Somkiat_Wattanasirichaigoon
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Professor
Somkiat
Wa/anasirichaigoon,
MD,
FRCST
Chairman,
Medical
Educa?on
Sec?on,
Medical
Associa?on
of
Thailand
Expert
Conference
on
Revision
of
Declara?on
of
Helsinki
Tokyo,
Japan.
On
March
1,
2013
50
years
1964
1975
1983
1
2
1989
3
1996
2000
4
5
2008
2013
6
1964
1975
1983
1996
2000
2008
2013
1989
1
2
3
4
5
6
1947,
Nuremberg
Code
1948,
Declara?on
of
Geneva
1992:
HIV
1982:
Human
subjects
1998:
Human
genome
project
Scien,fic
Research
and
Biomedical
Regula,on
and
Policy
Execu,ve
Branch
Departments
/
Agencies
All
Federal
Government’s
work
Forum
for
Ethical
Review
CommiIee
in
Thailand
(FERCIT)
Established
in
2001
h/p://www.fercit.org
FERCIT
NECAST
Research
manager
Facility
support
CREC
Na,onal
Research
Council
of
Thailand
(NRCT)
CREC
Secretariat
office
IRB
F
E
R
C
A
P
Health
System
Research
Ins,tute
Financial
support
Managerial
support
Accredita?on
Budget
University/Ins,tu,on
Staff
support
Submission
Human
research
Mul?-‐centered
projects
FERCIT
NECAST
Research
manager
Facility
support
CREC
Na,onal
Research
Council
of
Thailand
(NRCT)
CREC
Secretariat
office
IRB
F
E
R
C
A
P
Health
System
Research
Ins,tute
Financial
support
Managerial
support
Accredita?on
Budget
University/Ins,tu,on
Staff
support
Submission
Human
research
Mul?-‐centered
projects
• No
Na?onal
IRB
established
• No
legal
Na?onal
Bioethic
Advisory
Commi/ee
(NBAC)
• There
is
a
well-‐recognized
human
ethics
associa?on,
Forum
for
Ethical
Research
Commi/ee
in
Thailand
(FERCIT)
• FERCIT:
Ethical
prac?ce
guidelines
FERCIT:
The
Ethical
Guidelines
for
Research
on
Human
Subject
in
Thailand,
2007
Thai
version
English
version
adapted
from
the
revised
edi?on
of
the
Na?onal
Guidelines
for
Ethical
Research
on
Human
Subject,
2002
• 24
Ins?tu?onal
Review
Boards
(IRBs):
14
Medical
schools
and
10
Medical
centers.
• Mul?-‐ins?tu?onal
Review
Board
1. Central
Research
Ethics
Commi/ee
(CREC),
sponsored
by
Na?onal
Research
Council
of
Thailand
2. Ministry
of
Public
Health
3. Thai
Medical
Council
(only
stem
cell
research
project)
• “……
including
those
who
in
need
to
depend
on
others,
and
are
unable
to
express
their
opinion
freely
or
to
make
their
own
decisions.
– Hospitalized
paEents,
prisoners,
children,
the
mentally
impaired,
criEcally
ill
paEents,
psychoEc
paEents,
pregnant
woman,
and
the
economically
disadvantaged.”
17
We
provided
space
for
open-‐ended
answers
responsible
to
the
following
ques?ons:
1. Changes
in
some
parts
of
DoH.
2. Post-‐study
arrangements
3. Best
vs
Op?mal
treatments
(To
confirm
Item
No.
1)
2008 Version Proposal Commentary
The benefits, risks, burdens and
effectiveness of a new
intervention must be tested
against those of the best current
proven intervention, except in
the following circumstance
The benefits, risks, burdens and
effectiveness of a new intervention must
be tested against those of the best proven
intervention, except in the following
circumstance
We suggest to remove “current” because
it is difficult to precisely define what it
means (a period of time, and if so what?)
The use of placebo, or no
treatment, is acceptable in
studies where no current proven
intervention exists: or
Where for compelling and
scientifically sound
methodological reasons, the use
of placebo is necessary to
determine the efficacy or safety
of an intervention
and the patients who receive
placebo or no treatment will not
be subjected to any risk of
serious or irreversible harm.
