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Navigating Informed Consent with a Language Barrier

Miscommunication due to language barriers can impact the informed consent process which could result in malpractice lawsuits or regulatory actions.

Jeanne Varner Powell, JD


Attempting to obtain informed consent when a language barrier prevents the patient from fully understanding what you are saying is risky for you and the patient. Proceeding without an interpreter in these situations can result in patient harm and lead to regulatory investigations and malpractice claims for lack of informed consent.

One of the most important conversations you have with patients is an informed consent discussion. During this conversation, you share information to help your patient learn and understand the purpose, risks and benefits, and alternatives of the proposed treatment options.

Informed Consent and Language Barriers

Many patients have poor recall of informed consent discussions for various reasons including low health literacy, stress, distractions, and information overload. Accurate, effective clinician communication is therefore critical. To obtain meaningful consent, you need to provide the patient with sufficient information in terms they can understand and allow sufficient time for patient questions. You should also document a thorough summary of the conversation, including any patient questions or concerns.

Using a competent interpreter is essential for effective informed consent discussions with limited English proficient (“LEP”) patients. Miscommunication due to language barriers can result in poor exchange of information, misunderstanding clinician education and instructions, deficient shared decision making, malpractice lawsuits, and regulatory actions.1 Researchers who studied closed medical professional liability claims involving language barriers concluded:

  • In 91% of the cases, clinicians did not use “competent” interpreters2 and many times used the patient’s friends, family members, and even minor children.3

  • Over a third of the clinicians did not provide critical documents, such as informed consent forms and discharge instructions, in the patient’s language.4

The following case summaries taken from the closed claims study illustrate the risks of conducting an informed consent discussion without a competent interpreter.

Example One5

Parents sued a hospital and an orthopedic surgeon alleging medical negligence and lack of informed consent after their 4-year-old son lost the use of his right arm. The parents, who spoke only Spanish, brought the child to the hospital where he was diagnosed with a broken arm and occluded brachial artery. He underwent at least three surgical procedures during an extended hospitalization.

Consent forms signed by the parents were written in English. The informed consent form for the first procedure was presented to and signed by the parents before the surgeon arrived for the consultation. The surgeon did not speak Spanish and acknowledged that the language barrier made communications difficult. Documentation in the medical record stated, “Language problems prevent in-depth questioning of his past medical history,” yet no interpreter was provided to the parents during the hospitalization. A family member was used to interpret twice. The carrier paid $650,000 in damages to the Plaintiffs.

Example Two6

Parents of a 9-year-old girl who died from a reaction to Reglan sued an emergency medicine physician and a hospital. Plaintiffs presented evidence that the physician misdiagnosed the child with gastroenteritis. He prescribed Reglan but did not advise the parents about the drug’s side effects or that it was not recommended for pediatric use.

The physician said he told the parents to bring the child back if her condition worsened, but no interpreter was provided to the parents to help them understand the information provided. Instead, the patient and her 16-year-old brother interpreted during the encounter. Discharge instructions and other documents signed by the parents were all written in English. The Plaintiff’s expert testified that direct communication between the physician and the parents via an interpreter was necessary to facilitate the parents’ understanding of the care and treatment, medication side effects, and discharge instructions. The carrier paid a $200,000 settlement and $140,000 in legal fees.

Risk Management Takeaways

  • Use competent interpreters for informed consent discussions with LEP patients.

  • Document an interpreter’s name in the medical record.

  • Do not use children to interpret.

  • Engage all patients in a comprehensive informed consent discussion and answer their questions, prior to asking them to sign a consent form. Document the informed consent discussion in detail in the medical record.

  • Except in emergencies, the informed consent discussion should take place days or weeks prior to the procedure.

  • If at least 5% of the practice’s patients speak a certain language, consider translating vital documents into that language (consent forms, pre- and post-procedure instructions, HIPAA notices, medication education and instructions, forms the patient/parent signs)

  • Where translated versions of vital documents are not available in the patient’s language, use an interpreter and discuss the contents of the document with the patient.


1 The High Costs of Language Barriers in Medical Malpractice (citing IOM Unequal Treatment).

2 Id. The study defined a competent interpreter as a professional interpreter or bilingual staff; knowledgeable in ethics, standards of practice, confidentiality, the interpreter’s role, and medical terminology in both languages.

3 Id.

4 Id.

5 Id.

6 Id.