Requirements for ethics approval differ among institutional and provincial research ethics boards (REBs) including requirements for informed consent, a key element of the ethics submission and research process.

The requests for changes in the materials are at times complex or unclear. Studies that involve multiple hospitals or research programs require ethics approval in each applicable jurisdiction which can cause delays due to inconsistencies across REB requirements. Informed consent forms are getting longer but are not leading to increased awareness of risk on the part of the participant.

Participants often report dissatisfaction with these documents and have called for simplification of informed consent forms where possible.

The “Core Consent” Project aims to create and publish a template that addresses the legal and policy requirements in Canada for informed consent, focusing on presenting only the information that potential participants really need to make an informed decision, in an understandable way.

See ccctg.ca/core-consent for details

The Canadian Institute for Health Research Ethics Office and the Canadian Critical Care Trials Group (CCCTG) are working together on this project.

This project follows the methods of a previous one, developed by the CIHR Ethics Office with the Institute of Genetics, to create a core set of elements for documents used to obtain participant consent for human genomics research in Canada (this has been published in CMAJ).

The research team includes (in alphabetical order):

• Jaime Flamenbaum, Senior Ethics Advisor, Research Ethics Office, CIHR
• Holly Longstaff, Director, Research Integration & Innovation, PHSA
• Brenda Lucas, Executive Director CCCTG
• Srinivas Murthy, Investigator at BC Children's Hospital and Clinical Associate Professor, Department of Pediatrics, Faculty of Medicine, at University of British Columbia
• Brittney Schichter, Lead, Advanced Care Planning, PHSA

 For information, please contact brenda.lucas@ccctg.ca