Are you informed about informed consent?

October 16, 2017

You know informed consent is a basic principle of health care and your practice should take it seriously. But do you know exactly what it is, how and when to do it, and why it’s important for allergy practices?  Some physicians and practices have adopted a casual attitude towards informed consent, but it is something all allergy practices should take seriously.

Informed consent should be a conversation where the clinician explains the risks and benefits of a specific test, procedure or other treatment to the patient. During this exchange, the allergist should explain other available options and answer any patient questions. The patient should take an active role in the decision about their care, and confirm understanding of the discussion. Ultimately, the patient should agree to the test, procedure or treatment before it is performed (both verbally and in writing), or the patient and physician should jointly decide on another course of treatment.

An informed consent discussion can clarify treatment options and risks for the patient and prevent misunderstandings. A signed informed consent document can also protect the practice if something goes wrong. Taking the time to have a true informed consent discussion with patients has other benefits, including greater patient satisfaction and an improved physician-patient relationship.

However, there may be a tendency for practices to focus on getting the signed consent form rather than on making sure the patient truly understands the risks and alternatives of the suggested treatment. Don’t fall into that trap, because a patient’s signature on a consent form isn’t worth much if the patient doesn’t understand the suggested treatment, risks and alternatives.

“I sit and review the final skin test with the patient and family,” notes Kevin McGrath, MD, FACAAI, vice-chair of the Practice Management Committee. “I discuss the various treatment options and document I have discussed the risks, benefits, and options of allergy immunotherapy. I also cover the use of medications, environmental controls, and alternative therapies such as sublingual immunotherapy with tablets.  I provide a written four-page letter with details on allergy immunotherapy, which includes how it works, the risks, and benefits, and options of allergy injections. I document the discussion and letter in the patient’s chart.”

So, when is informed consent required for allergy practices? Informed consent laws vary from state to state, and national HHS guidelines exist only for participants in clinical research trials. Generally, an informed consent discussion should take place whenever a patient is asked to participate in a clinical research trial, or when you recommend an invasive procedure or test, including:

  • Oral food challenges
  • Any allergy challenge (drug challenge, other allergy challenge)
  • Allergy testing
  • Immunotherapy
  • Other procedures (rhinolaryngoscopy, etc.)

In addition, minors cannot give consent (most states recognize 18 as the age of majority for informed consent). For minors, parents or guardians have legal right to give consent. Be sure to check with your state medical society about your state’s law on age of majority and confirm there are no other state specific requirements.

When implementing informed consent in your practice, focus on the following:

  • Use everyday language instead of medical jargon when communicating with patients or parents. That extends to written consent forms, too.
  • Make sure the patient really understands the suggested treatment, risks and alternatives. A signature on a consent form is worthless without it.

The College has a wealth of patient educational resources that can help you with informed consent discussions. We have helpful fact sheets about allergy tablets and testing, immunotherapy, asthma diagnosis and treatment, rhinitis, and rhinitis diagnosis and treatment.

In addition, the College is developing shared decision-making tools which will be valuable in informed consent discussions. The immunotherapy shared decision-making toolkit will launch in a few weeks, and the severe asthma shared decision-making toolkit will be available in early 2018.

For more information about informed consent, check out the Joint Commission tips and safety actions.