Informed Consent Form Translation Services
GTS is the leading service for professional translation of informed consent forms in Chinese, Russian, Spanish, Vietnamese and over 80 other languages.
We have translated hundreds of informed consent forms. Clients include leading doctor’s and dentists’ clinics as well as some of world’s largest pharmaceuticals, medical device companies, biotech companies and contract research organizations (CRO).
When you order a consent form translation from GTS, your translations are delivered on time, within budget and in full compliance with applicable requirements. All translations are certified and delivered with a signed translation certificate of accuracy. We guarantee acceptance by your IRB of the informed consent forms that we translate.
Why Choose GTS as your translation company for informed consents?
GTS specializes in certified translation of Informed Consent Forms (ICFs) for hospitals, university medical centers, doctor’s offices, medical clinics, dental clinics and for multicenter research trials. We have translated hundreds of informed consent documents into all Asian and European languages. We also translate consent forms from any language into English.
Informed Consent Translation for Doctor’s Offices and Dental Clinics
Many doctor’s offices and dental clinics, especially in the USA, have patients that don’t speak the national language. For example, there is a large population of Spanish-speaking people in the USA. Doctor’s office in many fields of medicine, like plastic surgeons, oral surgeons and eye doctors require that patients fill out various consent forms. GTS provides doctor’s offices with a complete solution for consent form translation into other languages.
Informed Consent Translation Requirements in Clinical Trials
When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate. As required by 21 CFR 50.27, a copy of the consent document must be given to each subject. In the case of non-English speaking subjects, this would be the translated document (from FDA website).
Informed Consent for Non-English-Speaking Participants in Clinical Trials
When conducting clinical studies for a new drug, informed consent must be made available to each patient in their own native language. That makes informed consent translation a requirement in clinical trials which involve patients from different countries, and in countries with diverse ethnic groups (like the USA which has a large Spanish speaking population).
Informed Consent Form Prices
Informed consent forms start from several hundred words and can run up to about 7,000 words. Average price per page to informed consent form translation to Spanish: $37.5.
At GTS, this price includes professional translation by a certified medical translator, review and page layout in MS Word file format. Also includes a Statement of Accuracy certificate. Average price per page to translate an ICF into Spanish with back translation validation: $80 a page.
Certified translation of informed consent forms
GTS is a certified translation company-our Quality Management System (QMS) is certified as compliant with the ISO 17100:2015 standard.
When required by the IRB/ethics committee that monitors a clinical trial, we can provide back translation and validation of informed consent forms. All ICF translations are provided with a translation certificate of accuracy.
What is a translation certificate of accuracy?
A certificate of accuracy is a signed statement that attests to the accuracy of the translation. The translation certificate of accuracy will typically be printed on a company letterhead and will be signed by the Quality manager of the translation company.
Why is a certificate of translation accuracy required?
When a translation is required for official purposes, like informed consent forms in a clinical trial study, proof must be made that the translation was done professionally and accurately. The translation accuracy certificate represents that proof. Typically, the translation certificate of accuracy will be attached to the translation, together with the translation company’s quality certificate (e.g., ISO 17100:2015 certificate).
Drug companies that conduct clinical testing internationally require that clinical trials conform to the World Medical Association’s Declaration of Helsinki. These ethics committees require that the Informed Consent Form (ICF) be in a language that is clearly understood by the people participating in the clinical studies. This includes translation of the ICF to the local language.
If confidentiality of your documents is a concern, we can sign an NDA before you send us the consent form to be translated.
Related pages from the GTS Blog
GTS Translation Steps Up to Assist in COVID-19 Clinical Studies
Using Translation Services in Investigator Initiated Trials (IIT)