25 years Celebrating into the Ethical, Legal and Social Implications of Genetics, Genomics and Related Technologies at the Centre for Law and ...
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Celebrating 25 years of Research into the Ethical, Legal and Social Implications of Genetics, Genomics and Related Technologies at the Centre for Law and Genetics
Introduction
In 1994, Don Chalmers, Margaret Over the past 25 years, the CLG members have developed and
Otlowski and I, together with our maintained our mission of high quality, evidence-based ELSI
collaborator Loane Skene, began to research locally, nationally and internationally. The CLG has grown
discuss the need to investigate the significantly since 1994, and currently comprises 21 members,
ethical, legal and social implications including 10 core staff, adjuncts and research fellows, and 11 PhD
(ELSI) of health and genetic candidates. Over the years we have been able to enlist a number
technologies, from a distinctly of passionate and committed undergraduate students as research
Australian perspective. At the time, assistants and honours students. We also have an extensive network
Chalmers was Dean of the Faculty of of colleagues from across the globe. We list our current and past
Law at the University of Tasmania in staff, research fellows, postgraduates, research assistants and some
Hobart, Australia. He subsequently of our key collaborators on pages 25 and 26.
was given the title of Distinguished
Our opportunities for collaboration have been enhanced by the
Professor in 2010. Otlowski was a
generosity of our colleagues in providing funding to assist us
senior lecturer in Law, and soon
to travel to conferences, symposia and workshops across the
became a full professor. She was Dean of Law from 2010 to 2017,
globe. We have also been fortunate in being able to use our
and later the University of Tasmania’s Pro Vice-Chancellor, Culture
research funding to bring colleagues to Hobart for workshops
and Wellbeing. Skene had just returned to academic life at the Law
and conferences, and to co-convene workshops and conferences
School at the University of Melbourne, following a period working
elsewhere. Our CLG workshops and conferences are listed on
with the Victorian Law Reform Commission. Before retiring in
page 19.
2016, Skene had a long and distinguished career as Professor of
Law at Melbourne Law School and served as Chair of Melbourne The CLG has had a major commitment to national policy debates,
University’s Academic Board. including well-cited submissions to public inquiries. The CLG has
contributed to Australia’s national research ethics guidelines through
I was a humble undergraduate student in law back in 1994, but
contributions to the National Statement on Ethical Conduct in
brought my postdoctoral experience in cell biology to the group.
Human Research (National Statement), and to legislative reform
By 2000, after a stint in legal practice, I rejoined the Centre for Law
(particularly relating to intellectual property). CLG members have
and Genetics (CLG) team as a lecturer in law. I have now been a
been consultants to the Australian Law Reform Commission (ALRC)
professor of law for ten years and served as Chair of the University
and have been appointed to National Health and Medical Research
of Tasmania’s Academic Senate from 2013 to 2018 and acting Provost
Council (NHMRC) principal committees, as well as other national
during 2017 and 2018. My academic success is due in no small
and state bodies.
measure to the excellent mentoring I received from Chalmers and
Otlowski. Internationally, in addition to research collaborations with leading
scholars in the field, we have made contributions to policy
At the time we were starting our research program, the global
development with international agencies such as the Organisation
Human Genome Project (HGP) was already underway and major
for Economic Cooperation and Development (OECD), the World
funders in the US and Europe committed 3-5% of all HGP funding
Health Organisation and UNESCO. Chalmers, the founding director
to ELSI research. The HGP brought a clear international focus to
of the CLG, has provided significant inputs into policy debates
our CLG work. Although Australia made no matching ELSI funding
around ELSI research and practice, including membership of
commitment, in 1995 the CLG successfully obtained research project
the International Cancer Genome Consortium Ethics and Policy
funding from the Australian Research Council (ARC) to examine
Committee and the Regulatory and Ethics workstream of the
Australian perspectives on the legal and ethical implications of
Global Alliance for Genomics and Health. He was also one of the
human genetic research. By 1997, we were formally recognised by
founders of the international ELSI 2.0. Some of our key national and
the University of Tasmania as the CLG.
international appointments and contributions are listed on pages 20
Advances in genetic technologies have continued apace. As we and 21.
moved into the genomics era, the post-genomics era and now the
Our CLG team has produced around 250 peer-reviewed articles,
precision medicine era, concerns about core ELSI have followed.
books and book chapters. Our early career researchers and
The CLG has been fortunate in maintaining almost constant funding
postgraduates have written some 40 percent of these outputs,
from the ARC to continue our Australian ELSI research. We have had
collaboratively or as sole authors. Our CLG work has been published
an overall success rate of 73 percent through the ARC’s Discovery
in high impact science journals, including Nature Biotechnology,
Grant Scheme (11 out of 15 applications). Our grants and other
Science and Nature and in highly ranked Australian law journals
sources of funding are listed on page 16.
including New South Wales Law Journal, Federal Law Review,
Over time, our focus has shifted with the tides of technology. The Melbourne University Law Review, Monash Law Review and Sydney
overriding aim of our research is to promote effective governance Law Review. We list 15 of our key publications over the time since
of genetic and other new technologies in healthcare delivery the inception of the CLG research program on page 17, to illustrate
and biomedical research, and to facilitate equitable distribution the breadth of our contributions. We have also established an
of benefits, all with a distinctive Australian focus, informed by Occasional Paper series, to publish workshop papers, results of our
international developments. The mission of the CLG is to promote empirical studies and policy statements. A full list of our Occasional
safe, ethical, prudent and socially acceptable governance of Papers is provided on page 18.
genetic, genomic and related technologies to support healthcare
I am delighted to mark this—our 25th year of ELSI research—with this
delivery and biomedical research. We provide short summaries
summary of our activities over that time. I draw particular attention
of overarching CLG research themes in the next few pages of
to the recent news that Chalmers, the foundation Director of the
this report, and follow this with accounts of some of the most
CLG was made an Officer of the Order of Australia on 26 January
significant current ELSI research topics to which CLG members are
2019, for his distinguished service to education, particularly to health
contributing. We include some of our key outputs in each area.
law and medical research ethics, and to legal reform.
