Obtaining proper patient informed consent is necessary to abide by FDA and IRB regulations concerned with clinical trials. When trials are performed internationally, the process for obtaining informed consent is not just informing the patient about the trial, but doing so in his or her native language.
ICF translation is common with pharmaceutical companies and CROs performing international trials. However, one must be sure that the translation is flawless – or else the issue of not having gained full, legal informed consent from a patient can arise and delay time to trial.
So what can you do beforehand to ensure that the translation process goes smoothly? We address some of the best practices for pre-translation preparation of informed consent form materials, in our Tips for ICF Translation 2 part series below.
Tips for ICF Translation – Part 1
Tips for ICF Translation – Part 2
The informed consent form translation process is one that must be done with precision, and according to regulatory standards. Therefore, it is always best to prepare as much as you can in advance before contracting a professional translation agency, and to then discuss the best strategy for your particular project and timeline with your chosen LSP.
Still have questions about ICF Translation? Check out the resources below, or Contact a Translation Project Manager Today!
More Information on Translation in the Life Sciences:
- Life Science Translation Services
- Clinical Trial Translation Services
- Interpreting Services
- Languages Available for Translation
- Minorities Matter: Obtaining Patient Informed Consent With U.S. LEP Populations
- Tips For Overcoming Global Patient Recruitment Challenges
- Case Study: Short Notice Adverse Event Form Translation
Tips for Patient Informed Consent Form Translation Part 1
Clinical research translation services are essential for ensuring an ethical and statistically relevant international clinical trial. One stage of trials where this is particularly important is in the process of obtaining patient informed consent.
Having a thorough and accurate translation of your informed consent forms and other patient recruitment materials is necessary in order to gain FDA and IRB approval to conduct international clinical trials.
This is also the case for trials that take place in the U.S. that recruit patients with limited English proficiency. Preparation of these documents is essential before soliciting translation services in order to save costly mis-translations or re-dos.
So what are some of the best practices for document preparation for ICF translation?
Tip 1: Conform to all recommended ICH GCP standards and guidelines, and any local IRB or Ethics Committee requirements
Meeting specific language requirements is crucial in gaining regulatory approval. Ensure that your documents conform to these regulations by excluding exculpatory language, simplifying or clearly explaining technical wording, keeping the tone of your document as neutral as possible, and writing in a style that can be understood by everyone – not just researchers. Consent forms should be written at an eighth grade reading level.
Remember that an ICF translation will follow its source documents faithfully, so any complicated wording or improper toning will be reflected in the translated version.
There are very specific requirements for Informed Consent Forms that must be met for non-English speakers or individuals with limited English proficiency. If the subject does not clearly understand the information presented to them, and there is no IRB-approved, written translation given to them, any consent obtained may not be considered legitimate by the FDA, IRBs or Ethics Committees.
Tip 2: Get FDA and IRB approval of all English texts before translation
As stated before, an ICF translation will faithfully reflect the text in the source documents. Therefore, if you solicit translation before your English documents are approved, any changes that may come back from the FDA or IRB will not necessarily be reflected in your final translations.
Of course changes may occur during the course of the study, but having to re-send source documents with changes can complicate the translation process by delaying expected delivery, and incurring further costs.
The translation agency is not responsible for any changes made to the source document after the translation is finished, or even during the translation process unless properly notified. Even if they are notified, you may still incur extra costs for further translation and editing.
Therefore, it is best to have the final, English source materials approved before soliciting translation. Keep in mind that the quality of the translation will be determined not only by the translator, but also by the quality of the source document.
Tips for Pre-Translation Preparation of your Patient Informed Consent Form Materials Part-2
Tip 3: Use a professional translator with a background in the Life Sciences
Having a translator with industry expertise ensures that the consent forms will be translated accurately into your target language. This is guaranteed when you work with a professional translation agency.
Industry specialization coupled with cultural and linguistic knowledge of your target patient population is particularly important for the translation of documents used in patient recruitment. This is due to the fact that certain terms and concepts may not directly translate into your target language.
Take for example, the English term “subject” in reference to a patient participating in an international clinical trial. There may be no direct translation of subject in your target language, or a different word may be used in place of it. This can be seen in the Spanish language where it is more appropriate to use the translation for the word “patient “rather than subject.
Moreover, English clinical research terms may have several translations depending on the region. Using Spain as an example, in addition to Castilian Spanish, spoken dialects include Galician Spanish and Catalan.
Then there are the variations of Spanish spoken in different parts of Latin America. The English term, “randomization” for instance, proves problematic when translating for clinical trials, for this reason. There are four different ways it can be translated into Spanish, each depending on the region where the trial is taking place.
It is important, therefore, to use standardized industry-specific terminology when translating such documents. A translator with clinical trial translation experience will understand these linguistic nuances.
Requesting that your translator have a background in clinical research, and even a background in a particular field of medical research , will further ensure accuracy and limit the chances of a possible mis-translation.
Tip 4: Identify the subjects’ native languages and implement localization strategies
Before soliciting an ICF translation, you will need to identify the languages that are predominantly spoken by your target subjects. This may not be as simple as requesting translations in the national or official languages spoken where you will be conducting your trials.
Sometimes dialects and other minority languages may be more common amongst the population you are looking to enroll in your study.
Even if potential subjects are familiar with the national language, they may have limited proficiency. To ensure the best possible translation, you must provide clinical materials in the dominant language understood by your target patients.
The same goes for the style of language used and the format of your documents. Localization techniques become important when there are differences between Western cultural norms, for example, and those of your target population.
These could include everything from values and ideas, to reading style and number formatting. Documents that are not prepared with the target culture in mind can potentially lead to conveying unclear information down the line.
Making Sure You’ve Covered All the Bases for an ICF Translation
Preparing informed consent documents for multinational and multilingual trials requires being meticulous and paying close attention to detail. The translation requirement is an essential part of getting regulatory approval.
Therefore, the best way to cover all your bases is to make sure you prepare your source documents well in advance in accordance with regulatory requirements, and discuss any potential formatting or language concerns with your language service provider.
As long as you follow these tips you can rest assured that your informed consent documents will be approved, and time to trial won’t be delayed by costly translation mistakes.