Clinical Trials for Nano-bionics: Testing
Wearable and Implantable Medical
Devices
Appendices
Appendix A Participants ................................................................................................. 2
Appendix B Notes for Hosts ......................................................................................... 3
Appendix C Event Agenda............................................................................................. 4
Appendix D Setting the Agenda: Engagement Questions ............................... 6
Appendix E Suggested Actions and Further Questions................................... 7
Appendix F Discussion Rounds .............................................................................. 10
Appendix G Summary of host reports ................................................................... 18
Appendix H Invitation and Advertising ................................................................. 21
Appendix A Participants
1.
2.
3.
4.
5.
6.
Belinda Askew, Sydney
Helen Atkinson, Medical devices, Department of Innovation, DIISRTE
Elaine Attwood, Consumer’s Federation of Australia
David Belt, Wollongong
Kayla Belt, Wollongong
Dr Toni Campbell, Chief Operating Officer, ARC Centre of Excellence for
Electromaterials Science, Intelligent Polymer Research Institute
7. Dr Frederic Gilbert, Research Fellow, School of Philosophy, University of
Tasmania & Australian Research Council Centre of Excellence for
Electromaterials Science (ACES)
8. Dr Tony Gill, Acting Principal Medical Advisor, Therapeutic Goods
Administration (TGA)
9. Professor Don Iverson, Pro Vice-Chancellor (Health), Executive Dean of the
Faculty of Health and Behavioural Sciences, and Director of the Illawarra
Health & Medical Research Institute, University of Wollongong.
10. Dr Tejas Kanhere, Emergency Room Doctor, Wollongong
11. Associate Professor Rob Kapsa, Principal Fellow (Bionics) at the Intelligent
Polymer Research Institute (IPRI), University of Wollongong and Associate
Professor and Head of Research, Centre for Neuroscience and Neurology
Research, St Vincent’s Hospital
12. Elizabeth Khaletskaya, Sydney
13. Sofya Khaletskaya, Sydney
14. Daria Lonsdale, NETS-PACE, DIISRTE
15. Associate Professor Katina Michael, School of Information Technology and
Computer Science, University of Wollongong
16. Associate Professor Simon Moulton, Associate Leader, ACES Bionics
Program Intelligent Polymer Research Institute (IPRI), University of
Wollongong
17. Cathal O’Connell, PhD Student, University of Wollongong
18. Dr Anita Quigley, Senior Research Fellow, St Vincent's Hospital
19. Dr Wendy Russell, NETS-PACE, Department of Industry, Innovation,
Science, Research and Tertiary Education (DIISRTE)
20. Associate Professor Robert Sparrow, Australian Research Council Future
Fellow and Associate Professor, Philosophy Department, Monash University
21. Dr Elise Stewart, Research Fellow, Bionics, Intelligent Polymer Research
Institute (IPRI)
22. Ryan Sullivan, PhD Student, University of Wollongong
23. Professor Colin Thomson, Professor of Law, University of Wollongong
24. Dr Brianna Thompson, Research Fellow, Bionics. Intelligent Polymer
Research Institute (IPRI)
25. Christine Thompson, Wollongong
26. Professor Gordon Wallace, Executive Research Director, Australian
Research Council Centre of Excellence for Electromaterials Science (ACES)
27. Jo Williams, Wollongong
28. Andreas Wortmann, Research Fellow, Intelligent Polymer Research Institute
(IPRI)
29. Sue Young, Wollongong
Professor Susan Dodds, Dean of Arts, University of Tasmania & Ethics Program
Leader, Australian Research Council Centre of Excellence for Electromaterials
Science (ACES) & Eliza Goddard, Research Associated, Faculty of Arts,
University of Tasmania were also present in organisational roles.
2
Appendix B Notes for Hosts
The following notes were provided to question hosts by the facilitator Max Hardy of
Twyfords.
Thanks for offering to be a host for this workshop. Here are a few notes to help guide you in
carrying out this role. You are not expected to be the expert for the topic/question for which
you are the host, (although you could be). Your role is about helping everyone to contribute
to the conversation, and to record the key points that arise. The people who join your
conversation are also there to help you to record and confirm the key points. I will give you 5
minutes notice before the close of the round to make sure you get the key points recorded.
The questions and the length of time for each session are as follows.
Round 1 (45 minutes)
What is it about this question that brings you here?
Round 2 (40 minutes)
What would you like to add to this conversation? What is missing?
Round 3 (40 mins)
What did we learn?
What do think should happen next, and by whom?
What will we suggest to ACES, NHMRC and TGA?
What other questions might we need to explore?
A tip: If you know a lot about the subject, we want you to contribute but not dominate. Your
main job is to facilitate. This can be tricky. It can help to invite others to contribute first
before you share your views. If it’s too difficult doing both invite someone else in the group
to facilitate for a period of time. Usually someone is happy to step up in this way.
3
Appendix C Event Agenda
Time
Duration
Item
Approach
9.30
30 mins
Arrival
Register on arrival and provide a
copy of the survey to complete
Distribute Survey & fill
in
10.00
10 mins
Welcome, introductions
and housekeeping &
distribute consent form
Explain research part of the day
10.10
20 mins
Context and objectives
of workshop
ACES Project team member –
Susan Dodds
Explanation of STEP process Wendy Russell
Gordon 5 min talk about what is
being done, and what decision
makers are hoping to gain from
today.
10.30
10
Commitment from
ACES, NHMRC and
TGA
ACES, NHMRC and TGA to each
express their sincere interest in what
comes from this workshop, and to
consider any suggestions and
respond accordingly.
10.40
10 mins
Overview of what will
happen today
Max
10.50
40 mins
Setting the agenda

