IC Translation Service
(05/02/2007)

Question 1:

What would your take be on the process for Informed Consent as it relates to non English Speaking subjects. I have read the guidelines and what we are struggling with is who really can be a witness to the IC. Our translation services will translate but does not sign on the witness line. Who then is deemed eligible to be the witness? Is a family member acceptable? It can be very difficult logistically to find an individual that can speak both languages (other than a family member) plus have the research individual and translator in the room all at the same time. Do you have any suggestions or experience in guiding individuals on this.

Answer 1:

The short answer to your question is that FDA's regulations do not specify who is qualified to orally translate information for the subject during study visits, nor do the regulations prohibit using a family member in this capacity. A family member who is fluent in English and the subject's native language may be the only person available. The study site should work with IRB to develop appropriate procedures/processes as to how translation for subjects who do not speak English will be carried out.

I'm a little concerned, however, that you may have some confusion as to when a witness is needed. The simple fact of not speaking English does not require a witness. However, FDA does require a third person to witness the consent interview when the subject or representative is not given the opportunity to read the consent document before it is signed (see 21 CFR 50.27)(b). A witness is also required when a short form written consent document, stating that the elements of informed consent required by 21 CFR 50.25 have been presented orally to the subject or the subject's legally authorized representative (21 CFR 50.27(b)(2)). Considering that the witness "must be present to attest to the adequacy of the consent process and to the voluntariness of the subject's consent*," it would be very difficult for the witness to make such an attestation if the witness does not speak and understand the subject's language. [*See Final Rule, "Protection of Human Subjects; Informed Consent," Federal Register, vol 46, no. 17, January 27, 1981, Comment #52, pp. 8949-8950].

I've pasted excerpts from the Information Sheet pertaining to Non-English Speaking Subjects into this e-mail for your convenience:

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). [Emphasis added.]

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.

Some of the questions and answers in the "Frequently Asked Questions" Information Sheet may also be helpful:

39. Who should be present when the informed consent interview is conducted?

FDA does not require a third person to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before it is signed, see 21 CFR 50.27(b). The person who conducts the consent interview should be knowledgeable about the study and able to answer questions. FDA does not specify who this individual should be. Some sponsors and some IRBs require the clinical investigator to personally conduct the consent interview. However, if someone other than the clinical investigator conducts the interview and obtains consent, this responsibility should be formally delegated by the clinical investigator and the person so delegated should have received appropriate training to perform this activity.

40. How do you obtain informed consent from someone who speaks and understands English but cannot read?

Illiterate persons who understand English may have the consent read to them and "make their mark," if appropriate under applicable state law. The 21 CFR 50.27(b)(2) requirements for signature of a witness to the consent process and signature of the person conducting consent interview must be followed, if a "short form" is used. Clinical investigators should be cautious when enrolling subjects who may not truly understand what they have agreed to do. The IRB should consider illiterate persons as likely to be vulnerable to coercion and undue influence and should determine that appropriate additional safeguards are in place when enrollment of such persons is anticipated, see 21 CFR 56.111(b).

41. Must a witness observe the entire consent interview or only the signature of the subject?

FDA does not require the signature of a witness when the subject reads and is capable of understanding the consent document, as outlined in 21 CFR 50.27(b)(1). The intended purpose is to have the witness present during the entire consent interview and to attest to the accuracy of the presentation and the apparent understanding of the subject. If the intent of the regulation were only to attest to the validity of the subject's signature, witnessing would also be required when the subject reads the consent.

FDA recognizes that obtaining consent from non-English speaking subjects is a complex issue, and we are in the process of reviewing our policies and guidance related to informed consent and non-English speaking subjects.


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