Why Informed Consent is an Important Process in Your Practice

Doctors need to be aware that 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.

Doctors need to be aware that 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.

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

Unfortunately, lack of informed consent is a common allegation in malpractice claims. 

Without a well-documented informed consent process, it could be argued that your treatment was not consensual, creating a challenge for your defense. Appropriate documentation regarding the informed consent process not only helps your defense, it could also help you avoid a claim in the first place.

The informed consent process should 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 doctor 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 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.

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