Social Science, Public Engagement Social Science, Public Engagement and Genetic Databases: Lessons from and Genetic Databases: Lessons from

Generation Scotland Generation Scotland

Sarah Cunningham-Burley Sarah Cunningham-Burley and and

Gill HaddowGill HaddowUniversity of EdinburghUniversity of Edinburgh

Second ESRC Genomics Network/National Natural Second ESRC Genomics Network/National Natural Science Foundation of China Expert MeetingScience Foundation of China Expert Meeting

Generation ScotlandGeneration Scotland

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

Generation ScotlandGeneration Scotland

Scottish FamilyHealth Study

Genetic Health in the 21st Century

Donor DNA Database (3D)

February 2007 February 2006 March 2007

Advisory Board

Management Committee

21CGHManagemen

t Group

FutureDirections

Implementation

Group

InformaticsPublicInvolvement

NHS ClinicalGenetics

LaboratoryIntegration

Communications& PR

Governance & ManagementGovernance & Management

The GS consultationThe GS consultation

1st STAGE (2002-1st STAGE (2002-2004):2004):

Expert reviews of legal, ethical and engagement issues

Full day public event

17 “specialist” in-depth interviews

10 focus groups

2nd STAGE (2004 – 2nd STAGE (2004 – 2007):2007):

Workshops with citizen groups

Representative public survey

Participant exit questionnaires

Interviews with participating families

Independent anthropologist observing meetings.

3rd STAGE (2007 – 2009) yet to be funded

Interviews with non-participating families

Hard-to-reach groups

Re-interview specialists

Interview scientific committee

Exploring trustExploring trust

Trust in scientific progressTrust in scientific progress Homegrown trustHomegrown trust Willingness to participate – a token Willingness to participate – a token

of trust?of trust?

Exploring lack of trustExploring lack of trust

Runaway scienceRunaway science Use and abuse of personal dataUse and abuse of personal data Commercial accessCommercial access PrivacyPrivacy

Generating trust in Generating trust in Generation ScotlandGeneration Scotland

Education and mediaEducation and media Transparency and feedbackTransparency and feedback Governance, regulation and Governance, regulation and

ownershipownership

Engaging citizensEngaging citizens

Non-participantsNon-participants Three discussion events with Three discussion events with

volunteers from a Public volunteers from a Public Partnership GroupPartnership Group

Links with the GS teamLinks with the GS team

Discussions of access arrangementsDiscussions of access arrangementsNovember 2005:November 2005:

– Police, commercial and government access viewed negatively. Police, commercial and government access viewed negatively. One or two members had a positive view of pharmaceutical One or two members had a positive view of pharmaceutical access in order to develop new medicines.access in order to develop new medicines.

March 2006:March 2006:– Pharma access remained strongly disapproved of by some Pharma access remained strongly disapproved of by some

members and questions were raised about the limits of members and questions were raised about the limits of international governance.international governance.

September 2006:September 2006:– Views on pharmaceutical company access remained divided - Views on pharmaceutical company access remained divided -

those against pharmaceutical access gave reasons relating to those against pharmaceutical access gave reasons relating to the profit motive and exploitation of developing countries. They the profit motive and exploitation of developing countries. They tended to stress benefit-sharing. Those supportive of tended to stress benefit-sharing. Those supportive of pharmaceutical company access emphasised the need for GS pharmaceutical company access emphasised the need for GS to commercialise in order to achieve its goals and the cost of to commercialise in order to achieve its goals and the cost of research into new drug therapies.research into new drug therapies.

Wider representation: the surveyWider representation: the survey

Survey – 1001 respondentsSurvey – 1001 respondents Willingness to participateWillingness to participate AccessAccess GovernanceGovernance Discrete Choice Experiment identifying Discrete Choice Experiment identifying

optimum conditions for participationoptimum conditions for participation However, many prior and current However, many prior and current

contextual factors will be influentialcontextual factors will be influential

Willingness to take partWillingness to take partHow likely, if at all, do you think you would be to

take part in a study like this?

