KOMISI ETIK PENELITIAN

KESEHATAN

HEALTH RESEARCH ETHICS

COMMITTEE
Firman F. Wirakusumah

SEJARAH ETIKA PENELITIAN

DENGAN SUBJEK MANUSIA
DAN HEWAN

REFERENCES/GUIDELINES
International:

1932 Tuskegee, no treatment to study of syphilis for the black compared to the
white study in US
1947 Nuremberg Code
1964 Declaration of Helsinki (revised in 2002 and 2008)
1978 Belmont Report (3 basic ethics principles)
1991 Int. Guidelines for ethical review of epidemiological studiesCIOMS/WHO
1993 Int. Guidelines for Biomedical Research Involving Human Subjects
CIOMS/WHO (renewed in 2002)
1996 ICH Good Clinical Practice Guidelines (ICH GCP E-6)
2000 Operational Guidelines for Ethics Committees that Review Biomedical
Research (WHO-TDR)
FHI guideline
FERCAP guideline
2002 Surveying and Evaluating Ethical Review Practices (WHO-TDR)
2004 SIDCER-FERCAP Recognition Program

National Regulation
Health Law 23/1992 i.e health protection for research
participants and sanction for those disobey the Law.
Govt Reg 39/1995 NIHRD-MoH responsible to organize /
manage the human subject protection, review and approved
informed consent and compensation to those who were harmed
or injured due to research
Min.Dec 1333/2002 Informed consent in human research
Govt Reg 41/2005 Research involving foreign institution/
researcher

National RECs NETWORK

REC-USU
REC- UI

REC- UGM

RECUnpad

REC
UNHAS

NHREC = 1
REC...
REC...

NHREC
REC
UNUD

REC...

REC...
REC...

REC...

REC...

REC...
REC...

REC = 52
Recognized
by NHREC

RECs (Research Ethics Committees)

in Indonesia
In 2004 : 26 RECs in Universities, teaching
hospitals and research institutions
In 2006 : 30 RECs,
in 2008 : 29 RECs
in 2014 : 52 RECs
RECs voting Member composed of multi
disciplines, lay person, gender inequality,
4 - 20 voting members

Existing ethics
committees
1. National Health Research Ethic
Committee = NHR-EC
2. Institutional REC/IRB
3. National Bioethics Committee = NBC
Differ in functions

Functions
NHR-EC

1. To encourage the
implementation of ethic
principles in conduting Health
Research involving human
subjects
2. Capacity building program
(training, workshop,
networking)
3. Develop and revise national
guideline and SOP for ethics
review
4. Develop and maintain
national networking among
ERCs and international
collaboration
5. Act as advisory body on
critical issues, disputes on
particular problem

REC ~ IRB
1. Ethical review of health
research involving human
subjects and animal
2. To grant ETHICS
APPROVAL to conduct Health
research involving human
subjects and animal
3. Monitor the research
conduct of the approved
studies

THE IRB/REC
Institutional Review Board (IRB)/
Research Ethics Committee (REC),
Overseeing the trial holds the final responsibility
for :
- Safeguarding the rights
- Safety
- Well-being of clinical trial subjects
An independent body composed of :
Medical
professionals
Scientific

- Other members from outside those professions

RECs member disciplines

Homogeneous : Physician, Dentist

Multi disciplines : Medical doctor, Public
health, nutritionist, Biologist, veterinarian,
pharmacist, animal husbandry, Law,
Sociologist/Anthropologist, religious,
lay person
Lay person :

Secretariats clerk
Student at School of Medicines
Administration
Teacher (High School)
Invited experts/ad hoc

RECs Organization
Supporting secretariat and office
- investigators access to EC
- administration process and follow up
Budget allocation
- Institutional annual budget
Reviews fee
Self support

What is Ethics ?
The formal study of : what is good
and what is bad
What is Legal aspect ?
The formal study of : what is right
and what is wrong
What Ethics and Legal aspect are ?
The analyses of the processes by
which we decided what is good and
right to do

Justification for Ethical Guidlines

How should we decide if it is ethical to
conduct the study and enroll Mr/Mrs :
X/Y to the study?
More generally, why do we need ethical
guidelines or reqruitments for human
subject research?
HISTORICAL ETHICAL REASON

WMA General Assembly

Declaration of Helsinki
18th Helsinki, Finland, June 1964
29th Tokyo,Japan,October 1975
35th Venice, Italy, October 1983
41st Hong Kong, September 1989
48th SomersetWest,S.Africa, October 1996
52nd Edinburg, Scotland, October 2000
53rd Washington DC,USA,October 2002
55th Tokyo, Japan, October 2004
59th Seoul, Korea, October 2008

Declaration of Helsinki
Ethical Principles
Ethical principles for medical
research involving human subjects,
including research on identifiable
human material and data

Ethical Principles
Priciples for all Medical Research :
-

To protect the life,health,dignity,right

selfdetermination,privacy,confidential
Accepted scientific principles
Not harm to environment
Clearly described in research protocol
Apropriate scintific training and qualification
To protect disadvantage or vulnerable population
To be thought of risk and benefit individual or communities
Immediately stop a study when the risk are found.
Subject in medical research must be voluntary

Ethical Principles cont.......

-

Must be adequate in ; confidential of personal information,

inform of aims,methods, sources funding
Must normally seek consent for the collection, analysis,
storage and /or reuse
Validity of research approved by a research ethics commitee
Informed consent should be sought by an appropriately
qualified individual who is completely independent of this
relationship
Inform consent for subjects physically and mentally
incapable of giving consent should be obtains from the
subject or a legally authorized representative.
Reports of research not in accordance with the principles of
the Declaration should not be accepted for publication.

Additional : Ethical Principles

-

The physician may combine medical research with medical

care only :
The research justified ; potential preventive, diagnostic ot
therapeutic value
Physician has good reason to belive that the participation will
not adversely affect the health of patients as a subjects.
Benefit and risk should be the best current proven
intervention, except :
The use of placebo, or no treatment is acceptable in studies
where no current proven intervention exists or :
The use placebo is necessary to determine the efficacy or
safety of an intervention and the patiets will not be subject
to any risk of serious irreversible harm.

The Belmont Report

Ethical Priciples and Guidelines for the protection of

human subjects of research

Ethical Principles and Guidelines for Research

Involving Human Subjects
Boundaries between Practice and Research
Basic Ethical Principles : 1) Respect for Persons,
2) Beneficence, 3) Justice
Applications :1) Informed Consent,2) Assesment
of Risk and Benefits, 3) Selection of Subjects

8 Ethical Principles
Collaborative partnership
Social value
Scientific validity
Fair subject selection
Favorable Risk-Benefit Ratio
Independent Riview
Informed consent
Respect for Enrolled Subject

Fundamental Principles of
Human Research Ethics
Respect for person (autonomous,
protection of vulnerable groups and
informed consent)
Beneficence (max. benefits, min. risk,
avoid harm)
Justice (benefits and burdens equally
distributed)

Vulnerable person in
medical research.
In contemporary complex societies/differential social
status (unequal access to health, economic resources,
social and political power).
Negatively valued statuses in an individual/Inequality;
ethic, racism, sexism/gender, ageism, and classism.
Human subjects which harmful exploitation; low status
populations (ethnic group members, children, the poor,
women, soldiers, prisoners).
Dying patients, ill person; pregnant women, mentally
retarded children, the demented elder.

Informed Consent
Go wrong :
Participats lacks capacity
Researcher withholds important
information
Participart doesnt understand
important information
Researcher coerces participant
Researcher doesnt get agreement

Elements of informed consent

Should be :

Capacity to make autonomous decision

Disclosure of relevant information
Understanding of this information
Voluntariness of decision
Indication of agreement, e.g.
signature

Elements of informed consent

Capacity to make autonomous decision
Disclosure of relevant information
Understanding of this information
Voluntariness of decision

Risks and benefits of challenge

study
balancing :

Individual risk
Individual benefits
Societal benefit
Personal benefits

example :

- risk of dying of disease

- posibility of getting a new
- information more for subject
- produce vaccine
- publication
- satifaction of doing something
- thesis, desertation

Type of Review
Full Board Review
Full board review means that the research is reviewed at convened meetings
at which a majority of the members of the REC/IRB are present, including
at least one member whose primary concerns are in nonscientific areas. This
type of review applies to studies that are greater than minimal risk, or
minimal risk but do not qualify for expedited review.
Expedited Review
Expedited review means that the review can be done by a qualified IRB
reviewer rather than at a convened IRB meeting. Reviewers conducting an
expedited review may exercise all of the authority of the REC/IRB except
that they may not disapprove a study. When reviewers cannot approve the
research under expedited review, the study is referred for full board
review.
Exempt Review
The categories of research which are exempt from the regulations. Although
the category is called "exempt, the determination of exemption must be
made by the REC/IRB Office. Exempt projects are different from Expedited
or Full Board review in that they are not assigned an expiration date, do not
have to undergo continuing review and are able to undergo alteration without
REC/IRB approval.

Type of Review ... continue....

Reciprocal Review
Under a reciprocal agreement between REC/IRB
to accept the review each institution reserves the right to have its own
REC/IRB review the research.
Umbrella Grant Review
Umbrella review should be requested if ; REC/IRB approval letter is
needed to the funding agency for a training grant, center grant, or
program project grant that will support multiple research projects involving
human subjects.
REC/IRB approval represents approval of the grant in concept only.
Separate REC/IRB approval must be obtained for each human subjects
research project that receives funds from the grant.
Development Grant Review
Development grant review should be requested if; REC/IRB approval letter
is needed for a grant application but are not yet ready to begin research
with human subjects. "Development-only" approval shows that
the IRB has approved the study in concept. When you are ready to begin
your research with human subjects, submit a new study to receive the
final approval.

