Decree 2021-301 of 19 March 2021 and modification of the regulations governing research on human beings in France
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The Decree 2021-301 of 19 March 2021 published last Sunday modifies the regulations governing research on human beings in France.
It lays down certain provisions that provide legal protection for current practices. Thus, it is now formally codified that the Committee for the Protection of Individuals (CPP) can meet by videoconference and that it can issue approvals to sponsors subject to amendments. This change is in line with the European Clinical Trials Regulation no. 536/2014 of 16 April 2014. However, the Decree specifies that these amendments must be made by the sponsor within 12 days, which is a major point to keep in mind for manufacturers and sponsoring hospitals. Specific elements are also defined for the CPP information system (IS), which is also already operational.
Under the Decree, random draw by the national committee for human research is no longer used to select CPPs to evaluate files but instead they are selected by the CPP IS. In addition, amendments to a clinical trial file already approved by a given CPP are evaluated by the latter, and not by another CPP selected by random draw.
One of the major operational changes for the CPPs is their composition: this is extended to 28 members as opposed to 14 at present, including four lawyers and four association representatives. The principle of a member specialised in personal data is of course confirmed, as personal data issues are permanent. Unlike the other provisions, these specific composition rules will only come into force at the next renewal of the members.
It lays down certain provisions that provide legal protection for current practices. Thus, it is now formally codified that the Committee for the Protection of Individuals (CPP) can meet by videoconference and that it can issue approvals to sponsors subject to amendments. This change is in line with the European Clinical Trials Regulation no. 536/2014 of 16 April 2014. However, the Decree specifies that these amendments must be made by the sponsor within 12 days, which is a major point to keep in mind for manufacturers and sponsoring hospitals. Specific elements are also defined for the CPP information system (IS), which is also already operational.
Under the Decree, random draw by the national committee for human research is no longer used to select CPPs to evaluate files but instead they are selected by the CPP IS. In addition, amendments to a clinical trial file already approved by a given CPP are evaluated by the latter, and not by another CPP selected by random draw.
One of the major operational changes for the CPPs is their composition: this is extended to 28 members as opposed to 14 at present, including four lawyers and four association representatives. The principle of a member specialised in personal data is of course confirmed, as personal data issues are permanent. Unlike the other provisions, these specific composition rules will only come into force at the next renewal of the members.