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EXPERT CONFERENCE ON
THE REVISION OF
DECLARATION OF HELSINKI
IMPERIAL HOTEL, TOKYO
TOKYO, JAPAN
FEBRUARY 28, 2013 – MARCH 1, 2013
DECLARATION OF HELSINKI
RESOURCE POOR SETTING
&
“POST STUDY ARRANGEMENT”
BY
JOSE ASA SABILI, M.D.
PAST PRESIDENT, PHILIPPINE MEDICAL ASSOCIATION
CHAIRMAN, PMA COMMITTEE ON INTERNATIONAL AFFAIRS
I
would
like
to
thank
the
WMA
Organizing
Commi8ee
for
allowing
me
this
opportunity
to
share
my
insights
on
the
need
to
revise
the
Declara@on
of
Helsinki.
The
advancement
of
technology
in
the
prac@ce
of
medicine
has
already
provided
cure
to
some
diseases.
This
advancement
of
technology,
however,
has
equally
unlocked
the
vault
of
problems
that
pose
challenges
for
medical
prac@@oners.
These
challenges
take
the
form
of
serious
ethical
issues
which
are
now
brought
into
the
open
by
several
sectors
of
the
community.
It
used
to
be
that
the
innova@ve
medicines
are
first
tested
on
animals
before
they
are
tested
on
humans.
Now,
it’s
the
other
way
around
because
it
is
the
stem
cells
of
animals
that
are
now
tested
on
humans.
This
is
the
era
of
stem
cell
therapy.
Gene@c
engineering
was
first
applied
with
the
inten@on
of
improving
yield
for
plants,
but
now
gene@c
manipula@on
is
equally
applied
to
humans.
Introduc@on
What
are
the
risks
in
these
so
called
medical
advancement
that
were
not
exis@ng
before
and
more
importantly
what
are
the
new
breakthrough
of
hope
of
cure
that
these
new
trends
in
the
treatment
of
disease
can
really
offer?
In
my
country
alone
there
is
right
and
leN
employment
of
the
use
of
stem
cell
procedures.
Even
those
in
the
non-‐
medical
field
are
involved
in
the
treatment
with
use
of
stem
cells.
Even
some
doctors,
sad
to
say,
are
themselves
injec@ng
stem
cells
into
their
veins
in
the
hope
of
achieving
eternal
youth!
Are
we
to
ignore
the
fic@on
movie
en@tled
“X-‐MEN”.
But
of
course
the
world
will
be
lucky
if
the
result
of
the
medical
advancement
are
the
Avengers!
We
must
remember
that
the
fic@on
of
yesterday
has
become
the
reali@es
of
today.
Are
these
new
trends
or
situa@on
covered
by
the
Declara@on
of
Helsinki?
Thus,
I
join
the
WMA
in
its
serious
inten@on
to
revise
the
Declara@on
of
Helsinki
and
make
it
more
responsive
to
the
latest
developments
in
the
prac@ce
of
medicine.
There
must
be
a
re-‐defining
of
what
is
safe
prac@ce
of
medicine
in
the
light
of
all
these
new
medical
development.
More
importantly,
the
right
of
the
pa@ent
must
be
reinforced
with
these
so
called
new
scien@fic
breakthrough.
Medical
prac@@oner
must
be
involved
with
fresh
ethical
principles
in
their
effort
to
cure
the
illnesses
of
their
pa@ents.
Let
me
walk
you
through
a
short
history
of
the
Revision
of
Declara@on
of
Helsinki
and
its
perspec@ve.
WMA DECLARATION OF HELSINKI
v
History
v
Relevance
v
Future
DECLARATION OF HELSINKI
(Past, Present & Future)
The
Declara@on
of
Helsinki
was
adopted
year
1964
on
the
18th
WMA
General
Assembly
in
Helsinki,
Finland
and
underwent
several
revisions.
It
is
the
supreme
declara@on
pertaining
to
interna@onal
ethical
standard
in
human
medical
research.
History
would
reveal
that
aNer
its
first
major
revision
done
in
Tokyo
in
1975
and
series
of
revision
done
in
Italy,
Hong
Kong,
South
Africa,
Edinburgh
and
Seoul,
South
Korea.
We
are
now
in
the
process
of
doing
the
8TH
Revision
of
the
Declara@on.
