How effective is your informed consent process? - Linden Legal Strategies | Legal Advice. Simplified.

If you’re a physician, you know informed consent is a necessary part of treatment.  It is your responsibility to get informed consent. But, how well are you conveying the appropriate information to your patients?  Sure, you have worked out your spiel and cover the essentials of informed consent and consistently document the discussion in the chart, but, most patients do not have a great understanding of healthcare and medicine. When you have the informed consent discussion, do they really understand the treatment plan, alternative options, risks and benefits? How can you tell? What steps can you take to support your patient in their decision-making process and protect yourself?

Every good informed consent discussion is based on the premise that patients have the right to decide whether to engage in or undergo a particular medical treatment, course, or procedure and that such a decision should be informed, i.e. based on knowledge of the risks, benefits, alternatives of the proposed treatment. Remember, it is a discussion, not a lecture. Opportunity for questions is essential.

You probably have a good system for your informed consent discussions during your office visit, but patients are human, and they forget, get overwhelmed, caught up in the stress or the setting and may not fully understand their options or know what questions to ask. While you should always ask your patient if they have any questions during the visit; if they do not think of any, offer a way for them to contact you with questions after the visit. Have the patient tell you what the proposed treatment or procedure is in their words. This will give you a good idea of whether they understood what you said.

Providing take-home materials, access to online educational materials and videos, having follow-up discussions, and if necessary having interpreters assist with the process are all ways of ensuring you and your patient are on the same page when it comes to treatment selection. Remember to document any special patient concerns, requests, questions, and vocalized understanding of the discussion.

In addition to documenting an informed consent discussion in your chart, you need to have a separate form if you are doing an invasive procedure or treatment (think, anesthesia, chemotherapy, surgery, device placement).  The content of that form should be understandable to the patient and, as a physician, you need to do more than ask for a signature. Consider the informed consent for as an opportunity to walk through the informed consent discussion again – PLEASE do not shove a form in your patient’s face without having an eye-to-eye human interaction first. Often, when the form is being signed, some time has passed since the initial informed consent discussion.

Finally, refusal of a treatment after an informed consent discussion should also be well-documented with the reasons for refusal and a signed refusal form.  

To learn more about informed consent and how to get it right, contact Tanner Pilcher at