Home

CAREB releases Draft Guidance on Reporting of External (Non-Local) Serious Adverse Events to Research Ethics Boards

To the Canadian research ethics community,

After ongoing debate and consultation in the Canadian research ethics
community and internationally since 2003, the Canadian Association of
Research Ethics Boards (CAREB) formally endorses the recommendations
made by the Serious Adverse Event (SAE) Working Group after a workshop
held in Vancouver on April 30, 2009 in conjunction with the 2009 CAREB
National Conference and Annual General Meeting. This SAE Working Group
was led by two former Presidents of CAREB, Dr. Raphael Saginur
(2002-03), Chair, Ottawa Hospital REB, and Laurel Evans (2007-08),
Associate Director, Research Ethics at UBC.

The CAREB Board of Directors is pleased to present the attached
Draft Guidance on Reporting of External (Non-Local) SAEs to Research
Ethics Boards in Canada (see below). This Draft Guidance will be distributed for
comment purposes only. Comments regarding this Draft Guidance should be
submitted to board@careb-accer.org by November 30, 2009. At the end of
the 90-day comment period, CAREB will prepare and issue a final Guidance
document and will recommend that it be voluntarily implemented by all
Canadian Research Ethics Boards (REBs), at their individual discretion.

CAREB is a grassroots national membership organization intended to
represent the interests of all Canadian Research Ethics Boards (REBs)
and to reflect REB perspectives and concerns.

Please send your comments to the CAREB Board of Directors at
board@careb-accer.org .

Best regards,

Alex Karabanow
CAREB President