2.

Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall: enable the subject or his or her legally designated representative to understand: the nature, objectives, benefits, implications, risks and inconveniences of the clinical trial; the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate and the right to withdraw from the clinical trial at any time without any resulting detriment and without having to provide any justification; the conditions under which the clinical trial is to be conducted, including the expected duration of the subject's participation in the clinical trial; and the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical trial is discontinued; be kept comprehensive, concise, clear, relevant, and understandable to a layperson; be provided in a prior interview with a member of the investigating team who is appropriately qualified according to the law of the Member State concerned; include information about the applicable damage compensation system referred to in Article 76(1); and include the EU trial number and information about the availability of the clinical trial results in accordance with paragraph 6.

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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.