Professor Dianne Nicol
Director, Centre for Law and Genetics
Contents
03 Research Themes 16 The CLG's Grants 25 CLG Contributors
03 Genetic Discrimination 17 A Sample of Core 25 Academic Staff and Adjunct
04 Genetic Privacy CLG Team Publications Academic Appointees
05 Biobanking 18 Our Occasional Papers 25 Research Fellows
06 Patents and Licensing 19 Our Workshops 25 Key Australian
Collaborators
07 Genomic Data Sharing
20 Our CLG-Related 25 Major International
08 Public Trust and External Appointments Collaborators
Commercialisation and Other Contributions
26 Research Assistants
09 Innovative Health to Law and Policy
Technologies Reform
20 International
10 A Sample of Our Current 20/21 National
Research Interests
10 Stem Cells and Cloning 21 Prizes, Awards
11 Material Transfer and Fellowships
Agreements 22 Teaching and
12 3D Printing Postgraduate Studies
13 Germline 23 Completions
Genome Editing 24 Current Postgraduates
14 Return of
Research Results
15 Genetic and Genomic
Research with Aboriginal
and Torres Strait Islander
People
CRICOS Provider Code 00586B 2
Research Themes
Genetic Discrimination
The concept of ‘genetic discrimination’ The CLG has continued active Key Outputs
was an early topic to emerge amongst engagement in this area. Otlowski has
Margaret Otlowski, Kristine Barlow-
the ELSI of genetics. This concept been invited to give a range of public
Stewart, Sandra Taylor, Mark Stranger
featured in the first research project talks on this issue and is Chair of the
and Sue Treloar, ‘Investigating Genetic
for the CLG funded by the ARC, Australian Genetic Non-Discrimination
Discrimination in The Australian Life
‘Legal and Ethical Implications of Working Group formed in 2016 - an
Insurance Sector: Use Of Genetic Test
Human Genetic Research: Australian interdisciplinary group which has
Results In Underwriting 1999-2003’
Perspectives’ (Chalmers, Otlowski been advocating for policy reform. In
(2007) 14 Journal of Law and Medicine
and Skene, with Nicol as research particular, the group contributed to
367–395.
associate) in 1995-1998. Amongst the Joint Parliamentary Inquiry into
other things, this led to the first two the Life Insurance Industry, which Margaret Otlowski, Sandra Taylor,
of a series of CLG Occasional Papers subsequently recommended that a Kristine Barlow-Stewart, Mark
reporting on a national consultation moratorium be imposed on the use of Stranger and Sue Treloar, ‘The Use
process that canvassed the issues of genetic test information by Australian of Legal Remedies in Australia for
genetic discrimination in the Australian life insurers. The peak body for the Pursuing Allegations of Genetic
life insurance and employment life insurance industry, the Financial Discrimination: Findings from an
contexts authored by Otlowski. This Services Council, has since announced Empirical Study’ (2007) 9 International
issue of genetic discrimination was its intention to introduce a moratorium Journal of Discrimination and the Law
subsequently further explored in a on the use of genetic test information 3–35.
dedicated empirical interdisciplinary for risk-rated life insurance products.
Margaret Otlowski, Mark Stranger,
cross-institutional research project
The relevance of this issue has been Sandra Taylor, Kristine Barlow-
(2002-2004) led by Otlowski in
highlighted through the recognition by Stewart and Sue Treloar, ‘Practices
collaboration with Dr Sandra Taylor
key bodies of the potential for genetic and Attitudes of Australian Employers
from University of Queensland and
discrimination to be a barrier to the in Relation to the Use of Genetic
Associate Professor Kristine Barlow-
mainstreaming of genetics/genomics Information: Report on a National
Stewart from the Centre of Genetics
into healthcare and also a deterrent Study’ (2010) 31 Comparative Labor Law
Education in Sydney.
to public participation in genetic and Policy Journal 637–691.
CLG members (Chalmers, Otlowski research: Australian National Health
and Skene) were involved with the Genomics Policy Framework 2018-
Australian Law Reform Commission 2021 and also the Australian Council
(ALRC) Inquiry into the Protection of of Learned Academies (ACOLA)
Human Genetic Information, a key Report, The Future of Precision Medicine
focus of which was to examine the in Australia 2018. More recently, the
issue of genetic discrimination in life issue of genetic discrimination and its
insurance and employment (Chalmers implications for genomics in Australia
as consultant and member of the was canvassed by the Genomics Health
Advisory Committee and Otlowski Future Mission in 2018; Nicol was on
and Skene as consultants). CLG the Steering Group and chaired the
members also made submissions to ELSI Working Group of which Otlowski
the inquiry that were extensively cited was also a member.
in the Discussion Paper (2002) and
Final Report, Essentially Yours (2003).
Further opportunities to influence
policy in this area came through
membership of the NHMRC Human
Genetics Advisory Committee (HGAC -
Chalmers and Otlowski).
3 Celebrating 25 Years of Research utas.edu.au
Genetic Privacy
Privacy, and in particular the development of guidelines on the use Key Outputs
emergence of ‘genetic privacy’, has and disclosure of genetic information
Sergio Romeo-Malanda, Dianne Nicol
also been a topic raising ELSI that the to a patient’s genetic relatives under
and Margaret Otlowski, ‘Genetic
CLG has been engaged with from its section 95AA of the Privacy Act 1988
Testing and Protection of Genetic
inception. Due to the integral and and has published on this topic.
Privacy: A Comparative Legal Analysis
pervasive nature of privacy as an issue,
Privacy has also formed part of in Europe and Australia’ in Soraj
it has continued to be a feature of
consultancy work commissioned by Hongladarom (ed), Genomics and
most subsequent CLG large project
the NHMRC with which CLG members Bioethics: Interdisciplinary Perspectives
grants. Genetic privacy was also a
have been engaged - Otlowski and (IGI Global, 2011) 235–255.
central issue in the ALRC inquiry into
Nicol with CLG research fellow
the Protection of Human Genetic Margaret Otlowski and Dianne
Dr Mark Stranger on the Biobank
Information, and was the subject of Nicol, ‘The Regulatory Framework
Information Paper (2010) and
numerous submissions made by CLG for Protection of Genetic Privacy in
Otlowski on the Medical Genetic
members to this inquiry as well as Australia’ in Terry Sheung-Hung Kaan
Testing Information Paper for Health
other national and state inquiries into and Calvin Wai-Loon Ho (eds), Genetic
Professionals (2010). Nicol and
health privacy reform. The CLG was Privacy: an Evaluation of the Ethical
Otlowski were invited contributors
involved with the ALRC’s subsequent and Legal Landscape (Imperial College
to the ACOLA Report, The Future
Inquiry into Australian Privacy Law Press; 2013) 283–321.
of Precision Medicine in Australia
and Practice through Otlowski’s
2018 which included coverage of Margaret Otlowski and Lisa Eckstein,
involvement on the Health Advisory
privacy. This was also a key topic for ‘Genetic Privacy’ in Ian Freckleton and
Sub-Committee.
consideration by the Genomics Health Kerry Peterson (eds), Tensions and
CLG members have influenced national Future Mission ELSI Working Group. Traumas in Health Law (Federation
privacy policy through involvement on Press; 2017) 283–296.
