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
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