0 Ethics Lecture Essentials of Informed Consent

ACADEMY OF OPHTHALMOLOGY The speaker has no financial interest in the subject matter of this presentation.

ACADEMY OF OPHTHALMOLOGY Why is this Topic Important?  Obligation to be Truthful  Engenders Patient Trust  Develops Patient Autonomy  Integrity of the Profession

ACADEMY OF OPHTHALMOLOGY Origins of Informed Consent Philosophical Perspective  Beneficence Obligation to maximize benefit Obligation to minimize harm  Non-maleficence Doctrine of “ primum non nocere ” No deliberate harm  Justice: Equals should be treated equally  Autonomy (self governance)

ACADEMY OF OPHTHALMOLOGY 5 Beneficence  The Physician: Must have the best interests of the patient in mind Minimally influenced by other concerns  The Patient: Must trust that the physician their advocate/agent

ACADEMY OF OPHTHALMOLOGY 6 Non-malificience Primum non Nocere  The Physician: Must not intentionally harm or disadvantage a patient.  The Patient: Must trust that the physician will not willingly harm

ACADEMY OF OPHTHALMOLOGY 7 Justice  Prohibition against denying benefit: Capriciously By selective criteria  Obligation not to “selectively burden”

ACADEMY OF OPHTHALMOLOGY 8 Autonomy Self governance: “Being one’s own person, without constraints either by another’s action or by psychological or physical limitation.” Beauchamp, T. L., & Childress, J. F. (1983). Principles of biomedical ethics (2 nd ed.) New York: Oxford University Press

ACADEMY OF OPHTHALMOLOGY 9 Standards for Ophthalmology Academy Code of Ethics  Rule 2. Informed Consent. The performance of medical or surgical procedures shall be preceded by appropriate informed consent.  Rule 3. Research and Innovation. Research and innovation shall be approved by appropriate review mechanisms to protect patients from being subjected to or potentially affected by inappropriate, ill-considered, or fraudulent basic science or patient-oriented research. Basic science and clinical research are conducted to develop adequate information on which to base prognostic or therapeutic decisions or to determine etiology or pathogenesis, in circumstances in which insufficient information exists. Appropriate informed consent for research and innovative procedures must recognize their special nature and ramifications. In emerging areas of ophthalmic treatment where recognized guidelines do not exist, the ophthalmologist should exercise careful judgment and take appropriate precautions to safeguard patient welfare.

ACADEMY OF OPHTHALMOLOGY 10 Standards for Ophthalmology International Council of Ophthalmology  1.2. Standards. Obtain the informed consent of the patient for all interventions.  4.2. Standards. Inform research subjects of the nature of the investigation, and obtain special informed consent.

ACADEMY OF OPHTHALMOLOGY Principles of Informed Consent  Informed consent is a dialogue: 1- An assessment of patient competence to decide 2- Disclosure of relevant information 3- An assessment patients ’ comprehension 4- Affirmatively obtain consent from patient or surrogate  Informed consent occurs before a patient or surrogate signs anything  Informed consent is not a signature on a document.

ACADEMY OF OPHTHALMOLOGY 12 Practical Informed Consent Disclosure  The “reasonable person” standard What a “reasonable person” would want/need to know  The nature of the procedure and indications  Expected benefits, advantages  Possible risks, disadvantages (can’t be exhaustive)  Uncertainties inherent in the intervention  Reasonable alternatives, including observation

ACADEMY OF OPHTHALMOLOGY 13 Practical Informed Consent Documentation  Rationale: Why the treatment is proposed  Benefits: The advantages of the treatment  Risks and Complications: Potentially adverse effects If everything goes right If something goes wrong  Alternatives: What else can be done (e.g. observation)

ACADEMY OF OPHTHALMOLOGY 14 Practical Informed Consent Special Situations  Clinical research Patients have right to know they are subjects Includes retrospective reviews  Use of off-label drugs/devices  Offering second opinions:  Surgical co-management Patients have a right to know, and affirmatively consent to treatment by other providers  Misleading advertising: Subtle coercion may invalidate informed consent