Should a patient sign an Informed Consent Form in his mother tongue or in a language he understands the best?

The question was asked and commented by the GCP group of Linked in.

Shilendra pandey • the patient should sign the ICF in the language he understands best as the ICF contains information that need to be understood by the patient so well that he can take decision to participate in the trial and not come up later with complains that he was made a guinea pig.

Max Horneck • Dear Yulie,
actually this will not be an XOR. Usually people are most aware of their mother tongue however the real question is, have they been able to understand the risks and advanatages of the trial. Usually the investigator has to ensure that the patient will be able to make an educated decision. If the mother language does not contain adequate vocabulary or if the patient has left the community of the mother language at an age so he/she does not have the vocabulary to adequately understand the education given by the investigator a language best suitable should be selected. As far as I know there is no regulation that you have to sign informed consents in your mother language this is just a commonly used method because this fits most cases. However, the patient needs to fully understand the informed consent. I would be comfortable signing an English informed consent allthough this is neither my mother language nor the language I understand best.

Iftekhar Kazmi • Hi,
It is mentioned that informed consent should be taken in subjects understandable language. for more detail kindly refer below

* The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject’s legally acceptable representative and the impartial witness, where applicable. (http://ichgcp.net/48-informed-consent-of-trial-subjects)

regards. Iftekhar kazmi

Dainis Krievins, MD, PhD • Iftekhar is formally right. It’s true, GCP does not request directly mother tongue as language used for IC. However, it is very depends on auditors you may have. Some EMA auditors would give you a "finding", if you will not give IC in patient’s mother tongue. Of course, you may argue about GCP legislation, but we had no success with it.
Therefore, be aware, from one side patient should understand the IC (this is what really important), but for an other hand, beaurocrats from some regulatory agencies and auditors may see it in different way.

Yulie Feldman-Idov • Thank you for your comments. I agree with you that the patient should sign the ICF in a language which enables him full understanding of the ICF's content. GCP indeed does not require directly mother tongue as a language used for IC. However, like Dainis we have experience with requests to sign the patients in their mother tongue. Lately, we were requested by one of the sponsors to sign the patients specifically in their mother tongue. What do you think about this?

Jaime Morales Pintanel • they re not exclsuive. In my experience, you must have an ICF in his/her mother tongue and should be understable. My sites were located in places like Nicaragua, Iquitos, Tumbes, Buenos Aires and so and trust me, they gave no idea what is a pinta de sangre (pint of blood), for example.

Miguel de la Guardia • Yes, the document should be written in the language the subject understands best. But the language it is written in is not as important as how it is written. I have read documents in my native English that I can’t understand and I’ve read some that are well written in English, but the Spanish translation is comical at best. Literal translation of documents is often of poor quality or incomprehensible because the people doing the translation do not fully understand the context or colloquialisms of the various regions. As such, before those translations are finalized, a knowledgeable third party should proof read them for accuracy.

Lynda Cedar • All the communication with an enrolled subject in a trial must be in the langauge of the ICF signed by the subject. For more details, please read the regulatory Information at the FDA website (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm)

A Guide to Informed Consent - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators Contents):

Non-English Speaking Subjects:
To meet the requirements of 21 CFR 50.20, the informed consent document should be in language understandable to the subject (or authorized representative). When the consent interview is conducted in English, the consent document should be in English. 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. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.

If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be legally effective. If investigators enroll subjects without an IRB approved written translation, a "short form" written consent document, in a language the subject understands, should be used to document that the elements of informed consent required by 21 CFR 50.25 were presented orally. The required signatures on a short form are stated in 21 CFR 50.27(b)(2).

Illiterate English-Speaking Subjects:
A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law.
A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.

sajana Vattikuti • Hi all, In my view during the site start up itself, the CRO or the Sponsor Start up team will be asking the languages used in your locality and its surroundings. Based on the languages we mention, the set of ICFs will be set to the site for proof reading, review and Ethics Committee approval. It is upto Subjects discretion, which language he is convenient with on discussion with the Investigator. The local languages and English are usually suggested to the Site Startup team during Study Start up or Site Selection. If at all the ICF available at the site were not understood by the subject the comment mentioned by Lynda holds good.

