Informed Consent Best Practices – How to Minimize Risk

What Is Informed Consent?

When we hear the term "informed consent," we often automatically think of an informed consent form; however, that is but one element of the informed consent process. Informed consent is a critical process in which detailed communication between the physician and patient allows the patient to collect enough information to help him or her consent or decline a recommended treatment or procedure. This process is then memorialized through documentation in the medical record as well as by the patient/patient representative’s signature on the informed consent form.

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Why Is This Important?

According to the California Medical Association (CMA), it is well established under common law that a competent patient/patient representative has the right to the following:

To make their own medical care decisions about their body.

Be provided enough information to make their consent meaningful.

To consent or reject any proposed treatment or procedure.

When a physician fails to obtain proper consent prior to initiating a treatment/procedure in which consent is required, this may constitute battery and/or negligence. This can also be true if the provider exceeds the scope of the consent after it is obtained or if it is determined that the physician failed to provide the patient with enough information, such as significant risks or possible complications.

Case Study: A 17-year-old patient requested a tubal ligation following the birth of her first child; however, her OB/GYN, Dr. OB, who had been her physician since birth, declined. Instead he advised that if she still wanted it at age 21, he would perform it at that time. Once she turned 21, she did in fact return and Dr. OB agreed at that time. In early fall, Dr. OB performed a bilateral tubal ligation without complication. Unfortunately, five months later, the patient returned with a positive pregnancy test, but ultimately suffered a spontaneous miscarriage. 

In this case, it was determined that Dr. OB failed to advise the patient that while tubal ligation is an effective means of sterilization, there still exists a possibility of failure. This case was settled.

Required Elements of Informed Consent

What elements must be included during the informed consent discussion? According to the CMA, the following information must be disclosed in order to satisfy the informed consent requirements:

Explanation of the nature and purpose of the proposed treatment.

The risks, complications, and expected benefits of the recommended treatment, including the likelihood of success or failure.

Any alternatives to the recommended treatment and their risks and benefits.

The risks and benefits of declining the proposed treatment.

Mitigation/Risk Strategies

To avoid the allegations that are associated with improper or incomplete consent, we recommend the following strategies be considered:

For planned procedures, do not wait to obtain consent on the day of the procedure. The informed consent process should begin as early as two weeks prior to the planned procedure, preferably in the provider’s office setting. This allows enough time for the patient and physician to have a detailed discussion and to answer all the patient’s questions in a stress-free setting as opposed to a pre-op holding area.

Thoroughly document the informed consent discussion, being sure to include all the previously mentioned elements. Also be sure to include any pertinent questions that the patient had and what answer was provided.

Don’t just rely on the language in a standardized or general consent form. Your documentation of the informed consent conversation and the potential risks should be specific to the procedure being performed.

Ensure that the copy of the signed consent form is placed in the patient’s medical record and a copy in the hospital record as well if the procedure takes place in a hospital setting.

Stay within the scope of the procedure noted on the signed consent form. Outside of an emergent life-threatening occurrence that would require the physician to take immediate life-saving measures, do not be tempted to “fix other problems” you might encounter intraoperatively. For example, if the patient consented to an appendectomy and during the operative course an ovarian cyst is also discovered, it would serve the surgeon well to leave it alone and inform the patient post-operatively.  If something is identified that would be better served to be addressed at the time, the best practice is to consult family member(s) or a patient representative for consent.

Summary

Implementation of the recommendations above will not only help the physician should the patient later allege that he or she was not warned of the risks, but it will also allow the physician to ensure that the patient’s expectations are reasonable. 

 

Cynthia Mayhan is a Senior Risk Manager and Patient Safety Specialist for CAP. Questions or comments related to this article should be directed to CMayhan@CAPphysicians.com.

 

Sources

1. California Medical Association. (2021, January). Informed Consent. California Physician's Legal Handbook.

2. Great Valley Publishing Company, I. (2016, September). Six Best Practices for Informed Consent. https://www.fortherecordmag.com/archives/0916p28.shtml.

3. The Joint Commission (2016, February). Informed consent: More than getting a signature. Quick Safety: An Advisory on Safety & Quality Issues. https://www.jointcommission.org/-/media/deprecated-unorganized/imported-assets/tjc/system-folders/joint-commission-online/quick_safety_issue_twenty-one_february_2016pdf.