The issue of privacy/genetic privacy
national committees – including the
remains foundational to the CLG’s
HGAC (Chalmers and Otlowski) and
current work on the ARC-funded
the Australian Health Ethics Committee
project on genomic data sharing. One
(AHEC - Chalmers, Otlowski and
key issue in this project is the changing
Nicol). In addition, Otlowski was
nature of genetic/genomic privacy in
a member of the Federal Privacy
the era of whole genome sequencing,
Commissioner’s Health Leaders’ Forum
which generates massive quantities of
2004-2010. She was also involved in the
genetic information.
CRICOS Provider Code 00586B 4
Biobanking
The CLG became interested in Joanne Dickinson from the University Key Outputs
biobanking in the mid-2000s, when of Tasmania’s Menzies Institute for
Margaret Otlowski, Dianne Nicol and
it became clear that the next phase Medical Research (on the development
Mark Stranger, ‘Biobanks Information
of genomic research would require and governance of a Tasmanian
Paper 2010’ (2010) 20 Journal of
access to large collections of biobank). The NHMRC Information
Law, Information and Science 87–203,
human tissue from which genomic Paper on Biobanking, drafted by
reproduced with permission from
information could be extracted. Otlowski, Nicol and Stranger, was a
NHMRC, Biobanks Information Paper
This genomic information, linked significant development in the field in
(2010).
with health, genealogical and other Australia.
information, was seen as a vital tool Rebekah E McWhirter, Christine
The CLG has continued engagement
in understanding the genetic basis of Critchley, Dianne Nicol, Don
in biobanking. Of particular note, in
human disease. Internationally, large- Chalmers, Tess Whitton, Margaret
2014, the CLG hosted a Deliberative
scale population-wide collections Otlowski, Mike Burgess and Joanne L
Democracy event, inviting 25 diverse
started being funded, both publicly Dickinson, ‘Community Engagement
members of the Tasmanian community
and privately. The privately-funded for Big Epidemiology: Deliberative
to debate their concerns and hopes
Icelandic DeCode database was an Democracy as a Tool’ (2014) 4 Journal
relating to the creation of a biobank in
early entrant. The publicly funded of Personalised Medicine 457–474.
Tasmania over a two-weekend period.
UK Biobank, Canadian CARTaGENE
CLG collaborator Professor Michael Don Chalmers, Dianne Nicol, Jane
and others followed. The value of
Burgess from the University of British Kaye, Jessica Bell, Alastair V Campbell,
these collections, or biobanks (which
Columbia facilitated the event. CLG Calvin W L Ho, Kazuto Kato, Jusaku
became the accepted terminology, in
members Nicol, Chalmers, Otlowski, Minari, Chih-hsing Ho, Colin Mitchell,
around 2006) was largely as a resource
Critchley, Dickinson and Dr Rebekah Fruzsina Molnár-Gábor, Margaret
for future research projects. The
McWhirter participated. This event Otlowski, Daniel Thiel, Stephanie M
prospective nature of this research,
also marked the start of a five-year Fullerton and Tess Whitton, ‘Has the
and the linkage of genomic and other
contribution to the CLG by Tess Biobank Bubble Burst? Withstanding
information, immediately raised
Whitton, first as a research assistant the Challenges for Sustainable
concerns relating to consent, privacy,
and later as a research fellow, before Biobanking in the Digital Era’ (2016) 17
public trust, commercialisation and a
moving to the University of Melbourne BMC Medical Ethics 39–53.
host of other issues.
to undertake her PhD. Outputs
A CLG team (Chalmers, Nicol, Otlowski included three refereed articles. The
and Skene) received funding from the event also informed further research.
ARC for a five-year project (2005-2009)
Although ELSI issues arising from
to explore facilitation and regulation
biobanking have been canvassed for
of research and development involving
close to 15 years, new developments
human genetic databanks (as they
in genomics continue to push
were then called). The project resulted
technological boundaries. Privacy,
in close to 100 outputs (including
consent, return of research results,
books, book chapters, refereed and
data security, custodianship,
non-refereed journal articles and
commercial involvement and
conference proceedings) as well as
intellectual property protection
presentations and submissions to
remain live issues. The CLG remains
public inquiries, particularly in relation
committed to exploring these matters
to privacy (to the ALRC) and biobank
through our doctrinal, policy-oriented
governance (to the OECD). The project
and empirical research.
also marked the start of ongoing
collaborations with our current
Adjunct Professors, Christine Critchley
from Swinburne University (on public
attitudes towards biobanking) and
5 Celebrating 25 Years of Research utas.edu.au
Patents and Licensing
The completion of the HGP CLG members have also conducted Key Outputs
brought with it concerns around a considerable amount of work
Dianne Nicol and Jane Nielsen,
commercialisation, particularly around on the manner in which patented
Patents and Medical Biotechnology:
the patenting of gene sequences. inventions are used. In 2003, Nicol and
An Empirical Analysis of Issues Facing
Patents provide a right to exploit an Nielsen co-authored an Occasional
the Australian Industry (Centre for Law
invention, and patent owners may Paper investigating the impacts of
and Genetics Occasional Paper No 6;
exercise this right themselves or license patents and licensing practices on
2003).
a patent to another party to do so. In biotechnological research in Australia.
biomedicine, patents have implications This study was cited extensively by Dianne Nicol, Jane Nielsen, Christine
in research, product development and the ALRC in its Report No 99: Genes Critchley, John Liddicoat and Tess
access to healthcare. During the 1990s, and Ingenuity (2004) and has been Whitton, The Innovation Pool in
a ‘gene patent rush’ resulted in a huge influential since this time. A further Biotechnology: The Role of Patents in
number of applications for patent two Occasional Papers followed, Facilitating Innovation (Centre for Law
protection being filed in major western both of which examined the impacts and Genetics Occasional Paper No 8;
jurisdictions, including Australia. While of patent licensing practices on the 2014).
many of these applications lapsed, a biotechnology research environment
Dianne Nicol, Jane Nielsen and
number of patents considered to be in Australia, and the potential for
Verity Dawkins, D’Arcy v Myriad
potentially problematic were granted. patent pooling arrangements in
Genetics: The Impact of the High Court’s
The implications of this have been felt biotechnology. CLG members have
Decision on the Cost of Genetic Testing in
particularly strongly in the diagnostic been successful in obtaining ARC
Australia (Centre for Law and Genetics
testing arena and culminated in the funding to explore these issues
Occasional Paper No 9; 2018).
ongoing Myriad-BRCA gene patent through discovery project grants
litigation which resolved only recently. DP0557608 (to Nicol, in collaboration
with Dr Janet Hope and Distinguished
Issues associated with patent
Professor John Braithwaite from ANU)
protection over biotechnological
and DP0985077 (to Nicol, Nielsen
inventions have been at the forefront
and Critchley in collaboration with
of CLG research since its inception.
