Clinical Trials

Clinical drug trials (Phase I, II, and III) must be approved by Health Canada prior to their commencement. A copy of the Health Canada “No Objection Letter” (NOL) must be forwarded to the REB office, since without it the file will be incomplete. The REB will start the ethical evaluation of the project but without the NOL a final approval of the protocol will not be produced until the file is complete.

According to the Tri-Council Policy Statement (TCPS 2) a clinical trial is “any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies. Clinical trials may also include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to those that directly evaluate the treatment of participants.” (Chap. 11, p.163)

Please refer to Health Canada website.

Clinical Trial registration is mandatory

According to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TPCS 2, Article 11.3), clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry.

https://www.clinicaltrials.gov/

http://www.controlled-trials.com/

Review fees

Fees charged are for REB review and for the support provided by the Research Ethics Office (REO), not the approval. Please note that projects reviewed by the REB will be billed even if the project will not occur regardless of the cause of non-fulfillment.  

Review type

Fees

Description

  • Initial Full Board Review

$3,000

  • Initial review of the protocol
  • Ongoing review

$500

  • Annual renewal done by Full Board or Delegated review
  • Amendments requiring a Full Board review (incident report, TI and SAE) or changes requested by the industry (protocol amendment, consent form)

 

$500

 

  • Major amendement
  • Increasing the scope of the study

$3,000

  • Addition of one or two objectives, therefore a new study

 

  • This review fee applies to research projects funded by a third party (individual, private industry or when is contractually responsible, in totality or partially, for receiving data/publication rights and/or access to records for clinical trials that will be submitted to the REB for review.

Example :

  • Pharmaceutical products and medical device
    • Research team submitting a protocol finance by industry
    • Research protocol financed by a Government agency which is not peer reviewed

Form to generate the invoice 

Please complete the billing form (for internal use and available in French only at this time) and submit it to the REB Office. This step is part of the submission process (initial or renewal).