WORLD MEDICAL ASSOCIATION

DECLARATION OF HELSINKI (1964)
BASIC PRINCIPLE FOR
ALL MEDICAL RESEARCH

Appropriate caution must be exercised

in the conduct of research which may
affect the environment, and
the welfare of animals used for
research must be respected

Principles of animal as
subjects research
(experimental design)
3 R - 5 F

 Replacement: Aternative of changing animal to invertebrata or cell lines

(tissue culture),
Relatif : - use animal organs/tissues from slaughter house.
- use animal of lower ordo
Absolut: - replace the use of animal with tissue culture/computer
program.
(mengganti hewan coba dengan alternatif lain seperti hewan
invertebrata/kultur jaringan/program kompter)

Reduction: Alternative models to have minimal number of animal as

subject of study, strategies for obtaining comparable levels of information

from the use of fewer animals or for maximizing the information obtained
from a given number of animal without increasing pain or distress viewer
animals are needed to aquire the same scientific information.
(model alternatif agar dapat mengurangi jumlah hewan coba)

Refinement: Minimize severity of pain and

stress , modification of
husbandry or experimental procedures to enhance animal well-being or
eliminate pain and distress use of analgesics, anesthetics.
(mengurangi/menghindari penederitaan dan rasa nyeri ataupun stresseperti
pemberian analgesika dan obat anestesi)

5 Freedoms from
Hunger and
thirst

Discomfort

Pain, injury and

disease

Fear and
distress

Express natural
behavior

Free from hunger

and thirst

Free from discomfort

vs

Group housing
when ever
possible

Nesting materials

Enrichment devices for

rodents: Igloo, nest etc.

Human interactions

Enrichment
Devices for NHP

Freedoms from Discomfort

By making sure that animals have the right type of
environment including shelter and somewhere
comfortable to rest.
Environment in a barrier facility:

Temperature
Humidity
Ventilation (Air Change/ hour)
Lighting (Intensity and cycle)

Space/ cage size ( refer to The Guide for the Care

and Use of Laboratory Animals)
social vs solitaire; hierarchy

Freedoms from Pain, Injury & Disease

By preventing them from getting ill or
Injured and by making sure animals are
Diagnosed and treated rapidly if they do.

Vet care program

Choose non-invasive procedures when possible
The use of anesthetics and analgesic when needed
Choose an approved euthanasia method (AVMA
Guidelines on Euthanasia)

Free from fear and distress

Where am I ?
Why am I here?

What are
you going to
do to me?

Avoid visual/ auricular/ olfactorial

contact between preys and
predators

Minimized stress with environmental

enrichment

Free to express their natural

behavior

vs

Natural behavior of burrowing &

hiding

Ex-situ Breeding

Natural Behavior as social group

Ex-situ Breeding

Captive Island Breeding

The love for all living

creatures is the most noble
attribute of man
(Charles Darwin)

THE INTERNATIONAL
CONFERENCE ON
HARMONISATION (ICH)
Collaborating the European Union, the United
States, and Japan (since 1991)

Technical Requirement for Registration of

Pharmaceuticals for Human Use
ICH Harmonised Tripartite Guidelines for Good
Clinical Practise (1996) -> GCP

Principles of
International Conference on
Harmonisation (ICH) Good Clinical
Practice (GCP)
(clinical trial-human as subject)

Objective :
To define the ICH and its origin
To list the universal principles that form
the basis of GCP
To identify those who benefit from GCP

RESEARCH MISCONDUCT
Fabrication : menggandakan data, hasil penelitian
dalam catatan data dalam pelaporan hasil
penelitian.
Falsification : memalsukan/memanipulasi bahan
penelitian, alat, proses, merubah atau
menghilangkan data atau hasil sehingga mengubah
hasil pencatatan data.
Plagiarism : mengambil data penelitian orang lain ;
ide, proses, hasil atau kata-kata tanpa
menyebutkan sumbernya.

Conflict of Interest
(COI)
COI is a set of conditions in which
professional judgment concerning a
primary interest (such as patients welfare
or validity of research) tends to be unduly
influenced by a secondary interest (such
as financial gain). COI rules, formal and
informal, regulate the disclosure and
avoidance of these conditions
(Dennis F. Thompson)

What is wrong with

COI ?
COI is not an evidence of wrongdoing
For many professionals, it is almost
impossible to avoid having COIs from time
to time
A COI can, however, become an ethical or
legal issue if an individual tries or
succeeds in influencing the outcome of a
decision, for personal benefit

Rules for control of COI

To maintain integrity of professional
judgment
To prevent secondary interests from
dominating the primary interests in the
making of professional decisions
To maintain public trust in the profession

WORLD MEDICAL ASSOCIATION

DECLARATION OF HELSINKI (1964)
BASIC PRINCIPLE FOR
ALL MEDICAL RESEARCH

Appropriate caution must be exercised

in the conduct of research which may
affect the environment, and
the welfare of animals used for
research must be respected

Authorship
Each author should have participated sufficiently
in the work to take public responsibility for
appropriate portions of the content
One or more authors should take responsibility
for the integrity of the work as a whole
Authorship credit should be based only on (1)
substantial contributions to conception and
design, or acquisition of data, or analysis and
interpretation; (2) drafting the article or revising
it critically for important intellectual content; (3)
final approval of the version to be published
(Vancouver Group)

Risks and benefits of challenge

study
balancing :

Individual risk
Individual benefits
Societal benefit
Personal benefits

example :

- risk of dying of disease

- posibility of getting a new
- information more for subject
- produce vaccine
- publication
- satifaction of doing something
- thesis, desertation

THE INTERNATIONAL
CONFERENCE ON
HARMONISATION (ICH)
Collaborating the European Union, the United
States, and Japan (since 1991)

Technical Requirement for Registration of

Pharmaceuticals for Human Use
ICH Harmonised Tripartite Guidelines for Good
Clinical Practise (1996) -> GCP

Principles of
International Conference on
Harmonisation (ICH) Good Clinical
Practice (GCP)
(clinical trial-human as subject)

Objective :
To define the ICH and its origin
To list the universal principles that form
the basis of GCP
To identify those who benefit from GCP

Conflict of Interest
(COI)
COI is a set of conditions in which
professional judgment concerning a
primary interest (such as patients welfare
or validity of research) tends to be unduly
influenced by a secondary interest (such
as financial gain). COI rules, formal and
informal, regulate the disclosure and
avoidance of these conditions
(Dennis F. Thompson)

What is wrong with

COI ?
COI is not an evidence of wrongdoing
For many professionals, it is almost
impossible to avoid having COIs from time
to time
A COI can, however, become an ethical or
legal issue if an individual tries or
succeeds in influencing the outcome of a
decision, for personal benefit

Rules for control of COI

To maintain integrity of professional
judgment
To prevent secondary interests from
dominating the primary interests in the
making of professional decisions
To maintain public trust in the profession

WORLD MEDICAL ASSOCIATION

DECLARATION OF HELSINKI (1964)
BASIC PRINCIPLE FOR
ALL MEDICAL RESEARCH

Appropriate caution must be exercised

in the conduct of research which may
affect the environment, and
the welfare of animals used for
research must be respected

Authorship
Each author should have participated sufficiently
in the work to take public responsibility for
appropriate portions of the content
One or more authors should take responsibility
for the integrity of the work as a whole
Authorship credit should be based only on (1)
substantial contributions to conception and
design, or acquisition of data, or analysis and
interpretation; (2) drafting the article or revising
it critically for important intellectual content; (3)
final approval of the version to be published
(Vancouver Group)

SEJARAH DI INDONESIA :
KOMISI ETIK PENELITIAN
KESEHATAN (KEPK)

 8 Februari 1985 : Panitia Kode Etik

Penelitian FKUI mengadakan Forum
Diskusi
17 maret 1986 : FKUI, Lokakarya
Pembentukan Panitia Etik Penelitian
1 Oktober 1990 : Tim Etik Penelitian
Kedokteran FK Unpad (SK Dekan FKUP
no.46/PT.06H4FK/Kep/N/90)

PETA KEBERADAAN
KEPK, 2012

Sulut (1)

Riau (1)
Sumut (2)
Sumbar (2)
Sumsel (2)

Sulsel (1)

Jabar (2)
Jakarta (15)
Jateng (2)

DIY (4) Jatim (7)

75

Bali (1)

NTB (1)

POTRET DIRI KEPK

FKUP-RSHS
Di sesuaikan dengan :
PEDOMAN NASIONAL PENELITIAN
KESEHATAN 2007

KEDUDUKAN (a-e)
d. KEPK melaksanakan fungsinya secara
independen, yaitu bebas dari pengaruh
manapun, termasuk tekanan politik,
lembaga, profesi, industri atau pasar.
e. Untuk pembentukan KEPK, pimpinan
lembaga menentukan beberapa orang
sebagai formatur yang bersama pimpinan
lembaga menentukan keanggotaan. KEPK
pada sidang pertama memilih ketua dan
sekretaris. Selanjutnya sebagai badan
independen memilih anggota baru untuk
kemudian diangkat/ dikukuhkan oleh
pimpinan lembaga.

PERAN DAN FUNGSI (a-h)

h. KEPK bukan komisi penguji atau
penilai ilmiah (akademis), tetapi
merupakan komisi penilai dan
pengambil keputusan tentang kelayan
etis suatu penelitian kesehatan guna
mendukung terlaksananya penelitian
kesehatan bermutu

Keanggotaan (a-k)
a. Multidisiplin
c. Mutlak multidisiplin dan multisektor
dengan distribusi kepakaran yang
relevan, distribusi umur dan gender
yang seimbang, serta dilengkapai
orang (orang) yang terhimpun pada
ilmu kesehatan, ilmu hukum,
sosiologi, pendidikan dan filsafat
etika.

f. Jika diperlukan pada sidang penilaian

etik protokol penelitian KEPK dapat
mengundang konsultan bebas guna
melengkapi kepakaran etiknya.
i. Sistem rotasi keanggotaan
k. Pendidikan awal dan berkelanjutan
untuk anggota KEPK perlu
diupayakan dengan dukungan
lembaga

Penilaian Etik Protokol

Penelitian (a-p)
a. Dilakukan oleh sidang KEPK yang sah
b. Anggota KEPK dapat menerima
imbalan untuk jasa penilaian. Tidak
boleh sedemikian besar sehingga
menghambat pelaksanaan penelitian
c. Sah, bila dihadiri oleh > setengah
jumlah anggota

d. Sidang dilakukan sesuai kebutuhan,

paling sedikit diadakan setiap 3 bulan
f. Conflict of interest. Dia boleh hadir,
namun tidak ikut serta dalam
pembahasan dan pengambilan
keputusan
i. Anggota KEPK perlu diberi cukup
waktu untuk mempelajari protokol
penelitian yang akan dinilai

l. Protokol harus dilengkapi surat

persetujuan dari Komisi Ilmiah
lembaga yang menjamin bahwa
masalah penelitian aktual dan relevan
dan didukung oleh tinjauan
kepustakaan yang lengkap dan
mutahir, serta desain penelitian yang
memenuhi persyaratan. Jika lembaga
belum memiliki Komisi Ilmiah, maka
tugas tersebut menjadi tanggung
jawab Komisi Etik.

