The requirement of subjects’ informed consent Sample Clauses

The requirement of subjects’ informed consent. The requirement of informed consent is of capital importance in order to protect the fundamental rights of a subject in the context of medical treatment and research. From an ethical and legal point of view informed consent protects subjects and their fundamental rights to integrity and self- determination. Consent is the condicio sine qua non not only for the subject inclusion in a research project but also in order to legitimate the processing of personal data of the subject concerned. Since the aim of the present deliverable is to draft a protocol for data protection in neuGRID hereinafter the focus will be on consent for the processing of data rather than on consent for the enrolment in a research project. Directive 95/46/EC detects in consent the main criterion to permit the processing of sensitive data (Article 8.2 (a)). The explicit consent of the data subject - meant as any freely given, specific and informed indication of wishes by which the data subject signifies his/her agreement to the processing of his/her data – removes the general prohibition to process sensitive data stated in the article 8.1 of the Directive. Informed consent is not the unique condition that is able to overrule the ban to process sensitive data: in some national implementation of the Directive 95/46/EC, conditions other than informed consent permit the processing of sensitive data. In particular, in some cases (Belgium; Luxembourg; Norway; Sweden; United Kingdom) scientific research is considered to be in “substantial public interest”, in other cases (Austria; Cyprus; Denmark; Finland; France; Germany; Poland) the national law of implementation provides for a specific exemption to the ban of processing sensitive data based on research purposes. However these exemptions other than consent are not shared with all Member States and in the context of a uniform neuGRID protocol for data protection we have to find a common denominator ensuring the lawfulness of data processing. In this context, the informed consent of the data subject represents the best and safest solution in order to legitimate the processing of sensitive data. According to Data Protection Directive, consent must be: explicit (Article 8.2(a)), freely given (without duress), for a specific purpose (generic consent in not valid) and informed (Article 2(h)). There is little in Directive 95/46/EC as far as the form of consent is concerned. Article 8.2 simply states that the prohibition to process sensitive data ma...
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