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?