The protection of genetic data is a very serious and complex issue. For ACGT the protection of the patients' data is a crucial factor, as only if this protection can be guaranteed by ACGT patients will take part in the project. Therefore ACGT makes every endeavour to guarantee the privacy of the participating patients. Being in line with all relevant legal and ethical guidelines is seen as one of the major assets of ACGT.
One of the first milestones that were developed was a trustful data flow architecture that shall ensure ACGT's compliance with current data protection legislation, in particular with the European Data Protection Directive 95/46/EC. The overall concept consists of the idea that the concerned patient shall keep the power to decide what happens with his or her data, whilst enabling researchers to improve treatments and therapies for cancer. The concept developed has two main objectives: Keeping the data anonymous wherever possible and informed consents of the patients involved. Compliance with the internal data security and data protection regulations will be achieved by technical measures and contracts concluded by the partners and users of ACGT.
The patient's genetic data needed for ACGT will be collected by the attending physician of a hospital that has signed an agreement with ACGT. The patient will be informed by this physician inter alia about which data will be collected, for what purposes the data is collected and will be used, to which entities and databases they are transferred and who will have access to the data. After having received this information, the patient will have to sign an informed consent, in which he agrees to take part in ACGT. Of course the signing of this informed consent is absolutely voluntary. The concerned patient will receive treatment in any case, but can benefit from the results of ACGT only if he takes part in the project. The patient can of course withdraw his or her consent at any time without giving any reasons.
Furthermore an ACGT Data Protection Board will be set up. This Data Protection Board will take care of the technical and organizational measures to ensure data protection and data security. Compliance will be controlled very strictly by this Board, so that every patient can trust in a high level of data protection and data security.
Data protection and data security is of vital importance for ACGT, so if you have any further questions about this topic, please contact: legal(at)eu-acgt.org
