A review seeking to inform the design of a new framework for advice on the social, ethical and legal implications around advances in genetics.
Problems and Purpose
In response to the Comprehensive Spending Review and the review of arm’s length bodies, in October 2010, the Government agreed to reconstitute the Human Genetics Commission (HGC) as a Committee of Experts.
This project has been commissioned by the Department of Health to inform the design of a new framework for advice on the social, ethical and legal implications around advances in genetics. Specifically, it will consider how advice on these issues can best be formulated as well as the new Committee’s approach to public engagement, accountability and transparency; and how it maintains the confidence of stakeholders and the public. The committee will need to achieve these goals whilst operating in a constrained funding environment. [1]
The research was designed to explore the following issues:
- How can the expert committee best provide advice on the social, ethical and legal implications around advances in genetics to the Department of Health in a timely and cost effective manner?
- How can stakeholder views be incorporated into the design and oversight of the new committee?
- How can such involvement be sustained?
- How can horizon scanning of societal issues / risks be embedded into the work for the new committee?
- What role is there for wider societal actor’s involvement?
- What role should lay public involvement, public oversight or public dialogue play in the ongoing activities?
Background History and Context
Science, Trust, and Public Engagement
The year 2000 saw publication of the Phillips Inquiry into the BSE crisis, the House of Lords report on Science and Society, and the establishment of public commissions on human genetics and agricultural biotechnology. The Public Understanding of Science approach was increasingly complemented by Public Engagement in Science; in 2005, Sciencewise-ERC was created as a systematic new approach to upstream public involvement, by using public dialogue to inform policy that involves significant elements of science and technology, from investment in innovation to regulation of risk.
"Science, Trust and Public Engagement" focuses on exploring future pathways to good governance, seeking to review key lessons about the governance of science, emerging technology and innovation policy since 2000. It will do this by interviewing institutions and champions of public dialogue, accountability and social responsibility (Strand 1) while also supporting a series of action learning mini projects on emerging ways to embed societal accountability in policy (Strand 2).
Organizing, Supporting, and Funding Entities
The review will be overseen by the Human Genetics Strategy Group, together with support from Sciencewise-ERC. The research was conducted by TNS-BMRB and Involve.
The Department of Health (DH) is the government department responsible for public health issues. DH is the project sponsor and will jointly fund the initiative with Sciencewise-ERC.
The Human Genomics Strategy Group is a a cross-department working group and it will monitor the projects progress.
Involve are specialists in public participation and will be developing a dialogue toolkit from this project.
TNS-BMRB provides public policy research and insight to government and not-for-profit clients, and are the dialogue contractor. [1]
Sciencewise-ERC is a Department for Business, Innovation and Skills funded programme to bring scientists, government and the public together to explore the impact of science and technology in our lives. It helps Government departments and agencies commission and use public dialogue to inform policy making, involving science and technology issues. Its core aim is to develop the capacity of Government to carry out good dialogue, to gather and disseminate good practice, have successful two-way communications with the public and other stakeholders, and to embed the principles of good dialogue into internal Government processes.
Participant Recruitment and Selection
25 Interviews with DH identified stakeholder groups:
- Current HGC and HGSG members - 3
- Department of Health, Arm’s Length Bodies - 2
- Other Government Departments - 2
- Research Councils - 4
- Patient Organisations - 3
- Past Commissioners - 1
- Industry – 2
- Academics – 2
- Other (Charities, NGOs) - 6
Interviews with SAC Chairs: 4 chairs + 1 member
Interviews with SAC secretariats: 3
Interviews exploring partnership with other relevant bodies: 2
Workshop Attendees: 11 officials from across the Department of Health, BIS, MHRA, GO-Science, and Northern Ireland Assembly.
Recruitment was carried out by TNS-BMRB’s internal field team and staff at Involve based on a sample list developed by DH.
No incentives were paid as all respondents were taking part in a professional capacity.
Methods and Tools Used
This project involved conducting interviews with stakeholders as well as convening a workshop with government officials in order to examine and deliberate on research findings compiled by TNS-BMRB and Involve.
What Went On: Process, Interaction, and Participation
TNS-BRMB conducted an internal literature review, while Involve conducted desk research focused on public engagement. These literature reviews as a whole informed the subsequent development of the interview topic guides.
With permission, all telephone interviews with stakeholders were digitally recorded and transcribed to ensure an accurate record of the conversation for subsequent analysis.
A meeting was convened with the HGC’s membership to discuss the interim findings; this took place on the 5th April 2011.
A workshop was held with DH officials and officials from other Government departments to explore the findings from the draft report. The workshop was conducted on the 6th April 2011 at the Department of Health’s Wellington House offices in London. A presentation of the findings was followed by small group discussions of their implications. This workshop is more fully described in a separate report.
