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TCPS 2 - Revisions for Public Comment

The Panel on Research Ethics announces the release of proposed revisions to the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) for public comment. Written comments on the proposed revisions to TCPS 2 will be accepted until January 15, 2014. The set of revisions is now available online.

For immediate release –

Ottawa, ON (September 12, 2013) – In keeping with its mandate to ensure the evolution of the policy statement, the Panel on Research Ethics is seeking public comment on proposed revisions to the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2).

In December 2010, after extensive public consultation and on the recommendation of the Panel, the Canadian federal research Agencies (CIHR, NSERC and SSHRC) adopted TCPS 2 to replace the first edition of the Policy. This is the first set of changes proposed by the Panel since the publication of TCPS 2. Some of the Panel’s proposed revisions arise from its responses to interpretation questions submitted by the public. Many of those interpretations are posted on the Panel’s website as part of its ongoing interpretation service. Other revisions aim to strengthen and clarify responsibilities related to clinical trials.

The Panel also proposes to fully integrate CIHR’s Guidelines for Human Pluripotent Stem Cell Research (the Guidelines). These are currently incorporated by reference in TCPS 2. The integration of these Guidelines addresses the Agencies’ goal of providing a single reference document for the ethics of all research involving humans conducted under the auspices of institutions eligible for Agency funding.

The Panel’s proposed revisions are set out in two documents:

  • Proposed Changes to TCPS 2; and
  • Integration of the Stem Cell Guidelines.

Companion documents are also provided for reference purposes:

  • Highlights of Changes; and
  • Tables of concordance pertaining specifically to the Guidelines.

We invite written comments on the proposed set of TCPS 2 revisions. In light of those comments, the Panel will prepare final recommendations to the Agencies for their consideration and approval.

Following this round of consultation, the Panel will propose a more comprehensive revision to the policy statement focused on changes to Chapter 11 on clinical trials and on the subject of population and public health research. The Panel will seek public comment on this subsequent revision in 2014.

Comment Submissions
To promote the transparency of this public engagement process, the Panel requests that you include your name and the following demographics with your submission:

1. Province or territory
2. Affiliation: university, hospital, college, community organization, other
3. Capacity in which you are submitting the comments: REB member, researcher, student, administration, research participant,
representative of a group or organization
4. Your main discipline: Behavioural Sciences, Biomedical, Engineering, Health Sciences, Humanities, Interdisciplinary,
Natural Sciences, Social Sciences, other

All comments received (including identifiable information) will be posted to the Panel’s website after the closing of the comment period. If you do not wish to have your comments posted, please indicate that clearly at the beginning of your submission.

Please submit your written comments by January 15, 2014 by e-mail to: Secretariat@rcr.ethics.gc.ca or by mail to: 
Secretariat on Responsible Conduct of Research
350 Albert Street
Ottawa, ON  K1A 1H5
Canada

The TCPS was developed in 1998 by the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or “the Agencies,” to provide harmonized guidance on the ethical conduct of research involving humans. The Agencies formed the Panel in 2001 to interpret and promote the TCPS.

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