The ACGT ethical and legal requirements

This deliverable contains an analysis of the relevant ethical and legal requirements for ACGT. The first part of this document analyzes the ethical requirements regarding clinicogenomic research within the ACGT architecture, especially with regard to informed consent and disclosure of research results. In order to protect patients’ autonomy and their right to self-determination – the most basic principles to be respected in the context of medical research involving patients – the informed consent for participation in ACGT has to react in an appropriate manner to these challenges. In ethical terms, a tiered consent offering to donors the possibility to authorize a broader or more restricted range of research to be done with their samples and data and time frame they may be used for research would be preferable. However, this model is difficult to handle in practice. Therefore, a model of consent referring to a purpose of intermediate scope (clinicogenomic research on cancer) in the context of a specific structure or project (ACGT) is proposed, which is within the limits of ethical as well as legal considerations. Concerning the disclosure of research results, it is widely agreed that general research results must accessible for research subjects regardless of the inalienable right of the patients to access his or her personal data. Since clinico-genomic research may also yield individually relevant results, it is additionally recommended that ACGT provides the technical and organizational means for individual feedback processes of such results. The second part analyzes the legal requirements, particularly with regard to data protection and privacy. The goal to be achieved is to establish a structure where the competing aims of modern genetic research and the data protection needs of the ACGT D10.2 – The ACGT ethical and legal requirements 14/03/2007 Page 3 of 194 participating patients can be met. Genetic data is very sensitive data which differs from “normal” data in a crucial point: it cannot be anonymized completely and therefore falls under special requirements for data processing. In order to get as many data protection operations within ACGT outside the scope of the Data Protection Directive as possible, it is recommended to establish a Data Protection Architecture within the ACGT framework, which comprises a double pseudonymization procedure, the establishment of an ACGT Data Protection Board as central data controller and a Trusted Third Party. Furthermore we analyze the impact of the Directive 2000/31/EC on E commerce on ACGT. This analyzsis concerns the relationship between ACGT / physicians and researchers, dealing with service provider, users, contract by electronic means, etc. in the context of ACGT. KEYWORD LIST: Data Protection, Informed Consent, Access To Information, Feedback Of Individually Relevant Research Results, Anonymization ACGT D10.2 – The ACGT ethical and legal requirements 14/03/2007 Page 4 of 194 MODIFICATION CONTROL Version Date Status Author 0.1 09.01. 2007 Draft N. Forgó 0.5 22.01. 2007 Draft R. Kollek; J.-M. Van Gyseghem; N. Forgó 0.7 31.01. 2007 Draft R. Kollek; J.-M. Van Gyseghem; N. Forgó 1.0 06.02. 2007 Draft R. Kollek; J.-M. Van Gyseghem; N. Forgó 2.0 13.03. 2007 Final N. Forgó List of Contributors (authors) • M. Arning (UHANN) • B. Clearhout (Custodix) • S. Castille (Custodix) • N. Forgó (UHANN) • N. Graf (USAAR) • J. Herveg (FUNDP) • D. Kafetzopoulos (FORTH) • R. Kollek (UH) • T. Krügel (UHANN) • I. Petersen (UH) • Y. Poullet (FUNDP) • Cécile de Terwangne (FUNDP) • J.-M. Van Gyseghem (FUNDP) ACGT D10.2 – The ACGT ethical and legal requirements 14/03/2007 Page 5 of 194