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REB Bilingualism Policy With Respect to Informed Consent Documents
 
Enacted October 1, 2004

Informed consent forms must normally be available in both English and French. This requirement is based on the importance of free and informed consent in research, and the hospital's commitment to bilingual service for families and youth.

Under limited circumstances, the REB can waive the translation requirement. In order to obtain such a waiver, the investigator must demonstrate that it is either inappropriate or impracticable to require both French and English consent forms. In other words, the investigator would need to show that the additional financial, material, human, organizational and other resources needed to carry out a study in both languages are so burdensome as to render the research unfeasible. An investigator might argue, for example, that a study cannot be responsibly conducted in one or other official language because the outcome measures have not been yet been translated and the resources needed to do so are prohibitive. An investigator might also argue the bilingual requirement should be waived because the research is being conducted in a community in which neither official language is dominant (e.g., Inuktituk).

The decision to waive the requirement for consent forms in both official languages will be sensitive to the specific nature of the study. Projects are not likely to be given a waiver if they present more than minimal risk to participants or if they offer innovative therapies to patients that would otherwise be unavailable. To request a waiver for the requirement, please submit a 'waiver of requirement for French translation' event within ROMEO. A signature page will be required for this event. Click here to see a word version of the waiver of requirement for French translation signature page.

The translation of research documents (e.g., consent, assent, recruitment materials) can be completed following the instructions on CHEONET. If this option is not feasible, the documents can be translated by an employee who has a level of A+ from translation services for writing.

It is the responsibility of the Investigator to ensure that the translated materials are accurate and complete version of the original text and written at a reading level that is appropriate to the study population (for adults this is generally taken to mean a Grade 8 level of literacy). French documents should be submitted through Romeo using the "Translated Documents Form".
 
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