Reportes de información sobre los recursos del Sistema General de

The Nuffield Council on Bioethics established the Working Party on The collection, linking and use of data in biomedical research and health care: ethical issues in March 2013. The Working Party met ten times over a period of 18 months. In order to inform its deliberations, it held a public consultation and a series of 'fact-finding meetings' with external stakeholders and experts. It also commissioned two reports on topics relevant to the work of the project and received comments on a draft of the report from twelve external reviewers. Further details of each of these aspects of the Working Party’s work are given below and in Appendix 2. The Working Party would like to express its gratitude to all those involved, and the invaluable contribution they made to the development of the final report.

Consultation document

The Working Party launched a consultation in October 2013. The consultation ran until January 2014. 51 responses were received, of which 22 were submitted by individuals and 29 on behalf of organisations. Those responding to the consultation included researchers, interest groups and professional organisations. A full list of those responding (excluding those who asked not to be listed) is set out in Appendix 2. A summary of the responses is accessible on the Council’s website. Copies of individual responses will also be made available on the website in those instances where the Council has permission from respondents to do so.

Fact-finding

As part of its work, the Working Party held a series of 'fact-finding’ meetings. Invited guests gave brief presentations and then participated in discussion with Working Party members and other guests.

Big data: 19 July 2013

■ Francine Bennett, Mastodon C

■ Fiona Cunningham, EBI

■ Tim Hubbard, Sanger Centre

■ Martin Landray, University of Oxford

Patient/participant choices and privacy solutions: 12 September 2013

■ John Bowman, Ministry of Justice

■ Ian Brown, Professor of Information Security and Privacy and Associate Director (Cyber Security Centre), Oxford Internet Institute

■ Toto Ann Gronlund , Head of Patient and Public Partnerships, NHS CFH

■ Alastair Kent, Director, Genetic Alliance UK

■ John Loder, Young Foundation

■ Sam Smith, Privacy International

■ David Townend, Professor of Law and Legal Philosophy in Health, Medicine and Life Sciences, Maastricht University

■ Effy Vayena, Senior Research Fellow, University of Zurich

A P P E N D I X 1: M E T H O D OF W OR K I N G

Screening and risk profiling: 14 November 2013

■ Kerry Bailey-Jones, Health Lead, We Predict

■ Ramona Liberoff, Senior Vice President (Innovation Analytics, Nielsen UK

■ Grigorios Loukides, Lecturer in Computer Science & Informatics, Cardiff University

■ Monique Mackenzie, Consultant in DMP Stats and Statistics Lecturer, University of St Andrews

■ Anne Mackie, Director, National Screening Committee

■ Nora Pashayan, Senior Clinical Lecturer in Applied Health Research, UCL

■ Matt Sperrin, Lecturer in Health Data Science, University of Manchester

■ Paul Taylor, Reader in Health Informatics, UCL

Biomedical data in research and clinical practice across jurisdictional boundaries: 8 January 2014

■ Ruth Boardman, Bird and Bird

■ Marc Dautlich, Pinsent Masons

■ Paul Flicek, EMBL-EBI

■ Dennis Keho, AIMES Grid Services

■ Katherine Littler, Wellcome Trust

■ Ioannis Pandis, Imperial College London

■ Becky Purvis, AMRC

■ Judith Rauhofer, University of Edinburgh

■ Jane Reichel, Uppsala University

■ Jonathan Sellors, UK Biobank

Evidence reviews

In order to inform its deliberations, the Working Party commissioned two reports from external academics.487

The terms of the reviews are set out below.

Review 1: Actual harms resulting from security breaches or infringements of privacy involving sensitive personal biomedical and health data.

Purpose:to assist the Working Party in understanding:

(a) The nature of the actual harms resulting from security breaches involving sensitive personal biomedical and health data (i.e. misuse of personal data in terms of both system security, breaches of confidentiality and the potential to re-identify individuals from anonymised data). This applies both to the research and healthcare domain, and translation between them;

(b) the incidence and prevalence of such harms and the appropriate context in which to assess them;

(c) relevant definitions (e.g. meaning of ‘sensitive personal data’ in the regulatory context);

(d) the effectiveness of mechanisms of redress in documented known cases;

(e) possible alternative governance options for controlling data and their likely consequences; and

(f) the nature and significance of any drivers or conditions favouring misuse of data (e.g. a ‘black market’ in personal data).

The review was carried out by Professor Graeme Laurie, University of Edinburgh, Ms Leslie Stevens, University of Edinburgh, Dr Kerina H.Jones, Swansea University, and Dr Christine Dobbs, Swansea University. It is available at: www.nuffieldbioethics.org/project/biological- health-data/evidence-gathering/.

Review 2: Evidence relating to the history of the relationship between the private and public sector in the field of human genomics

Purpose:to assist the Working Party in understanding:

(a) The nature of the relationship between the public and private sectors in the development and execution of biological and health research;

(b) whether there is an identifiable change in the nature of that relationship e.g. from competition (Human Genome Project; BRCA identification) to collaboration (Genomics England);

(c) if such a change can be identified, what relationship, if any, does it have with the current conjunction of open data/open policy making?; and

(d) if the nature of public sector involvement in research has changed.

The review was carried out by Professor Paul Martin, University of Sheffield and Dr Greg Hollin, University of Nottingham and is available at:

www.nuffieldbioethics.org/project/biological-health-data/evidence-gathering/.

External review

An earlier version of the report was reviewed by twelve individuals with expertise in disciplines relevant to the project. These individuals were:

■ Professor Carol Brayne

■ Dr Deborah Peel

■ Professor Douwe Korff

■ Dr Eerke Boiten

■ Dr Effy Vayena

■ Harry Cayton OBE

■ Leila El Hadjam

■ Dr Mark Taylor

■ Dr Neil Manson

■ Professor Sheila M Bird OBE FRSE

■ Professor Steve Yearley

A P P E N D I X 1: M E T H O D OF W OR K I N G

The Working Party deeply appreciates the time and thought the reviewers brought to this investigation and thanks them for their helpful contributions.

The views expressed within this Report are those of the Working Party and the Council and do not necessarily reflect the views of any participants in the various activities undertaken by the Working Party in connection with this Report.