Professor Reiko Aoki from Hitotsubashi
Nicol has followed and provided
University in Japan).
expert commentary on the Myriad-
BRCA gene patent debate since the During this period CLG members made
mid-1990s. With colleagues Dr Jane many submissions to public inquiries,
Nielsen, John Liddicoat and Whitton, most of which investigated the
Nicol conducted empirical analysis prevalence, and the use and misuse of
of the implications of patents for the patents in genetic research. Patent law
provision of genetic testing. Liddicoat has undergone significant amendment,
joined the team as a research assistant and the CLG has been engaged in this
in 2010 and went on to complete his process for its duration. CLG work in
PhD and continue his work with us as this area continues, with focus shifting
a research fellow, before moving to recently to the impact of patents
Cambridge University. Most recently, in genomics research. Our current
Nicol and Nielsen were contracted by ARC-funded project investigating
IP Australia to investigate whether the the need to reform the regulatory
Myriad litigation in Australia has had environment for innovative health
any discernible effect on the cost of technologies includes consideration of
genetic testing. These issues centred the role of patents as a regulatory tool,
primarily around the question of encompassing deeper philosophical
whether patents can be granted on consideration of the role of patents in
biotechnological inventions. shaping research environments.
CRICOS Provider Code 00586B 6
Genomic Data Sharing
Rapid innovation in genomic GDS became one of the CLG’s major Key Outputs
technology, combined with the research projects, following receipt
Don Chalmers, Dianne Nicol and
dramatic decline in the cost of of funding from the ARC to undertake
Margaret Otlowski, ‘To Share or
sequencing data, has resulted in the this research over the next four years.
Not to Share is the Question’ (2014)
generation of massive amounts of All CLG staff are involved in the project
3 Journal of Applied and Translational
genomic data. Genomic data sharing and CLG adjunct Dickinson is our
Genomics 116–119.
(GDS) is becoming an essential scientific advisor. The grant funds a
component of clinical and research research fellowship for McWhirter Amber L Johns, Dianne Nicol, Nik
practice. Internationally, legal and and two PhD scholarships which have Zeps and Don Chalmers, ‘The Path
quasi-legal requirements may constrain been awarded to Vanessa Warren and to Reducing Duplication of Human
free and open GDS. However, these Stephanie Green. Research Ethics Review in Australia’
requirements might also provide (2017) 36 Medicine and Law 7–24.
Despite the large literature on GDS,
the assurances necessary to protect
there are few examples of systematic Lisa Eckstein, Don Chalmers,
donors, encourage research and
analysis based on real-world data Christine Critchley, Ruthie
innovation, and promote ongoing
sharing challenges. This project takes Jeanneret, Rebekah E McWhirter,
public trust in GDS activities.
a different approach. We have already Jane Nielsen, Margaret Otlowski and
CLG members have been working on interviewed a number of practitioners Dianne Nicol, ‘Australia: Regulating
key issues associated with GDS for a involved in genomic data sharing Genomic Data Sharing To Promote
number of years. The well-traversed across a range of areas. From these Public Trust’ (2018) 137 Human Genetics
issues associated with privacy, research interviews, we created a number of 583–591.
ethics, consent, intellectual property data sharing scenarios, which we will
rights and formalised transfers of data use to guide our legal, ethical and
and materials are all relevant, but must social analysis. The scenarios will be
be situated in the specific contexts validated by experts in the field and
of genomic data flows between from this combination of methods a
laboratories, regions, countries and list of emerging issues will be identified
sectors. In 2018, the regulation of which will guide our legal, ethical and
social analyses.
7 Celebrating 25 Years of Research utas.edu.au
Public Trust and
Commercialisation
There is widespread academic and funded commercialisation projects if private organisations are obliged
policy agreement that commercial have flowed from this. Members to share any benefits of the research
involvement in translational genomic started to focus particularly on with research participants and those
research is an inevitability. Product issues associated with public trust in need. Finally, our research has also
development is considered too risky and commercialisation in the early shown that general concerns about
and expensive for the public purse, 2000s. The 2004 article by Chalmers commercialisation may be alleviated
and therefore depends on industry and Nicol, Commercialisation of with independent governance
investment. However, industry will Biotechnology: Public Trust and mechanisms that incorporate public
only be involved if there is adequate Research, was a key milestone, representation, and an increased
return on investment. This presents and marked the start of Critchley’s awareness of the need for industry
problems for determining research involvement with the CLG. Since involvement.
priorities and equitable access to the then, our research has attempted to
products of translation. There are also examine the relationship between Key Outputs
implications for public confidence commercialisation and public trust by Don Chalmers and Dianne Nicol,
and support, with an extensive first, examining the specific aspects ‘Commercialisation of Biotechnology:
body of research suggesting that of commercialisation that generate Public Trust and Research’ (2004) 6
commercial involvement can erode most unease, and second, considering International Journal of Biotechnology
trust in researchers, regulators and mechanisms for alleviating concern. 116–133.
organisations. If a large proportion
While much more research is needed, Christine Critchley, Dianne Nicol and
of the public is less willing to
preliminary findings suggest that the Margaret Otlowski, ‘The Impact of
participate in genomic research and
place where the research is conducted Commercialisation and Genetic Data
provide permission to share their
(in the public or private sector) is a Sharing Arrangements on Public Trust
genomic information because of
more potent determinant of trust and Intention to Participate in Biobank
commercialisation concerns, this
than industry providing funding Research’ (2015) 18 Public Health
will have inevitable consequences on
to researchers employed in public Genomics 160–172.
research efforts. A significant question,
research organisations. The concept of
therefore, is how to balance the need Dianne Nicol, Christine Critchley,
public research organisations sharing
for industry involvement with the need Rebekah McWhirter and Tess
their data with private organisations
to maintain significant goodwill from Whitton, ‘Understanding Public
also erodes trust but may be alleviated
the public and patients. Reactions to Commercialization
if research participants are assured
Commercialisation and the legal that their privacy will be protected, of Biobanks and Use of Biobank
status of intellectual property rights that there will be ethical oversight Resources’ (2016) 162 Social Science
have been key pillars in the CLG’s in how the information is used and and Medicine 79–87.
research on the ELSI of genomics and
related technologies since 1994. Nicol
examined the patentability of human
genetic technologies for her Master of
Law thesis, awarded in 1997. The ARC
funded the first CLG project focusing
specifically on commercialisation in
1999 and a number of other ARC-
CRICOS Provider Code 00586B 8
Innovative Health Technologies
Innovative, personalised health The innovative heath technologies Key Outputs
technologies are being heralded project commenced in July 2018.
