The Fonds de recherche du Québec – Santé (Quebec health research fund) and the Quebec Minister of Health and Social Services recently published new standard legal clauses1 to be included in all information and consent forms that are used for clinical trials. The preparation of this document was completed as part of a consultation process that began in 2014 concerning the recognition of ethical reviews for multicentre research studies and subsequent follow-up work. The harmonization project aimed to resolve stumbling blocks created by the existing legal clauses and to simplify the interestablishment review process and discussions with industry.
The new tool consists of two main sections: (i) a consent form template; and (ii) an explanation of each of the clauses in the template. In addition to offering a consent form template that complies with applicable law and is ready to use along with the legal justification of each clause and specific references to the provisions of applicable national and international laws and treaties, this tool marks an important step for clinical research for the following reasons:
Reiteration of clinical research best practices
While the 2012 statement of principles entitled “Guide des meilleures pratiques en matière de contrats de recherche clinique avec les entreprises privées” (Clinical Trial Agreement Best Practices for Agreements with Private Industry) illustrated a wide spectrum of practices in research contracts (indicating which were best practices, which were good practices and which practices were simply to be avoided), this new tool sets out a single series of clauses that must be included. Thus, in light of the importance of harmonizing the provisions of research contracts and the clauses included in clinical consent forms, this tool confirms the “best practices” that must be followed in clinical research.
Additional details regarding the existing standards
The new tool complements the recommendations made in the aforementioned statement of principles and in other guidelines issued by government agencies and authorities. For example, it highlights some existing limitations on the use of research data and documents containing personal information and stresses that such information may not be communicated, held or otherwise used outside Quebec if it does not benefit from legislative protection equivalent to that provided under Quebec law.
The tool also raises the standards applicable to the drafting of such consent forms by making suggestions regarding the order in which clauses should appear. For example, the tool states that the clause relating to commercialization possibilities should not appear immediately after the clause relating to the non-waiver of rights, so that the two concepts are clearly dissociated.
By introducing such new standard clauses with the approval of a critical mass of stakeholders, the Minister and the Fonds hope to achieve greater harmonization in clinical trial consent forms.
It will be interesting to see if a favourable consensus on these standard clauses will emerge, thus limiting discussions about their content, even in the context of multicentre research projects involving foreign sponsors. We anticipate a favourable reaction given that the tool proposes a “ready-to-use” standard template drafted in French that complies with applicable legal requirements and contains numerous clauses that are justified by international treaties.