Home

CAREB Response to the Release for Final Public Comment of the Draft 2nd Edition of the TCPS

Dear CAREB members,

In response to the call for final public comment on the revised Draft 2nd Edition of the TCPS, I am happy to advise you that I have submitted the official CAREB response on behalf of the Board of Directors and the CAREB Public Affairs Committee (see link below).

CAREB believes that the revised Draft 2nd Edition of the TCPS is a substantial improvement over the initial draft circulated in 2008-2009 and we acknowledge and appreciate that a majority of the concerns outlined in our June 29, 2009 response to on the initial draft have been addressed. However, we have significant concerns with the changes made to Chapters 6 and 11. We believe that the recent changes to Chapter 6 (Governance of Research Ethics Review) adversely affect the role of Research Ethics Administrators (REAs) and, in fact, gives the appearance of trivializing the important and essential functions that we deliver. We have suggested possible wording changes to relevant Articles and to their corresponding application sections. CAREB also has concerns about the recent changes to Chapter 11 (Clinical Trials) and a section on this chapter has been added.

See response

Thank you all for your important contribution to the evolution of the federal guidelines.

Regards, Alex

CAREB President