Translating Informed Consent Forms (ICFs) usually brings up a debate, because sometimes the barrier to understand is not just which language the ICF is in, but the complex words and jargon used in it. Clinical trials are essential to make scientific and medical progress, but even more important is to guard the wellbeing of the human participants. Making sure that they understand and know what they are consenting when signing an ICF is their right and must be a priority. 

So… Do you need to use plain language? Do you need to translate the form into many languages? In this blog entry, we will unfold what you need to consider when translating or adapting an ICF. 

Contents:

What about ICFs regulations? 

Plain language & translation

Regulations state that Informed Consent Forms must be in language that the participant understands. This might mean that you need to translate it if you are working in another country or with foreigners that do not speak English. But it also means that in English it must be written clearly and in plain language. And when translated, ICFs must also be in plain language in the target language. 

The name “Informed Consent” says it all, the person signing that document needs to know and understand the extent of the procedure that they are agreeing to. A language barrier or a poor translation might risk violating a participant’s rights and can derail a clinical trial. 

When it comes to translating your ICFs it is necessary to have on board a specialized professional that knows how to work with patient-facing documents. You’ll need a translator that has an expertise in the life sciences industry to understand the source document but that can also work out a way to put it in simpler words making it more accessible for the public. 

The language it is in won’t mean much if the form was written by a high level surgeon or specialist doctor with intricate and specific language. If English speakers struggle to understand the language of Informed Consent Forms, imagine the difficulty that exists for people with limited English proficiency (LEP).

Limited English proficiency

As we mentioned, the regulation states that the ICFs must be in an understandable language. This is why in both the US Food and Drug Administration and the Department of Health and Human Services, the forms must be translated for all LEP patients.

In the United States, there are growing communities of people who do not understand spoken and/or written English. But this people, for different reasons, might bring key information to a clinical study that might get lost if they can’t participate because of a form in English. 

What do you need to know when translating ICFs? 

What is an Informed Consent Form?

An informed consent form is both an ethical and legal requirement for a human to take part in a clinical trial. These documents give the participant all the information that they need and it always includes: 

• A summary of the procedure or study.
• Its purpose.
• The duration and schedule.
• Expected procedures.
• Potential benefits and risks.
• Alternatives to participating.
• The rights and responsibilities of those involved (the participant, study administrators, sponsors, etc.).

Informed consent forms consist of two parts. One part is the information sheet that includes the aspects outlined above. The second part is the certificate of consent. Participants receive a copy of their informed consent form and information sheet. 

Do ICFs translation require a certificate of accuracy?

In most instances, the Institutional Review Board (IRB) must review and approve all translated versions of an informed consent form before it is used in a study. As part of the review and approval process and in order to satisfy most IRBs, Informed Consent Form translations must be submitted along with a certificate of translation accuracy. The Certificate of Translation Accuracy verifies that certified linguists were used and that a process (preferably a certified process) was employed while performing the translation.

Will you need back translation?

Sometimes, if a particular clinical trial is especially complicated or has associated risks, back translations of the ICFs might be required. This particular procedure involves taking the translated document and having a different translator (who has not seen the source document) translate it back to the source language. Later, the two versions will be assessed to confirm there was nothing lost in the translation, this provides an additional quality assurance step. 

Interpreting services might be advisable 

If participants speak another language or are limited in English proficiency, offering interpreting services is a good practice. While the only legal requirement is having the initial ICF translated into an understandable language, questions may arise when signing or during the trial. Plus, participants must know who to contact when different issues come up, and contacts should be able to communicate in a language participants understand.

Finding an ICF specialized translator

Informed Consent Forms are required for any study or medical procedure and anywhere in the world you might be carrying out trials you’ll probably need to translate ICFs. Ensuring that participants and patients understand what they are agreeing to is a must to respect their rights and the integrity of a clinical trial. 

At Win & Winnow, we have almost 20 years of experience in the life sciences industry, our specialized team helps you carry out your clinical trials in more than 100 languages. Contact us to get a free assessment and quote!