In keeping with The Ottawa Hospital (TOH) and the University of Ottawa Heart Institute (UOHI) policies on bilingualism, the Ottawa Health Science Network Research Ethics Boards expect that patient participants who are approached to participate in a clinical research project be able to receive recruitment materials, informed consent, and study documentation in the official language of their choice, English or French.

Translation applies to all research studies that involve patient participants at TOH and/or the UOHI, regardless of who the Board of Record (BOR) is (OHSN-REB, OCREB, CHEO REB or BOR through CTO Stream, etc.).

It is important to note that this is the basic OHSN-REB standard. Please check with your institution and adhere to their specific policies.

For initial ethics and registration applications, all documents being translated or verified by OHRI French Translation Services will be sent through the Clinical Research Registration Form (CRRF) (no longer sent via email):

• For ethics applications, the applicant will need to select a translation stream (Third Party/Sponsor, UOHI French Translation Services, PI/Study Team, or OHRI French Translation Services) for each document uploaded into the CRRF.
• For registration applications, the applicant will need to upload the applicable documents for OHRI French Translation Services to translate or verify into Ethics Tab 9 of the CRRF.

The translation process for Amendment is as follows:

• If Third Party (Sponsor, Translation Company or Certified Translator) and/or Heart Institute French Translation Services is translating:

  • After review of the English documents, the REB may request the translated documents prior to Amendment approval. If the translated documents cannot be provided in a timely fashion, the REB may move forward with Amendment approval; the approval letter will indicate approval for the English documents.
  • The email in which the Amendment approval letter is enclosed will detail when the French documents are due and will instruct study teams to forward the translated documents to the REB Office.
  • The study team will submit the translated documents to the REB Office.
  • The REB will review and process an approval letter for the French documents. The approval letter will be forwarded to the study team.

• If OHRI French Translation Services (Eric Lepine) is translating:

  • When an Amendment is approved by the REB, the letter will indicate approval for the English documents.
  • The REB will then send the applicable documents directly to Eric Lepine for translation on the study team's behalf.
  • Eric Lepine will return the translated documents directly to the REB.
  • The REB will process an approval letter for the French documents. The approval letter, along with the translated versions and certificate of translation, will be forwarded to the study team.

• If PI/Study Team is translating:

  • When an Amendment is approved by the REB, the letter will indicate approval for the English documents.
  • The email in which the Amendment approval letter is enclosed will detail when the French documents are due and will instruct study teams to forward the translated documents to the REB Office.
  • The REB will send the applicable documents directly to Eric Lepine for verification on the study team's behalf.
  • Eric Lepine will return the verified documents directly to the REB.
  • The REB will process an approval letter for the French documents. The approval letter, along with the certificate of verification, will be forwarded to the study team. If changes are required, tracked (showing the changes) and clean copies of the applicable documents will also be enclosed.

Note: This is a guide only. Turnaround time may vary due to holidays, sick leave, etc.