 5 Juni 1995 : di bentuk Komite Medik

RSUP Dr. Hasan Sadikin Bandung
5 Juli 1997 : dibentuk Panitia Etik
Penelitian (SK Dir RSHS No. 233/DI8.32/KP.01.1.1/VII/1997)
Status KEP-FKUP semula berada
dibawah FKUP, diubah menjadi
dibawah Komite Medik RSHS.

 17 Februari 1998 dikeluarkan SKB Dir

RSHS dan Dekan FKUP tentang Panitia
Etika penelitian RSUP RSHS FK Unpad.
18 Juni 1999 : disempurnakan menjadi
Panitia Etika Penelitian-Komite Medik (PEPKM RSHS-FKUP), kemudian menjadi KEPK
FKUP/RSHS sampai Desember 2010
10 Januari 2011 : diubah kembali menjadi
Komite Etik Penelitian Kesehatan
Fakultas Kedokteran Universitas Padjadjaran

Tugas pokok
KOMITE ETIK PENELITIAN
KESEHATAN-FK Unpad

Merumuskan tertib penelitian sesuai

dengan norma hukum yang berlaku
Menilai dan memberikan rekomendasi
kelayakan (ethical clearance) dalam
lingkungan FK Unpad

 Menilai aspek etik penelitian dan

memberi pendapat dan saran kepada
pimpinan FK Unpad serta memantau
pelaksanaannya di lapangan
Membina dan memberikan penyuluhan
mengenai etika penelitian kepada
calon peneliti
Membuat laporan kegiatan

MASALAH ETIK PENELITIAN

KESEHATAN KHUSUS DI INDONESIA

PEMANFAATAN
BAHAN BIOLOGI TERSIMPAN (BBT)

Bahan Biologis Tersimpan

BBT : spesimen klinis atau materi biologis lain
(contoh : isolat, DNA ) yang disimpan /
diarsipkan
Sisa penelitian, sisa pelayanan kesehatan
(sisa tindakan diagnostik/biopsi, tindakan
pengobatan/operasi atau autopsi) sengaja
disimpan untuk pemeriksaan di masa depan

Protokol Penelitian
Persetujuan Ilmiah
Persetujuan Etik
PSP
Pengumpulan
Bahan Biologik

ASAL BBT
Pelayanan Medik
Diagnosis, Terapi,
Operasi, Patologi,
Autopsi

Sisa
Bahan Biologik

BBT

Keadaan & Perkembangan BBT (1)

Bentuk BBT :
- sediaan mikroskopik (slides)
histopatologi, sitologi, sumsum
tulang dan blok-blok parafin.
- Serum dan komponen darah,
mikrobiologi/isolat, dlsb.

Keadaan & Perkembangan BBT (2)

Pemanfaatan BBT meningkat:
- Biomedical Research
- Teaching
- Jaminan mutu laboratorium (Laboratory
Quality Assurance )
- Ilmu genetika dan biologi molekuler
- Teknologi menegakkan diagnosa &
mempelajari penyakit
- Banyak Bahan Biologik dikirim lintas negara
termasuk BBT dengan me Kerjasama
ilmiah Internasional

Skandal Etik Pemanfaatan BBT

The Alder Heys Children Hospital Scandal

di Liverpool (UK) 1988-1995 :
Pengambilan dan penyimpanan organ-organ
anak-anak yang diautopsi

The John Moore Affair di California (USA)

Penderita kanker darah : Hairy cell leukemia
Operasi pengambilan limpa tanpa diketahui dan
izin pasien. Memanfaatkan limpa pasien demi
uang (pembuatan cell line)

PENELITIAN MENGGUNAKAN BBT

Penelitian menggunakan BBT harus
mendapatkan persetujuan etik penelitian
Idealnya, Subjek sudah memberikan
persetujuannya pada saat pertama penelitian
dilakukan, walaupun jenis pemeriksaan /
penelitian belum ditentukan

Kepemilikan dan Pengelolaan BBT(1)

Semua Bahan Biologik yang dikumpulkan untuk
penelitian kesehatan: milik lembaga pelayanan
atau penelitian
Kepala lembaga penelitian bertanggung jawab :
penyimpanan, pamanfaatan, pemusnahan BBT
BBT: Tidak boleh dijual atau diperdagangkan

Kepemilikan dan Pengelolaan BBT(2)

PI yang mengumpulkan bahan biologik mempunyai
hak pertama menggunakannya
Pemanfaatan BBT selanjutnya memerlukan izin
kepala lembaga
BBT hanya boleh digunakan untuk penelitian
kesehatan yang telah mendapatpersetujuan
Ilmiah dan Persetujuan Etik

PENELITIAN KERJASAMA
dan
MTA
(Material Transfer Agreement )

PENGERTIAN
LATAR BELAKANG
RUANG LINGKUP
DASAR HUKUM
ASPEK ETIK
ASPEK LEGAL

PRINSIP DASAR:
UPAYA PROTEKSI MTA
(Material Transfer Agreement)

PENELITI ASING

BBT (Bahan Biologis Tersimpan)

PENGERTIAN
PENELITIAN KERJASAMA INTERNASIONAL
Penelitian yang dilakukan oleh Peneliti Lokal
bersama Peneliti Negara lain, atau
Penelitian yang dilakukan oleh peneliti
beberapa negara secara bersama-sama

PERLU DIPERHATIKAN :
Penelitian yang dilakukan oleh Peneliti
Asing dan mengikutsertakan Peneliti
Lokal sebagai pengumpul spesimen
BUKAN PENELITIAN KERJASAMA

PENELITIAN KERJASAMA

umumnya

MENGGUNAKAN atau
MENGEKSPLORASI SUMBER DAYA
LOKAL
MENGGUNAKAN SUMBER DANA
NEGARA MITRA atau LEMBAGA
INTERNASIONAL, atau PATUNGAN
(termasuk melibatkan dana
pendamping negara lokal)

TUJUAN PENELITIAN KERJASAMA

Memecahkan masalah kesehatan lokal

Memecahkan permasalahan beberapa
negara (isu yang sama)
Mengembangkan /ujicoba produk teknologi
kesehatan/kedokteran
Memantau penyakit atau mengindentifikasi
karakteristik agen penyakit secara global
Mendidik/melatih (hubungan guru-murid)

LATAR BELAKANG
Tanggungjawab moral internasional untuk
membantu negara berkembang
Penelitian/mahasiswa internasional
meningkatkan status institusi/kepakaran
peorangan
Perlu EVIDENCE sebagai dasar pemecahan
masalah di negara berkembang
Perlu EVIDENCE banyak negara agar produk
dapat digunakan secara luas

LATAR BELAKANG
Karakteristik agen penyakit dan penyakit
sering berbeda di Negara/Kelompok
Masyarakat berbeda, pada waktu berbeda
Pengendalian penyakit menular diupayakan
sedekat mungkin dengan Sumbernya
Pengendalian penyakit menular harus dilakukan
secara bersama-sama (dalam era transportasi
global seperti sekarang ini)

RUANG LINGKUP
Sangat luas
Penelitian Laboratorium, Klinik, Masyarakat,
Lingkungan, dsb
Disesuaikan dengan PRIORITAS NASIONAL
Harus ada keseimbangan antara PRIORITAS
NASIONAL dengan PRIORITAS GLOBAL

DASAR HUKUM
UU no. 18/2002 tentang Sistem Nasional
LITBANG dan IPTEK
PP no.39 / 1995 tentang LITBANGKES
PP no. 41/2006 tentang Perizinan melakukan
Kegiatan dan Pengembangan bagi PTA,
Lembaga Litbang Asing, Badan Usaha Asing
dan Orang Asing
KEPMENKES no.1031/2005 tentang Pedoman
Nasional Etik Penelitian Kesehatan

ASPEK ETIK
Tidak memanfaatkan kelemahan
kondisi setempat
Harus memaksimalkan azas manfaat
(pemberdayaan, peningkatan
kapasitas)
Harus megacu pada standard etik
yang universal

ASPEK ETIK .......

Menerapkan standar minimal yang
berlaku dalam sistem pelayanan
kesehatan setempat
Memperhatikan tata nilai dan budaya
lokal tidak merusak tatanan yang
berlaku

ASPEK ETIK .......

Kepentingan subyek lebih diutamakan
Tidak berlebihan dalam membujuk
subjek untuk berpartisipasi
(INDUSEMEN)
Perlu persetujuan etik ke dua negara

ASPEK LEGAL
Tidak membahayakan kepentingan /
keamanan nasional
Memperhatikan kedaulatan bangsa,
hak atas kekayaan hayati, dan hak
atas kekayaan intelektual

Isu Khusus : MTA

Material Transfer Agreement (MTA)
= Perjanjian Alih Materi
Dibutuhkan untuk mengamankan
setiap pengalihan spesimen ke
luarnegeri

Titik-titik kritis untuk terjadinya

Pengalihan Spesimen
Penelitian Kerjasama Internasional
Surveilans Global (contoh: influenza, polio)
Laboratorium Supranasional untuk Kontrol Kualitas
(QC) dan Pemantapan Kualitas (QA)
(contoh: TB, HIV)
Diklat Internasional
Pelayanan Kesehatan
Lembaga Lokal-Asing (Internasional)

Prinsip Dasar
Spesimen klinik, materi biologis dan kandungan
informasinya : hak milik Indonesia, dilindungi
Pemerintah
Test dilakukan di dalam negeri
Kekecualian : pada situasi tertentu, diatur oleh
Pemerintah
Usaha proteksi

ISI MTA
Siapa pengirim, siapa penerima
Rincian materi yang akan dialihkan
Tujuan pemeriksaan / uji
Rincian uji, rincian spesimen yang akan diuji
Alasan dikirim ke luarnegeri
Pernyataan materi tidak akan dialihkan ke pihak
ke 3
Penjelasan apa yang dilakukan terhadap sisa
materi
Hak publikasi, Hak atas Kekayaan Intelektual

Rancangan Permenkes
tentang MTA
Prosedur permohonan persetujuan MTA
Kepada Ka Balitbangkes cq Tim Penelaah MTA
Kelengkapan:
Surat permohonan
Protokol penelitian & EC / surat rujukan
MoU
Daftar spesimen: rincian, tujuan, jenis test
Daftar peserta multisenter (bila relevan)
MTA

PENELITI ASING
Izin dikeluarkan oleh Tim Interdep
Kementerian Ristek
Peneliti asing harus mempunyai mitra
Indonesia dan harus mempunyai lembaga
penjamin

ETIK PENELITIAN
BATANTRAOH/OT-TO
Sri Harsodjo WS.

