Mastering Informed Consent

Posted: April 8, 2025

Questions posed during ACHCU’s monthly Coffee Chat live webinar often serve to reveal opportunities to extend education and develop additional resources for ACHC-accredited hospitals. In March 2025, the topic was medical record documentation. Informed consent was a specific focus, including variation in requirements for procedural consent vs. anesthesia consent. One participant took the issue of informed consent to a logical next step, asking, “Does the Informed Consent Form have to be written in the patient’s primary language if their primary language is not English?”

The intent of informed consent requirements is to ensure that hospital patients are participants in their care and that their agreement to a treatment plan reflects understanding of the proposed procedure, its risks and benefits, and alternatives.

Requirements for obtaining and documenting informed consent are clearly outlined in ACHC Standards.  Relevant standards include:

Required elements for the standards expand the guidance, noting that authorization from a patient who does not understand what he/she is consenting to does not constitute informed consent. This is why the informed consent discussion is an integral part of the process.

Hospital policy must define how it will meet the requirement to use the patient’s primary language for the informed consent discussion and for the written information on the Informed Consent Form to be signed. Policy may include a process that reviews an Informed Consent Form written in English through the use of interpreter services in lieu of requiring translations of the form to meet the needs of the patient’s primary language if the patient also consents to this process. Regardless of process, Informed Consent Forms must be written using simple sentences, in plain language that is easily understood, and preferably in the patient’s primary language.

Federal and state law govern when the use of interpretive services must be offered to the patient.

Both the discussion and consent should be separately documented in the patient’s medical record. This is where ACHC Surveyors will look for evidence that the discussion took place, that a non-English-speaking patient agreed to the format in which this was conducted, and that they subsequently consented to treatment having been given sufficient information to make an intelligent choice among alternative available options.

Hospitals should review their process with legal counsel, the compliance officer, health information/medical records leadership, and risk management leadership.