| National (Dutch) |
Medical Research Involving Human SubjectsAct
(Established in 1998,
changed in 2006)
|
• Ethics committee and government should authorize execution.
• Study protocol, extensive information letter and informed consent form should be written and documented according to certain standards.
• Independent physician should be available to provide additional information for participants. |
Data Protection Act
(Established in 2001)
|
• The data protection authority must be notified of all processing of personal data.
• Organisations can appoint their own internal supervisor, the data protection officer.
• Subjects have the right to know what happens to their personal information and to access their personal data.
• Valid consent must be explicit for collected data. |
| European |
European Data Protection Directive 95/96
(Established in 1995)
|
Seven principles are defined:
• Subjects should be given notice when their data are collected;
• Data should only be used for the stated purpose;
• Subjects should always give consent;
• Data should be kept secure from any potential abuses;
• Subjects should be informed about who is collecting their data;
• Subjects should be able to access and make corrections to their data.
• Subjects should be able to hold data collectors accountable for adhering to all of these principles. |
General Data Protection Regulation
(Expected in 2015-2016)
|
• Data protection of all European Union residents (even concerning foreign companies).
• Same rules apply to all European Union member states.
• Valid consent must be explicit for collected data.
• Rights of subjects are enhanced.
• Data Protection Impact Assessments are obligatory.
• Organisations are forced to prove compliance to the regulation
• The data protection authority needs to be notified within 24 hours after having become aware of the data breach (when feasible).
• Subjects have to be notified if adverse impact is plausible.
• Sanctions can be imposed up to a fine of 100 million Euros or up to 5% of the annual worldwide turnover. |
