Human Fertilisation and Embryology Authority (HFEA) launched a major public consultation on the creation and use of human-animal embryos for research, involving 104 participants in two part deliberative workshops.
Problems and Purpose
Human/animal embryos may be termed hybrids where they are created by mixing human sperm and animal eggs, or human eggs and animal sperm; or chimeras where animal cells are added to a human embryo during early development (or human cells to an animal embryo). The use of human/animal embryos in research was proposed as potentially leading to the development of new treatments for many diseases for which there were currently no effective cures. The proposed research using embryos with both human and animal DNA was potentially highly controversial, raising some profound moral and ethical issues.
The responsibility for regulating this research lay with the Human Fertilisation and Embryology Authority (HFEA), which was keen to explore how people balanced the ethics, risks and benefits of mixing human and animal genetic material.
The specific aims of the dialogue were to:
- Engage stakeholders in the scoping and development of the dialogue process in collaboration with the HFEA, and in line with the wider written and web consultation process
- Undertake a deliberative process with a diverse set of the public which accords with the Government’s Guiding Principles for Public Dialogue on Science and Technology
- Capture, analyse and report the results of the dialogue project so that they can be easily understood by policy makers and can inform the HFEA’s policy recommendations along with the results of the written and web consultation. 
Background History and Context
Researchers around the world have been using stem cells from human embryos in research to develop their understanding of a number of different diseases. Many scientists believe that embryonic stem cells may also, in future, lead to new therapies. The availability of human eggs and embryos is a major limiting factor for investigating and utilising this technique in humans. One alternative is to derive stem cells from hybrid or chimera embryos, created by mixing human and animal genetic material.
In 2000, the UK Government’s Chief Medical Officer concluded that the creation of hybrid embryos should not be allowed. However, a House of Lords Select Committee in 2002 suggested that human-animal embryos would be useful for research purposes. In November 2006, the HFEA received two research applications to derive stem cells from hybrid embryos using animal eggs.
Before reaching its decision, the HFEA decided to explore the issues with the public to test how people balanced the ethics, risks, and benefits of the research. 
Organizing, Supporting, and Funding Entities
Total budget: £140,000 (Sciencewise contribution: £60, 000)
The Department of Health and the Human Fertilisation and Embryology Authority (HFEA) commissioned the dialogue. Following an open call, Opinion Leader were contracted to deliver the project. Diane Warburton of Shared Practice was the independent evaluator. Sciencewise provided support expertise and funding in support of the dialogue.
Human Fertilisation and Embryology Authority (HFEA)
Commissioning agent for this project, the HFEA is responsible for licensing and monitoring UK fertility clinics and all UK research involving human embryos, and providing impartial and authoritative information to the public.
Opinion Leader is a research-based consultancy with expertise in influence, deliberative engagement, dialogue and insight.
Shared Practice is an interdisciplinary practice and they conducted the evaluation of this project. 
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
- Deliberative Dialogue: 104
- Written consultation: 810
- Public meeting: 153
- Opinion Poll: 2, 073
- Experts/Stakeholders: 25
- Advisory Group members: 16
A range of stakeholders with very diverse views were engaged, through a Stakeholder Advisory Group, in scoping and developing the dialogue process in collaboration with the Authority, and in line with the wider written and web consultation process.
The 104 deliberative dialogue participants were recruited to represent a diverse set of the public in terms of age, gender, social class, ethnicity and religious views (known to influence opinions on embryo research).
The groups were as follows:
- Belfast: 19 participants overall (10 men and 9 women)
- Glasgow: 18 participants (9 men and 9 women)
- London: 14 participants (6 men and 8 women)
- Manchester: 18 participants (9 men and 9 women)
- Newcastle: 20 participants (10 men and 10 women)
- Swansea: 17 participants (8 men and 9 women)
Participants were each paid £45 including travel expenses, to attend. This is normal practice in any form of deliberative research, and helps ensure that those who cannot afford to attend because of the costs of travelling etc can be encouraged to take part, thus ensuring a greater diversity of views at the event. 
44 participants from the previous workshop reconvened for the second part of the dialogue. The aim of recruitment for this stage was to provide a diversity of views, rather than a demographic sample. Participants from London were each paid £75 to attend. Participants from outside London were each paid £100, plus travel expenses. For those travelling longer distances, a night in a hotel was also provided, and train travel was organised for them.