Discuss at tables (Questions on
PP slide as well as at tables).

Each table prepares two
questions

Questions written down and
displayed on sticky wall.
Themed.

Sticky dot voting to select the
questions, bearing in mind the
criteria

6-10 questions identified
(dependent on numbers
attending – no more than 8 per
table, so if 60 come, we would
identify 8 questions).

Identify hosts for each question.
What brings you
here today?
What questions do
you most want to
explore?
11.30
45 mins
Round 1
What is it about this
Participants move to the tables
where they are most interested – no
more than 8 to a table. If a table is
4
Time
Duration
Item
question that brings
you here?
12.15
45 mins
Lunch
1.00
40 mins
Round 2
What would you like
to add to this
conversation? What
is missing?
1.40
10 mins
Break
1.50
40 mins
Round 3
What did we learn?
What do think should
happen next, and by
whom?
What will we suggest to
ACES, NHMRC and
TGA?
Approach
way too popular we will create a
second table for that particular
question, and even a third.
Host refers to main points arising
from previous round. Then poses
the Round 2 question to continue
the conversation.
Host refers to main points arising
from previous round. Then poses
the Round 3 question to continue
the conversation.
Host to summarise responses from
the table and prepare to report.
Key suggestions and questions
listed on Flip Chart paper for each
group.
What other questions
might we need to
explore?
2.30
40 mins
Host reports
Each host briefly share the output
from Round 3 and anything else
significant to have emerged.
3.10
20 mins
Break and prioritising
During break participants allocate
dots on their priorities – suggestions
and questions.
3.30
25 mins
Summary
Max to walk all participants through
what emerged from the prioritising
exercise.
Check out
Invitation for closing thoughts from
3-4 participants (time permitting)
Decision maker
responses
3.55
5 mins
Decision makers affirm efforts from
today and what surprised/pleased
them from the workshop today.
Distribute post survey
Ask participants to fill in post survey
Thanks and next steps
and
ACES project team member.
5
Appendix D Setting the Agenda: Engagement
Questions
Theme
Question
Votes
Current status of
regulation and
approval
How do nano-devices deliver drugs and what are some of the
limitations and challenges?1
17
Is there some technology device already out there that uses
nanotechnology? Evolution rather than Revolution!
What ‘Nano’ enabled wearable or implantable devices are
approved and in the market place?
Regulatory process
– future/ongoing
How do we set up a regulatory framework for deciding who is
eligible for a device?; If rehabilitation is acceptable, is
enhancement?
16
Can we regulate on the basis of where ‘nano’ is used?
What are the steps in getting nano-bionic products to the
market (and timeframe)?
When is it ethical to launch a nanobionic, first-in-human clinical
trial based on an animal model?; When is evidence sufficient to
start human trials?
Monitoring and
Information from
Devices
What are some of the potential side effects of implanted nanodevices and how are they detected and monitored?
14
What do patients need to feel comfortable with longer-terms
monitoring?
How transparent will future research be to the wider community
n regards to privacy? For example: Will an implanted device
enable you to be ‘tracked’ without recipient awareness?2
Transparency and
engagement
To learn more about nano-materials; Implications for public
policy
12
How do we inform and engage the community in
nanotechnology issues? Benefits and risks?
How can we improve transparency of current developments
and approval processes to allow recipients to make informed
choices based on what’s coming and when?
Managing
obsolescence
How should we manage obsolescence?
How do we
manage scope
creep?
How do we control the use of nano-bionic technology for good
to mankind versuss implanted for convenience or
encouragement?
10
Longevity of devices – what can we expect long-term of current
devices ad newer devices? (Function, safety, cost and access)
9
What kinds of safeguards can we introduce into therapeutic
implantable devices that ensure scope creep does not occur?
Will “epatients” have access to all the data emanating form
their device?
What happens when upgrades become available?
Trial participation
and Informed
1
2
How do we ensure informed consent is balanced? Risk versus
benefit
8
This question, prior to theming, received 8 votes.
This question, prior to theming, received 2 votes.
6
consent
How do we decide which members of the community should be
trial participants?
New ethical
issues?
Are there any new ethical issues with technology over existing
medical implant technologies?
2
7
Appendix E Suggested Actions and Further Questions
Suggested Action
Dots
Theme
Regulation needs to be in step with innovation
15
Current Status of regulation and
approval
All trial data and case reports should be submitted to a
national and international repository
11
Trial participation and informed
consent
Research funding should allow people to research in a
more realistic way (not just allocated a certain amount
of time). The TGA should work more closely with
AHEC and NHMRC to sanction targeted funding
towards research that minimizes risk and maximises
benefit (pictoral) 3
10
Managing Obsolescence
An independent body to assess new technologies
9
Transparency and Engagement
Should be legislated by law – patient centred decision
about what happens with data
8
How do we manage scope creep?
Similar to surgery – limit initial bionic device release in
networks of high quality centres with clinicians and
researchers
7
Regulatory process – future/ongoing
Currently there is no nano-device registered with the
TGA (some components are). We need to identify
where nano-materials are being used in human health
care
4
Current Status of regulation and
approval
Engagement processes involving all stakeholders
3
Transparency and Engagement
Hospitals/ health providers should provide Ecounsellors
3
How do we manage scope creep?
Trusted sources of information
2
Transparency and Engagement
They [patients/device recipients] should have the
option to own their own data (and onsell). Are they
educated enough to know what it means?
2
How do we manage scope creep?
Patients should be able to buy a device plan (like a
mobile phone plan) rather than one device (2)
2
How do we manage scope creep?
Trials of enhancements as well as therapies should be
regulated
1
Trial participation and informed
consent
Mechanisms to declare conflicts of interest should
strengthened and enforced
1
Trial participation and informed
consent


3
Disinterested/independent
No and/or revealed financial interested;
include information regarding alternatives
See image in Appendix F: Question Rounds, Managing Obsolescence
Suggested Action
Dots
Theme
Accurate patient information for informed consent
1
Current Status of regulation and
approval
We do need clinical trials of nano-enabled devices
0
Current Status of regulation and
approval
Intermediaries to communicate about scientific
developments to wider community
0
Transparency and Engagement
New communication models (post-deficit)
0
Transparency and Engagement
New agency to regulate company duty of care for
‘edevices’ (Ombudsman)
0
How do we manage scope creep?
Companies should have “data protection” policies (like
Google’s “hire a hacker”)
0
How do we manage scope creep?
Deveopment of regulation should consider what is
needed from a consumer perspective?
0
Current Status of regulation and
approval





