What Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 35: Clinical trials in emergency situations requires
This article establishes the specific conditions under which informed consent for a clinical trial may be obtained after the first intervention in an emergency situation, derogating from standard consent procedures.
Pillar: Biotech & Genomics · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536
SHA-256 integrity: 3832d62183e93f8531261384f40a3b13a3d4a86e8d588486da540591efd9c851
Primary Citations — 5 traced to source
- Article 35(1): ...informed consent to participate in a clinical trial may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the clinical trial...
- Article 35(1): ...provided that this decision is taken at the time of the first intervention on the subject...
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