Prijo_Sidipratomo
Télécharger un document PDF
Ethics
on
biomedical
research
in
Indonesia
and
a
view
point
from
Indonesia
Prijo
Sidipratomo
Chairman
Board
of
Ethics
Indonesian
Medical
Associa6on
Presented
on
WMA
mee6ng
Tokyo,
March
1st
2013
INDONESIA
• Indonesia
is
an
archipelago
comprising
approximately
17,508
islands
• It
has
34
provinces
with
over
238
million
people,
and
is
the
world’s
fourth
most
populous
country
• There
are
72
medical
schools,
53
of
them
have
been
accredited
• Currently,
about
10
medical
schools
are
ac6vely
involved
clinical
research
ac6vity
• Clinical
research
in
Indonesia
is
associated
with
some
poten6al
benefits
such
as:
Wide
variety
of
diseases
Availability
of
research
subjects
Rianto,
9th
Kitasato
–
Harvard
PH
mee6ng
2009
Important
health
problems
in
Indonesia
Important
health
problems
in
Indonesia
Indonesian
regula6on
ethics
on
biomedical
research
based
on
1. Nuremberg code (1947)
put emphasize on protection of the integrity of the research
participant and on their voluntary consent
2. Universal Declaration of Human Right
(United Nations, 1948)
Article 7 of the International Convenant on Civil &
Political right (1966) states:
No one shall be subjected without his/her free consent to
medical experimentation.
International Guidelines and
Principles Of Research Ethics
3. The Declaration of Helsinki (1964)
– Issued by the 18th WMA general assembly and has several
time been amended. Edinburgh the 52nd WMA-general
Assembly 2000, the latest.
– This Declaration of Helsinki is the key reference used in
formulating the National guidelines for health research,
every where
4. Operational Guideline for Ethics Committees that
Review Biomedical Research (WHO, 2000)
– The establishment of Health Research Ethics Committees
and used in Indonesia as the key reference.
– The development of quality and consistency-ethical review.
5. International Ethical Guideline for Biomedical
Research Involving Human Subject (CIOMS,
2002)
– CIOMS (Council of International Organization of
Medical Sciences)
– Low resource countries, national policy,
applying ethical standards in local situation
6. Others:
– International Guideline for Ethical Review of
Epidemiological Studies (CIOMS, 1991)
– Guideline for Good Clinical Practice for Trial
(WHO, 1995)
Adopted by European Union and Indonesia
(Pedoman Cara Uji Klinik yang Baik)
– International Conference on Harmonisation for
GCP(1996) adopted by BPOM → CUKB (2001)
7. Bioethics Communities of Work : Procedures and
Policies (UNESCO, Guide No 2, 2005)
– General and Specific Procedures and Policies of
Bioethics Committees
– Health Care Ethics Committers and Health
Research Committees
Seven
Ethical
Pillars
of
Clinical
Research
v AUTONOMY
v BENEFICENCE
v NON
–
MALFEASANCE
v FIDELITY
v
TRUTHFULNESS
v
CONFIDENTIALITY
v
JUSTICE
Ethics
on
biomedical
research
in
Indonesia
• Regula6on
Ministery
of
Health
No.
1333/2002,
agreement
on
human
research
• Regula6on
Ministery
of
Health
No.
1334/2002,
regarding
Na6onal
Ethics
Commi[e
on
Health
Research
• Na6onal
Ethics
Guide
lines
on
Health
Research
2004
• Ministerial
Decree
number
657/Menkes/PER/
8/2009
regarding
guidline
sending
the
specimen
for
health’s
R
&
D
Ethics
CommiIee
• 1982:
the
first
EC
in
the
country
was
established
• Today
ECs
exist
in
the
majority
of
schools
and
hospitals
which
are
conduc6ng
clinical
research
• 2003:
the
Minister
of
Health
established
the
Na6onal
Commi[ee
on
Ethics
of
Health
Research
with
the
tasks
to
improve
the
capability
of
the
ethics
commi[ees
• 2009:
there
are
34
ECs
throughout
the
country
NaJonal
Ethics
CommiIee
on
Biomedical
Research
• An
Independent
body
within
Research
and
Development
Ministery
of
Health
Tasks
:-‐
promote
ethics
in
health
research
-‐
prepare
naJonal
guidelines
-‐
develop
networking
of
ECs
-‐
review
special
protocols
-‐
monitor
insJtuJonal
ECs
-‐
report
to
MOH
annually
Map
of
ne[working
in
ethics
on
biomedical
research
Members
of
NaJonal
Ethics
CommiIee
on
Biomedical
research
Consists of :
A Researcher
A medical doctor
A lawyer
A lay man
A
biomedical
scien6sts
A
public
health
experts
A
philosopher
A
pharmacist
and
other
scien6sts
Total number of member 25 persons
Form
for
protocol
Na6onal
Ins6tute
of
Health
Research
and
Development
Clinical
Trial
Form
Na6onal
Ins6tute
of
Health
Research
and
Development
Indonesian
Food
and
Drug
Adminstra6on
Challenges
• Limited
resources
• Standard
Material
Transfer
Agreement
(SMTA)
• The
quality
of
Indonesian
reseacher
need
to
be
upgraded
• The
hardwares
or
modern
equipment
need
to
be
updated
• The
standard
accredited
laboratory
based
on
interna6onal
guideline
need
to
updated
• Post
study
access
• Cross
Culture
sensi6vity
Purwadianto
A,
Indonesian
MOH
2012
solu6on
• Transfer
of
Knowledge
from
developed
countries
• Transparancies
and
its
impact
for
the
benefit
also
for
developing
countries
where
the
research
is
done
• Capacity
building
for
the
present
reseacher
• Colabora6on
and
upgrade
the
infrastructures
to
present
standard
• Protec6on
and
Safety
for
the
subject
eg.
insurance
THANK
YOU