Tujuan umum :
Para peserta memahami pokok-pokok
etika pada penelitian Tanaman obat
(TO), Obat tradisional (OT) / Obat
bahan alam/Herbal (OBA/OH) dan
Pengobatan tradisional (Batantra)

KLASIFIKASI DAN JENIS

PENGOBATAN TRADISIONAL

Batantra
Batantra
Batantra
Batantra

Ketrampilan
Ramuan
Supranatural/Metafisika
Pendekatan Agama

A. Batantra Ketrampilan :
1. Pijat urut
2. Patah tulang
3. Refleksi
4. Akupresur

5. Akupuntur
6. Khiropraksi
7. Dukun bayi
8. Sunat

B. Batantra Ramuan :
1. Ramuan Indonesia (Jamu)
2. Gurah
3. Aromaterapi
4. Shinshe
5. Tabib
6. Homeopati (dosis minimal)

C. Batantra Supranatural / Metafisika

1. Tenaga Dalam (Prana) SN, Kalimasada, Perisai Diri,
Merpati Putih, Sinlamba, dsb.
2. Paranormal (Indera ke 6)
3. Reiky Master (Tibet, Jepang)
4. Qigong (China)
5. Kebatinan (Jawa)
6. Dsb

D. Batantra Pendekatan Agama

Cara Islam, Kristen, Katholik, Hindu, Buddha.
11/3/15

shws

12
1

UJI TO, DAN OH (OBA)

PRASYARAT BAHAN/
METODA UJI

BAHAN ALAM/
BAHAN DASAR
ALAM

Terdiri dari

Bahan Alam
Nabati
Bahan Alam Hewani
Bahan Alam Mineral

Dapat berupa

BAHAN
SEGAR
Terdiri dari

OH/OB
AI

SIMPLISIA

Simplisia
nabati
Simplisia
Hewani
Simplisia Mineral

HASIL OLAHAN SIMPLISIA

Ekstrak Medisinal

OBAT

Senyawa kimia murni untuk obat

Senyawa kimia murni untuk prekursor

SENYAWA KIMIA TUMBUHAN

Metabolit
primer

Fitokimia

Protein
Lemak

Alkaloid
Metabolit
sekunder

SENYAWA
KIMIA PADA
TUMBUHAN

Karbohidrat

Flavonoid
Minyak atsiri
Kuinon

Metabolit
tekanan

Steroid
Fitoaleksin

Tanin
Dsb,

Fitotoksin

ASAL BAHAN BAKU

Tanaman
budidaya

Tumbuhan liar :
Tumbuhan hutan
Tumbuhan
pekarangan
Tumbuhan kebun

Tanaman
petani

Tanaman
seleksi

PENGUMPUL/
PENYALUR

Kemitraan
Industri dg
Petani

INDUSTRI
OBAI

> 90 %

Tanaman
Budidaya
jaringan

OH/
OBAI

PENELITIAN
TO/OT/OBA(OH)

TO/OT/OBA :
OT : Ramuan/formula, atau tunggal. Berasal dari
tanaman, biota laut, bahan hewani dan bahan
mineral. Memiliki data empirik
TO : Bentuk simplisia atau hasil olahan (ekstrak),
Tidak selamanya memiliki data empirik (sebagian
besar hasil penelitian)
OBA: Ramuan, atau tunggal. Berasal dari (OH)
tanaman, biota laut, bahan hewani dan bahan
mineral. Tidak selamanya memiliki data empirik

Stand
raw material
NCE-Med.

Phytopharmaca

Stand extracts

Clinical studies

Chemst, pharm,
preclinical

Confirmation of
Empirical effect

Cultivation

Preclin/Clin.
Observation

Med. plants

R & D of plants

PEDOMAN UKOT : Inventarisasi

KEPUTUSAN

Kelp. 1
Aman (+)
Khasiat (+)

Kelp. 2
Aman (+)
Khasiat (-)

Produk akhir

Kelp. 4
Aman (-)
Khasiat (-)

Isolasi

Standardisasi
sederhana
Uji klinik

HASIL

Kelp. 3
Aman (-)
Khasiat (+)

Terus beredar
Boleh beredar
Tak boleh beredar, Tidak boleh
di masyarakat,
tanpa klaim
sampai penelitian beredar dan
diberi label
manfaat/indikasi lebih lanjut
dilarang dipakai
Kemenkes
(Jalur non formal)
(Jalur non formal)

Uji klinik
PROSES
LANJUT

Seleksi

Uji Pra Klinik OT

Uji praklinik

HASIL

Observasi

Bermanfaat

Teknologi Farmasi
(sediaan baru)
Uji klinik
Bermanfaat

FITOFARMAKA

Isolat
Uji klinik

Bermanfaat

OBAT
JADI

SITUASI
TO/OT/OH TERKINI

 Dulu :
OT untuk self med, trivial, self limiting.
Sekarang :
OTTO digunakan juga untuk penyakit
yang tidak dapat dikenali oleh awam.
Konsekuensinya dalam uji pra-klinik dan
klinik, PI harus yang kompeten dan ahli
Sebagai komplemen :
Interaksi OT-TO dengan sesamanya atau
obat konvensional sering tidak
diperhitungkan
Sebagai alternatif :

 Munculnya empirik baru:

hak istimewa tradisional, padahal tidak ada data
empirik,
Testimonium manfaat kesimpulan studi klinik
Seringkali dianggap aman,:
tidak masalah. intervensi teknik, fisik, mengandung
risiko
Toksisitas :
akut vs kronik terutama untuk OT-TO penggunaan
jangka panjang

 Situasi ilmiah terkini :

Website ribuan artikel
Balitbangkes 2009 > 6000 penelitian, > 500 spesies.
Badan POM uji klinik 9 tanaman unggulan + 11 tanaman
sudah diteliti + Monografi ekstrak (standardisasi)
Pokjanas TOI > 50x seminar, 4 review
B2P2TO2T : > 200 artikel tidak dapat di review

Teknologi karakterisasi/standarisasi
Implikasi ekonomi link dg industri, produk
komersial:

Kesinambungan pasokan, Keajegan kandungan,

Pasar yang menguntungkan

Memulai penelitian OT tidak lagi berdasar empirik

systematic review tanaman

 Studi epidemiologi : observasi klinik

Uji pra-klinik : GLP
Uji klinik :
1. Sesuai GCP / CUKB
2. Metoda valid : desain, one / two arm, randomisasi,
jumlah subyek, kriteria inklusi, cara makan,
pengukuran respon, parameter outcome,
pengamatan dan pelaporan KTD (adverse event)
3. Pelaksana : kompeten atau ahli dalam hal penyakit,
terapi standar yang ada, dugaan mekanisme kerja,
perkiraan respon, prediksi risiko-manfaat

Aspek Etik
Penelitian
Epidemiologi
Epidemiologi :
Klinik dan Komunitas
Poltekkes II; Garut 10-12 Sept. 2012

Tujuan Umum
Memberi orientasi bagi peneliti
tentang aspek dan isu etik
penelitian epidemiologi
(klinik dan sosial).

Tujuan Khusus
Membahas dan memberi penjelasan tentang:
Batasan, jenis penelitian epidemiologi
Isu etik yang perlu diperhatikan dalam penelitian
epidemiologi deskriptif & observasional
Aplikasi etik dalam penelitian epidemiologi
Beberapa prosedur dalam Kaji Etik (ethical review
)

Etik dalam Penelitian

Epidemiologi
Ethics for epidemiologist involved an
interplay between the model of public
health (protecting the public welfare) and
the model of medicine (protecting the
welfare of the individual), and must also
take into account ethical issues arising from
the social sciences
(Coughlin & Beauchamp, 1996)

Perbedaan antara
penelitian klinis dan epidemiologi
Klinis

Epidemiologi

1. Fokus individu
2. Subjek sakit
3. Sampel relatif kecil
4. Pengamatan relatif
singkat
5. Sumber informasi
umumnya pasien
6. Hasil bermanfaat
langsung untuk
subjek

1. Fokus populasi
2. Subjek sakit/sehat
3. Sampel relatif besar
4. Pengamatan relatif
lama
5. Sumber informasi
responden, catatan/
dokumen
6. Hasil tdk selalu
langsung dirasakan
responden

Sifat Khusus
Penelitian Epidemiologi
di komunitas
Penelitian pada populasi, terkait dengan
Lebih dari satu norma/nilai
Beberapa budaya/agama
Adanya berbagai tabu
Populasi marjinal
Potensi keamanan, keresahan

Pemanfaatan Hasil
Penelitian Epidemiologi

(deskriptif, observasi, kuasiksperimen)

Memperjelas pemahaman terhadap bahaya
fisik, biologis dan perilaku terhadap
kesehatan
Mengubah nilai dan perilaku untuk
meningkatkan kesehatan
Memperbaiki kebijakan dan program
kesehatan untuk meningkatkan status
kesehatan masyarakat umum/khusus

PENELITIAN EPIDEMIOLOGIS
YANG SERING DILAKUKAN
DESKRIPTIF & OBSERVASIONAL
Potong lintang (cross sectional)
Kasus-kontrol (case control)
Kohor (cohort)

Isu Etika
Terkait Penelitian Epidemiologi
1. Menghormati harkat martabat subjek
. Informed Consent, persetujuan setelah penjelasan (PSP)
. Confidentiality, menjaga kerahasiaan
2. Bermanfaat
. Maximizing benefit, memaksimalkan manfaat
. Minimizing harm, meminimalkan kerugian
3. Adil
. Tidak ada beda dalam perlakuan, manfaat dan beban
penelitian
. Conflict of Interest, mencegah konflik kepentingan

Persetujuan Setelah Penjelasan

(PSP)
(Informed Consent)