e.g. efficacy of treatment; acceptable risks;
the benefits
e.g. side effects explained
ensure support e.g. family
support groups provide independent advice
from others
Feedback from participants provides unbiased
valuable information for researchers
9
Questions for further
investigation
Dots
Theme
At what point does a procedure
stop being rehabilitation and start
being enhancement? What are the
implications?
7
Regulatory process – future/ongoing
Do we need a registry of nanodevices?
6
Current Status of regulation and
approval
When to upgrade? Invasiveness;
cost; (Size); Risk/benefit
6
Managing Obsolescence
How can scientists communicate
about new developments without
creating unrealistic expectations?
3
Transparency and Engagement
Can and should we move away
from privately directed research,
and towards publicly directed
research?
2
Regulatory process – future/ongoing
How can we open up conversation
about new technologies in the
future?
2
Transparency and Engagement
How do we ensure clinical trial
researchers disclose their findings
in a reasonable timeframe?
1
Trial participation and informed consent
How much lower is the level of
acceptable risk in trials of
enhancements rather than
therapy?
1
Trial participation and informed consent
Is the ethics of international device
trials different to that of
international drug trials?
0
Trial participation and informed consent
At what point does risk outweigh
reward in initial human targets?
How does continued data shift this
point? `
1
Regulatory process – future/ongoing
Should we have legislation to
protect “uninformed” patients
where risk is considered too high
for the reward? For patients
insistent on procedure, should
there be a class/program, to
restore choice?
0
Regulatory process – future/ongoing
Where is the nano-battery
technology research? How soon?
0
Current Status of regulation and
approval
Engineer/design/plan(& cost) for
obsolescence – end of functional
life. How best to design for
0
Managing Obsolescence
Questions for further
investigation
Dots
Theme
Should Government make private
companies take more
responsibility?
0
How do we manage scope creep?
Do patients want their own data?
(Health status etc)
0
How do we manage scope
Will the patient own their own
data?
0
How do we manage scope
What happens when a company
goes broke? What if the data is onsold?
0
How do we manage scope
minimum invasive upgrades
11
Appendix F Discussion Rounds
Theme: Current Status of Legislation and Approval
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Qu. How do nano-devices deliver
drugs and what are some of the
limitations and challenges?
Patient information for informed
consent e.g. efficacy of treatment;
Acceptable risks – benefits; Side
effects explained
We need to identify where nanomaterials are being used in human
health care
Where is the nano-battery technology
research? How soon?
Ans. Nano-patches – sub cutaneous
delivery; preventative drug delivery –
e.g. for epilepsy. Challenges/limitations
– capacity of long-term implants; how
to “recharge” devices and upgrade
devices. Regulation may be a rate
limiting step e.g. speed of progress
outruns the ability of regulators to keep
up.
Ensure support: E.g. family and
Support groups – independent advice
from others
What is needed from a consumer
perspective?
Currently there is no nano-device
registered with the TGA (some
components are)
Qu. Is there some technology device
already out there that uses
nanotechnology? Evolution rather than
Revolution!
Feedback provides unbiased valuable
information for researchers
Accurate patient information for
informed consent: e.g. efficacy of
treatment; acceptable risks; the
benefits; e.g. side effects explained;
ensure support’ e.g. family support
groups provide independent advice
from others
Support groups provide independent
advice from others
Do we need a registry of nanodevices?
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Ans. Yes, e.g. bone netting (fabric
device); components of cochlear
implants (external); nano-patches for
drug delivery.
We do need clinical trials of nanoenabled devices
Qu. What ‘Nano’ enabled wearable or
implantable devices are approved and
in the market place?
Feedback from participants provides
unbiased valuable information for
researchers
Ans. None – but many
parts/components being used.
Regulation needs to be in step with
innovation
13
Theme: Regulatory process – future/ongoing
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Similar to surgery limit initial bionic
device release in networks of high
quality centres with clinicians and
researchers
At what point does a procedure stop
being rehabilitation and start being
enhancement? What are the
implications?
Adequate evidence, mitigation of
risk
Adequate evidence: Risk vs Reward
Animal studies - In cases of
device/surgery placebo effect may
not be tested in humans
Once procedure/device is “out of the
gate” control is difficult if not impossible
At what pint does risk outweigh reward
in initial human targets? How does
continued data shift this point?
In certain uses, human trials are
permanent, e.g. artificial heart. What
improved safeguards introduce
chronic dependence?
Protocol propagation for bionics is
similar to that of surgery
Should we have legislation to protect
“uninformed” patients where risk is
considered too high for the reward?
For patients insistent on procedure,
should there be a class/program, to
restore choice?
When does reward outweigh risk?
Rehabilitation vs enhancement, e.g.
prosthetic leg. Amputee due to
trauma … trauma causes paralysis >
elective amputation > prosthetic
leg… trauma causes partial loss of
functionality > elective amputation >
prosthetic leg… fully functioning leg
> elective amputation > high
functioning prosthetic leg
Release will ultimately depend on
public demand
Lack of adequate animal models,
proof-of-concept may suffice; when
proof-of-concept is adequate. On a
case-by-case basis, but is governing
board transparent?
Limit or control initial device release in
high quality centre or network of
centres with clinicians and researchers
Can and should we move away from
privately directed research, and
towards publicly directed research?
14
Round 1 - What is it about this
question that brings you here?
Ignoring reimbursement from
medical programs. Is there an
ethical line between levels of
rehabilitation vs enhancement? And
if there is, where does it lie?
Round 2 - What would you like to
add to this conversation? What is
missing?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Independent body to assess new
technologies
How can scientists communicate about
new developments without creating
unrealistic expectations?
Can and should we move away from
privately directed research towards
government sponsored research?
Theme: Transparency and Engagement
Round 1 - What is it about this
question that brings you here?
Challenges for scientists engaging
community to understand scientists
work and balance:




