ETIKA PENELITIAN

KESEHATAN
Sumber :
KOMISI ETIK PENELITIAN KESEHATAN
BADAN LITBANG KESEHATAN, 2001

METODOLOGI PENELITIAN
BAGIAN KETUJUH
FKM UNAIR 241108

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LANDASAN NORMATIF

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 1. INTERNASIONAL
1. NUREMBER CODE TAHUN 1947
(UNTUK RINCINYA LIHAT
LAMPIRAN : 1)
2. WORLD MEDICAL ASSOCIATION
DECLARATION OF HELSINKI
TAHUN 1964 (UNTUK RINCINYA
LIHAT LAMPIRAN : 2)

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3. CIOMS (Council for
International Organizations
of Medical Sciences )
TAHUN 1993
4. WHO TAHUN 2000

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 2. NASIONAL

1.PANCASILA
2.UU tentang Kesehatan No.
23/1992
3.PP No. 39 / 1995

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 U.U. No 23/1992
• PENELITIAN DAN PENGEMBANGAN
TERMASUK DALAM SUMBER DAYA
KESEHATAN (PASAL 49 f.)
• PENELITIAN DAN PENGEMBANGAN
DIATUR DALAM PASAL 69 DAN
PASAL 70

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 PASAL 69

1. Penelitian dan pengembangan kcsehatan

dilaksanakan untuk memilih dan menetapkan
ilmu pengetahuan dan teknologi tepat guna
yang diperlukan dalam rangka
meningkatkan derajat kesehatan.

2. Penelitian, pengembangan, dan penerapan

hasil penclitian padamanusia sebagaimana
dimaksud dalam ayat (1) dilaksanakan dengan
memperhatikan norma yang berlaku dalam
masyarakat.

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3. Penyelenggaraan penelitian dan
pengembangan ilmu pengetahuan dan
teknologi kesehatan pada manusia harus
dilakukan dengan memperhatikan
kesehatan dan keselamatan yang
bersangkutan.
4. Ketentuan mengenai penclitian,
pengembangan, dan penerapan hasil
penelitian sebagaimana dimaksud dalam
ayat (1), ayat (2), dan ayat (3) ditetapkan
dengan Peraturan Pemerintah.

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 PASAL 70
1. Dalam melaksanakan penelitian dan pengembangan
dapat dilakukan bedah mayat untuk penyelidikan
sebab penyakit dan atau sebab kematian serta
pendidikan tenaga keschatan.
2. Bedah mayat hanya dapat dilakukan koleh tenaga
kesehatan yang mempunyai keahlian dan
kewenangan untuk itu dan dengan memperhatikan
norma yang berlaku dalam masyarakat.
3. Ketentuan mengenai bedah mayat sebagaimana
dimaksud dalam ayat (1) dan ayat (2) ditetapkan
dengan Peraturan Pemerintah.

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 PP No 39 /1995
• PENGATURAN PENELITIAN DAN
PENGEMBANGAN KESEHATAN :
• DILAKSANAKAN OLEH
PENYELENGGARA PENELITIAN
DAN PENGEMBANGAN KESEHATAN
• DILAKSANAKAN BERDASARKAN
STANDAR PROFESI PENELITIAN
KESEHATAN
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 UU KES 23/1992
PP 39/1995
PP 39/1995: - standar profesi penelitian
- mendapatkan ijin dari yang
berwenang
- PERSETUJUAN TERTULIS
setelah mendapat informasi
UU Kesehatan 23/1992:
menyalahi: denda Rp. 10.000.000
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 PRINSIP ETIKA PENELITIAN
HORMAT PADA MARTABAT MANUSIA
* KESEHATAN
* KESELAMATAN
* KESEJAHTERAAN
* KEADILAN
KAJIAN ETIKA DILAKUKAN OLEH KOMISI ETIK
YANG BERSIFAT:
• INDEPENDEN
• BEBAS DARI PENGARUH :
- POLITIK
- INSTITUSI
- PROFESI
- TUJUAN KOMERSIAL 12
PENELITIAN YANG MEMBUTUHKAN
ETHICAL CLEARANCE
• SEMUA PENELITIAN YANG MENGGUNAKAN
MANUSIA SEBAGAI SUBYEK PENELITIAN

