Ethical Dilemmas With Language Barriers & Informed Medical Consent

The foundation for obtaining informed consent came about as a result of the medical experiments and research that occurred during WWII. The need to establish parameters and guidelines to use during the trials of medical personnel, guards, officers and others involved with concentration camp and death camp atrocities became necessary. Prior to the Nuremberg Trials, no rules or concrete regulations were documented to prevent medical experimentation and procedures on unwilling participants.

Language Barriers

• Informed consent gives the individual the legal and ethical right to make choices about health care. Errors can occur in diagnosis, treatments and procedures when English is not the primary language, and hampers the ability to obtain a fully informed consent. Ethically, physicians are obligated to include the patient in health-care decisions. Federal and state laws guide health-care providers in obtaining consent, including the use of interpreters. The United States Department of Health and Human Services' regulation 45CFR46.116 requires informed consent be obtained only in the language understood by the patient or a proxy chosen by the patient.

Additional Considerations

• Many individuals feel a sense of helplessness when ill and that choices are out of their control. The ability to understand complex procedures, alternative therapies and the outcome can be affected by language as well as literacy level, mental competence and stress level. Written consent is not required for all procedures, but might require a discussion, such as for blood tests or x-rays. The individual who might refuse care doesn't necessarily indicate incompetence even if the care proposed is life-saving. Special telephone translators or interpreters, to obtain informed consent, are available in many facilities to avoid legal and ethical problems.

The Nuremberg Code

• The Nuremberg Code, published in 1949, was the initial effort to set standards to judge the individuals involved in medical experiments and crimes in Nazi Germany. The principle of informed medical consent with humans was the result of of the Nuremberg Code and forbids the use of undue pressure, threats, deception or ploys to gain consent. The code, while a step forward, did not serve to enforce the rules of obtaining informed consent, so violations continued to occur in Europe and the United States.

Additional History

• By 1964, the Declaration of Helsinki was established drawing from the Nuremberg Code for fundamental rules to further protect participants in research and medicine. The declaration established the requirement for independent guidance for participants and review of data. It also refused publication of any research projects that had not been externally reviewed. By 1974, the U.S. Congress established the National Research Act as a result of ongoing unethical practices in research and medicine. The goal of the act was to better control the treatment of human participants involved in medical research and obtaining a fully informed consent.