Miguel de la Guardia • @ Lynda - Very thorough review. Thanks.

Ludmila Sklyar • HI all. Thanks a lot for the question , Yulie and for review . I has this issue in one of my Audits . As resolution comment has been added in to the pt Source Data file, explain that despite the fact that pt mother tongue is Russian, Hebrew version of ICF was signed as the most understandable language.

Lynda Cedar • @ Miguel. - My pleasure. Any time. Thanks.

Cristina Gonzalez • Followin Sajana's comment, we do need to take into account the ICF whatever language is must be approved first by the ethics. For most of the trials in ww countries we can not foresee the patient's mother's tongue so...what we should do? submit to the ethics the most popular languages expected on each site? Is not far future situation...

Nethaji Bhosale • The language he understands the best

Dr. Socorrina Colaco • In India we usually prepare ICFs in English, Hindi, Kanada, Tamil, Telugu and other local languages and submit it for ethics approval. So the subjects can choose their preferred language.

Amit Hirve , MSc MRQA • He/she should sign the IC docs in his/her local language. IC documents should be written so that lay person can understand it and your mother tongue is the best language to understand something which is new and complex.

Cristina Gonzalez • One further question:if the Ethics Committees will be submitted with ICF in different languages, they would accept the documents in languajes other than local ones. Moreover, if a French ICF is submitted and approved, any change done in the French core document will affect to all the sites which have these ICF validated? Or could the Ethics trust in the French Ethics approval to accept their acceptance and avoid in that way to review all languages applicable?

Joseph Michael • The person should sign the ICF in language he/she understand best, in order to make proper judgment.

David BenJoseph • Of course the ICF should be in the language that the patient understands.
It could take long discussion about the definition of mother language. I organized many clinical trials in Bulgaria. For Europe it is clear that the ICF has to be written in the official language of the country. There could be minorities who does not understand well the official language. They could be considered non-eligible for the trial or they could have the documents in their 'mother language'. All ICF, questioners and diaries have to be translated. All the translations have to be verified and approved. The texts are specific so the best translators are not the philologists but medical specialist who deeply understand the terminology, meaning and equivalents in the local language. In case of mother language it could be for instance Turkish and it is possible to use a verified official translation. But the language could be Roma (Gypsy) and it cannot be translated because there is no written language. The next problem is that population that has problem in understanding the official language of the country could not understand the documents in their mother language because of poor education. If a patient cannot understand ICF, questioners and diaries, usually that patient cannot be compliant and should not included in a trial.
I think that most of the considerations are applicable in Latin America and Asia as well.

Dr.Arunava Banerjee • Thanks Lynda & David and rest. The issue is serious enough. Serious issue in many countries with mixed population group like India. As I am a Sub-Investigator in my site I have to take active part in ICF process. What I feel is the content matter of the ICF and patient information sheet(PIS) is most important.It is said that standard of language should be of 7th standard.Do you think the language of ICF and PIS nowadays are of 7th standard.I think they are not in most of the cases.These are always full of technical scientific words.
Now I work in a state where mother tongue is mostly Bengali. I have to go check the Bengali translations of English ICF in all the studies that our site participates. Simply in most cases my experience is horrible. Bengali translations are realy pathetic. There are many terms used in English which does not have an easy and understandable Bengali replacements.These are mainly scientific and tecnical terms. To be frank checking Bengali translations of English ICF is the most fearfull work that I have to do regularly at site level. Problem is such that if ever I myself have to participate in any clinical trial in my life I shall never go for Bengali ICF; I shall go for English one.But I shall definitely prefer to talk to my doctor in Bengali.
.We have to judge every patient individually. The education and social status are to be taken care of. It is common at my site that patients prefer English ICF although English is not their mother tongue.
In this matter we give open offer to the patient.In some cases a patient can be given 2 ICFs,one in English and the other in mother tongue.Let him go through the both and decide which one is more understandable to him and accordingly the ICF can be signed.
The source note should mention the whole issue in minute details and in that case I think auditors shoul not do much.Of course there are some of them who will create problems always.
Responsibility of the Investigator and EC is maximum here.