Extreme care must be taken to
avoid abuse of this option.
Where for compelling and scientifically
sound methodological reasons, the use of
any intervention less effective than the
best proven one, placebo or no treatment is
necessary to determine the efficacy or
safety of an intervention and the patients
who receive any intervention less effective
than the best proven one, placebo, or no
treatment, will not be subjected to
additional risks of serious or irreversible
harm.
The use of any intervention less effective
than the best proven one, placebo, or no
treatment, is acceptable in studies where
both conditions above apply and research
is necessary to develop a treatment option
adapted to local health care resources and
health priorities
“any” should be deleted and “additional”
should be added, because “risk of serious
or irreversible harm” is unavoidable in
some cases of clinical research regardless
of question of placebo control
However, we have allowed biomedical
research to test an intervention in resource
poor setting countries. It is limited to
cases where there are scientifically sound
methodological reasons to do so, where
there would be no additional risk of
serious or irreversible harm. These
criteria would not be fit for resource rich
countries.
Q1. Changes in some parts of DoH.
Q2
Drug
A
vs
Placebo
Clinical
trial
Phase
III
Drug
“A”
is
more
effec?vely
than
placebo.
a) No
further
sugges?on.
b) Suggest
a
nego?a?on
of
free
drug
“A”
to
both
treatment
and
control
groups
for
a
certain
period
of
?me.
c) Suggest
a
nego?a?on
of
free
drug
“A”
only
to
the
treatment
group
for
a
certain
period
of
?me.
In
regards
to
post-‐study
arrangement,
which
of
the
following
did
your
IRB
likely
opt
to
do?
Q2. Post-study arrangements Most
-‐
agree
Even
though
we
have
no
SOP
which
states
the
pracEce
of
Post-‐study
arrangements.
“Principle
of
distribuEve
jusEce
can
also
be
applied
at
community
and
country
levels.”
– A
common
problem
examples:
“the
trial
are
conducted
in
developing
countries,
but
aLer
the
end
of
the
trials,
drugs
or
vaccines
or
medical
devices
under
the
studied
cannot
be
made
beneficial
to
the
parEcipaEng
populaEons
or
countries”
due
to
their
high
cost
or
lack
of
disease/illness
for
such
drugs
or
vaccines
in
those
communiEes
in
developing
countries”
– “Thus,
the
principle
must
be
carefully
and
thoroughly
considered
to
bring
jusEce
to
all
levels
from
the
individuals
to
the
society.”
Q2:
Post-‐study
arrangements
Q3
Disease
“B”
Bone
marrow
transplanta?on
CURE
50%
Death
rate
+
Disease
“B”
Life-‐long
treatment
with
expensive
drug
Not
CURE
No
mortality
One
-‐year
treatment
with
expensive
drug
Be/er
condi?on
New
Protocol
Bone
marrow
transplanta?on
CURE
10%
Death
rate
+
Disease
“B”
Yes
or
No
IRB 1
2
3
4
5
6
7
8
9
QuestionNo.
1. Changes in some
parts of DoH.
√
√
NA ×
NA NA NA √
×
2. Post-study
arrangements
2.2
2.2
2.2
2.2
2.2
2.2
2.2
2.2
2.1
3. Best vs Optimal
treatments
√
√
√
√
√
√
√
√
√
1/3
-‐
yes
8/9
-‐
2.2
All
-‐
yes
Q3. Best vs Optimal treatments All
-‐
agree
“It
is
generally
unacceptable
to
use
placebo
in
a
control
group
in
a
trial
where
standard
treatments
or
medically
proven
medicines
are
available,
because
paEents
will
loose
medical
benefit
enEtled
from
parEcipaEng
in
the
clinical
trial.
However,
the
use
of
a
placebo
in
a
control
group
may
be
allowed
in
the
following
cases.
(1)
no
standard
drug
medically
recognized
for
the
treatment
of
the
disease
is
available”
best
current
proven…
best
proven…
best
locally
available
proven…
32
Thank you for your a