Genome editing : formulating an Australian community response: Report to decision makers, stakeholders, and members of the public

Genome editing is a new development in science that allows very targeted modifications to be made
to DNA, the genetic material that almost all living things possess. It can potentially be used in plants
and animals for such things as modifying the way they adapt to changes in the climate. It can also be
used in humans to prevent or treat certain diseases and disabilities. There are many other potential
uses. There are benefits and risks associated with genome editing, which raise many ethical, legal, and
social concerns. One of the applications of genome editing that is seen as being particularly ethically
fraught is its use to make changes to human DNA that can be inherited by future generations.
Over the past few years, a number of reports have been published on genome editing by eminent
scientific and policy groups. In general, these reports reveal a cautiously optimistic outlook for
the contributions that genome editing might make both to human health and welfare and to the
environment. However, they recognise the need for robust regulation of genome editing applications,
reflecting ethical norms and community values. They adopt a particularly cautious approach when it
comes to changes to human DNA that can be inherited. The reports uniformly call for community
engagement on genome editing, but provide little guidance on how this might be undertaken and to
what end.
This report provides background, methods, results and policy perspectives on a community
engagement project undertaken in Australia in 2020-2022, focusing exclusively on the use of genome
editing techniques in humans. The project was funded by the Genomics Health Futures Mission
(GHFM) of the Medical Research Future Fund (MRFF). The MRFF is a long-term investment by
the Australian Federal Government supporting Australian health and medical research. The MRFF
aims to transform health and medical research and innovation to improve lives, build the economy
and contribute to health system sustainability. Funds from the MRFF are invested in genomics
research through the GHFM, with the aim of improving testing and diagnosis for many diseases,
helping personalise treatment options to better target and improve health outcomes, and reducing
unnecessary interventions and health costs. The GHFM Roadmap lists ‘developing a better
understanding of the ethical legal and social implications (ELSI) of genomics and facilitating public
trust and public engagement’ as one of the priority areas for investment. This project was one of nine
ELSI-related projects selected for funding in the first tranche of GHFM funding. The team undertaking
this project brings expertise in respect of the ELSI of genomics and related technology (Nicol and
Rudge), deliberative democracy (Niemeyer, Dryzek, Curato and Veri), science and technology studies
(Paxton) and science communication (Pemberton).
The centrepiece of the project was the Australian Citizens’ Jury on Human Genome Editing. Although
we recognise that a discrete event such this is not a substitute for a wider process of public engagement
and debate, it can provide a valuable contribution. Deliberative events of this nature are particularly
Executive Summary
iv
important for complex issues such as human genome editing which raise profound ELSI affecting
the public interest. The citizens’ jury thus has an important ‘discursive’ role, allowing us to learn what
happens when the public interacts with the science under conditions that approach the deliberative
ideal, where norms of respect, reflection, and informed reason-giving are in play. Even so, while the
outcomes of these types of citizen deliberation are informative, providing important insights, they
should not be seen as decisive. Forming a discursive (or considered) public view requires an extensive
and ongoing approach. The outcomes of the Australian Citizens’ Jury thus provide important material
that can be harnessed to inform and engage the wider public.
The Australian Citizens’ Jury on Human Genome Editing also has a ‘decision-making’ role, by
identifying some of the most important policy questions that need to be addressed. These questions
cannot easily be answered in this initial step, but their foregrounding as part of this project constitutes an
important outcome. The citizens’ jury, along with wider engagement with experts and other members
of the community, has identified a range of matters that require policy consideration and further public
discussion.
The Australian Citizens’ Jury on Human Genome Editing was held at the Museum of Australian
Democracy at Old Parliament House in Canberra, Australia from 17 to 21 June 2021. Participants
heard from experts and engaged in a facilitated process to deliberate on the basic principles that
should underpin policy responses to current and future developments in human genome editing
technology. Participants were asked to deliberate on the following question: ‘under what conditions
(or circumstances) might the application of human genome editing technology be acceptable?’.
Alongside the citizens’ jury itself, a range of associated activities involving members of the public took
place, which are summarised in Figure 1. Highlights included:
• A study to examine the range of salient positions on genome editing that currently exist among
the public (discourse mapping), undertaken prior to the citizens’ jury.
• Recruitment of two cohorts guided by the mapping study in order to reflect both demographics
and the diversity of positions on genome editing in the community (discursive representation).
The first cohort comprised the 23 individuals who participated in the citizens’ jury (the participant
group). The second cohort comprised 21 individuals who did not participate in the citizens’ jury
but participated in other aspects of the project (the control group).
• Post-citizens’ jury interviews with the participant group.
• A follow-up online forum with some of the members of the participant group to finalise reported
recommendations.
• A survey on genome editing, the aim of which was to assess the medium-term impact of the
citizens’ jury on participants’ positions, and to compare their responses with the control group
and a broader sample of participants from the Australian population (the population group).
Figure 1 also shows the range of additional research material collected in association with the event,
the preliminary analysis of which informs this report.