Mina Saeed • Hi All, in my view, the subject should sign The ICF in language he better understands so he can voluntarily sign after understanding the risks and benefits of the trial but, I agree with Ludmila, that to escape the audit findings we add a comment in the patient source data file that despite her mother tongue, the specific language version of ICF was signed as the most understandable language. However in Egypt there are two versions of informed consent ; Arabic and English, and the patient must sign the two versions with note to file needed to clearly describe this issues.

Tania Betts • I agree with the comments being circulated, however I also think we need to look one step further. It is one thing to consent the subject into the study but once consented, will the subject be able to independently complete whatever patient-reported outcomes are required for the study, for example, patient diaries and questionnaires? Will these also be translated?

Yulie Feldman-Idov • Dear Tania,
If the subject is not able to independently complete diaries or questionnaires as required by the protocol (due to language barrier or other reason), then he is not eligible for the trial. It is important to have validated translations of these documents.

Anirudh Kulkarni • I agree with "Dainis " Some auditors argue about this. Therefore a informed consent process documentation is utmost important. something like this.

"When the patient came ?...what happened in the discussion.?...what questions did he ask ? and finally a sentence "the inform consent discussion was conducted in, XXX language in which patient knows to read and speak fluently, however the patient is comfortable signing ICF in XX langauge..(This may again not satisfy all auditors)

The other option is Video tape regarding consent process.This is common problem in India. They know how to read well and understand English but they will sign in local langauge.

Yulie Feldman-Idov • Dear all,
Thank you for your input. It was very informative and some interesting issues were brought up.

In our site we often encounter patients who do not have the vocabulary in their mother tongue to adequately understand the ICF's content, and their understanding of the official language of the country is much better. In this case, like Ludmila, Mina and Anirudh noted, the patient signs the ICF he understands the best and we add an explanation in the subject's source document. Hopefully this will satisfy the auditor.

As some of you indicated, translations have their faults and I also often see them at our site. It is clearly the responsibility of the EC and the site personnel to clarify the problematic terms and phrases, so the patient could fully understand the content of ICF.

Thank you again for sharing

Lynda Cedar • @Yulie - The pratice is correct when the subject signs the ICF developed in the language s/he understands the best. The best should mean: (1) the language was selected by the subject and (2) s/he fully understand the contents of the consent, verbally and in writing.
At my site, the translation of the ICF and other documents is done by a certified translator. The IRB has the liberty to review the translation of the ICFs in English or French to another language. So far, I haven't heard about any problem of translating the ICFs.

Thank you for sharing. Lynda.

Yulie Feldman-Idov • Thank you for the clarification Lynda.
Regarding translations:
From my experience, although the ICF and other documents we receive at our site are validated and done by certified translators, there are often terms that are not clearly translated, (especially words that are simply absent in another language) or very sophisticated language is used. Sometimes even the investigators who speak both of the languages, have difficulties with the translated version. In one case we received a very poor translation of the Russian version of ICF. A few months later the Sponsor sent us a far more understandable version of the same ICF (by different translation company). So choosing a translator can play an important role here.
In some of the comments above were mentioned similar difficulties in other languages.
At our site we clarify the problematic terms to the patient but usually do not report this to the CRO/Sponsor. Like David noted, the best translator is the medical specialist who deeply understands the terminology, meaning and equivalents of the language.

David BenJoseph • Thank you Ylie for the comment. Actually in trials where I played from the side of CRO I made translations from English to Bulgarian. As a VP of local ethic committee I have always read carefully the translations comparing with the English original and always recommended improvements of the language that made most of the sponsors angry but usually they decided to fulfill the requirements of the ethic committee.
The important texts and questioners have to be specially verified by the sponsor by back translation and subsequent discussion. For instance my translation was free but through to the meaning. The sponsor was aware about a missing word or the number of words in Bulgarian text was different. Their translator suggested a version that was word by word correct but the meaning was completely wrong or missing. We had a month meeting of all CRA and the sponsor and we discussed the translations. I was forced to follow the suggestion but I insisted on the correctness of my version. Finally the sponsor approved my version.
Another problem from a ICF I reviewed for the ethic committee: the English original text was 1.5 miles; the Bulgarian translation was 1.5 km. The sponsor argued strongly for the translation made my an authorized translator. We, the ethic committee, insisted that it is not equivalent and it could not be accepted.
Finally my opinion is that sponsors and CRO should be careful with the translations especially 'authorized translations'. Ethic committees/IRBs have to control the translated documents and are responsible for patients' safety.

