2 Amendments of Anna ZÁBORSKÁ related to 2012/0192(COD)
Amendment 88 #
Proposal for a regulation
Recital 6
Recital 6
(6) The Member States concerned should cooperate in assessing a request for authorisation of a clinical trial. This cooperation should not include aspects of an intrinsically national nature, nor ethical aspects of a clinical trial, such as informed consent.
Amendment 125 #
Proposal for a regulation
Recital 22
Recital 22
(22) The human dignity and right to the integrity of the person are recognized in the Charter of Fundamental rights of the European Union and by the judgment in Case C-34/10 (Brüstle v. Greenpeace). In particular, the Charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned. Directive 2001/20/EC contained an extensive set of rules for the protection of subjects. These rules should be upheld. Regarding the rules concerning the determination of the legal representative of incapacitated persons and minors, those rules diverge in Member States. It should therefore be left to Member States to determine the legal representative of incapacitated persons and minors.