatment for Minors
In an emergency, a healthcare provider may treat a child against a
parent’s wishes, without a court order.
IMAGE: 3011.SWF/FLA
In this case, the parents may sue the provider for medical battery.
The provider will not be found guilty of medical battery if:
• There was a real medical emergency.
• The parents were not acting in the best interests of the child
by refusing treatment.
• The court would have ordered the treatment that the
healthcare provider gave.
Page 11 of 19
3012
Minors and Custody
A babysitter may not consent to treatment for a child.
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A healthcare provider may treat a child in the care of a babysitter only:
• In an emergency, or
• If the parent left written permission for non-emergency
treatment
Page 12 of 19
3013
Minors and Custody
For a minor in the legal custody of child protective services:
• A parent cannot give consent for treatment.
• An authorized representative from child protective services
must give consent.
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Page 13 of 19
3014
Minors and Custody
If two parents both have custody of a child, and they disagree on
whether to give consent for treatment:
• A healthcare provider may legally treat the child after only one
of the parents gives informed consent.
• However, it is best to obtain a court order before treating the
child, to limit liability.
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Page 14 of 19
3015
Incapacitated Patient
IMAGE: 3015.SWF/FLA
An incapacitated patient is unable to understand the risks and benefits
of treatment.
Therefore, he or she cannot make an informed decision about
treatment.
Therefore, he or she cannot consent to medical care.
Page 15 of 19
3016
Incapacitated Patient: Consent from Authorized Representative
When a patient is incapacitated, his or her legal representative must
consent for treatment.
NO IMAGE
This representative may be:
• The person named in the patient’s healthcare power of
attorney (HPOA)
• A decision-maker chosen according to state law, if the patient
does not have an HPOA
• The court, if the patient has neither an HPOA nor a potential
decision-maker
Page 16 of 19
3017
Review
FLASH INTERACTION: 3017.SWF/FLA
Page 17 of 19
3018
Review
A mother refuses to give consent for treatment of her child. It is not an
emergency situation. You do not think the mother is acting in the best
interests of the child. The best course of action is to:
a. Go to court to ask for a court order to treat the child. If you get
the order, treat the child.
b. Tell the mother that you would treat your own child in the
same way. Then treat the child.
c. Declare the mother incompetent to make medical decisions
for her child. Then treat the child.
d. Ask your colleagues. If a majority of your colleagues agrees
with the recommended treatment, treat the child.
MULTIPLE CHOICE INTERACTION
CORRECT: A
A: Correct. To provide non-emergency treatment
against a parent’s wishes, the best thing to do is to get
a court order.
B: Incorrect. The correct answer is A. To provide nonemergency treatment against a parent’s wishes, the
best thing to do is to get a court order.
C: Incorrect. The correct answer is A. To provide nonemergency treatment against a parent’s wishes, the
best thing to do is to get a court order.
D: Incorrect. The correct answer is A. To provide nonemergency treatment against a parent’s wishes, the
best thing to do is to get a court order.
Page 18 of 19
3019
Summary
You have completed the lesson on special cases.
NO IMAGE
Remember:
• Emergency treatment may be given without informed consent.
• The extension doctrine makes it possible to address
unexpected situations that come up during a procedure.
• The parent of a minor child cannot refuse treatment in certain
cases.
• Minor children do not have the legal right to give informed
consent. Their parents must consent for them.
• Parents have the right to refuse treatment for their children. A
healthcare provider may ask for a court order to go against
this decision.
• A babysitter may not consent to treatment for a child.
• When a patient is incapacitated, his or her legal
representative must provide informed consent for treatment.
Page 19 of 19
[Informed Consent]
Course Glossary
#
1.
Term
disclose
Definition
reveal, make known
2.
3.
4.
doctrine
ethics
presumed
a belief or system of beliefs accepted by a group
motivation based on ideas of right and wrong
taken for granted as true
[Informed Consent]
Pre-assessment
1. What is the ethical basis for informed consent?
a. Respect for life
b. Respect for patient autonomy
c. Respect for healthcare resources
d. Respect for healthcare provider knowledge
Correct: B
Rationale: Respect for patient autonomy means that patients have the right to make informed decisions about the healthcare they receive.
2. What is the basis for medical battery?
a. States recognize a patient's right to privacy.
b. States recognize a healthcare provider's right to deny treatment.
c. States recognize the right of patients to choose their own treatment.
d. States recognize the right of healthcare providers to dictate treatment for patients.
Correct: C
Rationale: All 50 states in the U.S. recognize that patients have a right to choose their own treatment. Therefore, a provider who treats a patient
without obtaining consent may be liable for medical battery.
3. Informed consent must be obtained:
a. For surgical procedures only
b. Only when the treatment has a high level of risk
c. Only when the treatment is experimental or used off-label
d. For any treatment that involves touching the patient's body
Correct: D
Rationale: Informed consent must be obtained for any medical or surgical procedure that involves touching the patient's body.
4. The Joint Commission requirements for full disclosure are similar to legal and ethical requirements. In certain cases, however, the Joint
Commission requires disclosure of additional information. What is one of these cases?
a. Use of insulin
b. Use of painkillers
c. Use of anesthesia
d. Use of blood thinners
Correct: C
Rationale: The Joint Commission requires disclosure of extra information for participation in a research study, use of blood or blood components,
or use of anesthesia.
