11 Amendments of Andrés PERELLÓ RODRÍGUEZ related to 2012/0192(COD)
Amendment 221 #
Proposal for a regulation
Article 2 – paragraph 2 – point 10 a (new)
Article 2 – paragraph 2 – point 10 a (new)
(10a) ‘Ethics committee’: an independent body in a Member State – made up of healthcare professionals, laypersons and at least one knowledgeable patient with in-depth clinical experience, or a representative of such a patient – whose responsibility it is to ensure that the rights, safety and welfare of subjects participating in clinical trials are protected and to provide public assurance of that protection;
Amendment 233 #
Proposal for a regulation
Article 2 – paragraph 2 – point 17 a (new)
Article 2 – paragraph 2 – point 17 a (new)
(17a) ‘Subject from a vulnerable group’: a subject belonging to a particularly vulnerable population group in relation to a clinical trial as a result of their medical, social or economic circumstances;
Amendment 379 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patientn ethics committee shall be taken into account.
Amendment 384 #
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Where the subjects belong to vulnerable population groups, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial on the basis of expertise in the relevant disease, or the medical or social circumstances of the subject, or after taking advice on the specific clinical, ethical and psychosocial issues in the field.
Amendment 477 #
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the investigator considers the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator, without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result;
Amendment 483 #
Proposal for a regulation
Article 30 – paragraph 2 a (new)
Article 30 – paragraph 2 a (new)
2a. Both the incapacitated subject and their legal representative may revoke their consent at any time without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result.
Amendment 486 #
Proposal for a regulation
Article 31 – paragraph 1 – point a a (new)
Article 31 – paragraph 1 – point a a (new)
(aa) the informed and express consent of the minor has been obtained, where they are 12 years old and over,
Amendment 488 #
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the investigator duly takes into consideration, in accordance with the age and maturity of the minor concerned, 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 hiswithout giving a reason and with no liability or prejudice whatsoever being incurred by the minor concerned or their age and maturity; legal representative as a result;
Amendment 501 #
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 to his or her age and maturity. Minors who are 12 years old and over must also give their informed and express consent to participate in the trial.
Amendment 503 #
Proposal for a regulation
Article 31 – paragraph 2 a (new)
Article 31 – paragraph 2 a (new)
2a. Both the minor and their legal representative may revoke their consent at any time without giving a reason and with no liability or prejudice whatsoever being incurred by the minor or their legal representative as a result.
Amendment 504 #
Proposal for a regulation
Article 31 a (new)
Article 31 a (new)
Article 31a Clinical trials on subjects from other vulnerable population groups 1. A clinical trial on subjects from other vulnerable population groups may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met: (a) the subject concerned has received all relevant information from professionals trained or experienced in working with that group regarding the trial, the risks and the benefits; (b) the investigator considers the explicit wish of the subject concerned to refuse participation in, or to be withdrawn from, the clinical trial at any time, without giving a reason and with no liability or prejudice whatsoever being incurred by the subject as a result; (c) no incentives or financial inducements are given except compensation for participation in the clinical trial; (d) such research either relates directly to a medical condition from which the subject concerned suffers or it is relevant to the vulnerable population group to which the subject belongs; (e) the clinical trial has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage and both the risk threshold and the degree of distress are specially defined and constantly observed; (f) some direct benefit for the group of patients to which the subject concerned belongs (e.g. improved quality of life) is obtained from the clinical trial. 2. The subject shall take part in the consent procedure at all times. 3. The subject may revoke their consent at any time, without giving a reason and with no liability or prejudice whatsoever being incurred by the subject as a result.