Are you informed about informed consent?

| February 17, 2020

Are you informed about informed consent?

Pop quiz: what is informed consent, when is it required for allergy practices, and how exactly should it be done? Some physicians and practices have adopted a casual attitude toward informed consent, but it is something all allergy practices should take seriously.

Informed consent should be a conversation in which 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.

There may be a tendency for practices to focus on getting the consent form signed rather than 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, chair of the Practice Management Committee. “I discuss the various treatment options and document that I’ve 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 Health and Human Services 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 a procedure or test that includes any risk, even if small. These include:

  • 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 a 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. Consent can get more complicated when a parent or guardian is not readily available.

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 this.

The College has a wealth of patient education resources to help you with informed consent discussions. We have helpful fact sheets about allergy tablets and testingimmunotherapyasthma diagnosis and treatmentrhinitis, and rhinitis diagnosis and treatment. In addition, the College has several shared decision-making (SDM) tools that are valuable in informed consent discussions. Check out our SDM toolkits for severe pediatric asthma, severe asthma, atopic dermatitis and immunotherapy. A peanut OIT SDM toolkit will be published later this year.

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

How should you handle consents when the parent/guardian isn’t readily available or involved? Examples include minors in residential treatment facilities, group homes, or behavioral settings.

Tom Derrico, vice-chair of the Practice Management Committee and practice administrator of Certified Allergy & Asthma Consultants in Albany, New York, says, “These patients often come with aides or counselors who can’t consent.” Many such facilities/settings maintain a blanket consent from parents/guardians for diagnosis and treatment for those left in their charge. Some have a health care proxy or power of attorney naming the facility director, manager, etc. as authorized to consent. “We ask for a consent before scheduling, and if one doesn’t exist, we’ll ask about obtaining it from the parent/guardian. If nothing is available, we’ll see the patient but err on the side of extreme caution, taking a very conservative approach when it comes to testing and treatment. In cases where placement is through the state or other governmental entity over the objection of the parents, the bureaucracy can be a real challenge. My best advice would be to seek advice from the practice’s attorney or state medical society on how to proceed.”