Throughout the project, experts representing a diversity of views and disciplinary expertise (see
Appendix D) in the fields of genomics, healthcare delivery, bioethics, politics, social sciences and
other disciplines were also consulted. In particular, prior to the discourse mapping study, openended interviews with 34 experts were used to identify the relevant dimensions of the issue. These
and other experts were also invited to undertake a slightly modified version of the post-citizens’ jury
Executive Summary
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survey on genome editing to compare the responses of experts with the participant group, the control
group and the wider population. Experts were also invited to attend online workshops to canvass
the policy implications of the outcomes of the citizens’ jury and assist in their translation into policy
recommendations. Seven experts were invited to give presentations and answer questions at the
citizens’ jury, to assist participants in their deliberations.
The primary outcome of the citizens’ jury and the subsequent interactions with the participant group
was a set of recommendations, along with supporting reasons, both of which are provided in full in
Section 5 of this report. Participant discussions at the citizens’ jury and in the post-jury interviews,
online forum and survey revealed wide diversity in underlying discourses. This same diversity was also
detected in the population, control and expert groups. Some participants in each group expressed
reservations about any forms of genome editing, particularly those involving use of human embryos.
Others were much more enthusiastic about the promise of genome editing, and concerned that
excessive regulatory requirements could hamper progress. The citizens’ jury recommendations thus
reflect primarily the views of the majority of participants, which could perhaps best be described as
cautiously optimistic that genome editing could provide a valuable contribution to healthcare in the
future, provided that it is properly regulated, well researched and delivered equitably. To a large extent,
then, these views mirror those expressed in the reports of science and policy groups mentioned above.
The recommendations include both general principles and specific points relating to non-heritable
and heritable forms of genome editing. In summary, the recommendations illustrate that, in the view
of the majority of participants:
• Applications of human genome editing should be restricted to the alleviation of human suffering,
improvement to quality of life, and reduction of childhood mortality.
• Genome editing should be properly regulated, with regular review including stakeholder and
community input.
• Genome editing should be made available equitably to those most in need, and informed
consent must be assured.
• Clinical development of genome editing should be informed by adequate research to identify
and assess the potential risks and benefits, both to the individual and to society.
Participants were more cautious about heritable than non-heritable forms of genome editing,
emphasising that the former should only be considered at some stage in the future, after more research
to assure safety and efficacy, and more community engagement for guidance on how to proceed
responsibly with the technology.
Participants also considered genome editing research involving human embryos. Given that questions
associated with embryo research were not fully canvassed at the citizens’ jury, they were revisited in
post-jury interviews and an online forum. Many participants expressed particular discomfort with the
creation and use of human embryos specifically for research. For some participants, creation of human
embryos for research was and would continue to be untenable. However, a majority of participants
expressed in principle support, recognising the need for this form of research if heritable genome
editing is to become a reality, in the absence of other suitable alternatives.
Although not discussed in detail, the majority of participants also expressed cautious support for
mitochondrial donation, a technique that has since become legal in Australia, subject to stringent
regulation.
Preliminary Activities Australian Citizens’ Jury on Human Genome Editing Follow-Up Activities
Preliminary
Session
Group
Building
Information Information Deliberation Deliberation Close
PostDeliberation
Interviews
Participant
Forum
Population
Survey
Expert work
shops
Discourse
Mapping
Participant
Recruitment
Participant
Interviews
Scoping
Study
Day 1 Day 2 Day 3 Day 4
Other Activities
ACJ Design (Meetings/
consultation) Distribution of
fact sheet
(research involving
human embryos)
Expert witness
briefings
Information Pack development
(Assessment of information/knowledge
gaps/needs)
Participant
Information Pack
distribution
Interviews/Forums
Expert
workshops
(n=36)
Participant/
Control group
interviews
(n=44)
Participant
interviews
(n=23)
Expert
interviews
(n=34)
Mapping study
interviews
(n=31)
Participant
online forum
(n=10)
Australian Citizens’ Jury Participants (n=23)
Expert witnesses available to answer questions
Mapping survey
(n=31)
Recruitment
pool screening
(n=123) Population Survey (n=1008)
Expert Survey(n=30)
Evaluation
survey
Position mapping/deliberative reason surveys
Pre survey Mid survery Post survey Follow up survey (n=20)
Surveys
Introductions/
Ice-breaker
Process
briefing
Evening
reception
Group
generated
guidelines for
participation
Expert witness
presentations
Breakout
group
deliberations
Q&A
Expert witness
presentations
Breakout
group
deliberations
Q&A
Develop
preliminary
principles/
considerations
(breakout
groups)
Refine recom
mendations
(breakout
groups)
Synthesis of
recommenda
tions
(plenary)
Present
recommenda
tions
Response from
decision
makers
Final reflections
Issue scoping
Identification of
expert
perspectives
Survey
development
Identification of
public
discourses/
perspectives
Online
interviews
Baseline
surveys
(Citizens Jurors
and Control
Group)
Selection
based on
discourses/
perspectives
Online forum
• Clarification of
findings
• Review recom
mendations
Participant
report
finalisation
Survey:
• Population
• Experts
• Participants
Analysis:
• Position com
parison
• Transformation
Reflection of
ACJ outcomes
Review of
policy options
Online inter
views
Draft report
distribution
(For comment)
Report
finalisation
Figure 1: Public engagement activities conducted over the course