Persetujuan sukarela
Persetujuan individu; kelompok/ masyarakat
Penjelasan tidak boleh selektif
Tidak boleh memengaruhi secara berlebihan
(penekanan/coercion))
Perangsangan untuk ikut serta/iming-iming
sewajarnya (kompensasi)

Persetujuan Setelah Penjelasan

(Informed Consent ) ......
Isu khusus:
populasi yang berada di bawah pengaruh
populasi lain (narapidana, PSK, pekerja
pabrik)
populasi tersembunyi (gay, penasun)
populasi terasing
Perlu modifikasi dalam pemberian PSP

Catatan:
PSP tidak mutlak dibutuhkan
bila data diambil dari rekam
medis, catatan kelurahan,
data tanpa identitas

BAGAIMANA CARANYA
MEMPEROLEH PERSETUJUAN
DI MASYARAKAT?
DENGAN MEMPERHATIKAN SIFAT KHUSUS
PENELITIAN EPIDEMIOLOGI :
Penting : melapor dan menjelaskan pada
pimpinan setempat, tokoh masyarakat
mengenai rencana penelitian yang akan
dilakukan.
Dengan adanya PERSETUJUAN PIMPINAN
/TOKOH MASYARAKAT dapat dilakukan
pendekatan ke tingkat individu untuk
memperoleh Informed consent (PSP)

Menjaga Kerahasiaan (1)

(Confidentiality)
Menjaga kerahasiaan dengan:
Melakukan pengumpulan data dalam ruang
terpisah / pengaturan khusus
Tidak membahas data dengan orang selain
peneliti (terutama orang yang dapat
memengaruhi jawaban subjek)

Menjaga Kerahasiaan (2)

(Confidentiality)
Menjaga kerahasiaan data dengan:
menghilangkan identifikasi perorangan
Unlinked anonymous
Linked anonymous
ada identifikasi
Membatasi akses pada data
Penyimpanan ketat

Prinsip 2.

Memaksimalkan Manfaat
Hasil penelitian disampaikan kepada
populasi yang diteliti: langsung/tidak
langsung
Pelayanan kesehatan bagi populasi yang
diteliti : langsung/tidak langsung
Peningkatan kapasitas lokal, misal
pelatihan petugas kesehatan lokal,
kelengkapan peralatan, dsb

Meminimalkan Risiko/Kerugian
Mencegah kerugian pada kelompok, misal:
waktu, privasi, nama baik, dsb
Mengantisipasi dan meminimalkan risiko
fisik, psikis, sosial & mencari solusi
Mencegah/meminimalkan kerugian akibat
publikasi, misal: tidak sesuai norma/budaya,
kehilangan harga diri
(metodologi harus benar)

Prinsip 3.

KEADILAN (JUSTICE)

Subjek yang berpartisipasi penuh seharusnya memperoleh

manfaat lebih dari hasil penelitian
Pembagian keuntungan dan risiko: adil
Penting untuk menjelaskan apa yang akan dilakukan
terhadap data/informasi dan spesimen yang diambil dari
subjek dan memperoleh persetujuan dalam
pemanfaatannya
(Perhatian khusus pada janin, anak-anak, mahasiswa, wanita
hamil/menyusui, narapidana, negara berkembang)

Prinsip 3. lanjutan
Untuk meningkatkan keadilan dan konflik
kepentingan perlu adanya random sampling.

Mencegah Konflik
Kepentingan
Identifikasi konflik kepentingan yang mungkin
timbul
Setiap konflik kepentingan harus dinyatakan
secara tertulis dan dijelaskan kepada komisi
etik, calon subjek & masyarakat yg diteliti
Menjaga objektivitas ilmiah

Kaji etik
Penelitian Epidemiologi (1)
Tidak dapat dipisahkan dari kaji
metodologi
Merupakan keharusan dalam penelitian
epidemiologi
Penelitian multisenter: lulus kaji etik
semua senter, kecuali sepakat menunjuk
1 komisi etik
Penelitian dana luarnegeri : lulus kaji
etik negara donor & negara penerima
Anggota tim kaji etik dari masyarakat
awam mewakili kepentingan masyarakat
yang diteliti

Kaji Etik
Penelitian Epidemiologi (2)
Menjaga keseimbangan antara
perspektif individu & masyarakat
Mencegah ekploitasi kelompok rentan
Bila menggunakan kontrol, kaji etik
menjamin kelompok kontrol tidak
dirugikan
Menjamin adanya kompensasi bagi
subjek bila mengalami kerugian

Pedoman bagi penulis di

jurnal ilmiah

Artikel penelitian berisi hasil penelitian asli dalam ilmu

kedokteran dasar maupun terapan dan subjek kesehatan
pada umumnya

Deklarasi Helsinki :
Makalah penelitian yang
diterbitkan harus memperoleh
persetujuan komite etik penelitian

Publikasi

Bull World Health Organ. 2004 Dec;82(12):914-22. Epub 2005 Jan 5.

Respiratory syncytial virus infection: denominator-based studies in Indonesia,
Mozambique, Nigeria and South Africa.
Robertson SE, Roca A, Alonso P, Simoes EA, Kartasasmita CB, Olaleye DO, Odaibo GN,
Collinson M, Venter M, Zhu Y, Wright PF.
Vaccines and Biologicals, Department of Immunization, World Health Organization, 1211
Geneva 27, Switzerland. robertsons@who.int
OBJECTIVE: To assess the burden of respiratory syncytial virus (RSV)-associated lower
respiratory infections (LRI) in children in four developing countries. METHODS: A WHO
protocol for prospective population-based surveillance of acute respiratory infections in
children aged less than 5 years was used at sites in Indonesia, Mozambique, Nigeria and
South Africa. RSV antigen was identified by enzyme-linked immunosorbent assay
performed on nasopharyngeal specimens from children meeting clinical case definitions.
FINDINGS: Among children aged < 5 years, the incidence of RSV-associated LRI per
1000 child-years was 34 in Indonesia and 94 in Nigeria. The incidence of RSVassociated severe LRI per 1000 child-years was 5 in Mozambique, 10 in Indonesia, and 9
in South Africa. At all study sites, the majority of RSV cases occurred in infants.
CONCLUSION: These studies demonstrate that RSV contributes to a substantial but
quite variable burden of LRI in children aged < 5 years in four developing countries. The
possible explanations for this variation include social factors, such as family size and
patterns of seeking health care; the proportion of children infected by human
immunodeficiency syndrome (HIV); and differences in clinical definitions used for
obtaining samples. The age distribution of cases indicates the need for an RSV vaccine
that can protect children early in life. PMID: 15654405 [PubMed - indexed for
MEDLINE]

Infect Dis. 2010 Feb 15;201(4):553-7.

Mycobacterium tuberculosis Beijing genotype is an independent risk factor
for tuberculosis treatment failure in Indonesia.
Parwati I, Alisjahbana B, Apriani L, Soetikno RD, Ottenhoff TH, van der
Zanden AG, van der Meer J, van Soolingen D, van Crevel R.
Department of Clinical Pathology, Hasan Sadikin Hospital, Medical Faculty,
Universitas Padjadjaran, Bandung, Indonesia.
Animal studies have shown that the globally emerging Beijing genotype strains
of Mycobacterium tuberculosis are more virulent than other strains. We
examined whether Beijing strains increase treatment failure in a prospective
cohort study in Indonesia. Among 818 tuberculosis cases, positive sputum
culture results after 6 months of treatment were more common among
patients infected with Beijing strains (33.4%) than among those infected with
non-Beijing strains (relative risk, 1.94 [95% confidence interval, 1.26-3.00]),
even after adjustment for differences in drug resistance. These data suggest
that M. tuberculosis Beijing genotype strains have a higher capacity to
withstand tuberculosis treatment, even in the absence of drug resistance.
PMID: 20064071 [PubMed - in process]

J Obstet Gynaecol (Tokyo 1995). 1995 Oct;21(5):475-81.

Maternal and Perinatal Mortality/Morbidity Associated
with Cesarean Section in Indonesia
Firman F. Wirakusumah
Department of Obstetrics and Gynecology, School of Medicine,
Padjadjaran University, Bandung, Indonesia

Abstract
Objectives: To compare the frequencies of maternal mortality and perinatal mortality, and
severe morbidity among cases of cesarean delivery.
Study Design: A cohort study, the outcome of major interest (cesarean section) being evaluated
retrospectively and the cohort being hospital-based and actually covering a 10-year period. six
hundred sixty-three cesarean deliveries out of a total of 7,128 births in the period 1981-1983
and 761 out of 8,534 in 1988-1990 were analyzed. Chi-square statistical analysis and Linear
regression analysis were used.
Result : The maternal mortality was 985.7/100,000 live births and 757.5/ 100,OOO live births
in period I and 11, respectively. Perinatal mortality in the two periods was 125.6 per 1,OOO
live births and 90.8 per 1,OOO live births, respectively. Although the cesarean birth rate did
not increase, there was a decrease in maternal and perinatal mortality. The study demonstrated
that although overall maternal mortality was high, the fatality rate in cesarean delivery was low:
4.5 and 2.6 per 1,000 cesarean sections in period I and 11, respectively.
Conclusions : Maternal mortality and perinatal mortality following cesarean delivery
were more related to maternal illness rather than the surgery.
Key words: cesarean section, maternal mortality perinatal mortality, fatality rate

Research article
A comparison of cryopreservation methods: Slow-cooling vs. rapid-cooling based on cell viability, oxidative stress,
apoptosis, and CD34+ enumeration of human umbilical cord blood mononucleated cells
Tono Djuwantono1,2*, Firman F .Wirakusumah1, Tri H Achmad2, Ferry Sandra3, Danny Halim2 and Ahmad Faried
Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran-Dr. Hasan Sadikin General Hospital,
Bandung, Indonesia
2
Stem Cell Working Group, Faculty of Medicine, Universitas Padjadjaran-Dr. Hasan Sadikin General Hospital, Bandung,
Indonesia
3
Stem Cell and Cancer Institute, Jakarta, Indonesia
BMC Research Notes 2011, 4:371doi:10.1186/1756-0500-4-371
Published: 26 September 2011
1

Abstract
Background
The finding of human umbilical cord blood as one of the most likely sources of hematopoietic stem cells offers a less invasive
alternative for the need of hematopoietic stem cell transplantation. Due to the once-in-a-life time chance of collecting it, an
optimum cryopreservation method that can preserve the life and function of the cells contained is critically needed.
Methods
Until now, slow-cooling has been the routine method of cryopreservation; however, rapid-cooling offers a simple, efficient,
and harmless method for preserving the life and function of the desired cells. Therefore, this study was conducted to
compare the effectiveness of slow- and rapid-cooling to preserve umbilical cord blood of mononucleated cells suspected of
containing hematopoietic stem cells. The parameters used in this study were differences in cell viability, malondialdehyde
content, and apoptosis level. The identification of hematopoietic stem cells themselves was carried out by enumerating CD34 +
in a flow cytometer.
Results
Our results showed that mononucleated cell viability after rapid-cooling (91.9%) was significantly higher than that after slowcooling (75.5%), with a p value = 0.003. Interestingly, the malondialdehyde level in the mononucleated cell population after
rapid-cooling (56.45 M) was also significantly higher than that after slow-cooling (33.25 M), with a p value < 0.001. The
apoptosis level in rapid-cooling population (5.18%) was not significantly different from that of the mononucleated cell
population that underwent slow-cooling (3.81%), with a p value = 0.138. However, CD34+ enumeration was much higher in the
population that underwent slow-cooling (23.32 cell/l) than in the one that underwent rapid-cooling (2.47 cell/l), with a p
value = 0.001.

