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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– The most likely outcome with no treatment/procedure Principles of Informed Consent • Informed consent can be withdrawn at any time.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 ***************************************************************************** ************************ 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 • • • • • • 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