Tania Bubela, Yael Mansour and
as solutions to intractable health The project aims are to:
Dianne Nicol, ‘The Ethics of Genome
conditions. Procedures such as
1. comprehensively map current Editing in the Clinic: A Dose of Realism
genome editing, medicines such
regulatory requirements applicable for Healthcare Leaders’ (2017) 30
as biologics targeted to individual
to the translation into the clinic for Healthcare Management Forum 159–163.
patients, and devices such as
genome editing, 3D bioprinting and
3D-printed biological structures, Dianne Nicol, Lisa Eckstein, Michael
personalised biologics in Australia
to name a few, are enhancing our Morrison, Jacob S Sherkow, Margaret
and other jurisdictions;
capacity to identify and correct Otlowski, Tess Whitton, Tania Bubela,
individual bodily defects. The law 2. review and analyse these Kathryn P Burdon, Don Chalmers,
should play a key role in ensuring regulatory provisions for each Sarah Chan, Jac Charlesworth,
that the clinical translation of these of these three case studies, to Christine Critchley, Merlin Crossley,
technologies is regulated in ways provide a comparative analysis Sheryl de Lacey, Joanne L Dickinson,
that are responsive to societal of the regulatory environment in Alex W Hewitt, Joanne Kamens,
values and needs, ensuring safety, Australia as compared with other Kazuto Kato, Erika Kleiderman, Satoshi
effectiveness, access, affordability, jurisdictions; Kodama, John Liddicoat, David
allocative efficiency and fairness. While A Mackey, Ainsley Newson, Jane
3. compile an evidence base
insufficient oversight can impede Nielsen, Jennifer K Wagner, Rebekah
to assess compliance with
patient safety, resulting in unnecessary E McWhirter, ‘Key Challenges in
regulatory requirements, and the
morbidity and mortality, an undue Bringing CRISPR-Mediated Somatic
conduciveness of these existing
regulatory burden can impede the Cell Therapy into the Clinic’ (2017) 9
regulatory instruments to innovative
development of innovative health Genome Medicine 85–88.
technology translation for each case
products and associated heath and
study; Dianne Nicol and Jane Nielsen,
economic benefits.
‘The Role of Biotechnology Patents in
4. identify areas of over and under
For many years, the CLG has tracked Regulating Innovative Health Research
regulation and innovation pathways
the issues associated with translation and Development’ in Edward Dove
and blockages for each case study;
of genomic and related research and Graeme Laurie (eds), Cambridge
and
into the clinic. This became a major Handbook of Health Research Regulation
research project for CLG members 5. develop interactive maps for (in press).
Nicol, Nielsen and Dr Lisa Eckstein and regulatory frameworks for each
our collaborator Professor Cameron of the selected case studies,
Stewart from Sydney University in 2018, establishing guiding principles
with the award of an ARC Discovery transferable to other innovative,
Grant to investigate these issues. The personalised health technologies.
grant funds a postdoctoral fellowship
for Jenny Kaldor and two PhD
scholarships: one at the University of
Tasmania and one at Sydney University.
The Tasmanian scholarship has been
awarded to Pratap Devarapalli.
9 Celebrating 25 Years of Research utas.edu.auA Sample of Our Current
Research Interests
Stem Cells and Cloning
The CLG‘s focus on the national and assistant and PhD candidate Brendan Key Outputs
international policy, regulation and Gogarty, took responsibility for this
Dianne Nicol, Don Chalmers and
governance of human genetics extends area, tracking scientific and legal
Brendan Gogarty, ‘Regulating
to stem cell science. Interest in stem developments. They published on
Biomedical Advances: Embryonic Stem
cell technology accelerated with the international and national regulatory
Cell Research’ (2002) 2 Macquarie Law
report of the isolation of pluripotent developments, public trust and the
Journal 31–59.
stem cells from human embryos in role of regulation in these areas.
1998. The CLG tracked stem cell Don Chalmers and Dianne Nicol,
The CLG continues to undertake
technology and the explosion of ‘Embryonic Stem Cell Research: Can
research on the Australian dual
international reports following this the Law Balance Ethical, Scientific and
regulatory model of the Prohibition of
scientific announcement (for example, Economic Values?’ (Part 1) (2003) 18
Human Cloning for Reproduction Act the
Council of Europe, Convention for the Law and Human Genome Review 43–53
Research Involving Human Embryos Act.
Protection of Human Rights and Dignity and Part 2 (2003) 19 Law and Human
Chalmers and Nicol were sequentially
of the Human Being with regard to the Genome Review 91–108.
appointed to the NHMRC Embryo
Application of Biology and Medicine, on
Research Licensing Committee, Don Chalmers, Peter Rathjen, Joy
the Prohibition of Cloning Human Beings;
which administers both Acts and is Rathjen and Dianne Nicol, ‘Stem
House of Commons Science and
responsible for the licensing regime Cells and Regenerative Medicine:
Technology Committee, The Cloning of
created by the Research Involving From Research Regulation To Clinical
Animals from Adult Cells; and, National
Human Embryos Act. This approach Applications’ (2013) 20 Journal of Law
Bioethics Advisory Commission,
to licensing of embryos for research and Medicine 831–844.
Cloning Human Beings: Report and
purposes is largely replicated in the
Recommendations). Research
UK, Finland, Greece, The Netherlands,
standards for clinical applications were
Sweden, Singapore, South Korea, and
also developed at around this time in
China and in two states in the United
the form of the International Society for
States of America; California and New
Stem Cell Research Guidelines.
Jersey. Outright research bans apply
Significantly, the CLG was involved in in Germany, Austria, Ireland, Canada
the corresponding Australian debates, and the Philippines. New genome
public consultations and submissions, editing techniques have reopened
legislative initiatives and the resulting debates about the adequacy and
NHMRC Embryo Research Licensing appropriateness of these regulatory
Committee system. Chalmers and approaches.
