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

Ottawa Hospital Research Ethics Boards / Conseils d’éthique enrecherchesCivic Box 411 725 Parkdale Avenue, Ottawa, Ontario K1Y 4E9 613-798-5555 ext. 14902 Fax : 613-761-4311http://www.ohri.ca/ohrebStandard Operating ProcedureTranslation Of Research DocumentsSOP Number: OH1000 v. 03 Category: REB AdministrationSupersedes: OH1000 v. 02 Effective Date: 18/Sep/2012Subject: Translation Of Research DocumentsApproved By: REB Executive 12/Apr/2012dd/mmm/yyApproved By: Clinical Research Governing Council 26/Jun/2012dd/mmm/yyApproved By: Senior Management Team 09/Aug/2012dd/mmm/yy1.0 PURPOSEAll potential research participants at The Ottawa Hospital should have theopportunity to receive informed consent and study documentation in theofficial language of their choice, English or French.2.0 SCOPEThis Standard Operating Procedure describes the requirements for thetranslation of research documents as well as the criteria by which theResearch Ethics Board may consider exemptions to the policy.3.0 REFERENCES TO OTHER SOPs/POLICIES4.0 RESPONSIBILITY• The Ottawa Hospital Research Ethics Board (OHREB)5.0 PROCEDURES5.1 In keeping with The Ottawa Hospital policy on bilingualism, the OttawaHospital Research Ethics Boards expect that participants who areapproached to participate in a clinical research project be able toConfidential - Page 1 of 3 – Not for DistributionThe only approved version of this SOP resides on the SOP webpage. Printed copies are unofficial.

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.

writing, for the accuracy of the translation. The REBretains the right to have the French and/or English consentforms reviewed by an official translator at any time shouldconcerns regarding the concordance of the content arise.In addition, as part of its quality management system, theREB will perform an annual audit of a sample of consentforms approved under this exemption.5.4.3 All requests for exemption should be put forward in writing to theChair of the REB. The REB will oversee and manage languageand translation issues in human subject research as a matter ofdistributive justice.5.4.4 If approved, this exemption extends to all research relatedmaterials such as consent forms, advertisements, and any otherwritten information provided to the research participants.6.0 APPLICABLE REGULATIONS AND GUIDELINES7.0 ATTACHMENTS8.0 SOP HISTORYSOP Number Effective DateSummary of RevisionsDate ReviewedSOP OH1000 04Jan11 25Nov11 Section 5.3 – when translation isprovided by third party requirementfor submission of translationcertificate.Section 5.4.2 - Exemption added fortools validated only in onelanguage. Process for investigatorswhose first language is French or forbilingual investigators is clarified.SOP OH1000v. 0213Dec11 11Jun12 Section 5.4.4 was added to clarifythat if an exemption is granted thisexemption extends to all researchrelated materials.Confidential - Page 3 of 3 – Not for DistributionThe only approved version of this SOP resides on the SOP webpage. Printed copies are unofficial.