WMA DECLARATION OF HELSINKI
Adopted
by
the
18th
WMA
General
assembly;
Helsinki,
Finland;
June,
1964
and
amended
by
the:
29th
WMA
General
Assembly
Tokyo,
Japan;
Oct.,
1975
35th
WMA
General
Assembly;
Venice,
Italy;
Oct.,
1983
41st
WMA
General
Assembly;
Hong
Kong;
Sept.,
1989
48th
WMA
General
Assembly;
South
Africa;
Oct.,
1996
52nd
WMA
General
Assembly;
Edinburgh,
Scotland;
Oct.
2000
53rd
WMA
General
Assembly;
Washington
2002
55th
WMA
General
Assembly;
Tokyo
2004
59th
WMA
General
Assembly;
Seoul,
South
Korea;
Oct.
2008
DECLARATION OF HELSINKI
ISSUES
v
Resource
Poor
Selng
v
Post
Study
Arrangement
v
Informed
Consent
v
Use
of
Placebo
DECLARATION OF HELSINKI
(Resource Poor Setting)
ARTICLE
9
“Medical
Research
is
subject
to
ethical
standards
that
promote
respect
for
all
human
subjects
and
protect
their
health
and
rights.
Some
research
popula@ons
are
par@cularly
vulnerable
and
needs
special
protec@on.
These
include
those
who
cannot
give
or
refuse
consent
for
themselves
and
those
who
may
be
vulnerable
to
coercion
or
undue
influence.“
In
a
resource
poor
selng,
extra
cau@on
must
be
taken
in
the
selec@on
of
human
subjects,
making
sure
that
the
subjects
do
not
give
their
consent
because
of
economic
duress.
DECLARATION OF HELSINKI
(Resource Poor Setting)
ARTICLE
13
“Appropriate
cau@on
must
be
exercised
in
the
conduct
of
medical
research
that
may
harm
the
environment.”
In
a
resource
poor
selng,
a
research
finding
organiza@on
must
also
provide
appropriate
funding
for
the
disposal
of
the
research
drugs
or
materials.
DECLARATION OF HELSINKI
(Resource Poor Setting)
ARTICLE
15
The
research
protocol
must
be
submi8ed
for
considera@on,
comment,
guidance
and
approval
to
a
research
ethics
commi8ee
before
the
study
begins.
This
commi8ee
must
be
………
In
a
resource
poor
selng,
wherein
there
is
no
research,
ethics
commi8ee
in
the
physician’s
ins@tu@on,
the
physician
must
seek
approval
from
other
ins@tu@on
where
there
are
research
ethics
commi8ee,
whether
private
or
government.
DECLARATION OF HELSINKI
(POST STUDY ARRANGEMENT)
v
Pa@ent
access
to
best
proven
prophylac@c,
diagnos@c
and
therapeu@c
method
iden@fied
by
the
study?
v
What
happens
to
pa@ent
once
study
is
over?
v
Who
owes
to
whom
and
why?
v
Pa@ent
compensa@on
for
research
related
injury?
v
Pa@ent
access
to
result
of
research
subject?
v
Which
way
the
result
of
clinical
treatment,
shall
be
reported?
(Internet,
Private
or
Public
Publica@on
and
Interna@onal
Society
or
PROCTOR)
v
How
they
must
be
used
for
developing
clinical
standard
for
medical
care?
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH COMBINED WITH MEDICAL CARE
“36
No
mode
of
treatment
that
has
no
proven
safety
and
efficacy,
or
when
it
is
publicly
known
to
be
of
no
benefit
or
doubrul
benefit,
shall
be
employed
and
where
the
adverse
results
of
the
intended
mode
of
treatment
are
irreversible
and
unpredictable.”
(Dr.
Jose
Asa
Sabili),
Philippine
Medical
Associa@on
Declara@on
of
Helsinki
2013,
Tokyo,
Japan
At
this
point,
let
me
quote
from
a
dear
friend
Dr.
Bu
Castro,
a
doctor
lawyer
President
of
the
Philippine
Hospital
Associa@on
and
Past
President
of
the
Philippine
Medical
Associa@on
when
he
says,
“ In medical research, we treat not the
present but the future…
but we must likewise protect the future
by protecting the present.”
THANK YOU SO MUCH,
I LOVE YOU ALL!!!