3.

Informed consent may be obtained by the simplified means set out in paragraph 2, if all the following conditions are fulfilled: the simplified means for obtaining informed consent do not contradict national law in the Member State concerned; the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial; the clinical trial is a low-intervention clinical trial and the investigational medicinal products are used in accordance with the terms of the marketing authorisation; there are no interventions other than the standard treatment of the subjects concerned; the protocol justifies the reasons for obtaining informed consent with simplified means and describes the scope of information provided to the subjects, as well as the ways of providing information.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.