Nicol, together with our research
CRICOS Provider Code 00586B 10Material Transfer Agreements
The CLG became particularly We found that MTAs are an Key Outputs
interested in the legal issues associated important tool to track provenance
Jane Nielsen and Dianne Nicol, ‘The
with the transfer of research material of biological materials, and to
Legal Vacuum Surrounding Access to
between laboratories in 2013. A range facilitate collaboration. In a vast
Gene-Based Materials and Data’ (2016)
of biological materials are routinely majority of cases they need do
24 Journal of Law and Medicine 72–88.
transferred for genomic research, little more than this. From this
including but not limited to whole perspective, formalisation is a positive Jane Nielsen, Tania Bubela, Don
living organisms, human and other development in the materials transfer Chalmers, Amber Johns, Linda Kahl,
tissue, reagents, cell lines, plasmids environment. However, MTA practices Joanne Kamens, Charles Lawson, John
and vectors. The tradition of sharing remain inefficient and unwieldy and Liddicoat, Rebekah McWhirter,
these research tools is not new: are in need of reform. Unrealistic Ann Monotti, James Scheibner,
customarily, biological materials were expectations of commercialisation Tess Whitton, and Dianne Nicol,
freely exchanged between researchers, opportunities and unnecessary risk ‘Provenance and Risk in Transfer of
frequently without any type of legal aversion can also increase duration Biological Materials’ (2018) PLOS
documentation. Material transfer and complexity of MTA negotiations. Biology doi.org/10.1371/journal.
agreements (MTAs) began to enter Even where standard-form MTAs pbio.2006031
the picture as universities increasingly are used, there can be an irresistible
Jane Nielsen, Dianne Nicol, Tess
moved towards capturing the urge to ‘tinker’ with them. While a
Whitton and Don Chalmers, My
commercial potential of innovation. standard-form Australian MTA would
Way or the MTA: The Use of Material
Scholars became concerned that not be universally acceptable, there is
Transfer Agreements in Publicly Funded
MTAs could interfere with progress significant scope for alignment in key
Research in Australia (Centre for Law
in genomics, particularly if they MTA terms.
and Genetics Occasional Paper No. 10;
involve protracted negotiations and
The project culminated in 2016, with 2018).
include the following types of terms:
a workshop in Hobart which brought
grant-back provisions providing for
together experts from around the
an option to license patent rights to
globe. Discussions at the workshop
subsequent discoveries; prohibitions
corroborated the veracity of empirical
on researchers from sharing with other
findings from our ARC-funded study,
institutions; and pre-publication review
and highlighted the difficulty of
of research results.
introducing standard MTAs into a
In 2014 Nicol, Chalmers and Nielsen research environment dominated by
(as senior research fellow) received risk averse public institutions.
funding from the ARC to research this
topic from an Australian perspective.
The study included an empirical
component which involved interviews
with technology transfer officers and
scientists in universities and research
institutes, a survey of scientists
involved in transferring materials, and
detailed review and comparison of the
terms of a number of standard MTAs.
11 Celebrating 25 Years of Research utas.edu.au3D Printing
The CLG has invested significant There has also been significant concern bioprinting. This burgeoning area is
research time since 2013 considering about the safety of products produced progressing rapidly, and brings with it
the legal implications brought about using 3D printing and the capacity of many questions of a regulatory nature.
by 3D printing technologies. 3D existing product safety laws to protect These questions are being addressed
printing is a transformative technology consumers against 3D printed goods in our most recent ARC-funded project
which is revolutionising the way we that are either faulty, or not fit for on the regulation of innovative health
design and manufacture goods. It purpose. For example, consumers technologies.
facilitates precision and complexity in may use unsafe 3D printed products
manufacturing, and its great benefit in their home or car, or consume food Key Outputs
lies in the fact that designs may be from 3D printed plates that are not Jane Nielsen and Lynden Griggs,
customised. 3D printing is currently food-safe. It is not difficult to envisage ‘Allocating Risk and Liability for
being used for a range of applications a situation where a product is printed Defective 3D Printed Products: Product
by a range of users, and its uptake by and passed on without adequate Safety, Negligence or Something New?’
various industries and the public has warnings as to its safety. (2017) 42 Monash University Law Review
been nothing short of phenomenal. 712–739.
Finally, 3D printing is yet another
In 2013, Nielsen secured funding from way in which personal data may be Jane Nielsen and John E Liddicoat,
the University of Tasmania to research generated and aggregated. Already ‘The Multiple Dimensions of
this area. Along with the promise whole-body scanners are being used to Intellectual Property Infringement in
3D printing brings, the potential for produce body measurement data for the 3D Printing Era’ (2017) 27 Australian
legal issues has loomed large. 3D various purposes, including for fashion Intellectual Property Review 184–208.
printing makes it easier to ‘copy’ and and the production of miniature 3D
produce similar, functioning objects, ‘selfies’. The storage and sale of this Dinusha Mendis, Jane Nielsen,
so infringement of intellectual property data raises concerns, as there is no Dianne Nicol and Phoebe Li, ‘The
rights has been highlighted as a risk of guarantee of compliance with privacy Co-existence of Copyright and Patent
the technology. Many websites offer principles. Laws to Protect Innovation: Case Study
downloadable files from which objects of 3D Printing in UK and Australian
The study conducted by Nielsen (with Law’ in Roger Brownsword, Elaine
may be printed, and 3D scanners
assistance from Liddicoat) involved Scotford and Karen Yeung (eds), The
provide the opportunity to scan
interviews with those involved in Oxford Handbook of Law, Regulation and
objects from which printable files may
producing 3D printed goods for profit. Technology (Oxford University Press;
be derived.
It resulted in a number of outputs, 2017) 451–476.
and transitioned into researching
the legal and ethical implications of
CRICOS Provider Code 00586B 12Germline Genome Editing
One of the most exciting a short-term research fellow and Key Outputs
developments in biomedicine over the to host a workshop. The workshop
Tess Whitton, Dianne Nicol and Don
past few years is the vast improvement involved a group of scholars with
Chalmers, ‘Human Embryos, Genome
in the ability to directly alter the deep interest in the ethical, legal
Editing and Future Directions’ in Ian
genetic sequence of mammalian cells, and social implications of genome
Freckleton and Kerry Petersen (eds),
particularly through the adaptation editing. The workshop allowed the
Tensions and Traumas in Health Law
of Clustered Regularly Interspersed group to dissect the ethical, legal and
(Federation Press; 2017) 384–400.
