Good Clinical Practice Guide
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Thread: Translator signing ICF as a witness

  1. #1
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    Translator signing ICF as a witness

    Where an independent translator has been used during the consent process for a patient who cannot read/speak English, should the translator sign the consent form as a witness - would this person meet the definition of GCP 4.8.9 as an "impartial witness"?

  2. #2
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    The BARQA website answered a similar question about who was an independent witness (31st May 2011):-

    "A: ICH GCP E6 section 1.26 states the impartial witness is ‘a person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial’. Therefore other subjects participating in the study should be excluded as impartial witnesses. Doctors or nurses from other departments (rather than the department that the study team work for) are suitable as impartial witnesses as long as they are not under direct supervision of the Principal Investigator or other members of the study team. Patients in the clinic or wards who do not participate in the study are acceptable, as long as they have had no previous experience of the trial (e.g. patient withdrawal) that may introduce some element of bias. In most cases the subject’s relative can be an impartial witness, but there has been some debate that relatives may not be impartial; if this is questioned then I would suggest a person with no relationship to the subject or the study would be the best option."

    FDA have commented (02Dec2008) on a similar situation by saying:- "Hospital staff who are not under the direct supervision of the Principal investigator may be considered an impartial witness".

    So it would seem that the important element is the independence of the witness. Therefore you have to ask yourself whether the translator is independent of the investigator & staff?

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