Translating your informed consent forms put your clinical trial on the path to success. Discover why.
When conducting clinical research, informed consent is crucial. It goes way beyond having participants sign on a piece of paper.
A researcher’s initial contact with a potential participant is only the first step. The informed consent process doesn’t come to an end until participants are no longer involved in the research project.
Its purpose is to ensure research subjects understand what they’re agreeing to, so they can give their consent freely.
Now, how do you go about participants who aren’t proficient in the language of the study? Individuals from different backgrounds provide value to your research. So, it’s crucial to find a way to overcome their language limitations.
Let’s delve into informed consent and find out how translation can increase your patient engagement.
What is informed consent?
As new medical products are developed, there’s no knowing how well they’ll work, or what risks they may entail. By testing them in people, clinical trials assess whether new drugs are safe and efficient.
Anyone considering whether to take part in a clinical trial should understand their role as a “research subject”, so they can make an informed decision.
And this is where the informed consent process comes into the picture. Participants are given accurate, reliable and relevant information on key points such as:
- The purpose of the study and procedures involved.
- The schedule and duration of the research.
- Possible benefits and risks.
- Any medical treatment or compensation available for patients suffering treatment-related damages.
- Assurance that participation is voluntary.
- Confirmation that they may withdraw from the study at any point.
Participants can then weigh the pros and cons, and decide whether to join a clinical trial.
What is the role of informed consent in research?
Informed consent aims to ensure that participants enter research voluntarily. The proof of it is that they give their consent before joining the study.
But let’s take it one step further.
If patients don’t understand the scope of a clinical trial, they’ll be skeptical about taking part in it. Having accurate information encourages them to work together with the researchers.
Now, say you’re sued over a clinical trial. Informed consent protects you by proving that participants did understand the risks they may be exposed to.
So, you should ensure that potential participants:
- Receive transparent information.
- Can ask questions and discuss the research protocol with family and friends.
- Agree to participate without suffering any coercion or undue influence.
Now, informed consent isn’t a one-off but an ongoing interactive process. The researcher continues to provide information as the clinical investigation proceeds.
Written versus oral informed consent
Informed consent tends to come in the shape of a written document known as Informed Consent Form (ICF). But there may be cases where oral consent is more appropriate.
A written process is a straightforward way of signing the “research agreement” when:
- Participants are literate.
- The research is complex or has different stages.
Signed ICFs provide evidence that participants understood the terms of consent. Which may come in handy, for instance, if you need consent for copyright over data.
But consent can also be given verbally, without signing any form. For example, if:
- Participants are illiterate.
- They’re concerned about signing contract-like documents due to cultural or political reasons.
- Research is conducted through video conferencing.
When obtaining oral consent, make sure to record the conversation.
No matter how informed consent is given, you must allow enough time for participants to make up their minds. There should be no haste or pressure between the information-giving and consent stages.
What type of language should be used in informed consent forms?
Both the EU and the US require informed consent in clinical research. But they don’t dictate any specific language for informed consent documents.
These forms are often drafted by specialist doctors and pharmaceutical experts. As a result, technical and medical terminology find their way into texts that are meant for lay readers.
However, language in informed consent forms should be understandable to all participants. Which tends to be interpreted as meaning language at the 8th grade level.
That’s the way to go if you’d like to reassure potential participants and increase patient engagement in your clinical trial.
Now, if English native speakers struggle to understand ICFs, can you imagine the difficulty they entail for people with limited English proficiency?
Do you need to have your ICF translated?
You may think your ICF doesn’t need translating because you’re only conducting research in the United States.
Well, think of it this way.
The Hispanic percentage of the total population is almost 20%. Translating your ICFs into Spanish is key to engaging potential participants who don’t speak English proficiently.
This population adds value to research studies, providing insights that may not be discovered if they weren’t included. Without them, your study wouldn’t be as thorough.
Plus, participants need to know what will happen during the research project, and what their responsibilities are. Otherwise, the entire trial may be a failure.
What should you consider when translating your ICFs?
- Use plain language
Consent forms must be in a language that the participant understands. And the same applies to ICFs in the target language.
- Check whether you need a certificate of accuracy
Your Institutional Review Board (IRB) or ethics committee may require a document attesting to the fact that the translation is an accurate rendition of the source.
- Use back translation
Have the translated version of the Informed Consent Form translated back into the source language. The translator doing the job should have no contact with the original ICF.
A project manager will then assess the two versions to ensure the translation is accurate.
- Offer interpreting services
If the participant speaks another language, have someone available to answer their questions. An interpreter will help you interact with them and reassure them.
How to find a reliable language service provider for your ICF translations?
Finding the right supplier for your ICF translation project is key to improving patient engagement in your clinical trials. Check the LSP’s quality process to ensure they can add value to your research project.
At Montero, we’ve been awarded the ISO 9001 and ISO 17100 certifications, which proves our commitment to quality.
Would you like to find out more about our language solutions for Life Science? Contact us by clicking here.
