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Research in Canada

Schulman can serve as the Research Ethics Board (REB) for research studies involving human subjects that take place in Canada.

Canadian research is reviewed every Friday.

Because of provincial regulations, the Canadian review does not provide oversight for research sites in Alberta, Saskatchewan and Newfoundland and Labrador. Additionally, the Canadian review does not review research sites in Nova Scotia that are located in the Capital District Health Authority’s jurisdiction.

In Québec, Schulman will review research that involves only adults with capacity to consent.

Please reference our full Statement of Compliance and Research Ethics Board Attestation Memo for Canadian reviews on our Forms page.

Submit a Multisite Study

A sponsor/CRO requesting review of a new Canadian multisite protocol that has never been reviewed by Schulman must submit:

  • Multisite Study Submission Form or Minimal Risk Multisite Study Submission Form
    • If the study involves an investigational new drug or biologic or an investigational use of a marketed drug or biologic you will need to provide the CTA #. Additionally, if the study is a Phase I, II or III, provide a copy of the No Objection Letter (NOL) or the date of submission to Health Canada. With the exception of the NOL, this information can be provided on the submission form.
    • Review can occur without the CTA # and/or NOL; however, study approval cannot be granted until these items are received.
  • Protocol
  • Canadian Template Informed Consent(s) (Word format)
  • Clinical Research Budget Template

And, if applicable:

Submit a Single Site Study

A sponsor/CRO or Investigator requesting review of a new Canadian single site study for a protocol that has never been reviewed by Schulman must submit:

  • Single Site Study Submission Form or Minimal Risk Single Site Submission Form
    • If the study involves an investigational new drug or biologic or an investigational use of a marketed drug or biologic you will need to provide the CTA #. Additionally, if the study is a Phase I, II or III, provide a copy of the No Objection Letter or the date of submission to Health Canada. With the exception of the NOL, this information can be provided on the submission form.
    • Review can occur without the CTA # and/or NOL; however, study approval cannot be granted until these items are received.
  • Protocol
  • Canadian Template Informed Consent(s) (Word format)
  • Clinical Research Budget Template (Canada)
  • Curriculum Vitae (CV) of Principal/Qualified Investigator (PI/QI) and each Sub-Investigator (Sub-I), if not already on file – CVs must reflect experience, be signed and dated within the past 2 years.
    • Sub-I CVs are not generally required for site submissions on studies that have been qualified by the Board as minimal risk and/or non-interventional.

And, if applicable:

Deadlines: Full board reviews of Canadian studies occur every Friday. Study submitted by 3pm EDT/EST on a Friday will be reviewed on the following Friday.

Assignment to a board meeting is dependent upon the complete and accurate submission of all required documents. Refer to Federally Funded/FWA Study, Submitting a Device Study and Transfer of IRB Oversight for Study for additional requirements for these types of study submissions.