Download Informed Consent 1. General Principles 2. Risks

Informed Consent
Part 1: General Principles
Part 2: Risks and Alternatives Related to
Central Venous Catheter Insertion
Office of Graduate Medical Education
Perelman School of Medicine
University of Pennsylvania
Part 1:
General Principles of
Informed Consent
What is Informed Consent?
• The legal embodiment of the concept that each
individual has the right to make decisions affecting his
or her health.
• A dialogue between patient and physician about a
potential treatment/procedure
– When informed consent is done well, it strengthens the
physician-patient relationship with shared authority,
decision-making, and responsibility for outcomes
• Ethically, morally, and legally mandated. Many states
have codified informed consent into statutory law
What is Informed Consent?
“Consent is informed if the patient has been given
a description of the procedure…and the risks and
alternatives that a reasonably prudent patient
would require to make an informed decision to
that procedure…”
* All Language on this slide is from Pennsylvania State MCARE law
Informed Consent is a Duty of
Physicians*
• Except in emergencies, a physician owes a duty to
a patient to obtain the informed consent of the
patient or the patient’s authorized representative
prior to conducting the following procedures:
1) Performing surgery, including administration of
anesthesia
2) Performing any invasive procedure
3) Administering radiation or chemotherapy
4) Administering a blood transfusion
5) Inserting a surgical device or appliance.
* All Language on this slide is from Pennsylvania State MCARE law
Principles of Informed Consent
• The physician directly involved in the proposed
treatment or procedure should conduct the
discussion.
• The informed consent discussion should include:
–
–
–
–
A discussion of the actual treatment/procedure
Risks and benefits of the treatment/procedure
Alternative therapies (with associated risks/benefits)
Both severe risks that occur rarely and less severe risks
that occur more frequently
– The most likely outcome with no treatment/procedure
Principles of Informed Consent
• Informed consent can be withdrawn at any time. When
a physician allows a patient 24-48 hours to reflect upon
the decision, it validates the notion of informed
consent.
• Can be enhanced through appropriate use of
pamphlets, videos, or through involvement of support
staff (advanced practice providers or nurses)
• Must be in a language that the patient understands
Documentation of Informed Consent
• Informed consent discussions must be
documented on UPHS informed consent
documents
• Must be:
– Legible
– Dated and timed
– Authenticated (signature followed by credentials)
Who Signs Where?
Signature: __________________________________ Date: _________ Time: _______
Patient
Signature: ___________________________________ Date: _________ Time: ______
Authorized Healthcare Professional
obtaining & witnessing patient’s signature
Signature: ___________________________________ Date: _________ Time: ______
Attending Physician if applicable
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Must be legible.
If you need to correct an error on the document, make a single
line through the error and initial, date, and time the correction.
Part 2:
Risks and Alternatives to Central
Venous Catheter Insertion
Risks* of Central Venous Catheter
Placement
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•
•
•
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Bleeding
Localized Pain
Infection: insertion site or bloodstream
Blockage of blood vessel (clot)
Damage to the local artery or vein
Injury to chest or lungs including hemothorax or
pneumothorax
• Other unexpected risks or complications including death
• Also consider and discuss risks specific to the individual
patient (e.g. possible increased risk of infection in a patient
with immunosuppression)
*Risks listed on this slide are those that are included on the Penn
Medicine Informed Consent for Central Venous Catheter Document
You Must Review Alternatives* to
Central Venous Catheter Placement
Alternatives:
• There may be other ways to monitor your
condition or collect the information that is
obtained by a central venous catheter (e.g.
through non-invasive hemodynamic monitoring)
• There may be other ways to administer fluids,
medications, nutrition (e.g. through a peripheral
vein)
*Alternatives listed on this slide are those that are included on the
Penn Medicine Informed Consent for Central Venous Catheter Document