A public dialogue and nationally representative survey on attitudes to research involving Animals Containing Human Material (ACHM) was conducted in May-August 2010 by a consortium led by Ipsos MORI.
Problems and Purpose
The use of animals containing human material (ACHM) has a long-standing history in biomedical research, although little public consideration of this area has previously taken place. This public dialogue was part of a major study by a working group of the Academy of Medical Sciences to examine the scientific, social, ethical, safety and regulatory aspects of research involving animals containing human material, and to make recommendations for action [1]. The dialogue aimed to provide insight into public values, concerns and aspirations around these issues, and input to Government considerations of how this research should be regulated in the UK. [2]
The specific objectives of the project were to:
- Provide opportunities for members of the public to discuss and explore their aspirations and concerns relating to the scientific, social, ethical, safety or regulatory aspects of research involving ACHM
- Identify areas of consensus, disagreement or uncertainty on a broad range of issues raised by current and possible future scientific developments, and explore initial views and changes in opinion
- Inform the final recommendations made by the Academy for public policy and research needs
- Enable the Academy and the wider science community to build on previous experience in public dialogue, to pioneer innovative approaches in public engagement, and to develop knowledge and understanding of public dialogue and its potential for future applications.
Background History and Context
In 2007, to support the revision of UK legislation that was underway at that time, the Academy convened a working group to examine the use of embryos combining human and animal material in medical research. While the UK Human Fertilisation and Embryology Act (2008) (the HFE Act) ultimately provided a contemporary legislative framework for research involving human embryos (including human admixed embryos), it was noted that the regulatory and ethical challenges of the ‘animal end of the spectrum of human-animal mixture’ had received relatively little consideration or public attention. Therefore, the Academy’s 2007 report drew attention to the need to review the regulatory environment for research involving ACHM1.
In its 2007 report, the Academy committed to undertake further work in this area. It took the view that, as researchers seek to create more effective research models and evaluate potentially important medical interventions, there is a need to ensure a comprehensive system for the regulation of research involving ACHM that protects animal welfare, maintains the highest standards of safety and ethics and keeps the issues of public acceptability of research to the forefront.
The Academy’s 2007 report recognised the importance of public values and judgements in informing the continuing development of law and policy in relation to ACHM. However, it warned of a gulf between current and future scientific practices, and public awareness of them. The strength of public opinion around the creation of mixed human-animal entities was evident throughout parliamentary debates around the HFE Act (2008) and in associated media coverage. During that time, public values and concerns were explored in a wide public dialogue and consultation also supported by Sciencewise-ERC and undertaken by the Human Fertilisation and Embryology Authority (HFEA) on the creation and use of human-animal embryos for research.
The Academy’s study on the use of ACHM in biomedical research was launched in autumn 2009. The scope of the study was to examine the scientific, social, ethical, safety and regulatory aspects of research involving non-human embryos and ACHM, and to draw conclusions and make recommendations for action. A programme of public dialogue was commissioned to inform the study. [2]
Organizing, Supporting, and Funding Entities
Cost of Academy Working group study: £239 250 (Sciencewise funding £129, 250)
The project was commissioned by the Academy of Medical Sciences, sponsored by the Department of Health. Funding was provided through Sciencewise, the Department of Health, Medical Research Council, Wellcome Trust and the Academy of Medical Sciences).
The project was delivered by a consortium led by Ipsos MORI, including Dialogue by Design and British Science Association. Laura Grant Associates were contracted to evaluate the project.[3]
Delivered by:
Academy of Medical Sciences
The Academy of Medical Sciences (AMS) is the independent body in the UK representing the whole spectrum of medical science. Its mission is to ensure better healthcare through the rapid application of research to the practice of medicine.
Department of Health
The Department of Health (DH) is the government department responsible for public health issues. It exists to improve the health and wellbeing of people in England.
Ipsos MORI
Ipsos MORI is a UK market research company and led the delivery consortium.
The British Science Association
A registered charity that exists to advance the public understanding, accessibility and accountability of the sciences and engineering in the UK.
