Diffusion of the updated “Standard legal clauses for information and consent forms for clinical trials”
CATALIS Québec is pleased to announce that the revised version of the “Standard legal clauses for information and consent forms for clinical trials” has been published by the ministry of health and social services (MSSS).
The original legal clauses for consent forms, published in 2016 by the MSSS and the Fonds de recherche du Québec (Québec research funds – FRQS), were designed to standardize consent forms.
In 2020, CATALIS Québec created a working group that included legal and research ethics experts from research ethics boards (REBs) within the health and social services network (RSSS), pharmaceutical company representatives, and representatives from the MSSS and the FRQS. Its objective was to update the most recent version of the document. This version adapts to the current legal framework, broaden its scope to include incapable adults who are participating in research, and incorporate improvements to optimize the efficiency of these documents’ composition methods and their approval process by RSSS REBs.
As of February 15, 2021, the MSSS and the FRQ-S will be asking all RSSS REBs to apply these legal clauses without modifications when undertaking ethical reviews of the clinical trials submitted to them, other than in exceptional situations. This process is expected to optimize multi-centre project practice standardization and, in the long run, reduce clinical trial start-up times in Quebec.
To obtain the revised version of the Standard legal clauses for information and consent forms for clinical trials
The updated French and English versions of the clauses are available on the MSSS Web site. They can be used immediately for new research projects being submitted to REBs for assessment. Please note that requiring that clauses in consent forms currently under review – or that have already been approved – by your REB be updated is not recommended.
More information and an opportunity to discuss the revision of these legal clauses
To answer potential questions, allow those responsible for applying the legal clauses to discuss this issue, and foster a more uniform application of the clauses, the MSSS’ Direction de la recherche et de la coordination interne (research and internal coordination department) and the FRQS will host two virtual workshops on this revised version of the legal clauses.
About CATALIS Québec
CATALIS Québec is a non-profit organization dedicated to the advancement and operational excellence of clinical research in Quebec. Our mission is to optimize Quebec’s clinical research environment to maximize private investment and accelerate the development of innovative patient care.