NET Registry Ethics and Data Security Board

Members of the Ethics & Data Security Board

Chair:

  • Gregory Kaltsas, Greece

Members:

  • Anders Sundin, Sweden
  • Diego Ferone, Italy

The Ethic & Data Security Board is an independent board within ENETS Registry. It is made up of 3 members. Members serve a 3 year term, but can serve more than one term. Membership reflects the countries contributing to the ENETS Registry. The Ethics & Data Security Board reports to both the Working Group and ENETS Executive Committee.

In order that ENETS Registry properly complies with all EU Regulations, the Working Group created the Ethics & Data Security Board. The Ethics & Data Security Board deals exclusively with the ethical aspects and issues of data security. It is responsible for ensuring that all principals of registry ethics, data security concerning patient privacy, as well as, data transfer as defined by the European Community are properly adhered to. This additionally includes: role definitions of personnel, data collection, data documentation, data access, use of the database etc. The Ethics & Data Security Board works in cooperation with the Database Company to ensure all ethical issues, issues of data security and transfer are included into the database in a manner that does not interfere with data collection.

All ethical regulations are to be made available to all participants, i.e. National Registries, as well as, individual centres. The Ethics & Data Security Board must keep all participants informed on all EU Regulation changes.

An Annual Ethical and a Bi-annual Security Report is to be presented to ENETS Executive Committee, Working Group and all participating National Registries. The Ethical report will inform on the adherence of patient information and consent, data transfer and analysis etc. The Security Report summarises all technical security precautions followed by the Database Company and provides a detail audit on the individual access to the database for each National Registry Centre. Each Centre receives a copy of their Centres audit report.  
For the documentation of patient data in the ENETS European Neuroendocrine Tumour Registry the Ethical and Data Security Board is also responsible for developing standard consent regulation forms: patient information form, patient consent form and an ethic application form. Each National Registry must use patient forms; however, are permitted to use their own National forms, but must provide an adequate English translation to the ENETS Registry for verification of correctness.

The Ethical and Data Security Board must ensure that contracts on data transfer and data ownership between ENETS Registry and the national organisations responsible for the national neuroendocrine tumour registries are signed before data is input into the ENETS Registry Database.

Additionally, the Ethical and Data Security Board members also sit on the Scientific Steering Committee, which is the Committee solely responsible for the evaluation of scientific applications.