The DataSHIELD Legal Analysis Template Susan Wallace, University Of Leicester, Leicester, UK Jennifer Harris, Norwegian Institute of Public Health, Oslo, Norway

DataSHIELD …DataSHIELD uses distributed computing and parallelized analysis to enable full joint analysis of individual-level data from several sources—e.g. research projects or health or administrative data—without the need for those data to move, or even be seen, outside the study where they usually reside. Gaye, A. et al. DataSHIELD: taking the analysis to the data, not the data to the analysis. Int J Epidemiol 2014; 43(6):1931 Within each biobank personal data is: protected using security measures processed according to national law Only common query language and summary statistics (e.g. anonymised data) are transmitted to/from the web portal and analysis computer

DataSHIELD Repeated until answer reached

Rationale DataSHIELD is ethically robust Budin-Ljøsne, I et al. DataSHIELD: An ethically robust solution to multiple-site individual-level data analysis. Public Health Genomics 2015;18:87-96 Need to consider the legal implications of the use of DataSHIELD in cross-border applications DataSHIELD relies on the assumption that anonymised data falls outside current the data protection provisions, but true for every European country (?) General Data Protection Regulation (GDPR) is coming: ‘compromise’ language states that anonymised data will fall outside new data protection rules, but unknown if this position will be approved Unknown what is needed for non-European countries

UK analysis Only a UK analysis has been conducted Wallace SE, Gaye A, Shoush O, Burton PR: Protecting Personal Data in Epidemiological Research: DataSHIELD and UK Law. Public Health Genomics 2014, 17: DataSHIELD does comply with UK law DataSHIELD only processes anonymised data Although the biobank holds the link that can identify individuals, the data has been ‘changed’ sufficiently to protect participant data Common Services Agency v Scottish Information Commissioner [2008] UKHL 47 Does not breach an individual’s right to privacy under UK Human Rights Act 1998 R v Dept of Health ex parte Source Informatics Ltd [2001] 1 All ER 786

DataSHIELD Legal Analysis Template for Europe BioSHaRE and other projects are not limited to the UK! Working with Healthy Obese Project cohorts to determine factors that they [individual European researchers or biobanks] considered when agreeing to participate in DataSHIELD Doiron D et al. Data harmonization and federated analysis of population-based studies: the BioSHaRE project. Emerg Themes Epidemiol 2013; 10(1):12

What formal approvals were needed to be involved in a DataSHIELD analysis and in choosing variables? Do consent materials address: Is data is coded/anonymised? Is prior ethics approval needed for data access? Can data be shared outside institution? With whom can data be shared? Is there guidance on what constitutes ‘anonymised data’ in your country? Are there links to your biobank’s data security provisions?

Future plans I Revise SurveyMonkey questionnaire according to responses from BioSHaRE biobanks to create a template for biobanks who are considering using DataSHIELD Pilot questionnaire through BBMRI ELSI to gain their input and capture different country perspectives Identify and trial questionnaire with European biobanks who have not used DataSHIELD Finalise a ‘European’ template (dependent on any changes in data protection rules)

Future plans/questions? Approach European research ethics committees – if a biobank met the requirements of the template, could that be used to gain ethics approval? Can a similar exercise be used with other countries and jurisdictions, or are the differences too great? What happens if anonymised data falls under data protection rules in Europe?

Acknowledgement The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n° (Biobank Standardisation and Harmonisation for Research Excellence in the European Union - BioSHaRE-EU)