Lynda Cedar • @Yulie, thank you for the comments. In my practice, I experienced too what you explained above but later I put in place policies that prevent or at least facilitate the project management:
Regarding the ICF and recruitment:
1.The ICF (in any language) must stay simple and easy to understand by the subject. If an investigator is not able to understand the contents of the ICF or part of it (even words), therefore such ICF is not acceptable and cannot be submitted or approved.

2. The translator is certified for translation and has to demonstrate his capacity of fluently and fully using both language of the translation. Also, there are organizations in the US and Canada certified for translations in some fields (ex. clinical trials and medical research. The ICF should contain a minimum of technical words that have to be explained to the subject.

3. The ICF is not the only issue for those non-speaking English or French. After signing the, they have to comply with the rules and procedures of the study. Someone (interpreter ) to coach them. Indeed what happens if a subject falls in an emergency situation? At my site and province we are lucky, our staff is multi-ethnic, multilingual, most of the nurses, technicians and employees speak at least 3 languages!!!

4. We submitted our ICF template (initially approved by the IRB) to the sponsor for review and approval, if rejected (which never happens yet) we do not include subjects with very rare language (dialect). It is not worth for the study and wasting time.
When we outsource a study to another site (if not English nor French) we let them use the local language. They have the liberty to use their own ICF, we and the sponsor however reserve the rights to review it by our translator. In fact we always translate the ICF for our records, to know about its contents.

5. Finally, if the sponsor and/or the IRB is not able to review the ICF translated, therefore no subject with that language will be enrolled.

As a note, regarding David comment: in my view, it is not the sponsor or the investigator who has to decide whether to use miles or Km, the decision belongs to the subject, which unit s/he is used to. In absence of the subjects the decision belongs to the IRB.

Happy for sharing.

David BenJoseph • Dear Lynda,
Thank you for paying attention to my writing. Mile is not translated as kilometer. Actually these are measure units. So 1.5 mile is equal to 2.414 km. The distance is the same the units are different. So if a patient is tired after 1.5 mile or after 3 mile it should be the same distance for having standardized condition. It is not in power of IRB or the sponsor to change the distance in different locations. So in my capacity of a member and VP of an ethic committee I insisted on policies that the content should be exactly equivalent between texts in different languages concerning the same protocol (study). I hope that all we shall agree on this topic.

Lynda Cedar • Dear David,
Thank you for the clarification. I knew about the conversions (http://www.france-property-and-information.com/metric_conversion_table.htm) and I agreed on your comments. I just wanted to add that we should use the system of measurement that a subject understand better and is comfortable with.

David BenJoseph • You are absolutely right. For Europe usually it is in SI that is not so in UK and USA.

John Olszewski, Esq. • As with all things GCP, the best way to answer the question is to first ask, "Why?' So, for the present question, we must ask what is the purpose of the ICF? The ICF is primarily a legal document that provides one of several types of evidence that subject knew what he/she was getting into when enrolling in the trial. This evidence is used by FDA to assure compliance with the regulation that subjects knowledgably consent to participation, and it is used in legal battles against a sponsor/investigator where a subject claims that he did not know what he was getting into, i.e., that he/she was not "informed."

So, the answer to the question at hand is that the ICF document should be written in the language that would provide the best evidence in a legal battle or FDA inspection that the subject knew what he/she was getting into when deciding to enter a trial. That would be the language that the subject best understands. Any other language opens up a prosecutorial argument that the subject was not actually "informed" about the trial.

Of course, the ICF is intended to be part of the subject educational process and not be merely documentation evidence, but the fact is that most subjects do not read and comprehend the ICF regardless of the language.