5. When is it acceptable to provide treatment without obtaining informed consent?
a. In an emergency
b. In an inpatient setting
c. When a patient has a DNR order
d. When a patient refuses treatment
Correct: A
Rationale: In an emergency, patient consent is presumed. Treatment may be given without the usual process of informed consent.
6. Standing in line for a vaccination is an example of:
a. Non-consent
b. Implied consent
c. Atypical consent
d. Express consent
Correct answer: B
Rationale: Implied consent is consent given by patient behavior. One example of giving consent by behavior is standing in line for a shot.
7. What is the best definition for full disclosure?
a. All the information available about a recommended treatment
b. All the information a patient requests from a healthcare provider
c. All the information the physician decides to share with the patient
d. All the information a patient needs to make an informed treatment choice
Correct: D
Rationale: Full disclosure refers to all the information a patient needs to make an informed healthcare decision.
8. Which of the following would be considered acceptable under the extension doctrine?
a. A patient gives informed consent for gall bladder surgery. During the surgery, the surgeon sees a mass on the liver. The surgeon biopsies
the liver.
b. A patient gives informed consent for gall bladder surgery. Then she changes her mind. A year later, the same consent form is used to
perform a similar surgery.
c. A parent gives informed consent for treatment of her daughter. The consent form is kept on file. Later, the same consent form is used for
similar treatment on a different daughter.
d. A patient gives informed consent for a particular surgical procedure. While the patient is under anesthesia, the surgeon performs an
additional procedure previously refused by the patient.
Correct: A
Answer Rationale: The extension doctrine is used when a patient gives informed consent for a procedure, and during that procedure, additional
issues come up. The additional procedures must NOT be performed if it is not medically appropriate, it will interfere with the patient's ability to
have children, or the patient has previously refused the procedure.
[Informed Consent]
Final Exam
1. Which of these is an ethical duty related to informed consent?
a. Healthcare providers must not allow patients to refuse treatment.
b. Healthcare providers must make the best possible healthcare choices for their patients.
c. Healthcare providers must make every effort to convince patients to accept the recommended treatment.
d. Healthcare providers must communicate all the information needed for patients to make informed treatment choices.
Correct: D
Rationale: Healthcare providers have an ethical duty to provide patients with all the necessary information to make informed choices.
2. What is the legal basis for informed consent?
a. States recognize a patient's right to privacy.
b. States recognize a healthcare provider's right to deny treatment.
c. States recognize the right of patients to choose their own treatment.
d. States recognize the right of healthcare providers to dictate treatment for patients.
Correct: C
Rationale: All 50 states in the U.S. accept that patients have a right to choose their own treatment. Therefore, all 50 states have a legal doctrine of
informed consent.
3. The Joint Commission requirements for full disclosure are similar to legal and ethical requirements. In certain cases, however, the Joint
Commission requires disclosure of additional information. What is one of these cases?
a. Addiction treatment
b. Participation in a research study
c. Use of psychoactive medications
d. Procedures performed in an outpatient setting
Correct: B
Rationale: The Joint Commission requires disclosure of extra information for participation in a research study, use of blood or blood components,
or use of anesthesia.
4. In which case is it acceptable to provide treatment without obtaining informed consent?
a. A patient refuses treatment. His physician thinks this is a bad decision.
b. A patient gives consent for treatment. Later, the patient decides to stop treatment.
c. A patient gives informed consent for a procedure. During that procedure, additional issues come up.
d. A patient needs non-emergency treatment, but does not understand English. A translator is not available.
Correct: C
Rationale: Many states use the extension doctrine when it comes to informed consent. The extension doctrine is used when a patient gives
informed consent for a procedure, and, during that procedure, additional issues come up.
5. Who has the legal right to provide informed consent for the treatment of a child?
a. The child
b. A parent
c. A babysitter
d. The healthcare provider
Correct: B
Rationale: Minors do not have the legal right to give informed consent. A parent or legal guardian must give consent.
6. According to the reasonable patient standard, full disclosure is based on:
a.
b.
c.
d.
What the average physician would tell a similar patient in a similar situation
What this particular physician would tell a similar patient in a similar situation
What the average patient, in a similar situation, would need to know to make an informed decision
What this particular patient, in this particular situation, would need to know to make an informed decision
Correct: C
Rationale: The reasonable patient standard for full disclosure is based on what the average patient, in a similar situation, would need to know to
make an informed decision.
7. What is express consent?
a. Consent based on patient behavior
b. Making an appointment for a checkup
c. Standing in line to receive a vaccination
d. Consent by direct written or spoken words
Correct: D
Rationale: Express consent refers to consent by direct written or spoken words. This differs from implied consent, which is consent given through
a patient's behavior.
8. A patient agrees to treatment without receiving full information. This is an example of:
a. Consent
b. Medical battery
c. Lack of consent
d. Informed consent
Correct: A
Rationale: If a patient agrees to treatment without receiving full information, this is consent, but not informed consent.