An Open Invitation For Comments on a Discussion Paper:

“Refinements to the Proportionate Approach to Research Ethics Review in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)”

Call for Comments: Open from 22 December 2005 to 6 March 2006
As part of PRE's Ongoing Season of Consultations

ProGroup, a working committee of the Interagency Advisory Panel on Research Ethics (PRE)¹, addresses procedural and related definitional issues in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Further to PRE’s invitation of 22 December 2005, ProGroup welcomes comments on its Discussion Paper entitled Refinements to the Proportionate Approach to Research Ethics Review in the TCPS. The Paper presents suggestions for changes and areas of development in the TCPS related to the definition of “research” involving humans, proportionate approach to research ethics review and related issues. It also addresses the use of other elements beyond “risk” in making decisions on the level of research ethics review. These were identified in 2003 public consultations as priority areas of concern to the research ethics community.

The results of the consultation on this Discussion Paper will lead to proposed textual recommendations for the TCPS, which will be shared for community input later in 2006.

How to Submit Your Comments

To facilitate the processing of community input, an on-line consultation form has been created. It provides ample space for both specific responses and general comments on areas addressed in the Discussion Paper. Comments may also be submitted via fax or regular mail. The links to the Discussion Paper and the on-line consultation form, as well as the contact information are provided below. Paper copies of the Discussion Paper are available upon request through Secretariat@pre.ethics.gc.ca.

Please make your comments and suggestions as specific as possible. Examples and evidence supporting the point(s) being made should be referenced in your comments and/or copies of supporting documentation provided if possible.

Finally, we wish to engage as many members of the community as possible in this consultation process, and as such, we encourage you to share these documents with others who may be interested in responding.

Please remember that the closing date for the submission of comments is Monday, 6 March 2006.

ProGroup and PRE would like to thank you in advance for taking the time to respond to this consultation.

¹ The Interagency Advisory Panel and Secretariat on Research Ethics (PRE/SRE) was created 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) to provide independent and interdisciplinary advice to these three agencies on the interpretation, evolution and use of the TCPS.
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