CONTOH :
PENELITIAN FARMASETIKA
ALAT KESEHATAN
RADIASI DAN PEMOTRETAN
PROSEDUR BEDAH
REKAM MEDIS
BIOLOGIK
EPIDEMIOLOGIK
SOSIAL DAN PSIKOSOSIAL
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 ETHICAL CLEARANCE :
SUBYEK BINATANG
PENELITIAN DENGAN SUBYEK
PENELITIAN BINATANG:
- Namru-2 mempunyai Ethics Committee.
- FKH UNAIR mengeluarkan Ethical
Clearance untuk binatang.
- Peneliti Badan Litbangkes menyampaikan
permohonan Ethical Clearance untuk binatang
melalui Komisi Etik Penelitian yang ada.
- Diusahakan anggota Komisi Etik, yang
menguasai etik penelitian pada binatang.
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ANGGOTA KOMISI ETIK
MULTIDISIPLIN:
MEDIS DAN NON MEDIS
PEDULI THD KEPENTINGAN
MASYARAKAT
AWAM (LAY PERSON)
SEIMBANG UNTUK GENDER,
USIA, SOSIAL BUDAYA, DAN
AGAMA
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 SUSUNAN KOMISI ETIK
BADAN LITBANGKES
• DIBENTUK SEJAK TAHUN 1991
• KOMISI ETIK BADAN LITBANGKES (SK KA
BALITBANGKES No. HK.00.06.2.1.803) TH. 2001 :
• Penasehat : 1. Dr. Sri Astuti S. Suparmanto, MSc., PH
2. Prof. DR. Dr. Sri Oemijati
Ketua : Dr. Liliana Kurniawan, MSc., APU
Sekretaris : DR. Sudomo, APU
Anggota : 1. Dr. Ingerani, SKM
2. Dr. Soemartono, DHSA
3. Drs. Ida Bagus Indra Gotama, SKM., MSi
4. Drs. Lukman Hakim ., MSc., Ph.D, Apt
5. Drs. Arum Atmawikarta., SKM., MPH
6. Dr. Agus Suwandono, MPH., Dr.PH., APU
7. Dr. Suriadi Gunawan., DPH., APU 16
 SUSUNAN KOMISI ETIK
BADAN LITBANGKES
Anggota : 8. Dra. Harjani A. Marwoto
9. Dra. Sri Sugati Sjamsuhidajat., MM., Ph.D., APU
10. Dr. Soewarta Kosen., MPH., Dr.PH
11. Dr. Suhardi, MPH
12. Ir. Sri Soewasti Soesanto, MPH., APU
13. DR. Supratman Sukowati
14. Dra. Nani Sukasediati, MS
15. DR. Susilowati Herman
16. DR. Sandjaja, MPH
17. DR. Dr. Dwi Susilowati
Sekretariat : 1. Drs. Tri Djoko Wahono 3. Burman Siahaan
2. Ir. Inswiasri, Mkes 4. Anni Yulianti, SKM
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TANGGUNG JAWAB DAN
TUGAS KOMISI ETIK
1. MELAKUKAN REVIEW PROTOKOL PENELITIAN.
2. MEMBAHAS HASIL REVIEW
3. MENELITI INFORMED CONSENT
4. MEMBERIKAN ETHICAL CLEARANCE
5. MENGEVALUASI PELAKSANAAN PENELITIAN
YANG TERKAIT DENGAN ETIK
6. MENGHADIRI - RAPAT RUTIN 1 X/ BULAN
- BILA DIANGGAP PERLU

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 KELENGKAPAN BERKAS
PENGAJUAN E.C
 SURAT USULAN DARI INSTITUSI
 REKOMENDASI DARI PANITIA ILMIAH SUATU
LEMBAGA.
 PROTOKOL PENELITIAN,
 DAFTAR TIM PENELITI,
 CURRICULUM VITAE PENELITI UTAMA ATAU
KETUA PELAKSANA,
 ETHICAL CLEARANCE DARI INSTITUSI LAIN (BILA
ADA).
 PENJELASAN UNTUK PERSETUJUAN SUBYEK
 KUESIONER / PEDOMAN WAWANCARA (BILA ADA)
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 FORM CHECK LIST
KELENGKAPAN BERKAS PENGAJUAN ETHICAL CLEARENCE
KOMISI ETIK PENELITIAN KESEHATAN BADAN LITBANGKES
No. urut :
Hari/Tanggal :
Institusi :
Nama Peneliti :
Judul Penelitian :