Fairly unlikely, 14%

Neither likely nor unlikely, 8%

Fairly likely, 32%

Very likely, 18%

Certain to, 7%

Don't know/depends,

2%

Very unlikely, 11%

Certain not to, 8%

Who should be allowed access?Who should be allowed access? 63% are uncomfortable with lawyers being 63% are uncomfortable with lawyers being

allowed to use the data and 52% with the allowed to use the data and 52% with the government doing so. government doing so.

A significant minority (28%) do not want A significant minority (28%) do not want medical researchers outside the UK to have medical researchers outside the UK to have access. access.

Allowing pharmaceutical companies access to Allowing pharmaceutical companies access to data will have little impact on participation: data will have little impact on participation: 69% say pharmaceutical company access 69% say pharmaceutical company access would make no difference to whether they would make no difference to whether they would participate or not., 9% say it would make would participate or not., 9% say it would make them a little/more likely and 20% a little/more them a little/more likely and 20% a little/more unlikely. unlikely.

Why are a minority concerned Why are a minority concerned about pharmaceutical access?about pharmaceutical access?

The 20% of respondents who said that access The 20% of respondents who said that access to pharmaceutical companies would make to pharmaceutical companies would make them a little or much less likely to take part in them a little or much less likely to take part in the study were asked why that was the case. the study were asked why that was the case.

The most commonly stated reason was that The most commonly stated reason was that pharmaceutical companies make too much pharmaceutical companies make too much money, with 57% giving this response. A money, with 57% giving this response. A quarter (23%) say they do not trust these quarter (23%) say they do not trust these companies, 12% are concerned with companies, 12% are concerned with anonymity, saying that they are concerned the anonymity, saying that they are concerned the pharmaceutical company would know too pharmaceutical company would know too much about them or their personal information much about them or their personal information if they were given access to the data.if they were given access to the data.

Preferred model for study set-upPreferred model for study set-up

Benefit sharingBenefit sharing: 3% of profits given to the NHS (Scotland) : 3% of profits given to the NHS (Scotland) or health charitiesor health charities

Time period for holding information and samplesTime period for holding information and samples: if : if participants do not withdraw, everything will continue to be participants do not withdraw, everything will continue to be used with no time limit used with no time limit

WithdrawalWithdrawal: everything destroyed on withdrawal: everything destroyed on withdrawal Pharmaceutical accessPharmaceutical access: pharmaceutical companies NOT : pharmaceutical companies NOT

allowed access to DNA allowed access to DNA FeedbackFeedback: if possible, participants given any genetic : if possible, participants given any genetic

feedback that would be usefulfeedback that would be useful ConsentConsent: participants asked to renew consent once : participants asked to renew consent once

everything has been collected and research starts - in everything has been collected and research starts - in about five years time about five years time

Addressing public concernsAddressing public concerns

Some consensus in our work and Some consensus in our work and other consultationsother consultations

How can this influence How can this influence governance?governance?

Linking social scientific research Linking social scientific research with pragmatic legal solutions – with pragmatic legal solutions – benefit sharing?benefit sharing?

What happens next? What happens next? FeedbackFeedback

Feedback to those involved in Feedback to those involved in consultationconsultation

Feedback to GS Scientific Feedback to GS Scientific Committee and Advisory BoardCommittee and Advisory Board

Actions?Actions? Implications for governance – Implications for governance –

especially access policiesespecially access policies

What happens next? Public What happens next? Public engagement, public consultation engagement, public consultation

and social scienceand social science

Social science and interactional expertise Social science and interactional expertise Multi-disciplinary working and influencing Multi-disciplinary working and influencing

scientific and governance practicesscientific and governance practices Influence or side show – the big and small Influence or side show – the big and small

picturepicture Dialogue for what purpose?Dialogue for what purpose?