A cornerstone of the dental practice, as with most healthcare professions, is the requirement to obtain informed consent before commencing treatment and procedures. The ADA Code of Ethics provides that informed consent, at a fundamental level, honors and empowers patient autonomy and involvement, imposing upon the dentist the “duty to respect the patient’s rights to self-determination and confidentiality.” Obtaining informed consent, therefore, requires a discussion between dentist and patient (or the patient’s representative) of the risks, benefits and alternatives to a particular treatment plan or procedure such that the patient is actively and meaningfully involved in treatment decisions.
Just what constitutes informed consent varies based on the risk and complexity of a given procedure (and applicable State law and rules). In North Carolina, the information provided, must be sufficient to permit the patient or authorized person to understand the condition to be treated, the specific procedures and treatments to be provided, the anticipated results of the procedures and treatments to be provided, the recognized risks and hazards of the procedures or treatments, the risks of foregoing the proposed treatments or procedures, and alternative procedures or treatment options. And with the exception of two limited situations in which a practitioner does not need to obtain informed consent prior to commencement of the procedure or treatment – if treatment is rendered on an emergency basis and if the patient is incapacitated – the dentist must have this discussion every time.
Generally, North Carolina regulations define the informed consent requirement by risk. For routine, low-risk procedures, dentists need to discuss the procedures with the patient at the initial visit, obtain patient’s general consent to such procedures, document the personal discussion and general consent in the patient records, and use that general consent at all future visits of similar risk. Such procedures include examination, prophylaxis, cancer screening, application of fluoride, sealants, and basic restorations. For treatments and procedures aimed at addressing a diagnosed condition that carry an increased risk, the dentist must obtain informed consent for the specific treatment or procedure prior to the operation and the specific consent must be included in the patient record. Some examples are extractions, complex restorations, complex hygiene procedures, implants, bridgework, dentures, endodontics, orthodontics, sedation, anesthesia, and any type of surgery.
North Carolina law requires that this discussion be documented in the treatment record. Many dentists today consider it routine (and even best) practice to have patients sign a template or form by hand and include that document in the record. This is not strictly required by the rules. The rules require that the discussion be documented in the record. Forms are one way to potentially do this, but not the only way. Additionally, in an interpretative statement published on the website of the North Carolina State Board of Dental Examiners, the Board cautions against the overreliance on these types of forms. One concern is whether the patient has actually read the form and whether the required discussion has actually occurred, as opposed to the patient simply signing a form and invariably having little to no recollection of doing so or what the form covered if an issue ever arises.
Instead, the Board emphasizes that the treatment record should reflect the actual exchange of information between the dentist and patient regarding the conditions diagnosed, proposed course of treatment, expected result, risks involved in treatment, and alternative treatment options. This requires more personalized recommendations, which helps provide actual informed consent. Remember, any consent form needs to include all risks and complications, documents specific discussion with the patient, and must have been accompanied by an actual discussion. Record-keeping is key: the dentist must make sure to keep adequate records, including regarding informed consent. See 21 NCAC 16T .0101, et seq.
All of these requirements are heightened by pandemic-related concerns. It is essential that each dental office update any informed consent process to include the heightened risks posed by COVID-19. Furthermore, regarding the use of standardized consent forms, each practice and dentist must understand that, while useful, such forms cannot be the be-all and end-all of obtaining consent from patients. These forms should be updated on an ongoing basis and dentists must actually have a discussion with patients regarding the proposed treatment, the risks, alternative options and other matters identified in the rules, and then patient records must reflect this discussion.
