Jim Gearhart

by Jim Gearhart

The TCPS2: Canada Revises its Ethical Guidelines for Clinical Research

Anyone conducting clinical research in Canada must be familiar with and follow the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans. (The three councils in the document’s title oversee the range of human participant research in Canada. They are the Canadian Institutes of Health Research; the Natural Sciences and Engineering Research Council of Canada; and the Social Sciences and Humanities Research Council). This document, usually abbreviated as the TCPS, establishes Canada’s policies on protecting human research participants, and a revised version of it came out in December 2014. Quorum’s Regulatory Team has reviewed the new TCPS and prepared a crosswalk document that summarizes what has changed. Here also are some highlights of what we’ve noticed as significant or interesting elements of the newly revised TCPS:

  • Consent/Assent of Minors (TCPS Articles 3.3 and 3.10): In considering assent and consent of minors, the TCPS does not set specific ages for sharing information, securing assent, or getting full consent. The new guidance states that the age of assent should depend on “decision-making capacity” rather than the minor participant’s specific age.
  • Sharing clinical data: Canada appears to be ahead of US policies in calling for the public posting of all clinical data results. The TCPS requires that all studies be registered, and encourages researchers to make all results public, whether published or not.
  • Social/Behavioral Research: The TCPS lays out a few changes in approaching social and behavioral research. For one, it defines research in part as any disciplined inquiry and states that research should be defined according to the expectations of the relevant field. Also regarding a definition of research, one observation is that students’ thesis projects typically meet the definition of research and so require REB review.
  • Reporting of Incidental Findings: In this age of increased collection of biological samples (bio-banks) and full genome-mapping, the issue of incidental findings has become critical. Ethics boards and researchers struggle with whether, how, and when participants should learn about health information that comes to light during a trial. In this version of the TCPS, Canadian authorities unequivocally state that researchers should disclose incidental findings to the participant, but also allows for the possibility of exceptions from that requirement.
  • Alteration of Consent and Debriefing: This version of the TCPS also appears to be encouraging more research under an alteration or waiver of informed consent, but while making clear that participants should be debriefed whenever possible and appropriate, what this debriefing should look and feel like, and that participants should be given the option to withdraw from the research. This is a significant difference from US policies which only state that participants be provided with additional pertinent information after participation.

The TCPS2 provides guidelines, examples, and suggestions for ethics boards. For anyone more accustomed to the US Government’s body of regulations, the organization of the TCPS is less formal and it feels more advisory than prescriptive. The introduction to the TCPS defines its fundamental ethical principles for conducting experiments on people: Respect for Persons; Concern for Welfare; and Justice. The text then routinely refers back to those principles when setting or clarifying its review policies.

The December 2014 revision of the TCPS has some significant changes. Quorum’s Canadian ethics board, which reviews private and public-funded research in Canada, fully complies with the changes.

 


Tri-Council’s websites:

Canadian Institutes of Health Research

Natural Sciences and Engineering Research Council of Canada

Social Sciences and Humanities Research Council

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