ETIKA PENELITIAN KESEHATAN

ETIKA PENELITIAN KESEHATAN
Sumber : KOMISI ETIK PENELITIAN KESEHATAN BADAN LITBANG KESEHATAN, 2001 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes
LANDASAN NORMATIF 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

1. INTERNASIONAL NUREMBER CODE TAHUN 1947 (UNTUK RINCINYA LIHAT LAMPIRAN : 1) WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI TAHUN 1964 (UNTUK RINCINYA LIHAT LAMPIRAN : 2) 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

3. CIOMS (Council for International Organizations of Medical Sciences ) TAHUN WHO TAHUN 2000 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

2. NASIONAL PANCASILA UU tentang Kesehatan No. 23/1992 PP No. 39 / 1995 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

PASAL 69 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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

PP No 39 /1995 PENGATURAN PENELITIAN DAN PENGEMBANGAN KESEHATAN : DILAKSANAKAN OLEH PENYELENGGARA PENELITIAN DAN PENGEMBANGAN KESEHATAN DILAKSANAKAN BERDASARKAN STANDAR PROFESI PENELITIAN KESEHATAN 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

ANGGOTA KOMISI ETIK MULTIDISIPLIN: MEDIS DAN NON MEDIS PEDULI THD KEPENTINGAN MASYARAKAT AWAM (LAY PERSON) SEIMBANG UNTUK GENDER, USIA, SOSIAL BUDAYA, DAN AGAMA 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

SUSUNAN KOMISI ETIK BADAN LITBANGKES
DIBENTUK SEJAK TAHUN 1991 KOMISI ETIK BADAN LITBANGKES (SK KA BALITBANGKES No. HK ) TH : 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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 Burman Siahaan 2. Ir. Inswiasri, Mkes Anni Yulianti, SKM 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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) 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

No. urut : 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 Surat permohonan dari institusi Protokol Penelitian Penjelasan terperinci tentang tata cara pengambilan sampel (darah/urine/spesimen lainnya) dan tujuannya, serta manfaat bagi responden Daftar Tim Peneliti beserta keahliannya CV peneliti utama Rekomendasi dari scientific board / PPI Informed Consent (fomulir persetujuan) Naskah penjelasan untuk mendapatkan persetujuan dari subyek penelitian Ethical Clearence dari institusi lain (bila ada) Kuesioner/ Pedoman Wawancara (bila ada) 1 2 3 4 5 6 7 8 9 10 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes Catt : Seluruh berkas dibuat rangkap 3 (tiga).

PROSEDUR PENGAJUAN E.C CEK KELENGKAPAN BERKAS USULAN E.C SEKRETARIAT PPI LIT. HUMAN SUBJECT LENGKAP TDK LENGKAP Ka. P.E PENELITI PROSES ETHICAL REVIEW PERBAIKAN/KEKRGAN DITOLAK OK P.E E.C DITERBITKAN 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

ASPEK-ASPEK YG TERCANTUM DLM PENJELASAN UTK MENDAPATKAN PERSETUJUAN SUBYEK Latar belakang penelitian Berapa lama dan berapa banyak subyek penelitian diperlukan Perlakuan terhadap subyek Kemungkinan risiko kesehatan Penjelasan kompensasi bagi subyek 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

ASPEK-ASPEK YG TERCANTUM DLM PENJELASAN UTK MENDAPATKAN PERSETUJUAN SUBYEK Penjelasan terjaminnya rahasia subyek Pengobatan medis dan ganti rugi apabila perlu Nama jelas dan alamat penanggung jawab medis Partisipasi haruslah bersifat sukarela, setiap saat subyek dapat mengundurkan diri Kesediaan dari subyek penelitian 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

MENGAPA E.C PERLU ? * BAGI SUBYEK : KEPASTIAN PERLINDUNGAN HAM BAGI PENELITI : MENGHINDARI PELANGGARAN HAM PUBLIKASI ILMIAH DI JURNAL INTERNASIONAL 3. PENCAIRAN DANA PENELITIAN 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

LAMPIRAN 1: NUREMBERG CODE
9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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, 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

, 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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles
LAMPIRAN 2 : WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October th WMA General Assembly, Venice, Italy, October st WMA General Assembly, Hong Kong, September th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

INTRODUCTION 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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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." 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

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. 9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

Council for International Organizations of Medical Sciences (CIOMS)
9/19/2018 Bahan Sosialisasi Etik Penelitian Kesehatan - Balitbangkes

ETIKA PENELITIAN KESEHATAN

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