7 Amendments of Jean-Pierre AUDY related to 2012/0192(COD)
Amendment 15 #
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
Amendment 16 #
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or respected, irrespective of the position of his or her legal representative, no matter what ther age andor maturity of the minor may be;
Amendment 17 #
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The minor shall take part in the consent procedure in a manner adapted tobe free to give or withhold his or her consent irrespective of his or her age andor maturity.;
Amendment 18 #
Proposal for a regulation
Article 32 – paragraph 2 – subparagraph 1 – point a
Article 32 – paragraph 2 – subparagraph 1 – point a
(a) regarding incapacitated subjects and minors, the informed consent referred to in paragraph 1 shall be obtained as soon as possible from the legal representative and the information referred to in paragraph 1 shall be given as soon as possible to the subject;
Amendment 21 #
Proposal for a regulation
Article 76 – paragraph 2 a (new)
Article 76 – paragraph 2 a (new)
2a. The Commission shall report to the European Parliament annually on the controls and inspections conducted pursuant to this article.
Amendment 24 #
Proposal for a regulation
Annex 1 – part 12 – point 54 – indent 1
Annex 1 – part 12 – point 54 – indent 1
– in trials with minors or incapacitated subjects, the procedures to obtain informed consent from the parent(s) or legal representative, and the involvement of the minor or incapacitated subject shall be described;
Amendment 25 #
Proposal for a regulation
Annex 1 – part 12 – point 54 – indent 1 a (new)
Annex 1 – part 12 – point 54 – indent 1 a (new)
– in trials with minors, the procedures to obtain informed consent from the minor and the parents or legal representative, and the involvement of the minor, shall be described;