5
ELEMENTS REQUIRED FOR
INFORMED CONSENTS
✓ Risks, Benefits and Options: Explain the Benefits & Risks involved. Discuss side
effects, alternatives & possible consequences.
✓ Questions Answered and Resolved: Allow an opportunity for patients or members of
their support network to ask questions
✓ Patient Confirms Understanding: Ensure your patients have all the available facts they need in
a language they understand to make an informed decision.
✓ Patient Competency: Make sure your patients have the mental capacity to make a legally
informed decision. If your patient is a minor or is subject to a conservator or guardian ad litem, ensure
information is explained to and understood by the patient’s representative.
✓ Voluntary Agreement: Patients have the right to refuse treatment, even if their refusal may
result in loss of limb or function or even death. Best practice is to allow the patient or patient
representative to sign a procedure-specific informed consent indicating the patient’s voluntary
decision to proceed with the procedure.
Sample Script for Informed Consent Discussion - Cataract Surgery – Day of Surgery
Hi, I am Dr. XXXX. I will be performing cataract surgery on your left eye. You received information
about this procedure during your cataract evaluation, but I want to make sure we answer any
remaining questions before we begin. Do you have any questions?
If FIRST eye, consider the following explanation or something similar:
The cataract is the lens in your eye. Today we're going to remove that lens and implant a new lens. The
new lens sits inside the eye on a membrane. The chance you see better is 99% and the chance you see
worse is less than 1/1000. The alternative to surgery is to leave it the way it is. Common problems
include the membrane clouding up over time. That happens less than half the time. If that occurs, you
may have to come back and get a laser procedure to get rid of that cloudiness. Cloudiness usually occurs
a few years after the surgery, if it occurs at all, but timing is unpredictable. You likely will have to change
your glasses. Very rarely, more severe complications like retinal detachment and infection may occur,
but chances of severe complications are less than 1/1000.
TIME to TALK IT THROUGH: Approximately 2 – 3 Minutes