A new guideline on consent for clinical research that puts participant needs first and will help streamline approvals is published in CMAJ (Canadian Medical Association Journal) https://www.cmaj.ca/lookup/doi/10.1503/cmaj.250500 .
"The purpose of this guidance for policy is to present a core set of elements for participant consent documents to be used in clinical research across Canada and to facilitate harmonization of multi-site projects by simplifying the approval process for all those involved," writes Dr. Holly Longstaff, British Columbia's Provincial Health Services Authority and the Children's and Women's Health Centre of British Columbia Research Ethics Board, University of British Columbia, Vancouver, BC, with coauthors. "These core elements can be also used as a research ethics tool when evaluating research projects with human participants."
Developed by the Canadian Critical Care Trials Group in partnership with the Canadian Institutes of Health Research, the objective is that all researchers who apply to a Canadian research ethics board for approval will use the consent guidance, which is summarized in a downloadable template, to document informed consent.
"Regulatory elements have become mandatory for all study types, and the inclusion of institutional risk-management elements is common practice," write the authors. "This has resulted in bloated consent forms that, in many cases, do little to help the participant understand the risk elements and, in some cases, have even been shown to detract from a person's ability to make an informed decision."
The guideline sets out 75 core elements for participant consent forms to ensure transparency and participant understanding of their involvement in research studies, including sections such as "What do you need to know about taking part in research?", "What does taking part in this study involve?", "What are the possible harms and benefits of taking part in this study?", and more.
If used, this core set of elements, which has been organized into a fillable template for ease of use, is sufficient to meet regulatory requirements for research in Canada.
The guideline, template, and guidance elements are available in a range of formats at https://www.ccctg.ca/core-consent for immediate use.
