The number of individuals with Limited English Proficiency (LEP) is quickly on the rise in the United States. This has an impact on many aspects of the life science industry, including subject recruitment among minority populations whose native language is not English, and obtaining a proper informed consent translation services.
Why Should You Pay Attention To LEP Populations When Performing Clinical Trials?
Minority representation in clinical trials is crucial, especially as the demand for greater ethnic and racial diversity increases, along with pressure to take genetic factors into consideration. As such, international clinical trials are common. These trials will naturally involve subjects who do not speak English, resulting in the need for clinical research translation services. However, even if you aren’t performing clinical trials internationally, minority populations in the United States can still consist of multilingual individuals with limited English proficiency (LEP) who will need patient related documents presented in their native language.
The Growing Minority Populations
As minority populations with Limited English Proficiency increase in the United States, so does the need to address language barriers in subject recruitment. This is extremely important with informed consent translation, as any misunderstandings before a clinical trial can result in unnecessary consequences – both medical and legal in nature.
Based on data from the U.S. Census Bureau, between 2009 and 2013 60,361,574 people speak a language other than English at home, and 25,148,900 speak English less than very well. Currently the two largest groups of non-native English speaking minority populations residing in the United States are Spanish and Chinese speakers. While these two languages may be the most commonly spoken across the country (outside of English), the language you will need to consider for your clinical trial heavily depends on where in the country you’re planning on recruiting subjects. For example, if you are focusing on an area in California, you may need to focus more on Tagalog translation than Spanish or Chinese, due to the large Filipino population.
Do You Really Know Your Target Subject’s Native Language?
As stated above, by 2013, Spanish was by far the most common language spoken at home in the United States (62%), followed by Chinese Mandarin and Cantonese. That same year, Spanish speakers accounted for 64% (16.2 million) of the total LEP population, with Chinese speakers, both Mandarin and Cantonese (1.7 million), and Vietnamese speakers (835,000) being the next two most prominent LEP groups.
While these groups are reported as the most dominant, one key issue that is sometimes overlooked is the fact that many of these subjects may speak a dialect, or in some cases a completely unrelated language. Not accounting for these differences in language could result in poor communication. Take Spanish as an example – it is important to address differences between spoken Spanish among different Latin American populations, as well as not be taking for granted that all individuals from Latin American countries speak and understand Spanish. They may speak their own native indigenous dialect. Similarly, a Mandarin Chinese interpreter should not be used for a Cantonese Chinese speaking patient. As obvious as these points may seem, more often than not, subjects are presented with a document that they cannot understand or an interpreter who cannot communicate with them in their native language. This happens simply because the language they speak was not properly identified.
The Most Spoken Languages In The United States
Regulations and Requirements for Informed Consent Translation
U.S. federal regulations require that investigators provide translated informed consent forms (ICF) in the patient’s native language. The main challenge arises when subjects are presented with informed consent in English and there is no ICF translation available to them in their native language. This requires some preparation on the part of the investigator to address potential language barriers in the population they are seeking to enroll.
Due to the critical nature of an informed consent form, investigators must meet certain translation requirements, including that any patient information must be translated by an experienced translator. Moreover, if translation is not provided for individuals with LEP, as with poorly translated informed consent forms, there are serious legal and ethical ramifications.
When The Need For Informed Consent Translation Is Not Anticipated
When looking to recruit subjects for international clinical trials, translation of informed consent forms and other patient related documents is anticipated. However, when performing trials in the United States, you may not always be prepared for an LEP subject to join your trial. There are certain steps to take for informed consent translation if an LEP subject is being interviewed unexpectedly. According to the FDA guidelines on informed consent, the information of the approved English version of the consent document must be presented through oral translation, via a professional interpreter, to the subject. It is crucial in these instances to hire a professional interpreter, who is fluent in the native language of the subject. If you don’t, you can run the risk of the information presented to the subject not being fully understood, and thus not obtaining informed consent from the subject that is legally effective.
In these instances, a short form in the native language of the subject will generally have to be provided for approval by the IRB. Later on a full translation of the informed consent document may be required. Similar procedures need to be followed when providing ICF information to an LEP patient that is illiterate.
Obtaining Ethical Informed Consent
Language barriers are one of the biggest issues for investigators during subject enrollment as well as during the trial itself. It is crucial at every step of patient enrollment that individuals are able to understand what the trial entails, and that they can communicate and report any adverse effects or changes that occur during the course of the trial. Therefore methods set in place to ensure subjects can fully understand the information presented to them, and that an accurate clinical trial translation can be obtained, should be reviewed prior to beginning the enrollment process. This includes translating and culturally adapting all patient information whenever possible, and having professional interpreters on hand for unanticipated language needs. In addition to the recruitment phase, interpreters must be available for studies in which there is ongoing contact with the subject in order to facilitate study procedures and patient reporting of problems. Partnering with a CRO and a language service provider experienced in clinical and life sciences translation services is the best way to ensure that translation and interpreting needs are met during the recruitment process as well as throughout the course of the clinical trial.
- American Community Survey 2013
- U.S Census Bureau Detalied Languages Spoken At Home and Ability to Speak English 5 yrs. And Over 2009-2013
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