In addition to the deliberative dialogue, in early July 2007 an opinion poll was conducted to gauge the views of 2,000 residents of Great Britain and 60 residents of Northern Ireland. Participants were selected at random, with quotas set on age, sex, geographical regions, and housing tenure. To ensure a representative sample, data was weighted against the profile of the United Kingdom .
Methods and Tools Used
There were four distinct strands to the overall consultation: deliberative public dialogue, an open public meeting, an opinion poll and a formal written consultation.
The main focus of the public deliberative dialogue was to explore and understand various public perceptions, motivations and attitudes to creating human-animal embryos for research. The first stage of this work involved 12 small discussion groups held in London, Manchester, Newcastle, Belfast, Glasgow and Swansea.
The second part of the deliberative dialogue consisted of a full-day workshop attended by 44 of those who participated in the small groups: participants were selected at random and then reviewed to ensure a representative sample. The aim of this second stage was to explore the views and opinions of participants in more detail. A very diverse mix of expert speakers illustrated the different relevant issues and arguments. The workshop was recorded and a short film of the day was shown to the audience at the public meeting. 
Materials to aid discussion
A series of handouts was used to support the points made by the experts from the platform. These materials were drafted jointly by the experts and Opinion Leader with the HFEA. Again, a significant investment of time was made to ensure that the materials were fair, balanced, and understandable as it was recognised that this was vital to an effective engagement on these complex and very technical issues. 
What Went On: Process, Interaction, and Participation
Deliberative Work Part 1: Local Discussion Groups
Each meeting lasted two hours, although they were held at different times of day in different places. The process worked through a set of carefully designed steps to:
- Introduce the research area and variety of different types / origins of embryos
- Enable participants to consider and give their views on the creation and usage of the various types / origins of embryos in research
- Briefly introduce the current legal position in the UK regarding the usage of these embryos in research.
Discussion Group Agenda
- Introduction and warm up
- Prompt and gather participants' views on medical science and research, to provide the context for later discussions
- Prompt and gather participants' unprompted beliefs and opinions, with information only given on the HFEA's role and their receipt of the applications for research on hybrid embryos; the group considered immediate responses in terms of what they thought and felt and had heard about the issue
- Introduction to embryonic stem cell research, and discussion, with glossary provided of key terms and handout
- Introduction to the different types and sources of embryos that could be used / created for research, with more handouts on embryos from normal fertilisation, cell nuclear replacement / cloned embryos, cytoplasmic hybrid embryos, human chimera embryos, transgenic human embryos and true hybrid embryos, including the legal position
- Summary of key responses from the group
- Next steps, including preparation for the reconvened event for those that will attend, and signposting of the HFEA website if they wanted to make an input there; each participant was given the full consultation document to take away. 
Deliberative Work Part 2: Reconvened Public Meeting
The meeting lasted a whole day, from 9.30am (start at 10am) to 4.30pm.
- Introduction from Opinion Leader and HFEA, and then warm up exercise
- Presentation from platform from external expert to recap on the scientific information they had been given about the different types of embryos
- Group discussions about what they had thought since previous meeting, anything they had seen in the media, and overall arguments for and against creating human-animal embryos; plus initial data collection on views (at start of the day)
- Presentation from platform by external expert on why scientists want to be able to do this research
- Table discussions in response to presentation
- Presentation from platform by external expert on ethical arguments for and against human-animal embryos
- Table discussions in response to presentation
- After lunch, a panel presentation from four external experts with different views (10 minutes each)
- Table discussions in response to presentations
- Table discussion to develop questions for the panel
- Question and answer session with the panel
- Final table discussions on previous session, plus final data collection on views (at end of the day)
- Summing up and response by HFEA, and close by Opinion Leader.
Participants were seated in tables of 8 -10, each with a table facilitator and young scientists who was there to answer any scientific and technical questions. The people on the tables were mixed to ensure a diversity of views. 
Key messages from the public
There were three themes running through the different elements of the dialogue processes: the necessity for the research, the effectiveness of creating animal/human embryos for research and the desirability of the research.
