ethics of innovation in a crisis ideal presentation final · title: ethics of innovation in a...
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Ethics of surgical and device innovation during a crisisPresenter: D
r Katrina Hutchison (M
acquarie University)
katrina.hutchison@m
q.edu.auTw
itter: @katrina_hutch
This presentation includes new research undertaken w
ith Dr Jane Johnson, Professor W
endy R
ogers, A/Prof Bernadette Richards, D
r Robyn C
lay-William
s, Professor Guy M
addern, Dr
Quinn G
rundy and Dr Brette
Blakely, for Australian Research C
ouncil Discovery Project
DP200100883 “Support or Sales? M
edical device representatives in Australian hospitals”. It also builds on past research w
ith Professor Wendy R
ogers and Mr Angus M
cNair (2019).
Background: three theoretical
approaches to ethicsPrinciple-based
ethics•
Focus on right action, guided by (universal) rules or principles•
A widely accepted approach in bioethics
•Four principles: A
utonomy, Justice, B
eneficenceand N
on-M
aleficence(Beaucham
p & Childress, 2001)
Consequentialist approaches
•Focus on outcom
es–
maxim
izing good consequences•
Relevant to public health
(maxim
ising justice, efficiency)•
Consequentialist calculations can be involved in applying principles
(e.g. minim
ising harm)
Virtue ethics•
Focus on character–w
hat traits do ethical people have?•
Virtues might include hum
ility, honesty, trustworthiness, com
passion, em
pathy, courage, self-reflexivity
Principle-based framew
ork for analysing ethical issues in surgical innovation
Ethical IssueM
edical Ethics Principles
Description
Minim
ising harmPrinciple of non-m
aleficence; Principle of beneficence
•M
inimise harm
to patients•
In pre-IDEAL studies, harm to anim
als may be relevant.
•M
inimise risk of harm
to clinicians, e.g. reputational and psychological
Autonomy and consent
Principle of autonom
y•
Rigorous patient consent processes•
Explain theinnovative nature of the procedure
•Transparency about lim
its of existing knowledge
Justice issuesPrinciple of justice
•Ensure fair distribution of risks and benefits
•Avoid targeting vulnerable patient groups
•M
aximise access to successful innovations
Conflicts of interestPrinciple of beneficence; Principle of justice
•Clinical decisions should reflect clinical considerations
•Financial and other incentives can risk harm
to patients•
Fair access can be stymied by profit m
otive
Adapted from: Johnson &
Rogers (2012) and Rogers, Hutchison, & M
cNair (2019).
Applying the ethics fram
ework and guidelines in a crisis
How
might these highlighted ethical recom
mendations (from
Rogers, H
utchison & M
cNair 2019) apply across the ID
EAL stages in a crisis?
#1 Bifurcation of ethical considerations, depending on whether it
is a crisis-relatedversus a business-as-usual innovation
#2 Transitioning out of crisis contexts and into a “new norm
al” raises unique ethical challenges
#3 Staged approaches –like ID
EAL –have natural advantages in
dealing with these unique ethical challenges
Three take-home m
essages:
What about during a crisis?
Paradigm cases / exam
ples for highlightingethical considerations w
ill be different during a crisis…
… and relevant exam
ples depend on the nature of the crisis
Case studies for “norm
al” times from
R
ogers, Hutchison & M
cNair (2019:230)
Note also, bifurcation and different ethical considerations
Innovations unrelatedto
the crisisInnovations focused on the crisis*
*E.g. CO
VID-19: test kits, PPE, ventilators, lung transplants
Applying the ethical fram
ework in a crisis
Minim
ising harm
“Prioritize patient welfare over know
ledge generation and avoid “heroic” individual cure attem
pts”
•Ethical assessm
ents of patient welfare m
ay be different in a crisis•
How
urgently is new know
ledge needed? What are the potential opportunity costs?
•Exam
ple: ethical analysis of CO
VID-19 test kits in early 2020 m
ight accept a different threshold for how
accurate is accurate enough to minim
ise harm than w
ould normally apply for diagnostic tests.
