Ministère de la Santé et des Services sociaux

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Standard legal clauses for information and consent forms for clinical trials


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Experts in law and research ethics from the health and social services network (RSSS) as well as representatives from the Ministry of Health and Social Services (MSSS) and the Fonds de recherche du Québec - Santé (FRQS) have developed standard wording for legal clauses to be included in consent forms for clinical trials carried out in the RSSS.

The objective is to use these model legal clauses by default in the concerned consent forms and thus improve the efficiency of the process of writing these forms and their approval by research ethics boards (CER) of the RSSS. Ultimately, the clauses are intended for people asked to participate in clinical trials.

The main changes that have been made to this version compared to the previous one are summarized in the comparative change table (in French only).

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Online since: February 15, 2021
Last modification: May 26, 2021

Author: MSSS

Publication no : 20-727-01WA

No. ISBN (PDF) : 978-2-550-88549-8

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