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The study complied with the Declaration of Helsinki and was performed according to the responsible data protection board.
The study was approved by the Danish data protection board and by the appropriate scientific ethical committees in both countries.
The study (clinical trial reg. no. NCT00993720) was surveyed by the good clinical practice unit, Bispebjerg Hospital, Denmark, and approved by the Danish Medicines Agency and the Danish Data protection Board.
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While research communities attempt to create a European 'free-trade zone' for biobank information, legal scholars and data protection boards attempt to balance rights to privacy against the potential benefits of new digital technologies capable of aggregating both individual- and population-level data.
The study was also approved by the local data protection boards.
The study was approved by the national data protection boards of all four countries and by ethical committees in accordance with national laws and regulations.
Steps already taken include training and recruiting staff; discussing data protection with their board; reviewing and updating privacy policies; and undertaking audits.
These include the data protection agency and the board of RAI, the Italian public broadcaster.
This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent.
The teasing out of these issues represents a major challenge to research ethics boards and data protection authorities who are charged with the responsibility of determining when to allow collection of information without consent, when to press for increased quality control in recruitment, and when to permit local adaptation of the recruitment process.
Institutional Review Boards (IRBs) and data protection officers of the participating sites have approved the concept.
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CEO of Professional Science Editing for Scientists @ prosciediting.com