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To the CAREB-ACCER and broader Research Ethics Community: There is a need for action, accountability, and change for researchers and within Research Ethics Boards. We acknowledge that everyone, including the CAREB-ACCER Board of Directors, must work harder to understand and uphold our role in truth, justice, and reconciliation. This is an initial step in a […]
Category Archives: Position Statements
In May 2016, the REB Accreditation Working Group of the Canadian Clinical Trials Coordinating Centre (CCTCC) released its Draft Preliminary Recommendations (DRPs) for broad consultation. Attached is CAREB-ACCER’s response filed with CCTCC on June 20, 2016. File: CAREB-ACCER’s comments in response to the CCTCC REB Accreditation Working Group Consultation
File: CAREB-ACCER Response to Draft RDM Policy – 2018
In September, 2015, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced proposed revisions to the U.S. regulations for protection of human subjects in research. The proposed changes are intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. A […]
October 2011 – The CAREB Board of Directors recently filed comments to the Department of Health and Human Services (HHS) in response to an Advanced Notice of Proposed Rulemaking (ANPRM) entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Notice Number HHS-OPHS-2011-0005), published in the July 26, 2011 Federal Register (76 […]
September 2011 – The CAREB Board of Directors filed comments in response to the Tri-Agency’s proposed framework on the Responsible Conduct of Research (RCR). While it was agreed that the framework is well written, several aspects of the document could be strengthened in terms of scope and process. File: Final Comments Tri-Agency RCR Framework Sept 2011
July 2010 – CAREB issued their first 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. File: CAREB Guidance – AE Reporting […]