Nuffield
Council of
Bioethics
Responds to
the
Announcement
of UK
COVID-19
Human
Challenge
Trials
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Wednesday: November 11: 2020 || ά.
On
October 20 the UK Government announced that it would work
with partners to develop a COVID-19 human challenge study
model. This will include the manufacture of the challenge
virus and will be the first in-human characterisation study
for COVID-19. In human challenge studies, participants are
deliberately infected with the virus in question in order to
gain knowledge in controlled circumstances about how the
virus behaves or, in order to see, if, an investigational
vaccine provides protection.
In
response to this
Nuffield Council
of Bioethics has
said the
following: Given
the scale of the
global
challenges, that
COVID-19 poses,
challenge trials
could,
potentially,
play a useful
role alongside
the many other
studies,
currently taking
place. However,
they come with
their own unique
set of ethical
considerations
and risks, that
must be
addressed by all
those, involved
in the study, a
properly
constituted
ethics
committee,
researchers and
funders.
The World Health
Organisation:WHO
has published
guidance on the
issues, that
such a committee
should consider
and, also,
recommended that
any proposed
COVID challenge
study should be
reviewed by a
specialist
ethics committee
with the
necessary
scientific and
ethical
expertise. We
understand that
the Health
Research
Authority has
established such
a specialist
ethics committee
in order to be
prepared for any
applications to
run a challenge
trial in the UK
and we warmly
welcome the
establishment of
this committee.
Today’s
announcement
highlights an
early stage of
the human
challenge trial
process and will
require ethical
approval before
it goes ahead.
Those, involved
in the
developing the
study model and
in any specific
research
proposal, must,
now, consider
the following:
::: Scientific
justification:
is a challenge
study the most
appropriate
approach? Can
the same benefit
be gained for
lower risk in a
different kind
of study?
::: Engagement
with the wider
public.
Researchers and
funders must
consult and
engage with the
wider public
from the
beginning. They
must make sure
that public
concerns are
properly
understood and
addressed and
that anxieties
based on
misconceptions
can be avoided.
::: Assessment
of risks and
benefits:
potential
benefits must
outweigh risks,
taking into
account the
interests of
three groups:
participants,
society in
general and
third-party
contacts of
participants.
Researchers and
funders must
consider what
actions must be
taken to
minimise risks,
such as, finding
an appropriate
dose of the
challenge virus
and mitigate
those risks,
that remain, for
example, by
determining
which volunteers
are highly
unlikely to
develop serious
disease, how
volunteers will
be monitored and
ensuring that
they have access
to the best
possible care.
::: Informed
consent: There
are significant
challenges in
ensuring
volunteers
thoroughly
understand the
risks and the
uncertainty of
any benefit.
Volunteers will,
also, be
committing to
stay within a
bio-secure
facility until
they are no
longer
infectious.
The Council
hopes that this
process will
involve a wide
range of voices
in considering
how this might
go forward.
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