Dialogue by Design
Dialogue by Design specialises in running public and stakeholder engagement processes using online, paper-based and face-to-face methods.
Sciencewise-ERC
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
- Dialogue workshops: 70 public participants
- Omnibus survey: 1 046 public participants
- Experts/stakeholders: 19
- Academy working group: 16 members [2]
Participants were recruited face-to-face by experienced recruitment professionals to ensure that a mixed and broadly representative group of people took part. Participants were screened in terms of their views, primarily to allocate those with strong existing views into special interest groups. In line with standard practice, participants were paid a cash incentive of between £40 and £145 depending on the time commitment expected of them. [4]
Methods and Tools Used
The dialogue programme included qualitative and quantitative research, stakeholder engagement and opportunities for in-depth deliberative discussions among members of the public.
First, an initial literature review was undertaken to identify existing public opinion research.
Stakeholder engagement was then undertaken to identify the detailed aims for the dialogue as well as the themes and questions to cover with the public participants, and to help develop information materials to support the public's discussions. Stakeholders included representatives from industry, non-government, religious and animal welfare organisations. An Oversight Group for the dialogue was also set up that included the project sponsors, members of the Academy working group and representatives from organisations with an interest in the subject.
The deliberative phase of the programme brought together 70 members of the public with six experts in a series of workshops, discussion groups and interviews. Two deliberative workshops, each involving 21-22 public participants meeting for a full day on two occasions, were held in London and Newcastle. Two scientists attended each workshop to provide professional expertise. Three shorter discussions were also held with special interest groups: people with personal experience of serious health problems, such as patients and carers; those for whom animal welfare was important; and those for whom religious belief was important. Twenty, in- depth, follow-up, telephone interviews were conducted with participants in these events to explore some issues in further detail
The findings of the deliberative sessions were used to develop questions that informed a nationally representative survey of 1,046 respondents.
What Went On: Process, Interaction, and Participation
Workshop 1
Each workshop involved plenary sessions with all participants, and two breakout groups, each containing around ten participants. Each breakout group was joined by a scientist who was introduced as a source of information. The scientists moved between the groups throughout the day.
The first session on ‘what is human’ was frequently referred to in later discussions. Participants at both workshops engaged well in this session. The late morning and afternoon sessions were spent moving through a series of ACHM case studies. The flow between these was effective and the time allocated appeared appropriate. In many instances, groups had difficulty moving on from the debate about the use of animals in research and addressing the idea of mixing animal and human material, despite the work of the facilitators.
The science was introduced through a quiz, video and fact sheets. Only the most confident participants asked questions in plenary, but in the snapshot interviews, all said that the science was well‐explained.
In Newcastle, a key prompt in the last case study session was ‘what proportion of the monkey’s brain would need to be human for it to be human?’ Responses varied widely and it was at this point the debate opened up, with a diversity of views emerging from a group that had previously been mostly in agreement.
At the end of the day participants were set ‘homework’ – a set of questions they were to think about, discuss with others and respond to, and a ‘DNA origami’ exercise.
Workshop 2
The workshop took place in Newcastle on 5 June 2010, and was repeated in London on 12 June. The points below summarise the main activities in the workshop. Each session involved plenary sessions with all participants, and two breakout groups each containing around ten participants, which were mixed from the previous workshop so discussions happened between different participants. At the end of the day, the facilitators stepped away to allow smaller groups of participants to gather their thoughts and present these back to the wider group. Again each breakout group was joined by a scientist and they moved between the groups throughout the day.
Near the start of the sessions participants were asked to reflect on the dialogue so far. In Newcastle they were also questioned on the level of acceptance in their views and they were very aware that their views had changed: ‘my view at 10 o’clock was different to my view at 3 o’clock’ (Newcastle). Factors in changing views seemed to be: being informed; progression of information (i.e. that case studies became more extreme gradually); and the fact that humans share so much DNA with animals.
At both workshops, the facilitators explained the design of the dialogue (including that those with particular views would be consulted in sub groups) which participants found useful and interesting.
