4 Amendments of Silvia-Adriana ȚICĂU related to 2012/0192(COD)
Amendment 69 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 1 a (new)
Article 3 – paragraph 1 – indent 1 a (new)
- the rights of the subject to physical and mental integrity, to privacy and to the protection of personal data in accordance with applicable Union legislation are safeguarded;
Amendment 137 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent for each trial shall be written, dated and signed and given freely by the subject or his or her legal representative after having been duly informed of the nature, significance, implications and risks of the clinical trial. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witnwitness who represents the subject's interests may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 160 #
Proposal for a regulation
Article 78 – paragraph 3 – indent 1
Article 78 – paragraph 3 – indent 1
- protecting personal data in accordance with Regulation (EC) No 45/2001applicable Union legislation;
Amendment 164 #
Proposal for a regulation
Article 78 – paragraph 5
Article 78 – paragraph 5
5. No personal data of subjects shall be publicly accessible and such data shall be protected in accordance with applicable Union legislation.