The 7 Steps to Effective Informed Consent for Treatment

A guide for dentists and team members on obtaining effective patient informed consent forms.

By J. Kathleen Marcus, Esq

Of all the tasks dental team members may be a part of, obtaining effective informed consent from patients is among the most important. Informed consent is more than simply another form to sign, it's a collaboration between the patient and healthcare provider. The failure to obtain effective informed consent could end a dental practice, business, or even a career.

Unfortunately, team members (and dentists) are rarely taught why effective informed consent is critical to providing any dental treatment. In this article, we'll review seven essential elements required in properly obtaining informed consent from patients.

The Heart of Informed Consent

At the heart of informed consent is the belief that every adult of sound mind has the right to bodily autonomy. “True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.”[1]

The legal requirement to obtain informed consent from a patient prior to a medical procedure goes back several centuries to English Common Law. Originating in the criminal law of battery – an unwanted touching – practitioners were charged with a crime when a medical procedure was performed without the patient’s consent. Gradually, informed consent became shaped by the civil law of negligence. From there, the elements of effective informed consent were established.

In addition to being an issue if there is a lawsuit arising out of a dental procedure, providing effective informed consent is an ethical obligation required by licensing and regulatory bodies, like dental boards. Providing informed consent to patients prior to a procedure is a requirement of every U.S. state dental practice act and failure to obtain informed consent can result in the loss of the license to practice dentistry.

The Essential Elements of Informed Consent

For consent to dental treatment to be truly informed and the consent to be effective (evidence that the consent was both given and informed), each of the following must occur:

  1. The dentist discloses the dental diagnosis to the patient.
  2. The patient understands the diagnosis.
  3. The dentist informs the patient of the options for treatment (including the option not to treat).
  4. The dentist describes to the patient all risks and benefits of each of the treatment options.
  5. The patient understands all risks and benefits of each of the treatment options.
  6. The dentist and patient agree upon the procedure to be performed.
  7. The process of steps 1 through 6 is thoroughly documented in writing and signed by the patient.[2]

In litigation and in dental board prosecutions, the burden is always on the dentist to prove the patient’s signature was a voluntary choice free of undue influence. It's also the responsibility of the dentist to show the patient understood the information given by the dentist.

Some techniques to use (and document) as evidence that all the elements have been met include:

  • Ask patients to repeat what they heard. Many patients will be uncomfortable asking questions or admitting they didn't fully comprehend what was said. If the patient can explain what they've heard, that's important evidence that the patient understood it.
  • Use patient education materials (written and electronic). Patients often need dental problems and procedures explained multiple times and in multiple ways, with time to look at graphics or read in private.
  • Use procedure-specific consent forms. Be sure the consent names the diagnosis and procedure, and that the risks of the procedure are included. This serves as a reminder to the patient that, while you may have discussed many things, this is the specific course of action they've given consent for.
  • Keep narrative notes describing the informed consent process and the goals of care in the patient file. In the absence of filming the exchange, this is the best way to show the elements were met.
  • Create decision aids for particularly complex decisions. Patients may need a visual guide to remember how the risks and benefits fit together with a procedure choice and diagnosis. Of course, it's important these aids are unbiased.

Giving effective informed consent the time and attention necessary can prevent a lawsuit or a board complaint, as well as aid in establishing a valuable relationship of trust between patients, dentists, and team members.

References:

  1.  Canterbury v. Spence, 464 F.2d 772 (1972)
  2.  CMAJ, March 20, 2012, 184(5) 537, Informed consent for clinical treatment, Daniel E. Hall MD MDiv, Allan V. Prochazka MD MSc, Aaron S. Fink MD. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/pdf/1840533.pdf

Author: J. Kathleen Marcus, Esq is both Regulatory Counsel for DOCS Education and General Counsel to Strategic Dentistry, LLC. providing legal guidance for the companies in the Strategic family as well as being a benefit for the members of DOCS. A graduate of Temple University School of Law, and admitted to the Pennsylvania Bar, Kate has been an advisor, litigator, and writer on healthcare law since 1988. Kate is working toward her Master of Laws (LLM) degree in Public International Law from Queen Mary, University of London.

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