Project deliverable Open Access
Knoppers, Bartha Maria; Bernier, Alexander
The Centre of Genomics and Policy at McGill University has conducted an analysis of the ethico-legal requirements enshrined in data privacy law and research ethics guidance in Canada and the European Union. This Points-to-Consider document is intended to synthesize the elements of that research that are of relevance to the secondary use of health data by the cohorts of the euCanSHare project.
In this summary, we have provided a general overview of our research. In Part 1, we assess the sources of the ethico-legal requirements discussed. In Part 2, we consider a number of regulatory requirements in the laws of Canada and the European Union. Elements discussed include legal prerequisites to data use, individual rights in data, and prerequisites to the international transfer of data. In Part 3, the identifiability of data, and the use of safeguards to protect data, are considered. In Part 4, the foregoing ideas are synthesized into holistic proposals for data governance.
The conclusions of this Points-to-Consider document reprise the contents of recent and forthcoming academic publications that elaborate our findings in further detail.