The necessity of creating animal/ human embryos for research purposes when other sources of stem cells were available (namely human embryonic, adult and cord blood cells), was strongly debated at the open public meeting, resulting in mixed views. In the deliberative research, the majority felt that although adult and umbilical cord stem cells did not have the same ethical implications as embryonic stem cells, it was worthwhile pursing all avenues if there was a potential for greater understanding of diseases. Participants involved in the deliberative research felt it was necessary for scientists to use animal eggs. They were influenced by the argument that scientists need to create a biological model to study certain diseases and felt that using animal eggs would negate the shortage of human eggs.
Most of the participants in the deliberative research and omnibus survey supported the creation of cytoplasmic hybrid embryos if there was a clear rationale for the research. People wanted reassurance that any research conducted on cytoplasmic hybrid embryos would, or could, provide useful understanding of human diseases. There was concern that, because the cells that the embryos were derived from were not completely human, the results would not be transferable.
Most participants in the deliberative research believed that, although the embryo was special, it did not warrant the same level of respect as human beings. As such, it was acceptable to use embryos in research if the research had a clear potential benefit.
Initially there was an aversion to mixing human and animal genetic material as this gave rise to thoughts about creating ‘monsters’ and concerns about where it might lead next. However, although some concerns were still evident after deliberation, most believed that the potential benefits of being able to study serious diseases outweighed the initial aversion towards the mixing of genetic material.
In the omnibus survey, although most people supported the creation of cytoplasmic hybrid embryos if it may help to understand diseases, many still had concerns about it. As a result of concerns, participants in the deliberative research stressed the need for strict regulation and monitoring of licensed activities. 
Influence, Outcomes, and Effects
After careful consideration of the evidence gathered through the public dialogue, the HFEA decided that cytoplasmic hybrid embryo research should be allowed to move forward, with caution and careful scrutiny. In addition, any specific applications for licences to carry out such research had to demonstrate, to the satisfaction of an HFEA licence committee, that the research project was ‘both necessary and desirable’. These caveats directly related to public concerns expressed in the dialogue.
The dialogue improved policy and decision-making: gaining access to a wider range of views and so creating stronger evidence to achieve a more robust decision. Dialogue increased the accountability of decision-making by opening up the process and making it more responsive as well as more transparent.
The dialogue gave the HFEA confidence in its final decision, as it accorded with informed public views and there was also a rich understanding of why people held the views they did.
Analysis and Lessons Learned
The case study observes the following good practice exhibited by the dialogue, and lessons for future practice:
Summary of Good Practice
- The consultation process involved a diverse set of public in terms of age, gender, social class, ethnicity and religious views.
- Two-stage iterative dialogue process gave participants time to absorb complex scientific information.
- Deliberative public dialogue was part of a larger consultation process, which included a range of other engagement approaches (opinion poll, public meeting, formal consultation). The mix of methods provided lots of different ways to engage people and provided a broad range of data which allowed the HFEA to compare, integrate and triangulate views from the public and stakeholders.
- The whole consultation process was open and transparent, which reduces cynicism and distrust about these types of engagement process.
- There was a clear line from the dialogue to the final policy decision.
- The quality of the dialogue process positively impacted the credibility of the results with policy makers.
- The information provided to participants was clear, well-used and understood by all.
- The range of speakers at the reconvened deliberative public event and the open public meetings provided diverse perspectives for and against the use of embryos for research.
Lessons for Future Practice
- It takes time and resources to establish and support an effective Stakeholder Advisory Group, but this input can be invaluable in terms of the legitimacy and accountability of the dialogue, and the balance of views in the information provided to the public.
- Effective recording and reporting processes create confidence in dialogue findings, leading to confidence in later decision- making using the findings as evidence.
- With careful design and appropriate information provision, contentious subjects can be discussed calmly and productively.
- Participants want to know about the impacts and influence of their input. 
 Sciencewise (2007) “Case Study: Dialogue on Hybrid and Chimera embryos for research”, Sciencewise
 Sciencewise (2017) “Hybrids and Chimeras” Sciencewise [ONLINE] Available at: https://webarchive.nationalarchives.gov.uk/20170110132741/http://www.sciencewise-erc.org.uk/cms/hybrids-and-chimeras/
 Warburton, D (2007) “Evaluation of the HFEA public consultation on hybrid and chimera embryos”, Shared Practice, November 2007
 Human Fertilisation and Embryology Authority (2007) “Hybrids and Chimeras” HFEA, October 2007