Dhai-DoH-Helsinki-20141111
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Implementa)on
of
the
DoH:
Perspec)ves
from
the
Developing
World
Professor
A
Dhai
Immediate
Past-‐President
SAMA
Director:
Steve
Biko
Centre
for
Bioethics
Faculty
of
Health
Sciences
University
of
the
Witwatersrand
Johannesburg
CelebraFng
50
years
of
the
DoH:
Helsinki,
Finland.
November
2014
South
African
Unit
of
the
UNESCO
Interna)onal
Network
in
Bioethics
“
The
Declara+on,
through
the
past
50
years,
has
not
only
maintained
its
posi+on
as
the
most
widely
accepted
guidance
on
health
research
involving
human
subjects,
but
has
also
notably
influenced
interna+onal
and
na+onal
laws
and
regula+ons
on
biomedical
research.
Many
countries
in
Africa
have
developed
ethical
and
legal
instruments
for
health
research
with
the
spirit
and
principles
of
the
Declara+on
shaping
both
their
founda+on
and
core.
….
The
Declara+on
of
Helsinki
…
creates
a
sensi+ve
balance
in
which
progress
in
science
and
health
research
is
reconciled
with
protec+ng
the
rights
and
digni+es
of
the
vulnerable
that
par+cipate
in
research.”
Context
Vast
Dispari)es
• Recurring
refrain
throughout
DoH
(similar
to
Bill
of
Rights
of
SA
Cons)tu)on)
• General
principles
–
textual
bedrock
of
na)onal
ethico-‐
regulatory
instruments
in
SA:
– Na)onal
Health
Act
– Ethics
in
Health
Research:
Principles,
Structures
and
Processes
(Department
of
Health)
– General
Ethical
Guidelines
for
Health
Researchers
(HPCSA
–
basic
standard
to
adjudicate
complaints)
– Quasi-‐legal
status
of
guidelines
Protec)ons
of
Rights
and
Digni)es
• 15.
Appropriate
compensa)on
and
treatment
for
subjects
who
are
harmed
as
a
result
of
par)cipa)ng
in
research
must
be
ensured.
• 19,
20.
Vulnerable
Groups
and
Individuals
• 23.
Research
Ethics
CommiYees
• 32.
Research
using
iden)fiable
human
materials
and
data
such
as
in
biobanks
or
similar
repositories
• 37.
Unproven
Interven)ons
in
Clinical
Prac)ce
Specific
Aspects
of
DoH
2013
A
typical
statement
from
an
informed
consent
document
for
an
NIH-‐
sponsored
clinical
trial:
“If
you
are
injured
as
a
result
of
being
in
this
study,
you
will
be
given
immediate
treatment
for
your
injuries.
The
cost
of
this
treatment
will
be
provided
by
the
Department
of
Health
in
a
referral
hospital
or
your
insurance
company.
There
is
no
program
for
compensa+on
either
through
this
ins+tu+on
or
the
Na+onal
Ins+tutes
of
Health.
The
inves+gators
will
provide
you
with
reasonable
medical
care
as
is
available
at
the
.
.
.
hospital”.
Cleaton-‐Jones
PC.
Research
injury
in
clinical
trials
in
South
Africa.
The
Lancet.
2006;
367
(9509):
447
–
540.
15.
Appropriate
compensa)on
and
treatment
for
subjects
who
are
harmed
as
a
result
of
par)cipa)ng
in
research
must
be
ensured.
• 19.
Some
groups
and
individuals
are
par)cularly
vulnerable
and
may
have
an
increased
likelihood
of
being
wronged
or
of
incurring
addi)onal
harm.
All
vulnerable
groups
and
individuals
should
receive
specifically
considered
protec)on.
19,
20.
Vulnerable
Groups
and
Individuals
19.
Some
groups
and
individuals
are
par)cularly
vulnerable
and
may
have
an
increased
likelihood
of
being
wronged
or
of
incurring
addi)onal
harm.
All
vulnerable
groups
and
individuals
should
receive
specifically
considered
protec)on.
19,
20.
Vulnerable
Groups
and
Individuals
Vulnerable
groups
Dependent
RelaFonships
• Minors
• Adolescents
• Women
• Pregnant
women
• Fetuses
• Those
requiring
emergency
care
• Prisoners
• Vulnerable
communiFes
• Persons
highly
dependent
on
medical
care
• PaFents
in
intensive
care
units
• Neonates
• Those
at
the
end
of
life
requiring
terminal
care
• Those
with
impaired
capacity
to
communicate
• The
unconscious
person
• Other
special
groups.
• Older
persons
and
their
caregivers
• Persons
with
chronic
condi)ons
or
disabili)es
and
their
caregivers
• Wards
of
State
and
guardians
• Pa)ents
and
health-‐care
professionals
• Students
and
teachers
• Prisoners
and
prison
authori)es
• Persons
with
life-‐threatening
illness
• Employees
and
employers,
including
farm
workers
and
their
employers,
and
members
of
uniformed
services
and
hospital
laboratory
staff
and
their
employers.
