Conference Report

Workshop Two - Coimbra 13th and 14th November 2008

AGENDA

Thursday 13th November: Regulation

am The Regulation of Privacy

Welcome and Introduction: Taylor and Townend discussed the methodology of stages two and three, commented on the work achieved to that point, and outlined the way that the workshop would proceed (following the published information prior to the workshop).

Report on Stage One work: Taylor and Townend contextualised the stage two work in the findings of stage one. The aim of stage two being to assess the range of privacy visible in the regulations of genetic information and biobanking, the range that was visible in the first part was rehearsed.

Response to the work by Dr Anton Vedder and Simone Fennell, Tilburg Institute for Law, Technology and Society (paper attached)

The two papers were followed by discussion in the whole group.

The morning’s sessions on regulation of privacy were brought together in a paper by Professor Graeme Laurie University of Edinburgh and Chair of Ethics and Governance Council of UK BioBank “The UK Biobank Ethics and Governance Council” Professor Graeme Laurie

This was again followed by discussion in plenary session.  

pm: The Regulation of Biobanks

The Regional Co-ordinators gave short papers on their findings from the national reports on the law, particularly drawing out the reports on the regulation of biobanks.

This was followed by regional break-out sessions to discuss how far the regional reports were correct, and how far there were commonalities to draw out.

The sessions were recorded and the results were fed into the revision of the regional reports.

The discussions were asked to focus on the following questions:

  • What is the scope of the protection?
  • What biobank activities are (not) covered?
  • How is the sample/ data distinction drawn within regulation? (Asking the question how these different things are regulated across Europe from both a data protection perspective but also how the data protection position is modified by other regulation and professional guidance) 
  •  How identifiable does data need to be to be covered? (Asking questions about the kind of anonymisation capable of taking data outside the scope of regulation but also considering the issue of individual cf. group identifiability) 
  •  What is the nature and extent of the research exemption? What is the nature of the protection?
  • What is the nature of the consent? (Asking questions about how narrow consent needs to be to satisfy the regulations (or alternatively how broad it can be) but also considering questions of re-contact and or withdrawal)
  • Research and the vulnerable (asking ‘From whom must consent be sought?’ e.g. in the case of children but also considering further implications of research and the vulnerable e.g. whether information needs to be provided on possibilities of withdrawal when children come of age) 
  •  The provision of Information (Asking what information must be provided prior to participation and what information must be provided post participation, including questions about potential discrimination, benefits, and dissemination of research results) 

The findings of the groups were discussed in the plenary session. 

Friday 14th November: Implications of Regulation

am: Implications of regulation for science  

Dr Gudnason, director of the Icelandic Heart Association’s Heart Preventive Clinic and Research Institute presented his work in the IHA. The thrust of his paper concerned gaining and maintaining public trust and confidence when a number of activities were governed by the public interest. He spoke about the nature of science and trust in science. 

Dr Andrew Furley, Professor Laurie and Dr Gudnason sat as a panel to draw our issues of the consequences of regulation for science (and privacy protection).

pm: Implications of regulation for privacy

The participants re-grouped away from the regional groups to self selected breakout groups with an RC for each group, to consider the key issues that require further work to produce a coherent and better regulation of the area.

The groups were asked to consider this with the following framework.

What are the implications for privacy protection (taking into account impacts upon science) of yesterday’s (spread sheet) conclusions? vis a vis

  1. Scope
  2. Nature
  3. Research exemption from protection offered

and to focus upon determining the privacy implications of alternatives identified under each of these headings.

The final session brought the discussions of the self-selected groups into a plenary discussion.

Taylor and Townend drew the workshop to a close with a discussion of the stage three work and way of working.