Short Tandem Repeat (CRISPR) and social environment within which gene
CRISPR associated (Cas) systems. This editing is situated, and to debate how Christine Critchley, Dianne Nicol,
technology is positioned to become this technology might be safely and Gordana Bruce, Jarrod Walshe, Tamara
as transformative in the laboratory as ethically translated into the clinic and Treleaven and Bernard Tuch, ‘Predicting
the polymerase chain reaction, which unacceptable practices, whether of a Public Attitudes Towards Gene Editing
facilitated rapid multiplication of DNA legal, moral or social nature, curtailed. of Germlines: The Impact of Moral
strands in the 1980s. Although still very and Hereditary Concern in Human and
Nicol has been particularly active in
much a research tool, CRISPR-Cas has Animal Applications’ (2019) 9 Frontiers
this area, with two book chapters
been touted as having potential clinical in Genetics article 704.
on the regulatory environment
application in the treatment of cancer
for germline genome editing and Dianne Nicol, ‘The Regulation
and a range of other diseases. These
embryo research, and a paper of Human Germline Genome
technological advances in genome
reporting the results of a survey of Modification in Australia’ in Andrea
editing have reignited debates about
Australian public attitudes towards Boggio, Caesare Romano and Jessica
the potential for therapeutic germline
genomic editing (with Critchley Almqvist (eds), Human Germline
gene therapy, which is currently
and other colleagues). Her work Modification and the Right to Science:
prohibited in many jurisdictions, and
on the NHMRC Embryo Research A Comparative Study of National Laws
deeper philosophical discussions
Licensing Committee is informed by and Policies. In press.
around the manipulation of human
this research. In November 2018
embryos.
she was asked to present on the
In 2015, CLG members recognised Australian regulatory environment at
that ELSI of genome editing required the Second International Summit on
special attention. This is particularly Genome Editing in Hong Kong. The
the case in Australia, in light of the announcement of the alleged birth
prohibitory approach to regulation of first two genome-edited babies
of germline therapy, the prescriptive was a key topic for discussion at the
approach to regulation of embryo summit, illustrating the urgent need for
research and uncertainty about the research in this area.
regulation of somatic cell genome
editing. The University of Tasmania
provided funding in 2016 to initiate this
research, allowing the CLG to appoint
13 Celebrating 25 Years of Research utas.edu.auReturn of Research Results
Over the past decade, there has been on the communication of research Key Outputs
a growing discussion about the ELSI findings or results to participants
Lisa Eckstein, Jeremy Garrett and
involved in returning research results, including a decision tree for the
Benjamin Berkman, ‘A Framework
especially in the context of genetic and management of findings in genomic
for Analyzing the Ethics of Disclosing
genomic research. Many agree that research and clinical care.
Genetic Research Findings’ (2014)
researchers have an ethical obligation
Scholarly engagement on this issue 42 Journal of Law and Medical Ethics
to return at least some results to
by CLG researchers (Otlowski and 190–207.
participants, but satisfying this
Eckstein) include peer-reviewed
precept raises overarching questions Lisa Eckstein and Margaret Otlowski,
journal articles, book chapters, and
about what data researchers should ‘Strategies To Guide the Return
conference, workshop and panel
generate, the degree of verification of Genomic Research Findings: an
presentations. Otlowski, Eckstein
and analysis to which it should be Australian Perspective’ (2018) 15 Journal
and McWhirter regularly engage
subject, and the degree of clinical or of Bioethical Inquiry 403–415.
with genetic counsellors and other
other value that warrants an obligation
professionals in the area to discuss
of disclosure. As genomic information
legal and ethical challenges they
becomes ever more available, these
encounter with regard to return of
questions become increasingly acute.
results. CLG members are involved
Members of the CLG have been with the NHMRC Centre for Research
influential in addressing the Excellence on Translation of Genetic
frameworks for disclosure of genomic Eye Research (TOGER) led by Professor
research results in Australia and more David Mackey (Otlowski as CI and
broadly. Most notably, Otlowski Nicol on the Advisory Board); one of
chaired the initial working group (2015 the key ELSI issues encompassed in
to mid-2016) responsible for revising this program is the return of results
Chapter 3.5 of the NHMRC National to research participants, including
Statement on Ethical Conduct in Human incidental findings. The CLG will
Research, which deals with human continue to explore return of finding
genetic and genomic research. The decisions through the genomic data
revised chapter includes a new section sharing project.
CRICOS Provider Code 00586B 14Genetic and Genomic Research with
Aboriginal and Torres Strait Islander People
A key ethical issue for Australian Marika, developed practical strategies Key Outputs
genomics researchers is ensuring that for undertaking ethical genetic and
Rebekah E McWhirter, Djapirri
Aboriginal and Torres Strait Islander genomic research with Indigenous
Mununggirritj, Dipililnga Marika,
people are included in the benefits communities. Building on this, later
Joanne L Dickinson and John R
of precision medicine and genomics. work by CLG members identified
Condon, ‘Ethical Genetic Research in
The CLG has actively engaged with this potential harms to Indigenous
Indigenous Communities: Challenges
issue by identifying and assessing the Australians in the regulation of non-
and Successful Approaches’ (2012) 18
impact on Indigenous Australians as an consensual genetic testing of deceased
Trends in Molecular Medicine, 702–708.
important part of our wider projects individuals and in the exclusion of
in genomics. In 2014, we undertook a Indigenous participants from genomic Rebekah E McWhirter, Dianne
Deliberative Democracy event, which health research, as well as making Nicol and Julian Savulescu, ‘Genomics
highlighted the significance of this recommendations for preventing these in Research and Health Care with
issue for mainstream genomics and in practice. Aboriginal and Torres Strait Islander
facilitated the inclusion of Indigenous Peoples’ (2015) 33 Monash Bioethics
Chalmers sits on the governance board
voices in developing a trustworthy Review 203–209.
of the National Centre for Indigenous
biobank governance framework.
Genomics (NCIG), an Indigenous-
Similarly, our 2016 workshop on MTAs
led initiative to promote ethical
included examination of the potential
inclusion of Indigenous Australians in
effect of standardised MTAs on
genomics. The NCIG acts as custodian
Indigenous communities.
of genomic samples and data relevant
The CLG’s work in this area has to Indigenous Australians. In the
resulted in a number of peer-reviewed course of his appointment, Chalmers
publications, conference presentations has contributed to the management
and submissions to the NHMRC of Indigenous genomic resources in
regarding revisions of the National accordance with principles of respect,
Statement. As part of an NHMRC consultation, consent and trust.
Project Grant investigating genetic risk
Our current project on genomic
factors for vulvar cancer in Indigenous
data sharing will expand upon our
women resident in Arnhem Land, CLG
work to date by investigating the
members Dickinson and McWhirter,
impact of data sharing practices on
together with Professor John Condon,
Indigenous Australians, with the aim
Djapirri Mununggirritj and Dipililnga
of accelerating equitable access to the
benefits of precision medicine and
genomics.
15 Celebrating 25 Years of Research utas.edu.auThe CLG's Grants
• ‘Legal and Ethical Implications of • ‘Expand the capacity of an • ‘Delivering on the Promise of 3D
Human Genetic Research: Australian international multidisciplinary Printing: Identifying Legal Barriers’
Perspectives’, ARC Discovery Grant research network focussed on the UTAS Research Enhancement
1995–1997, $79,005 (Chalmers, ethical, legal and social implications Granted Scheme, 2013, $10,000
Otlowski and Skene). of emerging biotechnologies’, (Nielsen)
ARC International Linkage Grant
• ‘Legal Standards in the • ‘Material Transfer Agreements and
2006–2007, $20,000 (Chalmers,
Commercialisation of Human Open Science in the Genome Era’,
Nicol, Otlowski, Skene, Stranger,
Genetic Technology’, ARC Discovery ARC Discovery Grant DP140100301,
Professors Bartha Knoppers,
Grant 1999–2001, $115,000 2014–2016, $294,776 (Nicol and
Andrew Webster and Jeong-Ro
(Chalmers, Otlowski and Skene). Chalmers).