SA
-‐
HEALTH
RESEARCH:
PRINCIPLES,
STRUCTURES
AND
PROCESSES
Vulnerable
groups
InternaFonal
NaFonal
A
B
C
D
E
F
PaFents
X
x
X
X
PaFents
with
incurable
diseases
x
Those
with
serious
life-‐threatening
diseases
x
X
X
Those
at
the
end
of
life
requiring
terminal
care
X
X
The
unconscious/comatose
X
X
Those
requiring
emergency
care
x
X
Persons
with
chronic
condiFons
or
disabiliFes
X
Persons
highly
dependent
on
medical
care
X
PaFents
in
intensive
care
units
X
Challenges
with
informed
consent
X
x
X
ConsenFng
under
duress
X
Coercion
or
undue
influence
X
x
Elderly
persons
with
limited
capacity
to
consent
x
X
Those
with
impaired
capacity
to
communicate
X
X
Mentally
disabled
persons
X
x
Children
X
X
X
Wards
of
State
X
Neonates
x
X
Women
X
Pregnant
women
X
X
Fetuses
x
X
Groups
with
hierarchical
structuring
x
Juniors
/
subordinates
x
Students
x
X
Employees
X
Persons
in
dependant
relaFonships
X
X
Persons
confined
to
insFtuFons
X
Residents
of
nursing
homes
x
Prisoners
x
X
x
X
Those
on
welfare/social
assistance
x
X
Those
that
are
unemployed
x
Unfamiliar
with
modern
medical
concepts
x
Those
at
risk
of
harm:
physical,
legal,
social,
economic
x
X
Ethnic
/
Racial
minority
groups
x
X
Homeless
persons
x
Refugees/displaced
persons
x
Nomads
x
Disadvantaged
rural
black
men
X
Racial
and
ethnic
minoriFes
x
PoliFcally
powerless
x
Economically
disadvantaged
persons
X
X
EducaFonally
disadvantaged
persons
X
Vulnerable
communiFes
X
Other
x
X
• “This
commiYee
must
be
transparent
in
its
func)oning
…
and
must
be
duly
qualified.”
• “Aher
the
end
of
the
study,
the
researchers
must
submit
a
final
report
to
the
commiYee
containing
a
summary
of
the
study’s
findings
and
conclusions.”
• Will
enhance
local
guideline
documents
once
incorporated.
• Currently
many
poorly
func)oning
RECs
:
structures
merely
smokescreen
/
rubberstamping
commiYees.
23.
Research
Ethics
CommiYees
Moodley
K,
Myer
L.
Health
Research
Ethics
CommiYees
in
South
Africa
12
years
into
democracy.
BMC
Medical
Ethics
2007;
8(1)
Dhai
A,
Mcquoid-‐Mason
DJ.
What
is
the
func)on
of
Research
Ethics
CommiYees?
SAJBL
2010;
3(1):2-‐3.
• Subs)tuted
consent
and
safeguard
role
of
REC.
32.
Research
using
iden)fiable
human
materials
and
data
such
as
in
biobanks
or
similar
repositories
Sathar
A,
Dhai
A,
Van
De
Linde
S.
Collabora)ve
Interna)onal
Research:
Ethical
and
Regulatory
Issues
Pertaining
to
Human
Biological
Materials
at
a
South
African
Ins)tu)onal
Research
Ethics
CommiYee.
Developing
World
Bioethics
2013.
Sathar
A,
Dhai
A,
Van
De
Linde
S.
Collabora)ve
Interna)onal
Research:
Ethical
and
Regulatory
Issues
Pertaining
to
Human
Biological
Materials
at
a
South
African
Ins)tu)onal
Research
Ethics
CommiYee.
Developing
World
Bioethics
2013.
The
Ebola
Crisis
and
the
DoH
• All
ar)cles
of
DoH
applicable,
in
par)cular:
• 3.
Declara)on
of
Geneva
“The
health
of
my
pa)ent
will
be
my
first
considera)on”.
Interna)onal
Code
of
Medical
Ethics
“A
physician
shall
act
in
the
pa)ent’s
best
interests
when
providing
medical
care”
• 4.
Duty
of
physician
to
promote
and
safeguard
health,
well-‐being
and
rights
of
pa)ents,
including
those
involved
in
medical
research
• 7.
Medical
research
–
subject
to
ethical
standards
that
respect
and
ensure
respect
and
protec)on
of
health
and
rights
• 9.
Duty
of
physicians
involved
in
medical
research
to
protect
life,
health
dignity,
integrity,
right
to
self-‐determina)on,
privacy,
confiden)ality
of
research
subjects
•
12.
Research
to
be
conducted
only
by
individuals
with
appropriate
ethics,
and
scien)fic
educa)on,
training
and
qualifica)ons.
• 19,
20.
Vulnerable
Groups
and
Individuals
• 37.
Unproven
interven)ons
in
clinical
prac)ce.
The
Ebola
Crisis
and
the
DoH
• 37.
“Unproven
Interven+ons
in
Clinical
Prac+ce
In
the
treatment
of
an
individual
pa+ent,
where
proven
interven+ons
do
not
exist
or
other
known
interven+ons
have
been
ineffec+ve,
the
physician,
aQer
seeking
expert
advice,
with
informed
consent
from
the
pa+ent
or
a
legally
authorised
representa+ve,
may
use
an
unproven
interven+on
if
in
the
physician’s
judgement
it
offers
hope
of
saving
life,
re-‐establishing
health
or
allevia+ng
suffering.
This
interven+on
should
subsequently
be
made
the
object
of
research,
designed
to
evaluate
its
safety
and
efficacy.
In
all
cases,
new
informa+on
must
be
recorded
and,
where
appropriate,
made
publicly
available.”
The
Ebola
Crisis
and
the
DoH
• The
EVD
con)nues
to
spiral
and
external
sources
have
now
come
forward
to
assist
the
affected
countries.
However,
for
as
long
as
governments
in
these
countries
do
not
commit
to
strengthen
their
healthcare
systems
and
improve
the
underlying
social
determinants
of
health
aYempts
at
combapng
the
Ebola
crisis
and
other
crises
that
follow
could
end
up
being
ineffec)ve.
The
Ebola
Crisis
and
the
DoH
“The
World
Medical
Associa+on
is
to
be
congratulated
for
the
success
of
this
gem
of
an
ethical
guideline.
Best
wishes
for
another
50
years!”
Thank you