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Past Interpretations of the TCPS

Subject US Ethics Committee Review of Clinical Trials in Canada
Keywords jurisdiction, ethics review, clinical trials, international harmonization, ICH-GCP, OHRP
TCPS Articles 1.14
Date September 2003

PDF US_Ethics_Committee_Review_of_Clinical_Trials_in_Canada_Sept_2003.pdf

1. This is in response to your recent letter in which you inquire (i) whether it is appropriate for a United States (US)-based ethics committee to review a clinical trial to be conducted in Canada; and, (ii) if the ethics committee is to do so, what are the requirements? You further indicate that the Canadian site does not have its own ethics committee. Your question has been referred to the Interagency Advisory Panel on Research Ethics (PRE)1, which provides interpretation and guidance on research ethics matters regarding the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998 (with 2000, 2002 amendments).

(i) US Review of Canadian-Based Research

2. Your inquiry concerning the appropriateness of US-based ethics review of a Canadian-based clinical trial raises a fundamental question about which norms would apply to such research. It is our understanding that Canadian, US, and even international norms need to be examined to answer the question. Sometimes, the research protocol will specify the norms to apply. We are not in a position to advise on the required international or US norms.

3. Still, we do understand that US law and policy on human research would seem relevant. For instance, international provisions of US federal Drug and Medical Device law and other federal policy on human research policy may offer some guidance. We are aware, for example, that the US Department of Health and Human Services Office for Human Research Protections (OHRP) references--among the duties of US research ethics committees reviewing US federally supported research located outside the US--a requirement of adherence to both US federal policy and other international standards. OHRP2 specifies those standards to include the International Conference on Harmonization E-6 Guidelines for Good Clinical Practice (ICH-GCP-E6) and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of Canada. The ICH document has been adopted by Health Canada. As noted above, the Interagency Advisory Panel on Research Ethics has some responsibilities for the TCPS, including facilitating its interpretation.

(ii) The TCPS and Canadian Standards

4. In Canada, a researcher or institution that receives funding from either the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) or the Social Sciences and Humanities Research Council (SSHRC) must respect the standards of the TCPS as a condition of funding. One of the stipulations in the TCPS is that an institution is responsible for the ethical conduct of research undertaken by its faculty, staff or students regardless of the location where the research is conducted. Thus, review of research by that institution's Research Ethics Board (REB) is required, in addition to review by any agency having jurisdiction over the site of the research.

5. In some instances, then, the TCPS will apply to research conducted in non-university settings. If such settings lack a duly constituted REB, they will usually make arrangements with a sister Canadian institution to arrange for such review. Such a Canadian institution will typically be a standard university-based REB, but it also may include a provincial REB in some provinces, an REB designated by a professional body for such review, or even a Canadian private REB, so long as the local REB brings to the process the expertise, experience and post-approval monitoring duties contemplated by the TCPS. This is the spirit and logic of article 1.14 of the TCPS on the review of research in other countries or jurisdictions:

Research to be performed outside the jurisdiction or country of the institution which employs the researcher shall undergo prospective ethics review both (a) by the REB within the researcher's institution; and (b) by the REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where the research is to be done.

6. We interpret the logic of article 1.14 to further guide our response to your question. Exclusive reliance should be placed on US-based review only if arrangements with a competent and experienced Canadian REB of the kinds noted above are objectively impracticable, and then only if the standards of article 1.14 are maintained. For instance, post-approval monitoring duties may prove difficult if the committee is based in the US.

7. At a more general level, we invite your attention to Section 73 of the TCPS, regarding clinical trials. Finally, we also point out that the TCPS complements other potentially applicable Canadian federal or provincial norms that may impose other standards or limitations. For clinical trials involving new drugs and medical devices, for instance, Health Canada has adopted regulations and the ICH standards.4 Since those regulations specify the ethics review and REB membership requirements for drug trials in Canada, you may wish to consult Health Canada.5

We hope that this information assists you in your research ethics initiatives.

Sincerely,

Secretariat on Research Ethics
on behalf of
The Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  2. http://www.hhs.gov/ohrp/
  3. The TCPS supersedes the draft Code of Conduct, which you mention, and the Canadian Institutes of Health Research (www.cihr-irsc.gc.ca) has replaced the former Medical Research Council. For the TCPS, see www.pre.ethics.gc.ca/eng/archives/tcps-eptc/
  4. Health Canada, Therapeutics Products Directorate: www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e6_e.html
  5. See, e.g., C.05.001 (REB membership requires Canadian citizens or landed immigrants).