art_6__para_3

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use · European Union

3. In preparing its opinion, the Ethics Committee shall consider, in particular: the relevance of the clinical trial and the trial design; whether the evaluation of the anticipated benefits and risks as required under Article 3(2)(a) is satisfactory and whether the conclusions are justified; the protocol; the suitability of the investigator and supporting staff; the investigator's brochure; the quality of the facilities; the adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent as regards the specific restrictions laid down in Article 3; provision for indemnity or compensation in the event of injury or death attributable to a clinical trial; any insurance or indemnity to cover the liability of the investigator and sponsor; the amounts and, where appropriate, the arrangements for rewarding or compensating investigators and trial subjects and the relevant aspects of any agreement between the sponsor and the site; the arrangements for the recruitment of subjects.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.