SOP 1000 v.03 - Translation of Research Documents - The Ottawa ...

eceive informed consent and study documentation in the officiallanguage of their choice5.2 If the French documents are not available at the time of REBsubmission, the investigator can submit the English documents forreview and may receive a two-month conditional approval for therecruitment of English speaking subjects. If French documents are notsubmitted within the two-month period, the conditional approval will berevoked. It is in the best interest of the research team to submit to thetranslator immediately.5.3 If the French translation of research documents is performed by a thirdparty (i.e. sponsor, translation company), the translation must beverified by the REB official translator for TOH or Translation Servicesfor the University of Ottawa Heart Institute, or a certificate of translationmust be submitted with the documentation.5.4 Exemptions to this policy may be required depending on thecircumstances of the project.5.4.1 Exemptions will not be granted because research staff isunilingual or due to funding constraints.5.4.2 Exemptions may be granted in one or more of the followingcircumstances:• Studies where there is no anticipated benefit to the studypopulation.• Anticipated recruitment period of less than 2 months.• Use of questionnaires, data collection tools, cognitiveand/or psychological tests that have been validated only inone language.• Issues related to idiosyncrasies of the subject population(i.e. where French translation may be irrelevant for a studybeing done in a specific population).• On investigator-initiated studies, investigators or consentform authors whose primary language is French mayrequest that instead of having their English versiontranslated into French, as an alternative they may havetheir French version translated into English (theinvestigator’s second language). If any investigatorconsiders themselves or their consent form author to becompletely bilingual (regardless of their primary language,English or French), then the investigator may request anexemption from using the OHREB official translator orUOHI Translation Services. In this circumstance, theinvestigator must agree to assume responsibility, inConfidential - Page 2 of 3 – Not for DistributionThe only approved version of this SOP resides on the SOP webpage. Printed copies are unofficial.