A multi strand public engagement process addressing ethical implications of stem cell research in the UK. The project included deliberative workshops, q methodology and stakeholder interviews.
Problems and Purpose
As the basic building blocks of a human body, stem cells are important because they have the ability to become different cell types, and can be used to repair or regenerate damaged organs or tissues. Stem cells can now be artificially grown and transformed into specialised cell types. This leads to possible therapies for a whole range of conditions such as heart disease, diabetes, Parkinson’s disease or Alzheimer’s. [1]
The UK Stem Cell Initiative’s (UKSCI) vision is for the UK to consolidate its current position of strength in stem cell research and mature, over the next decade, into one of the global leaders in stem cell therapy and technology. To achieve this vision, five thematic areas were identified for development, together with 11 recommendations. As well as highlighting the need to fund basic science, clinical and translational research, these recommendations also included the need to extend the favourable regulatory climate to include clinical applications and to develop a sustained and coordinated dialogue with the public over the next decade.
This project was developed in response to the recommendations of the Pattison Report. Initiated by the Biotechnology and Biological Sciences Research Council (BBSRC) and the Medical Research Council (MRC), and supported by the Department of Innovation, University and Skills Sciencewise programme, the main aims of the project were to:
- engage the public about developments in stem cell research, so that their views can be taken into account in policy development by Research Councils, the scientific community and policymakers;
- contribute to creating an environment across sectors and groups that will sustain dialogue on issues relating to developments in stem cell research and their clinical applications.
In addition to these overarching aims, six objectives were identified:
- identify the range of views and concerns about the science and ethics of stem cell research amongst the wider public and their societal context
- include scientists and other stakeholders and investigate their views about stem cell research and the related social and ethical issues, involving key organisations such as the UK National Stem Cell Network and the UK Stem Cell Communications Coalition
- raise public awareness about the potential opportunities, challenges and uncertainties of stem cell research
- raise awareness among the scientific community, Research Councils and policymakers about the views and concerns of the wider public relating to stem cell research, and of the importance of dialogue
- inform development of a plan for a longer-term project of public dialogue and engagement around stem cell research
Background History and Context
Stem cell research has transformed our understanding of developmental biology, providing the potential to advance healthcare in a number of areas - from the identification of new drug targets in the development of pharmaceuticals to the promise of regenerative medicine.
The UK has been at the forefront of this research assisted by a supportive regulatory climate and favourable public opinion. However, stem cell science and technologies are rapidly progressing. The sources of human stem cells, together with advances in potential therapeutic and clinical applications, forge major ethical issues and challenges for the regulatory regime. For research to flourish, it will be important to understand and be responsive to wider social aspirations and concerns for science.
In March 2005, the UK Stem Cell Initiative (UKSCI) was established to ensure that the UK remains one of the global leaders in stem cell research. Chaired by Sir John Pattison, UKSCI produced a wide-ranging report on the central role of stem cell research to innovation in the life sciences and its importance to the UK economy more widely.
Organizing, Supporting, and Funding Entities
Total budget: £300,000 (Sciencewise contribution: £300,000)
The project was carried out by the British market Research Bureau (BmRB), initiated by the Biotechnology and Biological Sciences Research Council (BBSRC) and the medical Research Council (mRC), and funded by the Department of innovation, university and Skills’ Sciencewise programme.
Biotechnology and Biosciences Research Council (BBSRC)
The commissioning agent, BBSRC is one of 7 Research Councils that work together as Research Councils UK (RCUK). It is funded by the Government's Department for Business, Innovation and Skills (BIS). The BBSRC annually invests around £380 million in a wide range of research that makes a significant contribution to the quality of life for UK citizens and supports a number of important industrial stakeholders including the agriculture, food, chemical, healthcare and pharmaceutical sectors.
Medical Research Council (MRC)
The other commissioning agent, the Medical Research Council is dedicated to improving human health through science. It invests on behalf of the UK taxpayer. Its work ranges from molecular level science to public health research, carried out in universities, hospitals and a network of its own units and institutes. The MRC liaises with the Health Departments, the National Health Service and industry to take account of the public’s needs. The results have led to some significant discoveries in medical science and benefited the health and wealth of millions of people in the UK and around the world.
TNS-BMRB
The dialogue contractor for the stem cell dialogue, TNS-BMRB is the specialist social research division within TNS. It provides public policy research and insight to government and not-for-profit clients and offers a range of approaches including bespoke research and consultancy.
The British Market Research Bureau (BMRB) is one of the leading market research agencies in the UK and a key operating company within the Millward Brown Group which, in turn, is part of Kantar, WPP’s insight, information and consultancy division.
Sciencewise-ERC
Sciencewise is a Department of Innovation, Universities 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 policymakers in government departments and agencies commission and utilize public dialogue to inform decision-making in emerging areas of science and technology. 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.