Hubungan penguasaan kompetensi Asuhan Persalinan Normal (APN)

dengan pengetahuan dan sikap bidan dalam pelaksanaan
pertolongan persalinan normal di Kabupaten Jombang, Jawa Timur
H. Nawangsari. DK Sunjaya, FF Wirakusumah
Program Studi Magister Kebidanan Fakultas Kedokteran Universitas Padjadjaran Bandung

ABSTRAK
Tujuan: Memperoleh informasi mengenai hasil Pelatihan Asuhan Persalinan Normal (APN) pada
bidan di Kabupaten Jombang, Jawa Timur.
Rancangan/rumusan data: Rancangan penelitian ini menggunakan metode survei eksplanatoris,
terhadap pengetahuan dan sikap bidan dalam pelaksanaan pertolongan persalinan normal. Data
dikumpulkan secara potong silang. Subjek penelitian 199 orang responden. Analisis data
menggunakan prosedur analisis korelasi rank-Spearman, uji Mann- Whitney dan uji Fisher.
Hasil: Pada penelitian ini didapatkan bahwa pengetahuan berkorelasi positif dengan tingkat
pendidikan: (r = 0,233; p = 0,01). Sikap berkorelasi positif dengan masa kerja (r = 0,161; p
= 0,02) dan pengetahuan bidan (r = 0,3595; p = 0,00). Kompetensi bidan pasca APN
berpengaruh secara bermakna terhadap pengetahuan (p < 0,05) dan sikap bidan dalam
pelaksanaan pertolongan persalinan normal (p < 0,01). Kesimpulan: Pengaruh APN dalam
penguasaan kompetensi terhadap perubahan pengetahuan dan sikap bidan dalam memberikan
pelayanan tampak jelas. Perlu penelitian lebih lanjut dengan melihat beberapa faktor lain yang
relevan untuk menjawab peran bidan dalam memberikan pelayanan kesehatan ibu dan anak
secara umum.
Kata kunci: kompetensi bidan, asuhan persalinan normal, pengetahuan
[Maj Obstet Ginekol Indones 2009; 33-1: 3-7]

JIKK Vol. 4, No 2, 2013 : 9 -17

KORELASI KUNJUNGAN ANTENATAL CARE BURUH PABRIK
DENGAN HASIL LUARAN BAYI DI KABUPATEN KUDUS
Nasriyah, Yoni F. Syukriani, Firman F. Wirakusumah

ABSTRAK
Latar Belakang : Hasil luaran bayi merupakan hasil dari kehamilan yang dapat berupa hasil
luaran menguntungkan dan tidak menguntungkan. Kunjungan Antenatal care (ANC) yang
adekuat dan berkualitas dipercaya dapat mencegah terjadinya hasil luaran yang tidak
menguntungkan.
Tujuan : penelitian ini adalah untuk menganalisis kunjungan ANC buruh pabrik dengan hasil
luaran bayi yang tidak menguntungkan. Penelitian ini dilakukan di Kabupaten Kudus dari bulan
Februari - April 2013 dengan rancangan penelitian potong lintang dan didapatkan 92
responden.
Metode :Analisis dilakukan secara bivariabel dengan menggunakan uji Rank Spearman,
Hasil penelitian : menunjukkan ada korelasi antara kunjungan ANC dengan hasil luaran bayi,
untuk jumlah kunjungan (r=0,206., p=0,049) dan waktu kunjungan (r= - 0,455., p=0,000).
Simpulan: dalam penelitian ini adalah jumlah dan waktu kunjungan ANC berkorelasi dengan
hasil luar
an bayi, semakin banyak jumlah kunjungan ANC semakin baik hasil luaran bayi dan semakin
terlambat waktu kunjungan ANC semakin jelek hasil luaran bayi.
Kata kunci : Buruh pabrik rokok, hasil luaran bayi, Kunjungan ANC

Jurnal Pendidikan Kedokteran Indonesia ; Vol. 2 | No. 2 | Juni 2013

Kontribusi Stresor dan Motivasi Kerja Terhadap Kinerja Tenaga Kependidikan Berdasarkan Uraian Tugasnya di
Institusi Pendidikan Kesehatan Karya Husada Kediri
(Sebuah Analisis Jalur)
Wahyu Nuraisya, Firman F. Wirakusumah, Tina Dewi Judistiani
Fakultas Kedokteran Universitas Padjadjaran, Bandung

Abstract
Background : Quality of management education is an important aspect for the continuity of education and the
acquisition of quality outcomes. Human resource management requires good performance of educational
personnel in providing services to students and the lecturers themselves supporting the implementation of
tasks.For the lecturers, the demand of task implementation is sort of a stressor. A good motivation well-achieved
the performance of educational personnel.
Aim: This study aims to determine the corelation of stressors and motivation of the lecturers performance based
on job descriptions in the work of health education institution Karya Husada Kediri.
Method: This study is an analytical research correlated with cross-cutting approach. The population is all
educational personnel in health education institution Karya Husada Kediri. Study sample was 50 educational staff
with a total population of the technique. Collecting date using questionnaire.
Discussion: The results of correlation analysis using Pearson test found that work stressors negatively correlated
(r= -0.315) with the performance, and there is a positive correlation (r=0.408) between work motivation and
performance. The results of analysis using path analysis showed a influence between stressors and simultaneously
with the performance of work motivation with square values of r=0.359 and the influence of other variables that
are not observed at 0.641.
Conclusion: Low work stressors and highly motivation could raise the performance of the educational personnel at
health education institute Karya Husada Kediri so in that way there is much more thing to do how to deal with work
stressors and motivational improvement to gain better performance.
Keywords: performance, work motivation, job stressors, educational personnel, job descriptions

Jurnal Orasi Bisnis Edisi ke-VIII, November 2012. ISSN: 2085-1375

KORELASI KEPEMIMPINAN DENGAN KOMITMEN DAN LINGKUNGAN
KERJA DOSEN BERDASARKAN KRITERIA MALCOLM BALDRIGE
(Suatu Survei Eksplanatori Pada Dosen Program Studi D3 Kebidanan di Propinsi Daerah Istimewa Yogyakarta)
Hesty Widyasih, Mamun Sutisna, Firman F. Wirakusumah
Abstract
Leadership in the field of midwifery diploma 3 hopefully can bring to positive change, the increase of
organization quality which is a place of midwife graduates will exist in society. Leadership factor will
facilitate to build high work commitment and good work environment. Malcolm Baldrige criteria is a work
management system that can measure leadership, work commitment and work environment. This study aims to
analyze correlation between leadership with work commitment and environment based on Malcolm Baldrige
Criteria. Research design using analytic correlative study with explanatory survey. This study is quantitative
research with crosssectional study. Subject of this study is 60 lecturers of diploma 3 midwifery in Province
DIY.
The research was conducted in March-April 2011 using questionnaire based on Malcolm Baldrige
Criteria. Data reasearch was analized by Rank Spearman and Chi Square with level of significant
based on p value<0,05.
There is positive correlation between leadership and work commitment (rs=0,740, p value <0,001). Leadership
has positive correlation with work environment as shows rs=0,719 and p value<0,001. The chi square result of
leadership and work commitment and environment corellation shows p value<0,001. The more effective
leadership the higher work commitment. Also the more effective leadership the better work environment. Age
and work experience have no correlation with variable in this study. Marital status shows no difference
between respondent who are married and unmarried. Leadership has positive correlation with
lecturers work commitment and work environment based on Malcolm Baldrige Criteria.
Keywords : Leadership, Malcolm Baldrige Criteria, Work commitment, Work environment

Majalah Kedokteran Bandung (MKB) Vol. 42 No. 3, 2010

Polimorfisme C1167T Gen Reseptor Tipe II Transforming Growth Factor-,
Kadar Soluble Endoglin, dan Vascular Cell Adhesion Molecule-1 pada Preeklamsia

Anita D. Anwar, Tri Hanggono Achmad, Sofie R. Krisnadi, Firman F. Wirakusumah

Abstrak
Transforming growth factor- (TGF-) diduga berperan pada preeklamsia. Reseptor TGF- tipe
II (TR-II)dihasilkan dari transkripsi gen TGF- receptor type II (TGFBR2). Polimorfisme gen
TGFBR2 pada basa C1167Tdapat menyebabkan hipoksia yang menginduksi iskemia serta
meningkatkan produksi solubel endoglin (sEng) danvascular cell adhesion molecule-1 (VCAM-1).
Tujuan penelitian ini untuk mengetahui korelasi polimorfisme genTGFBR2 pada basa C1167T
dengan kadar sEng dan VCAM-1 ibu preeklamsia. Subjek adalah ibu preeklamsia usia kehamilan
2842 minggu dan kehamilan normal sebagai kontrol, masing-masing 120 orang. Penelitian
dilakukan diRumah Sakit Hasan Sadikin, Bandung, September 2008Mei 2009. Sampel berupa
darah vena, pemeriksaanpolimorfisme dilakukan dengan DNA Wizard genomic DNA purification,
kadar sEng dan VCAM-1 dengan imunoesai. Hasil penelitian menunjukkan polimorfisme CT pada
kelompok preeklamsia 92 (76,7%) dan kontrol 70(58,3%) {p<0,001; OR (95%CI): 2,35 (1,30
4,26)}. Kadar sEng (ng/mL) 12,46 berbanding 10,29 pada kelompokkontrol {p<0,001; OR
(95%CI): 3,71 (2,116,57)}. Kadar VCAM-1 berbeda bermakna, yaitu 1.218,43
berbanding705,59 {(p<0,001; OR (95%CI): 7,56 (4,1114,0)}. Disimpulkan terdapat perbedaan
proporsi dan korelasipolimorfisme C1167T gen TGFBR2, kadar sEng, dan VCAM-1 antara
preeklamsia dan kehamilan normal.
Kata kunci: Polimorfisme gen TGFBR2, preeklamsia, sEng, VCAM-1

