Prijo_Sidipratomo

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