Mark Lawrence • It may be that the limitations of a dialect mean that people habitually use the official language for scientific terminology anyway. To illustrate this, look at us English speakers. We habitually use Latin for science, beginning from a time when English was just a hybrid dialect spoken in a dark rainy corner of the Roman Empire. But as anyone who deals with user-acceptance knows, Latin medical terms can spell trouble. It's best to use language that people are comfortable with, if this is possible without over-simplifying.

Most participants don't read ICFs for science, they read them because they want to know what they are getting involved in, and what the risk is for themselves. At this point, regardless of the scientific terminology, it is imperative that language is used that people understand.

The best thing to do is to try out the ICF on a few people. For example find 10 people without medical training and with a fairly representative range of educational backgrounds and ask them a set of questions that cover the key points, such as "According to the form, what should you do if you experience bad side effects?"

That way you can refine the ICF and address any ambiguities in the language, technical terms, difficulties with the format and type. Repeat this process once or twice until everyone is fairly happy with the ICF (90% able to answer is a good target) and then use this as a master copy.

Once you've got a reliable master copy (which you'll enter into your dossier) then find some translators, and get faithful translations made into as many dialects and languages as you'll encounter in your test.

Not only is user-acceptance testing of ICFs the right thing to do ethically, but having evidence that you have carried it out can save your skin in lawsuits.

[declaration of interests: I operate First Read This Limited, a company that carries out user-acceptance testing of ICFs and PILs)

Ranjan Kumar A Subject of Clinical Trial should sign Infored Consent in language that she/he best understand. No doubt mother tongue is the most understandable language for any person but it can't possible to provide exact script of the consent form. Hence Informed consent form should be most closest script of his/her mother tongue by which subject undertand most

Jakub Wasilewski for sure subject should sign ICV in language he knows the best, no metter if it is official language in specific country or not. ICF must be fully understood by patient. Translation is not problem in this case. Bigger problem is discussion with patient - showing and signing ICF is only final step of consenting.

Lynda Cedar, Ph.D @Jakub - That is true. Read my comments about it above.

Anand Kawade Patient should signed the informed consent form as he/she signing routinely only after understood the study procedures, risks & benefits etc .completely.It may happen that patient understood the study procedures best in marathi( mother tounge) while he signed& dated in english as he officiated for that

Hugues Nicolaythe ICF should be in the language that the patient understands, without any doubt.

Lynda Cedar, Ph.D * Draft Guidance Document on Exculpatory Language in Informed Consent - On September 7, 2011, the Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) announced in the Federal Register the availability of a joint draft document entitled, "Guidance on Exculpatory Language in Informed Consent," and are inviting public comments on that document. The joint draft document, among other things, does the following: 1. Provides guidance on the regulatory prohibition on the inclusion of exculpatory language in informed consent. 1. Includes examples of language that OHRP and FDA consider acceptable as well as examples of language that the agencies would consider exculpatory. 1. Clarifies that OHRP and FDA have concluded that language in informed consent is not exculpatory if it informs subjects that, by agreeing to allow the use of their biospecimens for research purposes, they are giving up any legal right to be compensated for the use of the biospecimens. This represents a change from OHRP's November 15, 1996 guidance on point, "Exculpatory Language in Informed Consent," which identified as "exculpatory" certain informed consent statements in which subjects gave up any rights they might have in their biospecimens. OHRP and FDA now consider these statements to be acceptable for inclusion in informed consent, and they are restated as examples of acceptable language in the draft guidance. Thus, for example, it would now be acceptable to include language in a consent form such as "I give up any property rights I may have" in biospecimens, or "I voluntarily and freely donate" the biospecimens to a particular institution. When finalized, the draft document will supersede OHRP's November 15, 1996 guidance entitled, "Exculpatory Language in Informed Consent" and question number 52 in FDA's January 1998 guidance entitled, "Institutional Review Boards Frequently Asked Questions - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators." The Federal Register notice of availability, the joint draft guidance document, and instructions for how to submit comments can be accessed on the OHRP website at http://www.hhs.gov/ohrp/newsroom/rfc/. The joint draft document can also be accessed on the FDA website at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGudiances/default.htm.

