2 Amendments of Seán KELLY related to 2012/0192(COD)
Amendment 50 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) A data subject should always have the option to give broad consent, to be given to the treating institution, for his or her data to be used for historical, statistical or scientific research purposes, and to withdraw his or her consent at any time.
Amendment 135 #
Proposal for a regulation
Article 28 – paragraph 2 a (new)
Article 28 – paragraph 2 a (new)
2a. When the subject is required to give his/her consent for a clinical trial, the option of broad consent should be available to the subject, to be given to the treating institution, for his data to be used after the end of the clinical trial for historical, statistical or scientific research purposes, and to withdraw consent at any time.