[MKB. 2010;42(4):16974].
Peran Siklooksigenase dalam Pertumbuhan Kanker Leher Rahim
Supriadi Gandamihardja, Firman F. Wirakusumah, Nurhalim Shahib, Herri S. Sastramihardja, M.
Farid Aziz
Abstract
Ekspresi dan penghambat selektif siklooksigenase-2 (COX-2), seperti selekoksib yang telah dipakai
luas sebagaiantiinflamasi, diketahui berperan pada kanker dengan menghambat proliferasi dan
pertumbuhan tumor sertameningkatkan apoptosis. Tujuan penelitian ini untuk mengetahui pengaruh
penghambat COX-2 selektif dan peran COX-2 pada pertumbuhan tumor. Metode penelitian adalah
uji eksperimental dengan pretest-posttest control groupdesign yang dilakukan di Rumah Sakit
Hasan Sadikin Bandung, November 2007Oktober 2008. Dua puluh pasiendiberi penghambat
selektif COX-2 serta kemoradiasi dan 21 pasien mendapat kemoradiasi saja. Dilakukan pemeriksaan
COX-2, Ki-67, kaspase-3 secara imunohistokimia, serta ukuran serviks dengan USG
transabdominal,praradiasi dan pascaradiasi. Data dianalisis dengan tes Wilcoxon dan korelasi
Pearson. Penghambat COX-2 selektifmengakibatkan penurunan sangat bermakna tingkat ekspresi
COX-2, yaitu 10% pada kelompok kontrol dan 42%pada kelompok perlakuan (p=0,001), serta
ekspresi Ki-67 sebagai penanda proliferasi sebanyak 48% dan -3% pada kelompok kontrol
(p=0,007). Tingkat ekspresi kaspase-3 sebagai penanda apoptosis meningkat dengan
pemberianpenghambat COX-2 selektif sebesar -59% dan 16% pada kelompok kontrol (p<0,001).
Penghambat COX-2 selektifjuga menyebabkan bertambahnya pengecilan tumor, yaitu: 88%
dibandingkan dengan 83% pada kelompok kontrol(p<0,001). Simpulan, COX-2 berperan dalam
kanker leher rahim dan penghambat COX-2 selektif menurunkan proliferasi dan meningkatkan
apoptosis, sehingga terjadi pengecilan tumor.
Kata kunci: Apoptosis, COX-2, kanker leher rahim, penghambat COX2 selektif, pertumbuhan tumor

Research Article ISSN: 2319 9563

ROLE OF CHLOROGENIC ACID FROM LAMPUNG ROBUSTA COFFEE AGAINST GENE EXPRESSION OF MIRNA
(MICRO RNA) 146 A ON HEPATOCELLULAR CARCINOMA CELLS
Asep Sukohar, Hening Herawati, Arief B. Witarto, Setiawan,
Firman F. Wirakusumah, Herry S. Sastramihardja

ABSTRACT
The use of herb to cure cancer takes a concrete breakthrough. It means that it is very essential to have a
development on herb referring to a standar quality, efficacy and safety. Therefore, we need an analysis against the
mechanism of herb on molecular level.
Chlorogenic Acid (CA) is an active compound isolated from traditional plants from robusta coffee that is used as a
chemopreventive therapy Hepatocellular Carcinoma (HCC), allegedly works as an anticancer and prevents the cell
from destruction, also inhibits the growth of the cancer cells through the inhibition of free radicals. The research
was done by in vitro, by using the Cell Lines Hep-G2 series 1886, obtained from Riken Cell Bank-Tohoku University.
The aim of the research is how to understand the mechanism of CA in inhibiting HCC growth by using the model of
Cell Lines Hep-G2 series 1886 through a series of gene expression. The type of research is experimental on 72
sample groups. 1 group consists of 250 thousands cancer cells. The research uses 3 doses of CA: 727, 500 and 250
M, with 3 times repeated measurement, and then compared after and before the exposure. The role of those doses
CA against Hep-G2 is analysed by comparing the expression of miRNA 146 A, before and after the exposure on 0, 8,
18 and 24 hours. The data is tested statistically with different test, t, repeated measurement, pearson and multiple
linear regression.The lowest expression decrease of miRNA 146 A happened in the group 24 hours after the
exposure at doses of 727 M CA (0.85), followed by 500 M (1.28) and the highest expression increase happened at
a dose of 250 M (1.61), continued with a statistical test at the 8 th and the 18th hour Cq values miRNA 146 A
significant difference p<0.05 at all doses CA (727,500 and 250 M). The conclusion of the research is CA plays the
important role on the reduction of miRNA 146 A expression.
KEYWORDS : Chlorogenic Acid, Hepatocellular Cancer and miRNA 146 A.

International Journal of Research in Pharmaceutical and Nano Sciences 2(6), 2013, 776 - 84.

Research article
A comparison of cryopreservation methods: Slow-cooling vs. rapid-cooling based on cell viability, oxidative stress,
apoptosis, and CD34+ enumeration of human umbilical cord blood mononucleated cells
Tono Djuwantono1,2*, Firman F .Wirakusumah1, Tri H Achmad2, Ferry Sandra3, Danny Halim2 and Ahmad Faried
Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran-Dr. Hasan Sadikin General Hospital,
Bandung, Indonesia 2 Stem Cell Working Group, Faculty of Medicine, Universitas Padjadjaran-Dr. Hasan Sadikin General
Hospital, Bandung, Indonesia 3 Stem Cell and Cancer Institute, Jakarta, Indonesia
BMC Research Notes 2011, 4:371doi:10.1186/1756-0500-4-371
Published: 26 September 2011
Abstract
Background
The finding of human umbilical cord blood as one of the most likely sources of hematopoietic stem cells offers a less invasive
alternative for the need of hematopoietic stem cell transplantation. Due to the once-in-a-life time chance of collecting it, an
optimum cryopreservation method that can preserve the life and function of the cells contained is critically needed.
Methods
Until now, slow-cooling has been the routine method of cryopreservation; however, rapid-cooling offers a simple, efficient,
and harmless method for preserving the life and function of the desired cells. Therefore, this study was conducted to
compare the effectiveness of slow- and rapid-cooling to preserve umbilical cord blood of mononucleated cells suspected of
containing hematopoietic stem cells. The parameters used in this study were differences in cell viability, malondialdehyde
content, and apoptosis level. The identification of hematopoietic stem cells themselves was carried out by enumerating CD34 +
in a flow cytometer.
Results
Our results showed that mononucleated cell viability after rapid-cooling (91.9%) was significantly higher than that after slowcooling (75.5%), with a p value = 0.003. Interestingly, the malondialdehyde level in the mononucleated cell population after
rapid-cooling (56.45 M) was also significantly higher than that after slow-cooling (33.25 M), with a p value < 0.001. The
apoptosis level in rapid-cooling population (5.18%) was not significantly different from that of the mononucleated cell
population that underwent slow-cooling (3.81%), with a p value = 0.138. However, CD34+ enumeration was much higher in the
population that underwent slow-cooling (23.32 cell/l) than in the one that underwent rapid-cooling (2.47 cell/l), with
a p value = 0.001.
1

International Journal of Integrated Health Sciences, Vol 2, No 1 (2014)

Correlation between Protein-with-Molecular-Weight-53 (p53), Burkit Cell Lymphoma 2 (Bcl2),

and Fas Ligand (FasL) and Vascular-Cell-Adhesion-Molecule-1 (VCAM-1) mRNA Expression
Levels in a Pathogenesis Study of Preeclampsia
Mintareja Teguh, Made Kornia Karkata, Firman Fuad Wirakusumah, Johanes Cornelius Mose,
Mieke Hemiawati Satari, Leri Septiani

Abstract

Objective: To determine the role of protein-with-molecular-weight-53 (p53), burkit cell lymphoma 2

(Bcl2), Fas ligand (FasL) mRNA, and vascular cell adhesion molecule 1 (VCAM-1), known as the
apoptosis-related molecular pathway, in preeclamptic patients.

Methods: Observation on the correlation between the mRNA levels of p53, Bcl2 and FasL and VCAM-1
in 31 subjects at 28-42 weeks gestational age was med in this study using the real time reverse
transcriptase-polymerase chain reaction (RT-PCR).

Results: The results showed that p53 mRNA increased (>1.2350 ng/L) in the preeclampsia group
compared to the normal pregnancy group (p=0.010), Bcl2 mRNA was lower (0.9271 ng/L) in the
preeclampsia group than the control group (p=0.041). There was also a tendency of increased FasL
mRNA expression (>0.5509 ng/L) in the preeclampsia group compared to the normal pregnancy group
(p=0.300). The level of VCAM-1 elevated (>890.08 ng/mL) in the preeclampsia group compared to the
normal pregnancy group (p=0.001). In preeclampsia, the correlation between the Bcl2/p53 ratio and
VCAM-1 was r=0.541 (p=0.002), whereas the correlation in normal pregnancy was r=0.099 (p=0.595).

Conclusions: There are correlations between the mRNA expression levels of p53 and Bcl2 as an
intrinsic pathway of apoptosis along with the VCAM-1 levels in the incidence of preeclampsia.
However, no correlation is found between FasL mRNA expression and the incidence of preeclampsia.

