Informed Consent: More Than a Signature

Informed consent is not just a piece of paper. Informed consent is a process—discussion, questions and answers, followed by understanding, comprehension, decision and, ultimately, consent.

Healthcare providers must ensure the patient gives knowledgeable consent. This means the provider has explained all the pertinent information regarding the proposed treatment/procedure; has provided the patient the opportunity to ask questions and has answered those questions to the patient's satisfaction; has documented the informed consent process in the medical records; and has secured the patient's signature on a thorough informed consent document signifying knowledgeable consent.

Where and how you obtain informed consent matter as well. A study published in the Journal of Bone and Joint Surgery in 2005 found that an orthopedic surgeon's risk of incurring a medical malpractice claim increased when informed consent was obtained on the hospital ward or in a pre-operative area. The risk was lower when informed consent was obtained in an office setting by the attending surgeon (and the discussion was documented in the surgeon's office notes).

And in medical malpractice suits that proceed to trial under a theory of lack of informed consent, when a thorough, executed informed consent document exists, the provider successfully defends the lawsuit 74% of the time.

Real world case study
A patient presented to the ER complaining of fever and intense lower abdominal pain, which the ER physicians determined was caused by acute diverticulitis. Subsequent to an informed consent discussion with the attending surgeon, the patient consented to emergency laparoscopic surgery by first signing the hospital's informed consent document and then signing another informed consent document required by the attending surgeon (not a hospital employee).

The laparoscopic procedure was successful, but during the operation the attending surgeon and two surgical residents encountered improper anatomy placement and inadvertently severed the patient's vas deferens. The severing resulted in a testicular infection and the patient's subsequent sterility.

The patient sued both the hospital—legally responsible for the actions of the two surgical residents—and the attending surgeon, alleging medical negligence and lack of informed consent. At trial, the plaintiff's lawyer argued that not only was it negligence to sever the vas deferens, but the hospital's informed consent document did not reflect any mention of risk to the urinary tract or reproductive capability.

However, the second informed consent document—which was more thorough and contained the handwritten notation, "risks include . . . urinary function . . . sterility . . . impotence"—showed that the attending surgeon had discussed tertiary risk to the urinary tract and reproductive capability.

The jury returned a verdict of no liability against the attending surgeon yet found the hospital liable for the negligence of the residents, premised on the hospital's informed consent document not delineating the potential risk of damage to the urinary tract or reproductive anatomy.

Practice tips

• Explain things simply and plainly; you greatly decrease the chances of future problems if the patient knows exactly what is going to happen and what to expect post-procedure. (Malpractice claims oftentimes originate from a "surprise" negative outcome; a patient who understands the result as "the risk the doctor warned me about" is less likely to file a claim.)
• Discuss expectations, perhaps even questioning what the patient expects as a result. Patients often have unrealistic expectations for the outcome of a procedure.
• Never guarantee success; document in the informed consent that the patient understands and acknowledges there is no guarantee of success.
• Provide the patient any educational materials you have regarding the disease, condition, treatment, etc., and note such in the chart; consider highlighting phrases in the materials you believe particularly relevant.
• The greater a procedure's risk, the more carefully and thoroughly you should explain things to the patient.
• Include whatever risks and potential complications are specific to the procedure, instead of merely relying on the language included on a pre-printed form.
• If the patient has an increased risk of complication, discuss such thoroughly with the patient and note those increased risks/complications on the informed consent document and in your office notes/chart.
• If possible, conduct the informed consent discussion in an office setting prior to the scheduled date of the procedure; document the discussion and patient's consent in your office notes/chart.