Activities of Maria do Céu PATRÃO NEVES related to 2012/0192(COD)
Plenary speeches (1)
Clinical trials on medicinal products for human use (debate)
Amendments (3)
Amendment 456 #
Proposal for a regulation
Article 28 – paragraph 1 – point d a (new)
Article 28 – paragraph 1 – point d a (new)
(da) The prior interview with the investigator or a member of the investigating team in order to obtain the subject’s informed consent should include a test of full understanding on the part of the subject and/or their de facto representative by, for example, asking them to summarise the information which they have received.
Amendment 468 #
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Written information given to the subject and/or the legal representative for the purposes of obtaining his or her informed consent shall be presented in the mother tongue of the subject and/or representative and be kept concise, clear, relevant, and understandable to a lay person. It shall include both medical and legal information, as well as any controversial ethical issues, as necessary. It shall inform the subject about his or her right to revoke his or her informed consent.
Amendment 470 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. The subject shall be provided with a contact point where he or she mayafforded the possibility and necessary conditions to obtain further information.