Informed Consent Guidelines

Introduction to Informed Consent

• A comprehensive informed consent template must include clear documentation of risks, benefits, alternatives, and expected outcomes of the procedure, with verification that the patient understands this information before proceeding, including procedure-specific risks and long-term implications, according to the American College of Cardiology and other guideline societies 1, 2
• The informed consent process should include a statement confirming the patient has had the opportunity to ask questions, documentation that the patient verbalized understanding, and confirmation that information was provided in the patient's preferred language, with documentation of use of interpreter services if applicable 2

Elements of Informed Consent

• Informed consent should include expected benefits, common side effects and complications, serious but rare complications, and procedure-specific risks, as well as available alternative procedures or treatments and their comparative risks and benefits, to facilitate patient understanding and decision-making, as recommended by the American College of Cardiology 1
• Informed consent forms should be written at an appropriate reading level (6th-8th grade) and be available in multiple languages common to the local population, with accessible formats for patients with visual impairments, to ensure patient comprehension, according to the American College of Cardiology and other guideline societies 3
• Informed consent should include a clear statement that the patient may withdraw consent at any time, with a process for documenting withdrawal of consent and an explanation of any implications of withdrawal, to protect patient autonomy, as stated by the American Society of Anesthesiologists 4

Consent Process

• Consent should be obtained in a non-pressured environment, with sufficient time provided for the patient to review information, and for outpatient procedures, information should be provided well in advance, while for inpatients, information should be provided with adequate time before the procedure, to ensure patient consideration of options, according to the American College of Cardiology 3
• The consent process should include verbal explanation by the provider performing the procedure, supplemental written materials at an appropriate reading level, and consideration of multimedia approaches for complex procedures, as well as an opportunity for follow-up questions before the procedure, to facilitate patient understanding and engagement, as recommended by the American College of Cardiology 3

Special Considerations

• For patients with diminished capacity, the process should include the role of healthcare proxies or legal representatives, and documentation of surrogate decision-making when applicable, to ensure protection of patient rights and interests, according to the American Society of Clinical Oncology 5
• In emergency situations, there should be a clear process for addressing these situations and documenting the decision-making process, to balance urgent care needs with patient autonomy and informed decision-making, as noted by the Code of Ethics for Emergency Physicians and the American Academy of Periodontology 6, 7, 8, 9

Maintenance and Review of Consent Forms

• Regular review and updating of consent forms are necessary, with documentation of when forms were last updated and by whom, and a process for incorporating new risk information, as well as periodic assessment of patient comprehension, to ensure consent forms remain accurate and effective, according to the American Society of Anesthesiologists and other medical societies 3, 10, 11
• The process for addressing disagreements between patient and surrogate should be clearly outlined, including documentation of resolution process and access to ethics consultation if needed, to provide a framework for resolving conflicts and ensuring patient rights and interests are respected, as stated by the American Society of Clinical Oncology 5, 10

Documentation of Informed Consent

• The essential element of informed consent is documenting that both parties understood and agreed to the plan, which is a crucial aspect of patient-centered care and meeting legal and ethical requirements, based on the principles of beneficence, autonomy, and justice, according to the American Society of Anesthesiologists and other medical societies 10, 11
• The discussion should include explanation of the proposed plan of care, benefits and risks of the treatment plan, alternative options, expected outcomes, and potential complications, and should be documented in a clear and concise manner, with patients encouraged to ask questions and express concerns, as recommended by the American Society of Anesthesiologists and other medical societies 2, 12, 13
• The proper medication informed consent process includes:

• The documentation of the discussion is most important, and should include a clear statement of agreement from both the patient and POA, such as "Both the patient and POA expressed agreement with proceeding with [specific plan]" or "The patient and POA consented to the proposed treatment plan after discussion of alternatives", according to the American Society of Anesthesiologists and other medical societies 2, 10, 14

Patient Rights and Responsibilities

• Patients have the right to ask questions, decline specific interventions, access clinical records, seek a second opinion, and end treatment at any time, with the understanding that all information shared during sessions is confidential with certain exceptions, as stated by the American Academy of Child and Adolescent Psychiatry 13
• Patients should have sufficient time to consider options and discuss with family when possible, and physicians should ensure patient understanding through a recommended approach to assessing patient understanding and addressing questions or concerns, according to the American Academy of Child and Adolescent Psychiatry and other medical societies 11, 9