CCI Institute for Excellence: Non-English Informed Consent Forms
The purpose of informed consent forms (not to be confused with provider attestation forms) is to ensure the patient clearly understands the risks, benefits, alternatives, risks of alternatives, and, in some form, the likelihood of success. These items are present in the Joint Commission standards, but aside from the standards, the intent of informed consent should be embraced. As our population becomes increasingly diversified in languages spoken, complete communication of this information the proper completion of non-English informed consent form needs to be prioritized.
Guiding Principles for Informed Consent Forms
Most importantly, the information delivered in an informed consent form must be provided to the patient in a manner that the patient understands. This involves more than simply printing and delivering a form to a patient. Unfortunately, many patients from foreign countries and the U.S. may also be illiterate. Therefore, not only written, but also oral presentation of the information is important. The requirement is that the information be communicated to the patient and that some note is made that the patient understands and agrees. This can be achieved by a signature on the form or by a note indicating the person presenting the information attests to the patient’s understanding and acceptance.
Anatomy of Informed Consent
In the construction of an informed consent form, several factors should be considered:
1. A form is designed to be read by a patient. The form must be understandable and easy to read.
2. We healthcare providers are presenting the form, and we are supposed to elicit a response indicating that the patient understands the content of the form: specifically risks, benefits, alternatives, risks of alternatives, and likelihood of success of the procedure.
3. The patient must then sign the form, or if the information is presented orally, an attestation must be made by the provider that the patient understands and agrees.
Acknowledging this, we must make sure that the form is completed ENTIRELY in the language of the patient. Any written additions must be in the language of the consent. Additionally, unless the person obtaining the consent is fluent in that language and certified as an interpreter, that person must sign the form indicating that they presented the information to the patient. This would normally be the interpreter’s or provider’s signature.
Unfortunately, most informed consent forms that have been reviewed lack the following items in the discussion of risks, benefits, and alternatives:
1. Risks of alternatives, including no treatment.
2. Likelihood of success.
For Spanish, this would be written:
- Riesgo de alternativas, incluido el riesgo de no tratamiento.
- Probabilidad de éxito.
These two items are required for full Joint Commission compliance.
The Role of Trained Medical Interpreters
In the proper execution of the informed consent form, one must determine if, in fact, the patient can read the document. In cases of non-English informed consent, the person obtaining the consent must be a trained medical interpreter. Even though a provider may have been educated in a language, seldom does a provider know medical terminology unless they have received medical training in that language. If the patient has officially appointed a family member as a healthcare proxy, consent can be obtained from that designated individual in English, and the interpreter must sign the form. Keep in mind that there have been several sentinel events related to misinterpretation of procedures to non-English speaking patients. This has occurred when family members who also do not know medical terminology try to translate. All signatures must be dated and timed.
Who Can Interpret for a Patient?
There are specific rules outlining who can interpret for a patient. Patient interpreters may be:
1. A family member who is bilingual and has been designated officially as a healthcare proxy. This is an advantage that is frequently overlooked. Official healthcare proxies can usually make all medical decisions.
2. A language line provider who can take a form and translate it verbally to the patient.
3. A physician or nurse who has been medically trained in the foreign language and who has passed basic medical language competencies which are on file for accreditation review. Hospitals have also used language line interpreters to assess the competency of local staff.
Recommendations for Implementing Non-English Informed Consent Measures:
Implementing non-English informed consent measures goes far beyond translating your informed consent form into another language. At a minimum, we recommend:
1. Subscribing to a language line service and training all staff on how to use it.
2. Assessing the competency of local staff to interpret and translate.
3. Acquiring properly constructed forms in languages that can be stored electronically and printed on demand.
4. Training staff on a few basic phrases in frequently encountered languages to initiate the process.
5. Providing training exercises.
Accommodating non-English speaking patients is incredibly important. Imagine how terrifying it would be to require surgery in a country where no one speaks your language. By implementing a non-English informed consent protocol and learning a few key phrases just to get started, healthcare providers can put non-English patients at ease, and be sure the patient understands.
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