Tri‑Council Policy Statement
In Canada, the responsibility for the protection of human research participants rests with the Panel on Research Ethics (the Panel or PRE). PRE is an interdisciplinary and pluralistic advisory body, which reports to CIHR, NSERC, and SSHRC regarding the promotion of ethical research involving humans. Currently, PRE promotes and supports the implementation and interpretation of the current Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans, 2nd edition (TCPS2).
In 2017 PRE published Proposed Revisions to TCPS 2 (2014) [PDF - 98KB] on research involving human cells and cell lines. A period for public consultation was held from October 17, 2017 to January 5, 2018. All comments received are now posted online – unless the contributor requested that they remain confidential – including the following detailed commentary with proposed revisions by François Baylis and Mark C. McLeod.
2008 - The Panel on Research Ethics initiates a public consultation on the first major revisions to the original (1998) Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans. Researchers at NTE participate in a series of public consultations from 2008 to 2010. Submissions made in 2009 and 2010 are available on our archived TCPS webpage. In December 2010, the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans, 2nd edition (TCPS2 [PDF - 1.7 MB]) is released.
September 2013 - PRE publishes proposed revisions to the (TCPS2 [PDF - 239 KB]), for public comment. Researchers at NTE participate in the public consultation process. Of particular interest is the proposed integration of the CIHR Guidelines for Human Pluripotent Stem Cell Research into the TCPS2. This is something that researchers at NTE argued for in 2009 [PDF - 46 KB], 2010 [PDF - 40 KB], 2011, and 2012 [PDF - 135 KB]– our perseverance paid off. For a detailed account of the history and the ethical challenges, see: Baylis, F. & Downie, J. (2012). Unfinished Business: Ongoing ethical exceptionalism in the oversight of human pluripotent stem cell research in Canada [PDF - 135 KB].
January 15, 2014 - Another issue of ongoing concern is research involving women of childbearing potential, pregnant women, and breastfeeding women. This is something that researchers at NTE have been working on since the mid-1990s – long before the introduction of the original TCPS in 1998. Some of our concerns are listed in our submissions to the PRE on the problematic guidance and practices regarding the inclusion/exclusion of women in research.
February 2014 - The PRE website posts the public consultation comments for the TCPS 2.
March 21 2014 - The Secretariat on Responsible Conduct of Research (SRCR) releases consultation comments, activities report, and closed-captioned webinars. The SRCR expresses their gratitude for the thoughtful responses of Canadian researchers and maintains to consider this feedback in their preparation of recommendations to the Tri-Council who are responsible for approving revisions to TCPS 2.
April 2014 - The Interagency advisory Panel on Research Ethics shares its responses to written requests for the interpretation of the TCPS 2. In addition, the SRCR expands its interpretation services to include the Tri-Agency Framework: Responsible Conduct of Research.
February 7, 2017 - Françoise Baylis, Matthew Herder & Trudo Lemmens write a submission on the proposed revisions to chapters 6 & 11 of the TCPS2 which pertain to the Governance of Research Ethics Review and Clinical Research, respectively [PDF - 89 KB].
Update: December 20, 2017 - Françoise Baylis & Marcus MacLeod provide comments [PDF - 741 KB] on the Tri‐Council Policy Statement: Proposed Revisions to TCPS 2 (2014) Research Involving Human Cells and Cell Lines.
Updated as of 4 April 2018.