No Persyaratan

1 Surat permohonan dari institusi

2 Protokol Penelitian

3 Penjelasan terperinci tentang tata cara pengambilan sampel

(darah/urine/spesimen lainnya) dan tujuannya, serta manfaat bagi responden

4 Daftar Tim Peneliti beserta keahliannya

CV peneliti utama
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6 Rekomendasi dari scientific board / PPI

7 Informed Consent (fomulir persetujuan)

Naskah penjelasan untuk mendapatkan persetujuan dari subyek penelitian

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9 Ethical Clearence dari institusi lain (bila ada)

10 Kuesioner/ Pedoman Wawancara (bila ada)

Catt : Seluruh berkas dibuat rangkap 3 (tiga).

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 PROSEDUR PENGAJUAN E.C
CEK KELENGKAPAN
USULAN E.C SEKRETARIAT
BERKAS

PPI
LIT. HUMAN SUBJECT LENGKAP TDK LENGKAP

Ka. P.E PENELITI

PROSES PERBAIKAN
ETHICAL REVIEW /KEKRGAN

DITOLAK OK P.E

E.C DITERBITKAN
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 ASPEK-ASPEK YG TERCANTUM DLM
PENJELASAN UTK MENDAPATKAN
PERSETUJUAN SUBYEK
1. Latar belakang penelitian
2. Berapa lama dan berapa banyak subyek
penelitian diperlukan
3. Perlakuan terhadap subyek
4. Kemungkinan risiko kesehatan
5. Penjelasan kompensasi bagi subyek
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ASPEK-ASPEK YG TERCANTUM DLM
PENJELASAN UTK MENDAPATKAN
PERSETUJUAN SUBYEK
6. Penjelasan terjaminnya rahasia subyek
7. Pengobatan medis dan ganti rugi apabila perlu
8. Nama jelas dan alamat penanggung jawab
medis
9. Partisipasi haruslah bersifat sukarela, setiap
saat subyek dapat mengundurkan diri
10. Kesediaan dari subyek penelitian
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 PEMANTAUAN PELAKSANAAN
PENELITIAN OLEH KOMISI ETIK

• PEMANTAUAN BERKALA PERLU

DILAKSANAKAN OLEH KOMISI
ETIK
• KOMISI ETIK BADAN LITBANGKES
MEMINTA DIKIRIMKAN LAPORAN
PELAKSANAAN KEJADIAN YANG
BERKAITAN DENGAN ETIK,
SEPERTI EFEK SAMPING, KEJADIAN
YANG TIDAK DIHARAPKAN.
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 MENGAPA E.C PERLU ?
* BAGI SUBYEK :
KEPASTIAN PERLINDUNGAN HAM
• BAGI PENELITI :
1. MENGHINDARI PELANGGARAN HAM
2. PUBLIKASI ILMIAH DI JURNAL
INTERNASIONAL
3. PENCAIRAN DANA PENELITIAN

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 Research Ethical Clearance Committee
Airlangga University Research and Public Services
Institute
• Chairman : Prof. Dr. H. Sodibjo, HP, dr, DTM
• Vice Chairman: Prof. Dr. Aboe Amar Joesoef, dr, SpS(K)
• Secretary : Fedik A. Rantam, drh, PhD
• Members :
• Prof. Dr. H. Yoes Prijatna Dachlan, dr, MSc
• Prof. H. Kuntoro, dr, MPH, DrPH
• Prof. Dr. Hj. Rika S. Triyogo, dr, SKM
• Prof. Hj. Retno L.S., drg, MHPD
• Dr. Hans Lumintang, dr, SpKK
• Dr. L. Dyson, MA
• Haryono Mintarum, SH, MS
• Dra. Sudijah, MA
• Agoes Soebekti, drs, Psi, M.Kes