University of Nottingham
Finally, the project evaluator was Dr. Alison Mohr from the University of Nottingham Institute of Science and Society [3]
Participant Recruitment and Selection
Forty-nine stakeholders were allocated to one of nine groups comprising research scientists; clinicians; church and faith groups; pro-life groups; funders of research; medical research charities; regulators and government; private sector organisations; and social scientists and ethicists.
200 members of the public were recruited from across the UK, with 40 participants selected from the following areas: London, Cardiff, Newcastle, Edinburgh and Bristol. Participants were selected to reflect the local socio- economic profile of the workshop area and also to reflect the spread of UK attitudes to stem cell research.
Methods and Tools Used
The Research was organised into the following stages:
- Scoping and launch
- Recruitment
- Expert Interviews
- Deliberative workshops
- Q methodology
- Analysis, report and final launch
Stakeholder Interviews
In-depth telephone interviews were undertaken with stakeholders, each lasting approximately 45 minutes. Issues explored included the overall vision for stem cell science; the UK’s position with regard to research, funding and regulation; the technical, ethical and social issues concerning TS cells; the technical, ethical and social issues concerning ES cells; and issues around clinical and other applications of the science. Interviews were audio-recorded and transcribed. The interviews were used both to provide primary data for the research itself, and also to inform the content of the deliberative workshops.
Public Dialogue
This phase involved a series of deliberative workshops engaging the public and scientists in a debate around stem cells. In each of the five UK locations, the workshops were reconvened three times. Workshop 1 introduced stem cell research and explored general aspirations and concerns for the science and clinical treatments. Workshop 2 looked in-depth at the social and ethical issues related to the sources of stem cells. Workshop 3 focused on future applications of stem cells and the wider social implications of stem cell banks, therapies and clinical trials.
Q Methodology
This phase involved 50 members of the public in a process to sort a series of statements made about stem cells relative to how much they agreed or disagreed with them. The results of the ‘Q-sort’ were then subjected to a factor analysis, to cluster individuals according to the degree of correlation between their rankings statements.
What Went On: Process, Interaction, and Participation
Workshop 1: Visions of Stem Cell Science
The first workshop explored participants’ aspirations and concerns for medical science, their understandings of stem cells and their views on a variety of stakeholder positions on science and ethics. It specifically aimed to understand the direction, pace and visions relating to stem cell research, which inform research trajectories and investment in UK stem cell science, and which ultimately provide social context into which discussions around specific applications are given meaning.
It organised discussion around the following themes and stages:
- Introduction
- Aspirations for Medical Science
- Preventative Medicine
- Curative Medicines
- Medical Treatments
- Understanding and Current Views on Stem Cells
- The impact of advances on human dignity and autonomy
- Social, commercial and financial impacts
- Governance
- Reflecting on the Day
Workshop 2: Sources of Stem Cells
The second workshop looked in depth at the technical and ethical issues associated with different sources of stem cells. Specifically, it examined TS cells, including AS cells, those derived from foetal material and those from cord blood; and ES cells, including those derived from In-Vitro Fertilisation, those from SCNT, and those from cytoplasmic hybrids; and Induced Pluripotent Stem cells.
Workshop 3: Stem Cell Applications
The final workshop examined the use of stem cell banks and the development of stem cell lines for different research and clinical uses. It then explored the need for informed consent and the potential treatment of different patient groups using stem cell therapies, patients and clinical trials. It concluded by examining some of the non-therapeutic uses of stem cells as well as reflecting on the three workshops overall.
Stakeholders
In addition to the public dialogue, telephone interviews were conducted with 49 stakeholders to explore professional and interest group views in depth. The structure of the interview broadly mirrored the workshop structure, with a focus on the visions, sources and applications of stem cell research. Findings have been aggregated into one of nine stakeholder groups and are described next (full details of this process can be found in Appendix 1 of the Final Report [2])
Summary of Findings
- There was widespread though conditional support for stem cell research and therapies.
- Support was related to the sources of stem cells, the purposes of research and the clinical risks in treatments.
- There were ethical and social concerns related to both tissue-specific stem cells (TS cells) and embryonic stem cells (ES cells).
Tissue-specific stem cells
- Adult stem cells (AS cells) were the least controversial source of stem cells, having proven clinical applications.
- Concerns related to their plasticity; the difficulty of harvesting cells from certain areas of the body; and being able to culture cells in vitro to make them available for clinical practice on a large scale.
- There were concerns from certain scientists, and groups opposed to embryonic research, that too little focus was given to AS cell research in the UK.
- Stem cells derived from cord blood were valued as a benign method of collection. There was support for the donation and use of cord blood for public purposes. There were concerns around the storage of cord blood for private use, due to the perceived limited clinical value of the material and the potential exploitation of parents.