Yoon).
• ‘Legal and Ethical Regulation of • ‘Expanding the Centre for Law and
• ‘The Innovation Pool in Australian
the Use and Commercialisation of Genetics to Achieve Local, National
Biotechnology: Assessing Strategies
Human Biological Material’, ARC and International Recognition for
for Fostering Innovation through
Discovery Grant DP0208258 2002– Research Excellence’, UTAS Strategic
Patenting and Patent Pooling’,
2004, $364,323 (Chalmers, Nicol, Research Funding, 2015–2016,
ARC Discovery Grant DP0985077,
Skene and Otlowski). $235,000 (Nicol, Chalmers and
2009–2013, $412,000 (Nicol, Nielsen,
Otlowski), with renewal of $87,000
• ‘Biotechnology Patent Licensing in Critchley and Aoki).
in 2017.
Australia: A Preliminary Study’, UTAS
• ‘The Age of Personalised Medicine:
Institutional Research Grant 2002– • ‘Reforming the Regulatory
Regulatory Challenges for Australia’,
2003, $20,000 (Nicol and Nielsen). Environment for Innovative Health
ARC Discovery Grant DP110100694,
Technologies’, ARC Discovery Grant
• ‘Facilitation and Regulation of 2011–2014, $281,000 (Nicol,
DP180101262, 2018–2021, $628,576
Research and Development Chalmers, Otlowski and Critchley).
(Nicol, Nielsen, Eckstein and
Involving Human Genetic
• ‘Ensuring the Utility and Stewart).
Databanks’, ARC Discovery Grant
Sustainability of Tissue Banks:
DP0559760, 2005–2009, $602,594 • ‘Genomic Data Sharing: Issues in
Supporting Translational Research
(Chalmers, Nicol, Otlowski and Law, Research Ethics and Society’,
in Australia through Informed
Skene). ARC Discovery Grant DP180100269,
Regulation and Community
2018–2021, $614,454 (Nicol,
• ‘Co-operative Intellectual Property Engagement’, NHMRC Project
Otlowski, Critchley, Eckstein,
Management and Technology Grant, administered through the
Chalmers and Nielsen).
Transfer for the Australian University of Sydney, 2012–2015,
Biotechnology Industry’, ARC $437,215 (Professor Ian Kerridge,
Discovery Grant DP0557608, 2005– Stewart, Otlowski, Nicol and
2007, $331,586 (Hope, Nicol and Critchley).
Braithwaite).
CRICOS Provider Code 00586B 16A Sample of Core
CLG Team Publications
1. Don Chalmers, Margaret Otlowski, 6. Don Chalmers and Dianne 11. Christine Critchley, Dianne Nicol,
Dianne Nicol and Loane Skene, Nicol, ‘Human Genetic Research Margaret Otlowski and Don
‘Legal and Ethical Implications of Databases and Biobanks: Towards Chalmers, ‘Public Reaction To
Human Genetic Research: Australian Uniform Technology and Australian Direct-To-Consumer Online Genetic
Perspectives’ (1995) 3 Law and the Best Practice’ (2008) 15 Journal of Tests: Comparing Attitudes, Trust
Human Genome Review 211–220. Law and Medicine 538–555. and Intentions across Commercial
and Conventional Providers’ (2015)
2. Dianne Nicol and Jane Nielsen, ‘The 7. Christine Critchley, Dianne Nicol,
24 Public Understanding of Science
Australian Medical Biotechnology Margaret Otlowski and Mark
731–750.
Industry and Access To Intellectual Stranger, ‘Predicting Intention To
Property: Issues for Patent Law Biobank: a National Survey’ (2010) 12. John Liddicoat, Tess Whitton
Development’ (2001) 23 Sydney Law 22 European Journal of Public Health and Dianne Nicol, ‘Are the Gene
Review 347–374. 139–144. Patent Storm Clouds Dissipating? A
Global Snapshot’ (2015) 33 Nature
3. Dianne Nicol, Don Chalmers and 8. Margaret Otlowski and Dianne
Biotechnology 347–352.
Brendan Gogarty, ‘Regulating Nicol, ‘The Regulatory Framework
Biomedical Advances: Embryonic for Protection of Genetic Privacy 13. Dianne Nicol, Christine Critchley,
Stem Cell Research’ (2002) 2 in Australia’ in Terry Sheung-Hung Rebekah E McWhirter and Tess
Macquarie Law Journal 31–59. Kaan and Calvin Wai-Loon Ho (eds), Whitton, ‘Understanding Public
Genetic Privacy: An Evaluation of the Reactions To Commercialisation
4. Don Chalmers and Dianne
Ethical and Legal Landscape (Imperial of Biobanks and Use of Biobank
Nicol, ‘Commercialisation of
College Press; 2013) 283–321. Resources’ (2016) 162 Social Science
Biotechnology: Public Trust and
and Medicine 79–87.
Research’ (2004) 6 International 9. Don Chalmers, Dianne Nicol,
Journal of Biotechnology 116–133. Margaret Otlowski and Christine 14. Jane Nielsen and Dianne Nicol, ‘The
Critchley, ‘Personalised Medicine in Legal Vacuum Surrounding Access
5. Margaret Otlowski, ‘Exploring the
the Genome Era’ (2013) 20 Journal of To Gene-Based Material and Data’
Concept of Genetic Discrimination’
Law and Medicine 577–594. (2016) 24 Journal of Law and Medicine
(2005) 2 Journal of Bioethical Inquiry
72–88.
165–176. 10. Rebekah E McWhirter, Christine
Critchley, Dianne Nicol, Don 15. Lisa Eckstein, Don Chalmers,
Chalmers, Tess Whitton, Margaret Christine Critchley, Ruthie
Otlowski, Michael Burgess and Jeanneret, Rebekah E McWhirter,
Joanne L Dickinson, ‘Community Jane Nielsen, Margaret Otlowski and
Engagement for Big Epidemiology: Dianne Nicol, ‘Australia: Regulating
Deliberative Democracy as A Tool’ Genomic Data Sharing To Promote
(2014) 4 Journal of Personalized Public Trust’ (2018) 137 Human
Medicine 459–474. Genetics 583–591.
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