Low level awareness; fun
educational events (e.g.
Powerhouse), Need to
communicate risks too. Also
need dialogue.
Different models of
communication. Scientists
need to know what ‘public’
think and how to communicate.
Connect to things that are
more familiar to people.
Informed choices: need to
know risks and benefits.
Policy challenge regarding new
Round 2 - What would you like to
add to this conversation? What is
missing?
Trusted sources: mother of end-user.






Information about other
options, alternative strategies
difficult to come by or biased
Government has pulled back
too far (just provide links)
Need trusted sources with
information and social
ramifications. Need someone
is appropriate context e.g.
parents
A lot of biases
Little information regarding
nanotechnology. Not enough
controversy?
Media sets benchmarks for
communication. Politicians
15
Round 1 - What is it about this
question that brings you here?




technology as viable prospect
e.g. cochlea; need to take risks
Uncertainty, especially
regarding risks
Scientists communication – via
intermediaries/interface
Push for young scientists to
communicate and engage
People engaged more when
products demonstrated
Round 2 - What would you like to
add to this conversation? What is
missing?






Media interface contributes to this.
Media and scientists have a
responsibility to communicate in an
ethical way.


Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Trusted sources of information:
Disinterested/independent
How can we open up conversation
about new technologies in the future?
needs to respond to “media
heat”
No awareness of new
improved versions of devices
(approvals). Could stages be
revealed (to end user)?
Communities want to be
involved but don’t find
opportunities. Information
through informal networks; ad
hoc; random
Even low awareness in
medical community
High cost, high stakes
Even interested people can
have trouble getting robust
information
Something like CHOICE?
Reputation, independent, *no
financial interests (financial
interests need to be revealed)
Information regarding alternatives

Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Confidence in technology
affected by perceptions of bias,
push
Interests change (source of
funding) - cultural shift, e.g.
charity > government funded
Nature of funding (e.g.
competitive) can affect
interests (perverse incentives)
No and/or revealed financial interested;
include information regarding
alternatives
16
Round 1 - What is it about this
question that brings you here?
Information about new breakthroughs,
benefits to public, not just medical
examples of other applications.
Round 2 - What would you like to
add to this conversation? What is
missing?
Independent body to assess new
technologies; peak body