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 LAMPIRAN 1:
NUREMBERG CODE
 NUMBER 1
• The voluntary consent of the human
subject is absolutely essential.
• This means that the person involved
should have legal capacity to
• give consent; should be so situated as to
be able to exercise free
• power of choice, without the intervention
of any element of force, fraud, deceit,
duress, over-reaching,
• , or other ulterior form of
constraint or coercion; and should
have sufficient knowledge and
comprehension of the elements of
the subject matter involved, as to
enable him to make an
understanding and enlightened
decision
• This latter element requires that, before the
acceptance of an affirmative decision by the
experimental subject, there should be made
known to him the nature, duration, and
purpose of the experiment; the method and
means by which it is to be conducted; all
inconveniences and hazards reasonably to
be expected; and the effects upon his health
or person, which may possibly come from
his participation in the experiment.
• The duty and responsibility for
ascertaining the quality of the consent
• rests upon each individual who
initiates, directs or engages in the
• experiment. It is a personal duty and
responsibility which may not be
• delegated to another with impunity.
 NUMBER 2
• The experiment should be such as to yield
fruitful results for the good
• of society, unprocurable by other
methods or means of study, and not
• random and unnecessary in nature.
 NUMBER 3
• The experiment should be so designed
and based on the results of animal
experimentation and a knowledge of the
natural history of the disease or other
problem under study, that the anticipated
results will justify the performance of the
experiment.
 NUMBER 4 AND 5
• 4. The experiment should be so conducted as
to avoid all unnecessary physical and
mental suffering and injury.
• 5. No experiment should be conducted,
where there is an a priori reason to believe
that death or disabling injury will occur;
except, perhaps, in those experiments
where the experimental physicians also
serve as subjects.
 NUMBER 6, 7, AND 8
• 6. The degree of risk to be taken should never exceed that
determined
• by the humanitarian importance of the problem to be solved
by the
• experiment.
• 7. Proper preparations should be made and adequate
facilities provided
• to protect the experimental subject against even remote
possibilities
• of injury, disability, or death.
• 8. The experiment should be conducted only by scientifically
qualified
 LAMPIRAN 2 :
WORLD MEDICAL ASSOCIATION
DECLARATION OF HELSINKI
Ethical Principles
for
Medical Research Involving Human
Subjects
 Adopted by the 18th WMA General Assembly
Helsinki, Finland, June 1964
and amended by the
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of
South Africa, October 1996
and the
52nd WMA General Assembly, Edinburgh, Scotland, October
2000
 INTRODUCTION

1. The World Medical Association has

developed the Declaration of Helsinki as
a statement of ethical principles to
provide guidance to physicians and
other participants in medical research
involving human subjects. Medical
research involving human subjects
includes research on identifiable human
material or identifiable data.
2. It is the duty of the physician to promote and
safeguard the health of the people. The
physician’s knowledge and conscience are
dedicated to the fulfillment of this duty.
3. The Declaration of Geneva of the World
Medical Association binds the physician with
the words, "The health of my patient will be
my first consideration," and the International
Code of Medical Ethics declares that, "A
physician shall act only in the patient's interest
when providing medical care which might have
the effect of weakening the physical and mental
condition of the patient."
4. Medical progress is based on research
which ultimately must rest in part on
experimentation involving human
subjects.
5. In medical research on human
subjects, considerations related to the
well-being of the human subject should
take precedence over the interests of
science and society.
6. The primary purpose of medical research
involving human subjects is to improve
prophylactic, diagnostic and therapeutic
procedures and the understanding of the
aetiology and pathogenesis of disease. Even the
best proven prophylactic, diagnostic, and
therapeutic methods must continuously be
challenged through research for their
effectiveness, efficiency, accessibility and
quality.
7. In current medical practice and in medical
research, most prophylactic, diagnostic and
therapeutic procedures involve risks and
burdens.
8. Medical research is subject to ethical standards that promote
respect for all human beings and protect their health and rights.
Some research populations are vulnerable and need special
protection. The particular needs of the economically and medically
disadvantaged must be recognized. Special attention is also
required for those who cannot give or refuse consent for
themselves, for those who may be subject to giving consent under
duress, for those who will not benefit personally from the research
and for those for whom the research is combined with care.
9. Research Investigators should be aware of the ethical, legal and
regulatory requirements for research on human subjects in their
own countries as well as applicable international requirements. No
national ethical, legal or regulatory requirement should be allowed
to reduce or eliminate any of the protections for human subjects set
forth in this Declaration.
Council for International
Organizations of Medical
Sciences
(CIOMS)