Quite a few people in Newcastle said they had tried the DNA origami, but nobody had brought it with them. A few people in London (four or so) had brought their DNA origami. Some different levels of acceptance emerged within the groups. This was revealed by the homework, which was a successful way to get people to write down their own views and not be influenced by the group.
In the late morning, groups were given a number of ACHM scenarios with the purpose of the research, the type of animal and amount of human material involved. They were asked to place these on a spectrum of acceptability. This sorting activity was very effective at drawing out different views, as pairs of participants were asked to give reasons for ranking a particular scenario as more or less acceptable than another.
After lunch, groups recapped on the human qualities discussed in workshop 1 (e.g. the potential to lead richer lives than animals, mental capacity, language, complexity), and discussions explored whether it was acceptable to give these qualities to animals and how this should be regulated.
Each group then split into smaller groups which were asked to prepare a poster and 2 minute presentation to help other members of the public understand the issues covered in the workshop. The facilitators stepped away at this point. In Newcastle a few groups were unclear on the task, but it seemed better understood in London. Several groups produced what seemed like an advertisement for ACHM research, especially in Newcastle. In some groups the human material aspect was overlooked and the presentation focused on animal research more broadly. It was also sometimes the case that the presenter gave a one‐sided view of the whole group’s opinions, or presented as if the group had reached consensus when this was not always the case.
The day finished with some plenary discussion about science communication and a discussion of the next steps for the dialogue. [5]
Key Messages from the Public
Overall, public participants in the dialogue accepted and were supportive of ACHM research on the condition that such research is conducted to improve human health or to combat disease. A minority of participants did not find ACHM research acceptable even to address human health problems.
The majority of participants decided how acceptable they found ACHM research by ‘trading off’ their view of the purpose of the research against concerns about the process it involves. The benefits of ACHM research were considered highly persuasive because of the perceived benefits to human health. This view was strengthened further if the health problem being addressed was seen as serious (terminal, debilitating or intractable). Changes involving animal and human reproductive systems were felt to be furthest away from current boundaries of acceptability. Key concerns included that entities produced in this way might genuinely ‘cross the boundary’ between human and animal, raising moral and practical difficulties.
Public participants had more concern around experiments ‘in vivo’ (on living animals) rather than ‘in vitro’ experiments (e.g. in test tubes), involving changes to external rather than internal tissues where they changed an animal's appearance (in part because the results could be more easily visualised) and on changing the brain of an animal where it might affect an animal's cognition. For many participants, animal welfare was important. Participants often transferred general concerns about the welfare of animals used in research directly onto the subject of ACHM. Some participants expressed concerns that certain ACHM research might cause greater animal distress – this would be seen as less acceptable (e.g. if animals’ limbs or external organs were modified to be more human, or if animals had their cognition enhanced).
There were also concerns about risk, particularly of experiments that might cause ‘cross-contamination’ or genetic mutations outside the laboratory. Participants worried that these could threaten humans, animals and the ecosystem as a whole. They were also worried that sanctioning some ACHM research now would eventually lead to more unacceptable research in future – the ‘slippery slope’ argument.
A further important dimension for participants was about who would benefit from the research. Many participants were concerned that medical benefits should be distributed fairly and equitably.
In terms of research regulation, the two main factors for participants were the need for transparency and independent supervision. In addition, participants wanted to see regulation that focused on animal welfare, minimised risk, and that reflected their views on the kind of animal that is created and the tissues and organ types involved. [2]
Influence, Outcomes, and Effects
The dialogue informed the Academy’s working group study on ACHM and was an important source of evidence for the study. The Academy’s final report made recommendations for national and international regulation of future research using ACHM, and included direct quotations from the public dialogue report and from participants. Key areas of public concern (especially ACHM research involving the brain, reproductive tissues and the external appearance of animals) were included in the types of research that the Academy recommended should be given specialist scrutiny in future.