•In contrast, continuing ‘business-as-usual’ research or innovation m
ay give rise to unacceptable risks of harm
–e.g. health system
overload and infection considerations during pandemic
“Obtain relevant ethics approvals / oversight”
•Expedited ethics review
and oversight processes (or exemptions) m
ight apply in a crisis,•
… but com
pliance with ethics policy should never be a substitute for ethical analysis.
“Use supported training to m
inimize learning curve harm
s”•
How
do ethical considerations related to learning curves change in a crisis?•
What is regarded as an acceptable level of training? W
ho provides it and how?
•Exam
ple: impact of C
OVID
-19 changes to hospital access on training and support provided by m
anufacturer employees
Applying the ethical fram
ework in a crisis
Autonomy and consent
“Develop com
prehensive consent mechanism
s with disclosure of
experience with innovation, any know
n risks and likelihood of unknown
risks”•
How
might consent processes be affected by a crisis?
•Availability of inform
ation•
Availability of personnel•
Availability of time
“Resolve issues of consent for longitudinal data use and including for
nested RC
Ts”•
How
might crisis factors affect dow
nstream data use?
•N
ote possible impacts on crisis-related longitudinal data, and business-as-usual data
(e.g. will the
crisis disrupt collection/consent for registries etc?)
Applying the ethical fram
ework in a crisis
Justice issues“R
ecruit diverse patients to ensure justice across different subgroups and m
aximise utility of results”
And
“Address access and equity issues caused by factors such as financial and geographic barriers”•
What is the im
pact of the crisis on recruitment processes and fairness?
•O
n equitable access to innovations?•
Does the crisis itself disproportionately im
pact some groups?
“Report all results/outcom
es in accessible ways to inform
future research and practice”•
Example: C
OVID
-19 research –benefits
to transparency and information sharing m
ight need to be w
eighted against decreasein quality.
Applying the ethical fram
ework in a crisis
Conflicts of interest
“Identify and manage conflict of interest”
•R
isk that exemptions and expedited approvals processes w
ill be exploited by unethical players
•Especially in grey area betw
een crisis-relatedand business-as-usual
innovations
The ethics of transitioning to a ‘new norm
al’
•So far, I have concentrated on ethical issues during the crisis period.
•H
owever, from
an ethical perspective the challenges associated with
transitioning out of a crisis are just as significant… if not m
ore significant.
•All sort of things that m
atter, ethically speaking will be differentduring a
crisis. •
Weighing of individual patient w
elfare vs need for knowledge
•Form
al ethics oversight processes and regulatory approval processes•
Training in new techniques and m
anagement of learning curves
•Inform
ed consent expectations and processes•
Research m
ethodology, including recruitment of participants
•Publication and peer review
of evidence
•Any ID
EAL framew
ork for evaluating innovations in crisis contexts must offer
guidance, including ethical guidance, for transitioning out of the crisis.
The need for a staged framew
ork
•C
risis contexts are temporary
•Indeed, it is appropriate to think of them
as having stages. The nature and duration of these stages depend on the sort of crisis
•W
hen it comes to evaluating innovations during a crisis, there are ethical issues
associated with transitioning
between these different stages
•Including •
The transition into a crisis context, which changes the ethical considerations
pertaining to evaluation of “business-as-usual” innovations•
And the transition to a ‘new
normal’
•W
hen it is ethically critical to ensure that exemptions, expedited processes, and
crisis-time ethical w
eightings do not continue to apply to post-crisis use of innovative procedures and devices.
•The ID
EAL framew
ork already recognises stages of surgical innovation•
Any process for evaluating innovations during a crisis needs to recognise the stages of a crisis, too
•And recognise that ethical issues arise at each stage, but also w
hen transitioning betw
een stages
References
1.Johnson J, R
ogers W. (2012). Innovative surgery: the ethical
challenges. Journal of Medical E
thics, 38(1), 9-122.
Rogers W
, Hutchison K, M
cNair A. (2019). Ethical issues across
the IDEAL stages of surgical innovation. A
nnals of surgery, 269(2), 229-233.
3.Blakely B, R
ogers W, Johnson J, H
utchison K, Grundy Q
, Clay-
William
s R, R
ichards B, Maddern
G (2020 -m
anuscript) Ethical and regulatory im
plications of the CO
VID-19 pandem
ic for the m
edical devices industry and its representatives. Work-in-
progress manuscript.
Thank you.Q
uestions and discussion?