Trusted sources – position of authority,
credentials, spectrum – science,
industry, users (more trusted). Interests
affect trust.
Technology assessment – path
to market may become
blocked downstream
Super bodies of knowledge
regarding a particular area
(internationally)
Need information about what’s
in the pipeline
Alternatives may conflict e.g.
nano-bionics via stem-cell
treatments
Lack of information about
what’s coming
Go public – oversimplify
(relates to IP and competition),
talk up. Very difficult to balance
right to know what’s coming vs.
raising hopes
Media and public awareness
favour stories of application
UK post-BSE. Deficit model – public
just need to be informed. Ineffective
passive consultation
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Intermediaries to communicate about
scientific developments to wider
community
New communication models (postdeficit)
Two-way
Dialogue
Big picture questions
Challenge, early stage: can’t find endusers. Peer review, extended peer
Social goals, futures. Platform
technologies – very difficult to predict
Engagement processes involving all
stakeholders
17
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?
review? Other backgrounds.
Questioners. Opposing views.
Movie/vox pops about new devices.
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
More acceptable outcomes?
More efficient processes?
Government agencies need to work on
transparency. Community
engagement, policy, transparency>
informed choice
How to frame conversations about
emerging technologies?
Scientists talk up potential of work –
some problems with expectations
(timeframes), for example stemcells.
Hope; hype; disappointment cycles
What kind of world do we want?
Logical conclusions; big picture
questions; human enhancement,
longevity; Who should have access?
Why?
Existing regulatory framework
o
o
o
TGA – safety, efficacy
MSAC –
reimbursement
Cost-benefit
challenges
Insurance – criteria may not be up-todate
18
Theme: Managing Obsolescence
Round 1 - What is it about this
question that brings you here?
People and devices wear out and
questions arise as to how we maintain
the benefits without deterioration of
function, safety and possibility for
improvement (technology and upgrade)
Round 2 - What would you like to
add to this conversation? What is
missing?
Recognition of potential “self” and
identity issues
Duty of care to accommodate
redundancy and inform, engage antiredundancy measures
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Research funding should allow people
to research in a more realistic way (not
just allocated a certain amount of
time). The TGA should work more
closely with AHEC and NHMRC to
sanction targeted funding towards
research that minimizes risk and
maximises benefit (pictorial)4
When to upgrade? Invasiveness; cost;
(Size); Risk/benefit
Engineer/design/plan(& cost) for
obsolescence – end of functional life.
Design for minimum invasive upgrades
Nano-devices – Injectable;
Retrievability: What happens when the
“device” has done its job?
Desire vs need:


Upgradability (surgical).
Detract from access to new
technology;
Wearable: issues of equality
4
19
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?

Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
and enablement;
Accessibility to better
alternatives as they arise
(perhaps not bionic)
When does an “upgrade” become a
new “device”? (New trials?)
Theme: How do we manage scope creep
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?
Commercial Misinformation
Safeguards
Yes, new agency to regulate company
duty of care for ‘edevices’
(Ombudsman)
Should Government make private
companies take more responsibility?
Patient access to information
Should devices be made ‘upgradable’
(Yes-controlled by competition)
They [patients/device recipients]
should have the option to own their
own data (and onsell). Are they
educated enough to know what it
means?
Do patients want their own data?
(Health status etc)
What data is collected by devices and
who has access to this information?
Better definition of ‘data capture’ and
what constitutes information
Should be legislated by law – patient
centred decisions on what happens
with data
Will the patient own their own data?
How do we control malicious intent
(RFID zapping etc)?
Patient controlled/informed use of
‘edata’ (Control of scope creep)
Hospitals/health providers should
provide: E-counsellors
What happens when a company goes
broke? What if the data is on-sold?
20
Round 1 - What is it about this
question that brings you here?
Round 2 - What would you like to
add to this conversation? What is
missing?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Is there some control over private
companies and what sort of information
they can collect/sell?
All data/information derived from a
patient should only be used to improve
the device
Patients should be able to buy a device
plan (like a mobile phone plan) rather
than one device
When a company goes broke, who is
responsible for device failure?
New independent body to regulate
emerging and converging
nanotechnology
Regulation needs to be in step with
innovation
Should the government make private
companies take more responsibility?
Clearly distinguish between
health/non-health use of
data/information (No non-related
research)
Companies should have “data
protection” policies (like Google’s “hire
a hacker”)
Do we need a body that interfaces
between companies and the
government?
Upgrades optional
21
Theme: Trial participation and informed Consent
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Round 3 – What did we learn? What
do you think should happen next,
and by whom? What will we suggest
to ACES, NHMRC & TGA? What
other questions might we need to
explore?
Suggested actions
Further questions
Trials of devices need to be considered
alongside of and with trials in surgery
All trial data and case reports should
be submitted to a national and
international repository
How do we ensure clinical trial
researchers disclose their findings in a
reasonable timeframe?
“Framing” can shape patient choices
Risk and benefit calculus is different
where there is no existing treatment
Trials of enhancements as well as
therapies should be regulated
Is the ethics of international device
trials different to that of international
drug trials?
(Therapy vs enhancement: different
risk-benefit calculus)
Question arises with both trials and
usage
Mechanisms to declare conflicts of
interest should strengthened and
enforced
How much lower is the level of
acceptable risk in trials of
enhancements rather than therapy?
Questions of ethics in international
trials
The more novel the choice the harder
to establish informed consent
(What risks should we participants to
take)
We need a better understanding of
existing regulatory mechanisms
I’m interested in fairness and justice
We must consider conflicts of interest
Round 1 - What is it about this
question that brings you here?
It’s a difficult and open question
It needs to be answered before trials
commence
Round 2 - What would you like to
add to this conversation? What is
missing?
I want to minimise harm in trials
Because people are vulnerable
Take account of vulnerability but also
likelihood of use: prisoners?; pregnant
women?; Children
Arrangements for funding trials
22
Appendix G Summary of host reports
Current status of regulation and approval (Host: Elaine Attwood)
Started with a question: How do nano-devices deliver drugs and what are some of the
limitations? Discovered issues related to long term capacities of implanted devices, such as
recharging, upgrading etc). Raised further questions about the status of nano-battery
research, and see that the energy side of nanomedicine is really important. In response to
questions, found out that currently there are no nano-devices registered with TGA, but some
components are. Raised a further question: Do we need a register of nano-devices? At the
international level they looking at this issue. Suggested the following actions: specify when
nano-metrics are being used and the importance of clinical trials of nano-enabled devices