The audience for the Academy’s report includes policy makers in the UK Government, regulatory bodies, biomedical scientists, research funders, academic philosophers, social scientists, bioethicists, professional organisations and their international equivalents. The report is particularly intended for the Government bodies that regulate ACHM in the UK (principally the Home Office, Department of Health, and the Human Fertilisation and Embryology Authority) and the groups and advisory bodies that provide guidance to researchers (including the Steering Committee of the National Stem Cell Bank and research funders including the Medical Research Council).
One input based on the Academy’s report was to the Home Office consultation on options for transposing an EU directive on the protection of animals used for scientific purposes. The Home Office response states they will take account of the Academy of Medical Sciences recommendations on authorisation of projects on ACHM.
Analysis and Lessons Learned
Summary of good practice and innovation
The public dialogue was fully integrated into the Academy’s study on ACHM. The timing of the programme allowed the dialogue to inform and influence the Academy’s expert working group considerations, alongside scientific and other evidence, at an early stage of the study. In addition, the different stages of the dialogue worked well in sequence.
Evidence from the different elements of the dialogue (i.e. from the workshops, discussions with specialist groups and public-opinion survey) was seen as consistent and coherent. This gave increased credibility and confidence in the dialogue findings.
The series of two, full-day workshops with each group in this dialogue was effective and made efficient use of participants' and contractors' time. Participants particularly valued the scientists’ input because they were able to answer specific questions in depth. Feedback from participants indicated that the range of ways in which the science was communicated to them was excellent; participants felt the materials were accessible and not patronising. They did not feel that the scientists allowed their personal views to influence the dialogue and felt they were careful to give only factual information. Furthermore, participants were positive about the open discussions in small groups, where people with different views were able to come together to listen and share ideas.
A synopsis of the Academy’s report was produced to provide an accessible summary for a broader public audience. This was sent to all dialogue participants, together with a summary of press coverage from the report’s publication and pre-paid cards to provide an opportunity for participants to provide further feedback.
Lessons for future practice
1) Dialogue is an intense process and required a great deal of time and commitment from the Academy staff and the Oversight Group. Being realistic in anticipating and allocating this time commitment helps to ensure the process runs smoothly and delivers a credible outcome.
2) Some of the expert scientists were concerned that they may have introduced bias at the groups simply by being present and felt unsure about whether their contribution had been appropriate. Some scientists reflected that additional support and information would have been useful in helping them to prepare for the events.
3) It is valuable to balance the seniority of the experts involved in any Oversight Group and the deliberative events with their ability to commit time, and to build capacity in those with more limited experience or understanding of public dialogue.
4) Public participants were very interested in how the dialogue worked, but could not confidently explain what it was supposed to achieve, even though the Academy and the contractors explained it at the start. It is important that public participants are clear about what their involvement is expected to achieve and, therefore, what is expected of them. [2]
5) At some points in Newcastle, discussions were dominated by males, or male participants spoke over female participants. In London there were a number of strong, confident women in the group, and it did not seem to be either male or female dominated. A range of facilitation techniques were used to good effect, such as asking participants to discuss the case study with their neighbour. Asking each pair to feed back ensured everyone had a clear opportunity to input into the discussions, although the potential flow of the conversation was a little interrupted as a result. [5]
See Also
Public Consultation on Human-Animal Embryos for Research
Openness in Animal Research Dialogue
References
[1] Ipsos MORI (2010) “Exploring the Boundaries: Executive Summary” Ipsos MORI, September 2010
[2] Sciencewise (2010) “Animals containing human material: Case Study”
[3] Sciencewise (2017) “Animals Containing Human Material” [ONLINE] Available at: https://webarchive.nationalarchives.gov.uk/20170110121122/http://www.sciencewise-erc.org.uk/cms/animals-containing-human-material/
[4] The Academy of Medical Sciences (2011) “Animals Containing Human Material”, The Academy of Medical Sciences, July 2011
[5] Grant, L and Williams, B (2010) “Exploring the Boundaries: A Dialogue on Animals Containing Human Material: Evaluation Report”, Laura Grant Associates, 23 November 2010