Keywords: Bcl2, FasL, p53, Preeclampsia, VCAM-1

International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Issue 8, 2014

MIR-423-3P USED AS REFERENCE GENE FOR MIRNA 146 A IN CELL LINES HEP-G2
Assep Sukohar, Hening Herawati, Arief B. Witarto, Hendra T. Sibero, Setiawan,
Firman F. Wirakusumah, Herry S. Sastramihardja

ABSTRACT
Objective: We explored the stable reference genes for miRNA 146 A by RT-PCR in the cell lines
Hep-G2 that were treated chlorogenic acid. We must do a series of tests in order to get a
reference genesBased on the literature there are 7 candidates recommended reference
genesmir3p, 5p, 103, 21, and let-We conducted using four candidates reference genemir3p, 16, and .
; -423-423-, 19116, 7a. ; -423-103, 21.
Methods: In vitro study was performed in Hep-G2 cells. The samples were divided into control
group and experiment group treated with 727M chlorogenic acid. Samples were analyzed at 0, 2, 8,
18, and 24 hours after beingtreated with chlorogenic acid.
Total RNA was isolated from Hep-G2 with RNA extraction kit (miRCURYTM RNA Isolation Kit-Cell
and plant Exiqon, Code Number 300110) and reverse transcribed to cDNA with Primerscript RT
Reagent Kit (miRCURY LNATM Universal RT microRNA PCR, Polyadenylation and cDNA synthesis kit
Exiqon, Code Number 203300). The primers for miRNA 146 A were Code Number 204688 from
Exiqon (forward and reverse), and quantitative real time reverse transcription polymerase chain
reaction was performed using SYBR Master Mix with Code Number 203450 (Exicon). MiRNA
profiling was performed in four pairs of mir, consist of; mir-423-3p, 103, 21, and mir-16. By using
the mean expression value of all expressed mir, we identified the most stable candidate reference
genes for subsequent validation with normfinder software.
Results: Data from RT-PCR were analyzed using Normfinder software. We found out that mir
expression with good stablity is mir-103 and the best combination from two genes are mir-103 and
mir-423-3p. Finally mir-423-3p is found more stable than mir-16, 21, and 103.
Conclusion:
We conclude the stable reference genes for miRNA 146 A treated with chlorogenic acid is mir-233p.
Keywords: Chlorogenic acid, Hep-G2, Mirna 146 AReference genes, mir-423-3p, Reference genes.

Waktu
Dua minggu sekali rapat pleno bulanan
(Full Board Meeting), dari usulan penelitian
yang dibagi 3 Divisi :
1) Ilmu Kedokteran Dasar, 2) Uji Klinik dan
3) Penelitian Komunitas
Penelitian Strata 0 - 3, Perusahaan Farmasi,
Institusi pendidikan: FK Unpad dan
Institusi Pendidikan lain)
Lain - lain

Good Clinical Practice (GCP)

Cara Uji Klinik Yang baik (CUKB)

Cara Uji Klinik

GCP Certificate
Yang baik (CUKB)

FAKULTAS KEDOKTERAN
UNIVERSITAS PADJADJARAN
BANDUNG
KOMISI ETIK PENELITIAN KESEHATAN
HEALTH RESEARCH ETHICS COMMITTEE
Jl. Eijkman No. 38 # 3, Bandung 40161
web: www.kepk.fk.unpad.ac.id
E-mail : erc.fkunpad@yahoo.com
Afiliasi : Komisi Nasional Etik Penelitian Kesehatan (KEPK)
NIH-USA: IORG-IRB Number: 00008626,
FWA for the Protection of Human Subject: 00018324
FERCAP Accredited

Mekanisme Seminar Usulan Penelitian

Kesehatan Terpadu (S2)
Proposal penelitian (Akademik+Etik)

Undangan seminar (Ketua PPs+Komite Etik)

Ujian Terpadu Akademik dan Etika Penelitian

Rapat penilaian

Izin meneliti + ethical clearance/approval

Sanur Beach Hotel, Bali

17-20 November 2013

Konsultan
Konsultan Independen
Independen
N
o

Nama

1
2
3
4
5
6
7
8
9
10
11

Dr. Ike Sri Redjeki, dr., SpAn-KIC, KMN,M.Kes

Prof. Dr. Tatang Bisri, dr., SpAn-KNA
Dr. Diah Dhianawaty, Dra., M.Si
Prof. Dr. M. Nurhalim Shahib, dr
Dr. Achadiyani, dr., M.Kes
Dr. Hadyana Sukandar, Drs., M.Sc
Dr. Rd. Tina Dewi Judistiani, dr., SpOG
Dr. Ahmad Muhtadi, MS., Apt
Prof. Dr. Anas Subarnas, M.Sc., Apt
Dr. Eriska Riyanti, drg., SpKGA
Dr. Mieke Hemiawati Satari,drg.,MS
Prof. Dr. Herri S. Sastramihardja, dr.,
12
SpFK(K)
13 Prihatini Ambaretnani, Dra., MA., Ph.D
Dr. Hermawan N. Rasyid, dr., SpOT-K.,
MT(BME)., FICS
Prof. Dr. Fachry Ambia Tandjung, dr., SpB.,
15
SpOT-K, M.Phil(Orth)., FICS
14

Spesialisasi

Afiliasi

Anesthesiology
Aneshtesiology
Biochemistry
Biochemistry
Cell Biology
Epidemiology
Epidemiology
Pharmacy
Pharmacy
Dentist
Dentist

FKUP/ FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
Pharmacy Unpad
Pharmacy Unpad
Dentistry Unpad
Dentistry Unpad

Pharmacology

FMUP

Sociology
Orthopaedics
Orthopaedics

Social & Political

Science
Dr. Hasan Sadikin
Hospital
Dr. Hasan Sadikin
Hospital

N
o

Name

17 Dr. Bambang S. Noegroho, dr., SpB., SpU

Background
Surgeon

18 Prof. Dr. Hendro Sudjono Yuwono, dr., Sp.B-KBV

Surgeon
Dr. R. Reni Farenia Soedjana Ningrat, dr.,
19
Physiology
M.Kes., AIF
Dr. Vita Murniati Tarawan,
Obstetrics &
20
dr.,SpOG.,AIFO.,M.Kes.,SH
Gynaecology
21 Dr. Dewi Marhaeni Diah Herawati, drg., M.Si
Nutrition
22 Dr. Hadi Susiarno, dr., SpOG., M.Kes., MH.Kes
Obstetrics & Gynaecology
23 Prof. Dr. Johanes C.Mose, dr., SpOG-K
Obstetrics & Gynaecology
24 Prof. Dr. Tuti Wahmurti Arie Sapiie, dr., SpKJK
Psychiatry
25 Dr. Meita Dhamayanti, dr., SpA(K)., M.Kes
Paediatrician
26 Prof. H. Herry Garna, dr., SpA-K., Ph.D
Paediatrician
Dermatology & Venereal
27 Dr. Oki Suwarsa, dr., SpKK (K)., M.Kes
Dis
28 Dr. Elsa Pudji Setiawati, dr.,MM
Public Health
Dr. Arief Syamsulaksana K, dr., SpM(KVR).,
29
Ophtalmology
MM., M.Kes
30 Dr. Sutarya Enus.,dr., SpM-K
Ophtalmology
Dr. Ratna Anggraeni Agustian., dr., M.Kes..,
31
ENT
SpTHT-KL(K)
32 Dr. Arto Yuwono Soeroto, dr., SpPD-KP
Internal Medicine
Prof. Dr. H. M. Rachmat Soelaeman, dr., SpPD33
Internal Medicine
KGH
34 Dr. Anam,dr., SpS
Neurology
35 Dr. Sadeli Masria,dr.,DMM.,MS.,SpMK
Microbiology
36 Herry Herman, dr., PhD., SpOT
Molecular Biology

Affiliation
Dr. Hasan Sadikin
Hospital
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP
FMUP

Staf
Kantor
Administrasi
Staf Kantor Administrasi
Kaur :

Ipur Purwatiningsih

Staf:

(September, 2013)

Cicih Carnasih (Maret, 2014)

Ade Komarudin (Maret, 2014)
Sita Purnadewi (staf IT) (Maret, 2014)

INFRASTRUCTURE : Program/activities ICT system

Development of Networking System provide complex
infrastructure network between FMUP; departments, libraries
and administration inside into global network
Global
Network

Hospital
Network

UNPAD

FMUP

RSHS

RSMC

Proses
Proses mengajukan
mengajukan Izin
Izin Penelitian
Penelitian online
online
kepk.fk.unpad.ac.id
kepk.fk.unpad.ac.id

Pelatihan
yang
telah
diadakan
Pelatihan yang telah diadakan

Kantor
Kantor Administrasi
Administrasi KEPK
KEPK FK
FK Unpad
Unpad
Alamat :

Gedung RS Pendidikan 3rd floor

Jl. Eijkman No. 38,
Bandung 40161
INDONESIA
Tel/Fax (direct): +62-222038697
email: kepk.fk.unpad@gmail.com
Information system (URL):
kepk.fk.unpad.ac.id

Laporan Kegiatan 2014

LAPORAN KEMAJUAN ETIK

PERIODE JANUARI - MARET 2015

JUMLAH 241

LAPORAN KEMAJUAN ETIK

PERIODE JANUARI - MARET 2015

LAPORAN KEMAJUAN ETIK

PERIODE JANUARI - MARET 2015

LAPORAN KEMAJUAN ETIK

PERIODE JANUARI - MARET 2015

FERCAP ACCREDITED

Tagaytay City - THE PHILIPPINES 2014

FERCAP ACCREDITED

Tagaytay City - THE PHILIPPINES 2014

SIMPULAN
Aspek Etik penting yang perlu diperhatikan dalam
Penelitian Kesehatan, dibahas :
Tujuan Umum Penelitian dibidang Kesehatan :
Filsafat Penelitian, aturan perundang-undangan, komisi etik di
Indonesia, prinsip etik secara umum dan khusus: subjek
manusia, hewan coba, objek: BBT, tanaman obat/batantra,
penelitian Epidemiologi, kerjasama penelitian dengan Luar
Negeri (MTA)
Tujuan Khusus pada Subjek Manusia :
Subjek dipilih secara adil, manfaat & beban sesuai, Prosedur PSP
adekuat, Privasi subjek & kerahasiaan data terjaga, risiko
diminimalkan & manfaat melebihi risiko, ada aturan ketat untuk;
melindungi subjek lemah, prosedur untuk memantau
perlindungan subjek, prosedur penyampaian hasil
Harapan :
Hasil penelitian
dapat Ethical Approval/Clearance untuk di publikasikan dalam
Jurnal Ilmiah di Dalam Negeri maupun di Luar Negeri

Terimakasih