Social Science, Public Engagement and Genetic Databases: Lessons from Generation Scotland Sarah Cunningham-Burley and Gill Haddow University of Edinburgh Second ESRC Genomics Network/National Natural Science Foundation of China Expert Meeting

Generation Scotland The aim of Generation Scotland is to create an ethically sound, family - and population-based infrastructure to identify the genetic basis of common complex diseases. The Generation Scotland concept has been evolving for several years, and now involves three complementary projects, the Scottish Family Health Study, Genetic Health in the 21st Century and the Donor DNA Databank. Starting in 2006, these projects will recruit a cohort of 50,000 individuals with control cohorts)

Generation Scotland Scottish Family Health Study Genetic Health in the 21 st Century Donor DNA Database (3D) February 2007February 2006March 2007

Advisory Board Management Committee 21CGH Management Group Future Directions Implementation Group Informatics Public Involvement NHS Clinical Genetics Laboratory Integration Communications & PR Governance & Management

The GS consultation 1st STAGE ( ): l l Expert reviews of legal, ethical and engagement issues l l Full day public event 17 “ specialist ” in- depth interviews l l 10 focus groups 2nd STAGE (2004 – 2007): l Workshops with citizen groups l Representative public survey l Participant exit questionnaires l Interviews with participating families Independent anthropologist observing meetings. 3rd STAGE (2007 – 2009) yet to be funded l l Interviews with non-participating families l l Hard-to-reach groups l l Re-interview specialists l l Interview scientific committee

Exploring trust l Trust in scientific progress l Homegrown trust l Willingness to participate – a token of trust?

Exploring lack of trust l Runaway science l Use and abuse of personal data l Commercial access l Privacy

Generating trust in Generation Scotland l Education and media l Transparency and feedback l Governance, regulation and ownership

Engaging citizens l Non-participants l Three discussion events with volunteers from a Public Partnership Group l Links with the GS team

Discussions of access arrangements November 2005: –Police, commercial and government access viewed negatively. One or two members had a positive view of pharmaceutical access in order to develop new medicines. March 2006: –Pharma access remained strongly disapproved of by some members and questions were raised about the limits of international governance. September 2006: –Views on pharmaceutical company access remained divided - those against pharmaceutical access gave reasons relating to the profit motive and exploitation of developing countries. They tended to stress benefit-sharing. Those supportive of pharmaceutical company access emphasised the need for GS to commercialise in order to achieve its goals and the cost of research into new drug therapies.

Wider representation: the survey l Survey – 1001 respondents l Willingness to participate l Access l Governance l Discrete Choice Experiment identifying optimum conditions for participation l However, many prior and current contextual factors will be influential

Willingness to take part

Who should be allowed access? l 63% are uncomfortable with lawyers being allowed to use the data and 52% with the government doing so. l A significant minority (28%) do not want medical researchers outside the UK to have access. l Allowing pharmaceutical companies access to data will have little impact on participation: 69% say pharmaceutical company access would make no difference to whether they would participate or not., 9% say it would make them a little/more likely and 20% a little/more unlikely.

Why are a minority concerned about pharmaceutical access? l The 20% of respondents who said that access to pharmaceutical companies would make them a little or much less likely to take part in the study were asked why that was the case. l The most commonly stated reason was that pharmaceutical companies make too much money, with 57% giving this response. A quarter (23%) say they do not trust these companies, 12% are concerned with anonymity, saying that they are concerned the pharmaceutical company would know too much about them or their personal information if they were given access to the data.

Preferred model for study set-up l Benefit sharing: 3% of profits given to the NHS (Scotland) or health charities l Time period for holding information and samples: if participants do not withdraw, everything will continue to be used with no time limit l Withdrawal: everything destroyed on withdrawal l Pharmaceutical access: pharmaceutical companies NOT allowed access to DNA l Feedback: if possible, participants given any genetic feedback that would be useful l Consent: participants asked to renew consent once everything has been collected and research starts - in about five years time

Addressing public concerns l Some consensus in our work and other consultations l How can this influence governance? l Linking social scientific research with pragmatic legal solutions – benefit sharing?

What happens next? Feedback l Feedback to those involved in consultation l Feedback to GS Scientific Committee and Advisory Board l Actions? l Implications for governance – especially access policies

What happens next? Public engagement, public consultation and social science l Social science and interactional expertise l Multi-disciplinary working and influencing scientific and governance practices l Influence or side show – the big and small picture l Dialogue for what purpose?