Yulie Feldman-IdovThanks Lynda

Lynda Cedar, Ph.D. My pleasure Yulie. Any time.

prasad pendyala M.Pharm The main aim of ICF is that need to be understood by the patient so well that he can take decision to participate in the trial or not so it should be in a language that the patient can understand to his best of knowledge about the risks

Yvonne Quinn For future reference I suggest you also add a note in the chart if the subject has a mother tongue ( French) and is also bilingual ( English) and is fluent in both. The note should indicate the language preference of the subject because of his fluency in both laguages. Of course the study nurse and PI will confirm that the subject has read and fully understood the contents and their questions have been answered.

Liping Zhou I agree with majority of you that the subject should be provided an consent form in the language that she/he understand the best. Here we more focus on the consent form itself but it is also important to ensure that the consent process should be performed in the language that the subject understand the best. We do see sometimes the investigators could not speak local dialect (e.g. mandarin vs.cantonese)... According to ICH GCP 4.8.6, the language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.

Deepak Assudani, MBBS, PhD I had a related query to this one. Is it acceptable if the contact details of the investigator on ICF is in a different language than the rest of the ICF. Sometimes the ICF has a blank space for the site to write the contact details of investigator, which they may write in english although the ICF is in some regional language. Although ideally both should be same, but would regulators look at this as a serious finding?

Haresh Dodia Mr. Deepak, it must be same as the language of ICF. Volunteer may not be knowing the english and that's why he/she given the different language ICF. Additionally, contact detail is one of the most critical thing which volunteer use in case of emergency/adverse event. If the volunteer does not understand the language properly, how will he/she contact the investigator? However, if any document/ICF support that the subject know English language in addition to language of ICF, it could be acceptable for that particular subject.

Lynda Cedar, Ph.D @Deepak: at the time the subject is asked to sign the ICF (developed in the language that he fully understands) the investigator is usually known. A blank space might be left in the ICF for contact information if needed, it will contain only names and tel. numbers. In fact, as long the ICF explains to the subject what to do in the case he needs to contact the research team, names and tel numbers can be provided later on (inserted in that blank space).

Deepak Assudani, MBBS, PhD. Thanks Lynda and Haresh. As Lynda has rightly mentioned that generally the investigator and the site address is known to the patient. In such a case, its not clear whether these details on ICF have to be provided in the ICF language itself (considering it is not documented that patient can read english as well as Haresh mentioned). None of the guidelines have specifically addressed this.

Lynda Cedar, Ph.D. @Deepak: I'm sorry for the miscommunication... even for recurrent participant (BA/BE for example), the information is provided verbally and in writing at the session of information about the research. If at that time the contact information (cell phone and names) is not known yet, it can be inserted in the blank space later on. As a note: only written information provided is valid, this is the only way that it can be tracked.

BARNALI BISWAS • Take a simple example of any document if it reads, say in french and signature done in english. The logic is simple that the person understands the local language but signs in english, which is most common by everyone for any purpose. In case of clinical, Now it will entirely depend upon the subject in which language he understand the best. Example, ICF in french completely understood by the volunteer and signs in english. which is acceptable as GCP says that the ICF should be understandable to the subject. signing in the document itself confers that the subject is aware and agreed with the document.

David BenJoseph • Dear Ms Biswas, How do you make difference between signature in French and in English? Both languages use Latin characters and I don't see how the name will looks differently.

Traian Andrei Manu • Regardless of what language you would use you'd have to document also that the subject understands better the official language or his mother language. You could have in the same country sites that would only use mother language and other sites using the official language. Of course you would have to 360 degrees verify the translations and everything. Upon this there is going to be a problem with the CRA verifying the mother language ICFs, but that's another discussion.

Suresh Lakkireddy • The language used in ICF in witten and oral should be understandable to the subject, need not be the mother toungue, which is more rational and also the GCP requirement.

T.B. (Puma) Smagge • Of course the mother tongue should be offered. What the person signs up to is what the person best understands.