Interviews were conducted over the phone by experienced qualitative researchers using detailed topic guides - included below - to ensure consistency of approach.
Findings
Key messages from the engagement process are as follows.
The HGC was perceived as expert, independent and praised for the openness and transparency of its work. Its ability to collaborate with a range of actors and its commitment to principles of public engagement were also valued.
There were concerns around duplication in governance between HGC and other bodies. More significantly, the governance of genomics and the biosciences more generally was seen as fragmentary, overlapping and bureaucratic.
There were mixed views as to the appropriate governance and institutional response to these issues, and as a consequence, whether a formal Committee was needed. Those in favour of a Committee wanted a body to promote public debate and scrutiny around the societal implications of using genome wide information in healthcare, particularly in relation to privacy and equity. To fully act in the public interest, the Committee should not be a statutory body, or even placed within a Government department, but rather should be fully independent. Those less in favour questioned whether a formally constituted independent group of experts was needed to provide such advice to the Department, suggesting that a smaller group providing strategic advice would be more effective.
Overall, the idea of reconstituting the Commission as a Departmental Expert Committee was seen as problematic from both these perspectives. It would neither be fully independent to fulfil the role of an ‘HGC like body’ or nimble enough to meet Departmental needs.
Three alternative models emerged:
- A ‘light touch Committee’ to advise the Department on best available evidence to support policy or identify areas of work to be outsourced for wider debate
- An ‘internal sounding board’ to play a more strategic and advisory role for the department, again with an outsourcing function
- A formal Committee of Experts, having a reasonable amount of autonomy from the department and leading significant independent studies
The substantive focus of the Committee was also considered. Overall, there was a marginal preference for a Committee with a remit that focused beyond human genomics and genetics, particularly across areas in healthcare and the biosciences, rather than in classical bioethics areas – such as organ transplantation.
Critical for the Committee would be to consider its role in relation to emerging healthcare regulatory structures. The extent to which such a structure would subsume the remit of the Committee was thought to be an issue.
Overall, it was noted that the ethical implications of genetics and genomics go beyond health. As such, a strict Department of Health focus was believed to institutionally constrain governance given wider public concerns in this area. Those advocating a narrower healthcare remit generally saw this as desirable only if the Committee served a ’sounding board’ function in the department.
Many key issues for the Committee related to ongoing governance issues from previous HGC studies. These included access to genetic information; direct to consumer testing; stratified medicines; and offender DNA profiling. Wider issues around the use of synthetic biology for medicine production and the use of somatic gene therapy for the treatment of cancers were also cited.
Overall, there was seen to be a need for the Committee to be able to respond quickly to step changes in research which change the ethical landscape – such as the hybrids debate in stem cell research. While specific future issues were not pinpointed in this regard, the key issue was that the Committee could identify, act on and report in a timely fashion.
There were four main issues identified in relation to Committee membership:
- Achieving a blend of expertise across health, biosciences, social sciences and humanities. A particular stress was placed on clinical expertise. Lay people involvement was felt important in helping to question the assumptions of ‘expert’ members.
- Seeking to preserve the institutional memory and value of the Human Genetics Commission, both in relation to the substantive knowledge of the Commission, and also in terms of its brand values around openness and transparency.
- Pursuing an opportunity to draw in fresh perspectives, including those less traditionally associated with governance Committees such as industry.
- Issues arising out of a potentially broader remit, potentially complicating the Committee’s structure and ways of working.
The issue of independence of the Committee was raised early on by respondents. Specifically, there was a strong need to clarify and codify the relationship of the Committee to the Department of Health and other Government Departments.
Overall, there were a number of critical governance questions that needed to be explored in relation to independence. Specifically, there was a positive correlation between perceived independence and the extent to which the Committee can have:
- scope to contradict or constructively criticise the Department;
- the final decision on what advice is made public;
- space to set its own direction and programme of work;
- the resources/budget to commission work
Influence, Outcomes, and Effects
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Analysis and Lessons Learned
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See Also
Citizens' Inquiry into the forensic use of DNA and the National DNA Database
Reviewing Public Engagement on Science Policy (Science, Trust, and Public Engagement Strand 1)
Patient and Public Views on the Health Research and Clinical Trials Approval Process
Public Consultation on Human-Animal Embryos for Research
References
[1] “Science, Trust & Public Engagement: Genomics, Genetics and redesign of the Human Genetics Commission” [ONLINE] Available at: https://webarchive.nationalarchives.gov.uk/20170110132926...
[2] TNS-BMRB and Involve (2011) “Genomics and trust: designing a new framework for Government advice on genetics and society”, May 2011