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CAREB Issues its first Guidance Document

Dear CAREB members,

On behalf of the Board of Directors of the Canadian Association of Research Ethics Boards (CAREB), I am pleased to issue the CAREB guidance document "Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada". This document is intended to assist the research ethics community in Canada in standardizing the reporting of unanticipated problems, including certain adverse events, and should be viewed as a recommendation only.

This is the first guidance document ever issued by CAREB, and the attached background document details the long history behind the creation of this document by CAREB.

We are aware that there are REBs in Canada who already have instituted similar policies, at least for external adverse event reporting. It is our hope that through CAREB we are able to share these policies, as well as the successes and challenges in implementing them in order to promote further standardization across REBs in Canada. If you are interested in collaborating on this effort, please contact Janet Manzo (janet.manzo@oicr.on.ca)

I would like to thank and congratulate the members of the SAE Working Group, who worked tirelessly on behalf of the CAREB membership to develop this policy. The members of the group are:

* Joseph M. Connors - former Chair, University of British Columbia - British Columbia Cancer Agency REB
* Laurel Evans - Associate Director, Research Ethics, University of British Columbia
* Ann Ferguson - British Columbia Interior Health REB
* Janet Manzo - Executive Director, Ontario Cancer Research Ethics Board (OCREB)
* Richard Neuman - former Co-Chair, Human Investigations Committee, Memorial University, Newfoundland
* Raphael (Ray) Saginur - Chair, Ottawa Hospital REB
* Suzette Salama - Vice-Chair, Hamilton Health Sciences REB
* Marianne Vanderwel - Director, Human Research Participant Program, IRB Services

Attachments:

* CAREB guidance document - July 2010
* History of CAREB guidance document - July 2010
* Health Canada response to CAREB guidance document

Kind regards,

Sharon Freitag
President
Canadian Association of Research Ethics Boards (CAREB)