- Public participants supported the right of the individual to choose whether they donated their cord blood to the NHS, chose to store it privately or requested incineration. There were concerns that the collection and storage of cord blood stem cells should be adequately governed.
- Stem cells derived from foetal material were the most controversial of all the tissue-specific sources. This was due to moral concerns, how informed consent was gained and the research purposes of foetal material.
Embryonic cell research
- The plasticity and ability to culture ES cells had significant value, relative to the limitations of adult cells.
- Whilst the research value of ES cells was highly regarded, their ultimate use in clinical practice was less so.
- For certain groups, ES cell research was a tool to understand diseases rather than something that would ultimately have widespread therapeutic use in treatments.
- For others, it was a significant way forward in understanding and developing treatments for a number of serious conditions such spinal cord injury, neurological and ophthalmological conditions.
- The risk involved in treatments – particularly due to the potential for tumours to arise from undifferentiated cells in therapies and for tissue rejection - was a concern across all groups.
- Despite many of the ethical issues associated with ES cells, the morality of not treating patients with serious diseases when there were tools available to gain understanding and potential therapies generally outweighed these concerns.
- There was general acceptance of using In Vitro Fertilisation (IVF) procedures to provide embryonic stem cells, as long as consent was gained and the process regulated. However, there were a significant number of participants who held a strong ethical conviction that the creation of embryos for research was wrong.
- A key issue for IVF was with regard to informed consent around the donation of human eggs and the difficulty in monitoring the ultimate use of embryonic stem cells lines. There were significant concerns around the payment of women to donate their eggs.
- Somatic cell nuclear transfer (SCNT) was seen as promising by certain scientific and clinical stakeholders, due to the success of cloning with non- human primates. For the public, despite initial concerns, SCNT was believed to overcome many of the issues associated with tissue rejection that accompany other uses of other embryonic and adult stem cells. Concerns around efficiency levels in cloning were highlighted and there were anxieties that technical problems in the procedure may have an impact on the quality and safety of stem cell lines generated.
- For the public, the creation of cytoplasmic hybrids was initially the least supported means of creating embryos for research purposes. Views changed when participants learnt that the animal egg was only used as a shell for human nuclear material and such embryos were used for research purposes only. In particular, hybrids were seen to reduce the need for human eggs for research purposes.
- There was excitement, particularly from stakeholder groups, around the potential for induced pluripotent stem cells (IPS cells) to provide the functionality of ES cells, without the attendant ethical issues.
- Despite this, it was recognised that IPS cell research was in its infancy, and there were concerns about the safety of gene modification.
Research and therapies
Whilst the UK’s research standing was perceived to be good relative to Europe and on a par with the US, there was a sense that the UK was now starting to get left behind. The need to invest in basic research was valued by the public and stressed by professionals.
Learning how to differentiate and control stem cells, as well as overcoming the immunological issues, were viewed as the most significant factors limiting the development of treatments. There were significant concerns around the potential to form cancers or develop infections through treatments.
Concerns were expressed about research being pushed to deliver applications too soon, either because of public expectations or commercial pressures.
The combined insights from adult and embryonic stem cell research were seen as fundamental in developing therapies. Many respondents believed that treatments would come from being able to reprogram adult stem cells, using embryonic stem cells as tools to understand how to do this.
Whilst participants felt that stem cell research should be directed towards serious diseases, what constitutes such a disease was contested.
Recommendations
- There was conditional support for funding all avenues of stem cell research. A focus on basic and translational research should be priorities. For clinical research, priority should be given to serious diseases or injuries for which the current treatments are limited.
- Key concerns expressed during the dialogue focused on whether research using embryonic stem cells is necessary and how 'serious' disease is defined. These issues are likely to evolve in the future, making it difficult to establish firm guidelines on stem cell uses and donor consent. Ethics committees will need to account for donor and public views as the science develops.
- There were significant health and wealth opportunities to be gained from stem cell research. There needs to be greater investment and coordination between public (research councils and NHS) and private (pharmaceutical and venture capital) sectors to achieve this goal. There is a significant opportunity for a coordinated campaign by medical research charities to raise the resources and profile of stem cell science.
- The involvement of the private sector raised concerns about the means and ends of research. For public trust to be maintained, therapies should reflect public rather than solely commercial interests, with a focus on serious diseases. Moreover, the need to protect and exploit intellectual property rights needs to be balanced with the need to disclose information in the public interest. Research councils and universities should account for these factors when commercialising research.
- Whilst legislation in the UK was supported, tight regulation and the number of relevant authorities were viewed as cumbersome by a range of groups, including researchers, clinicians and the public. There needs to be coordination between regulators to ensure the seamless transition of research into routine clinical practice, which takes account of the novel aspects of cell-based therapies.
