Translating Informed Consent Forms
Translating Informed Consent Forms (ICF) is one of the most critical steps in the recruitment of patients for clinical trials. It is not only a requirement in cases where individuals are not adequately fluent in English, but an integral part of good clinical practice guidelines and maintaining ethical standards. So when is it necessary to perform a translation and what should you keep in mind?
1. What is Adequately Proficient
If the individual being recruited for a clinical study can read and understand English adequately, meaning at the sixth grade level or above, then an ICF translation is not necessary and the form may be given to the patient in English.
If the individual cannot read English, but understands spoken English, then someone from the clinical trial staff can read the Informed Consent Form to the them in the presence of a witness, and document that the patient has understood and accepted the terms. Documentation involves having all three individuals sign the consent form: the subject, the person reading the form and the witness.
All individuals with Limited English Proficiency (LEP), or individuals who have not had the opportunity to adequately develop fluency in English, and have difficulty speaking or reading in English will need to have the Informed Consent Form translated for them into their native language.
2. Literacy versus Proficiency
If the individual cannot read English, but is adequately literate in their own language, then a translated version of the ICF and all other relevant information should be provided to them in their native language.
If the individual cannot read proficiently in his or her own language, but understands the spoken language, then the translated version of the Informed Consent Form should be read out loud to them in their native language. A signature must then be obtained from the person giving informed consent, the person acquiring consent and a witness in order to document that the consent was obtained orally.
3. Who Should Perform the Informed Consent Forms Translation
In accordance with regulations, Informed Consent Forms must be provided in a language that the participant clearly understands. This means that it must be written clearly and simply in both the source and target languages.
When translating informed consent, the translator should be someone who has qualified translation and localization experience, has a background in clinical research, but also has daily interactions with patients and knows how to effectively communicate with them. For example, a physician who specializes in a particular field may not be the ideal translator as they may be more likely to use medical terminology that the patient is not familiar with.
4. Certification of Translation Accuracy
In most cases, an Institutional Review Board (IRB) must review and approve all translated versions of an ICF before it is used in a clinical study. ICF translations must be submitted for approval along with a certificate of accuracy to verify that certified linguists were used to perform the translation via an approved process.
This is because in the past translation was sometimes performed by non-professional translators and the result was often inaccurate and low quality. It should be noted that the process of translating ICFs, and other essential clinical documentation, involves several important steps in contrast with other more simple types of document translation services.
5. When Translating Informed Consent Forms is Not Enough
It is also important to keep in mind that patients may need to have clinical study personnel available to answer any questions they may have regarding their participation in a study.
If the participant speaks a language other than English, and is not adequately comfortable speaking in English, then measures should be taken to have an interpreter or a qualified person who speaks the patient’s native language. The person responsible for interpreting services should not only be fluent in both languages, but should also have the ability to discuss issues or concerns that the patient may want to go over with the clinical investigator or other personnel in charge of the study.
Language Connections has years of experience translating clinical trial documents, including patient Informed Consent Forms.
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
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