(cochlear and epilepsy).
Also asked what’s needed from a consent perspective? Decided that we need accurate
patient information in order to ensure informed consent. This should include information
about efficacy (acceptable risks and benefits, side effects, physical changes in device), as
there is the likelihood that accuracy leads to acceptance. Noted, recipients are a valuable
resource for researchers – they provide independent and accurate advice about they’re
feeling.
Resulted in the suggested action that regulation needs to be in step with innovation – if one
gets ahead of the other it can be frustrating for those who develop devices (e.g.
obsolescence of device by time it gets out), as well as to the community (recipients and
carers).
Regulatory process – future/ongoing (Host: Ryan Sullivan)
Asked: How do we know we have enough evidence to move from animal research to
patients then to the general population. Also asked: At what point does a procedure stop
being treatment and start being enhancement? For example, someone has lost both legs,
now walk, with prosthetics, but what about someone who is ‘functional’ who wants to run
faster? Where’s the baseline for rebuilding patients and what about funding or
reimbursement?
With respect to clinical trials, asked: At what point does the risk outweigh the reward? Heart
transplant? When a new procedure doesn’t have a placebo effect. If we decide that In
response only if there is a certain severity they should have a procedure (that way risks
worth it) should we have legislation informing recipients of the degree to ensure informed
consent. But what if someone understands the risks and still gets a benefit?Also discussed
funding and motivational career research, and privately funded and publicly funded research.
Asked: With devices (e.g. cochlear) where there is no animal model that is clinically relevant,
how should they be regulated? Suggested action: Have certain key institutes work together
to look at these concepts and proposals and work outwards from these. As when a surgeon
changes a protocol, which then becomes a new standard, we could do the same with
developing protocols for devices (moving out).
Transparency and Engagement (Host: Wendy Russell)
Discussion around these questions was focused on community engagement with new
technologies, with a concern for transparency and informed consent. The
importance and difficulty of finding trusted sources of information was raised– a lot of experts
are people with interests in the technology and finding a disinterested source of balanced
information is difficult in this context. The importance of intermediaries to communicate
information to public e.g. media, professional communicators, was noted.
23
Posed the suggestion that there is a need for an independent body that assesses new
technologies looking at range of perspectives, and with no interest in the technologies. It’s
important to move beyond merely informing the public, and to have discussions about
emerging technologies, including how we’re moving into the future and some of the social
goals of these technologies. Recognised that the wider community has a right of say in these
new technologies
Decided that engagement processes that include a range of stakeholders have a potential to
lead to more acceptable outcomes and technologies, as well as lead to more efficient
processes of development and regulation
Raised the following questions for further exploration: How do scientists/media communicate
new technologies? How can we avoid unrealistic technologies?; How can we open up
conversations about new technologies beyond just safety, to talk about the technologies
more broadly?
Managing Obsolescence (Host: Rob Kapsa)
Started with 2 questions: How should we manage obsolescence? What about the longevity
of devices? From these distilled two questions: What are the implications of devices?, and:
What are the impacts for the people they are being used in? We noted that people and
devices are not too dissimilar – they both wear out. Raised questions when get an implant –
doctor says 50% chance of getting 100% etc. you might die. Implanted never thinks they’ll
die.
In the 2nd round – have an implant got benefit but don’t want benefit to change, the low
percentage where the hermetic seal deteriorates. You want you have to be as good as
coming out or to be able to be changed with minimal loss of function etc. and not ate away
access to different technologies that might to it better
In the 3rd round – recognized the potential of issues to self and identity from devices. For
example, how might a 3 yr. old how progress through school and maintain their sense of
self? Might they be the subject of bullying? Or might they be seen as special because they
have cool technology? Asked: Who has the duty of care to accommodate the understanding
of redundancy? And what about issues related to informed consent and obsolescence? For