- The governance of clinical trials was viewed as risk-averse by certain research and commercial respondents. Providing there was informed consent and potential risks had been fully explained, there was public support in trialling experimental therapies with patients. The views of patients should be paramount when making decisions around the development of stem cell therapies.
- Future dialogue should focus on the cultures and practices of research within institutions. Whilst large structured dialogue events are important, it will be fundamental that the everyday practice and discussion of science is mindful of societal views. Uncertainties in stem cell science should be communicated openly if the public debate is to avoid being dominated by hype. Substantive areas of interest include the private banking of cord blood and the potential of induced pluripotent stem (IPS) cells.
Influence, Outcomes, and Effects
Impact on Policy
Firstly, the findings directly informed the Department of Health’s study of cord blood banking policy and practice.
The findings were also considered by a workshop of policymakers from BBSRC, MRC and Department of Health. They were further used as a form of ‘social intelligence’, considered by the BBSRC Bioscience for Society Panel and used to make recommendations to the BBSRC Strategy Advisory Board. The Strategy Advisory Board advises [the BBSRC] Council on strategic issues relevant to BBSRC’s science and innovation obligations, including training, skills and science in society.
Impact on Policy Makers
The dialogue contributed to the development within BBSRC of ‘a culture and the appropriate structures with which to feed the findings of the public dialogue into its decision-making processes.’ Secondly, the dialogue enabled the Department of Health and the MRC to continue to progress in the current direction with greater confidence. Finally, the dialogue contributed to the organizations’ public image and reputation, and was built on in a range of major reports. [1]
Analysis and Lessons Learned
Summary of good practice and innovation
- The project began with a desk research study of previous public engagement on stem cell research (by OPM) and then BMRB carried out the rest of the process. This included an omnibus public-opinion survey (to 1,013 individuals) and 49 stakeholder interviews (recruited on the basis of a detailed stakeholder analysis).
- An oversight group contributed to the design of the dialogue process and the information materials to be used by the public. The Group’s 19 independent and diverse members represented a broad range of interests including universities, non-government organisations and others.
- One scientist and one social scientist/ethicist attended each workshop. Their role was to provide information to assist participants in their deliberations and to engage in the process, listen to the public and contribute to the discussions.
- A key focus in the workshop design was creating the time and the space to encourage debate between the public and specialists. This two-way sharing of information was critical to the development of the project and the understanding of all those involved
- The final report integrated the feedback from the public at the workshops and from stakeholders who had taken part in the initial interviews. [1]
The evaluation report provides the following lessons and emerging themes:
The Stem Cell Public Dialogue was clearly a challenging exercise to plan, stage and report, given the range of stakeholder interests and conflicting positions in this area of research and the ambitious scope of the sponsors’ stated aims and objectives. Evaluating the exercise posed its own challenges in light of resource constraints, the lack of established models of high-quality evaluation in this area and the wider critical interrogation that is emerging of the diverse political meanings and purposes of public engagement activities around science.
The report suggested that the high levels of support for stem cell research noted in the dialogue report and the low levels of disagreement found at the workshops need to be interpreted with some caution. The structuring of expert roles in the dialogue process, and the ambiguity of this particular dialogue in relation to the wider research policy context for stem cells had some impact on the quality of the dialogue especially in terms of the reproduction of a deficit model and the tendency for participants to defer to particular experts. In this context, the report also warns against the common tendency to treat public dialogue as an exercise in gathering data on public attitudes which can then be used to justify policy decisions.
Public engagement exercises are starting to generate more critical evaluation as represented by a few articles discussed in our literature review and the new ESRC Seminar Series on critical perspectives on public engagement. Amongst the challenging new suggestions emerging from this work, the report highlights two issues. It is argued that engagement exercises should be evaluated not only in terms of the dialogue organizers’ work and its impact on public participants, but also in terms of their impact on the sponsors themselves and their capacity to respond. A related criterion raised in this context is the capacity of dialogues to help articulate new positions on the issues (a sign that some genuine dialogue has taken place). This is an area that the report claims they have not been able to explore given resource constraints, but it deserves further attention if public engagement is to fulfill more of its democratic potential. [4]
See Also
References
[1] Sciencewise (2009) “Case Study: Stem Cell Dialogue” Sciencewise
[2] Bhattachary, D (2009) “Stem Cell Dialogue: Final Report” BMRB
[3] Sciencewise (2017) “Stem Cell Dialogue” [ONLINE] Available at: https://webarchive.nationalarchives.gov.uk/20170110131544/http://www.sciencewise-erc.org.uk/cms/stem-cell-dialogue-delivered-by/
[4] Mohr, A (2009) “An independent evaluation of the BBSRC and the MRC Stem Cell Dialogue Project 2008”, University of Nottingham, May 2009