Informed Consent – A Form and So Much More

Not only does informed consent give patients the right to determine their own treatment, it also helps protect you, the ND, in the event of an unexpected outcome.

Unfortunately, lack of informed consent is a common allegation in naturopathic claims. Without a well-documented informed consent process, it could be argued that your treatment was not consensual, creating a challenge for your defense. 

Processes to Consider with Informed Consent

Informed consent is more than a form. It is an important process that includes informing patients about the material risks and benefits of treatment, as well as alternatives to the recommended treatment.

As you think about your comprehensive informed consent process, make sure to include:

  • The specific procedure to be performed (written in an easy-to-understand manner—beyond the use of clinical terminology)
  • A description of how the procedure will be performed
  • The clinical rationale for why the procedure is needed (including the condition being treated)
  • The benefits of having the procedure performed
  • The likelihood of success of treatment
  • The consequences of not electing the treatment
  • The material risks of the procedure
  • The recovery expectations including:
    • “Red flag” symptoms of problems
    • Limitation expectations
    • Follow-up expectations
  • The risks and benefits of alternatives to proposed treatment
  • The date of the procedure
  • The signature of the patient and the ND, as well as any healthcare staff witnessing the consent
    • Informed consent should not be delegated. The ND is accountable for obtaining the patient's consent
    • When applicable, a statement confirming the procedure and recovery expectations should be explained to any surrogate
  • Confirmation that the patient (surrogate or guardian) understood the treatment and agreed to proceed with it
    • In the case of a surrogate/guardian, note the nature of the relationship
  • Documentation that the patient is unable to speak/understand English and/or needs interpretative services or visual assistance tools, if applicable
    • Name of any interpreter
  • Confirmation that the patient (surrogate or guardian) was able to ask questions and have them answered

In addition to documenting the conversation and its elements, make sure to include a copy of your consent form (see sample below) in the records. If you use educational materials to supplement your communication, document the resource used, the version number and its publication date. It is also important to check with your local legal counsel as state and federal requirements may vary.

As always, if you have questions about the informed consent process, don’t hesitate to call our Claims Advice Hotline at 800-242-4052.

Sample Informed Consent Form

Appropriate documentation regarding the informed consent process not only helps your defense, it could also help you avoid a claim.

At NCMIC, we understand that a form can help with your documentation, and we have developed the following sample form for your consideration. Keep in mind that we do not require use of this form and you should be familiar with your specific state requirements. Additionally, the sample informed consent form should be considered a starting point that you tailor to your practice.

Is Informed Consent Confusing to Patients?

By Fraser Smith, ND

Given that naturopathic medicine is typically noninvasive, how do you explain possible adverse events without creating unnecessary fear in the patient?

It can be helpful for your informed consent conversation to include examples of both common and uncommon possible adverse effects of naturopathic care. For example:

  • A more common, but less serious, side effect of some herbs is gastrointestinal upset
  • A rarer, but critical, effect of some herbs is central nervous system disturbance or seizures 

By focusing your remarks, you actually obtain better informed consent because the patient is more likely to comprehend a logical explanation of what could happen versus a barrage of information. That makes for more authentic informed consent. It will also avoid the unnecessary step of putting any unnecessary fear into the patient.