example, might change an implanted device after 12 years, there’s cost issues; what if the
implanted device doesn’t work any better? and risks of surgery. Who has the duty of care to
inform and engage people, to try to understand what decision they are making?
Further Questions: When do you upgrade a device? Should be based on invasiveness, cost,
risk/benefit. Suggesed action: NHMRC needs to allow people to research in a more realistic
way – not based on a certain amount of time. TGA should interact more with the
Government and the NHMRC to sanction more targeted funding towards research that
minimises risk and maximises benefit, and enables user support directly out of government
assistance.
How do we manage scope creep? (Host: Anita Quigley)
Raised issues about devices and data collection. For example, data is collected (e.g. pace
maker measuring blood pressure), who has access to that and will it be used for something
else in the future?
The following questions relating to privacy were raised. Should we make private companies
take more responsibility for data collection and use? Yes, but how should this be done?
Through the TGA? Should there be an organization, or ombudsman, that is responsible for
the information of devices and can regulate private companies? In addition, who owns the
data? Companies? Individuals? Patients should have more of a say about what happens to
their data and should be informed about what data is collected and what it could mean.
24
It was raised that patients may not understand the data and what is being collected. Is there
a role for education? It was suggested that "ecounsellors" could be employed by health care
providers or companies.
Further concerns about data protection included: What happens to a patients data if a
company goes broke? Can it be bought and used by another company and used for a
different purpose? It was noted that Google hires and challenges hackers – a similar
strategy could provide small companies with the ability to better protect data.
Should patients have the option to buy a device plan, like a mobile plan?
Trial particpation and informed consent (Host: Rob Sparrow)
Noted that these questions are at the ground of clinical trials – until they are resolved, it is
unlikely that trial protocols are ethical or good. With respect to informed consent – found the
question easier to relate to devices, than the question of trial participants.
Felt that the distinction between therapy and enhancement plays a key role, that the levels of
acceptable risk might be different with enhancements rather than therapies (acceptable risk
might be higher with enhanacements). Concerns about conflict of interest were expressed
and the importance that participants are informed about the commercial interests of people
conducting trials was noted. Also discussed data collection, through both trials and usage in order to allow people to have the best sense of both the risks and benefits, it is important
to collect as mcuh data about the technology as possible.
Suggested actions: That there be a national and international repository of data relating to
trials, which is responsible for collecting all data relating to trials – the good and bad results;
that regulation should extend to enhancements and not just therapies. (existing regulatory
regimes concentrate on therapeutic devices, but there may be eventual uses for
nantechonology that aren’t therapeutic and may escape regulation); and strengthen control
over conflict of interest.
Further questions: How an acceptable level of risk may differ in cases of enhancement and
therapy?; How to get researchers to disclose findings in a reasonable time frame? How do
you balance concerns about allowing commercial interests in development of new
technology with the need to ensure transparency by collecting all the data?; and, given
controversy aurrounding some international clinical drug trials in the devloping world, would
trials of devices be any different? (A different ethics for devices? Will devices come out at
the end of the trial?)
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Appendix H Invitation and Advertising
Invitation & Registration
http://nanobionicdevicesandclinicaltrials.eventbrite.com.au/
26
Newspaper
‘Implant Offers Epilepsy Hope’, Illawarra Mercury, Thursday 20th September, 2012, p.11.
27
Radio
Interview with Gordon Wallace, Centre of Excellence for Electromaterials Science, University
of Wollongong, and Susan Dodds, Professor of Philosophy, University of Tasmania, on ABC
Illawarra Mornings program, with Nick Rheinberger, 17th September 2012, 10am. The
interview discussed Gordon and Sue’s roles at ACES, the reason for hosting a public
engagement on nanomedicine, medical bionics and clinical trials, and the objectives of the
public engagement event. They invited interested members of the community to attend.
28