(a)

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;

← art_29__para_2__text_1 · All articles · art_29__para_2__point_a__text_1 →

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